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FORMULARI UBAT-UBATAN, KEMENTERIAN KESIHATAN MALAYSIA BIL. 2/2017 (OGOS 2017) (Dikemaskini pada 11 September 2017) No. Generic Name MDC Category Indications Dosage 1. Abacavir Sulphate 600 mg and Lamivudine 300 mg Tablet J05AR02964 T1001XX A* Antiretroviral combination therapy of HIV infection in adults and adolescents from 12 years of age with the following criteria: i)Patients unsuitable or failed other HAART treatment ii)Patients who are at high risk of renal impairment iii)Patients with osteoporosis or at high risk of bone loss ADULTS & ADOLESCENT (> 12 years of age): Recommended dose is one tablet once daily. Not to be used in adults or adolescents weigh less than 40kg. CHILDREN : Not recommended 2. Acarbose 50 mg Tablet A10BF01000 T1001XX A/KK Only for treatment of: i) Non insulin dependent diabetes mellitus (NIDDM) when diet therapy is insufficient; ii) Non insulin dependent diabetes mellitus (NIDDM) in combination with existing conventional oral therapy where glycaemic control is inadequate. Restriction: i) As second/third line treatment of diabetes type 2, with HBA1c < 8%. ii) For patient who have postprandial hyperglycemia when treated with combination of available oral anti- diabetic/insulin. iii) The use of acarbose should be reviewed 6 months after initiation and stopped if HBA1c reduction is less than 0.5%. Initially 50 mg daily, increase to 3 times daily up to 100 mg 3 times daily. Max 200 mg 3 times daily 3. Acetazolamide 250 mg Tablet S01EC01000 T1001XX B Reduction of intraocular pressure in open-angle glaucoma, secondary glaucoma and peri-operatively in angle- closure glaucoma 250mg 1-4 times a day, the dosage being titrated according to patient response 4. Acetazolamide 500 mg Injection S01EC01000 P4001XX B Reduction of intra-ocular pressure in open-angle glaucoma, secondary glaucoma and peri-operatively in angle- closure glaucoma Adult : 250-1000mg per 24hours, usually in divided doses for amounts over 250mg daily 5. Acetylcysteine 200 mg/ml Injection V03AB23520 P3001XX A* Antidote for paracetamol poisoning Diluted with dextrose 5% and infused IV. Initial, 150 mg/kg IV in 200 ml over 60 minutes, then 50 mg/kg IV in 500 ml over 4 hours, followed by 100 mg/kg IV in 1000 ml Page 1 of 296

FORMULARI UBAT-UBATAN, KEMENTERIAN KESIHATAN MALAYSIA … · FORMULARI UBAT-UBATAN, KEMENTERIAN KESIHATAN MALAYSIA BIL. 2/2017 (O GOS 2017) (Di kemaskini pada 11 September 2017) No

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FORMULARI UBAT-UBATAN, KEMENTERIAN KESIHATAN MALAYSIABIL. 2/2017 (OGOS 2017)

(Dikemaskini pada 11 September 2017)

No. Generic Name MDC Category Indications Dosage1. Abacavir

Sulphate 600 mgand Lamivudine300 mg Tablet

J05AR02964T1001XX

A* Antiretroviral combinationtherapy of HIV infection inadults and adolescents from 12years of age with the followingcriteria: i)Patients unsuitable orfailed other HAART treatmentii)Patients who are at high riskof renal impairmentiii)Patients with osteoporosis orat high risk of bone loss

ADULTS & ADOLESCENT (> 12 yearsof age): Recommended dose is onetablet once daily. Not to be used inadults or adolescents weigh lessthan 40kg.CHILDREN : Not recommended

2. Acarbose 50 mgTablet

A10BF01000T1001XX

A/KK Only for treatment of:i) Non insulin dependentdiabetes mellitus (NIDDM)when diet therapy isinsufficient;ii) Non insulin dependentdiabetes mellitus (NIDDM) incombination with existingconventional oral therapywhere glycaemic control isinadequate.Restriction: i) As second/thirdline treatment of diabetes type2, with HBA1c < 8%.ii) For patient who havepostprandial hyperglycemiawhen treated with combinationof available oral anti-diabetic/insulin.iii) The use of acarbose shouldbe reviewed 6 months afterinitiation and stopped if HBA1creduction is less than 0.5%.

Initially 50 mg daily, increase to 3times daily up to 100 mg 3 timesdaily. Max 200 mg 3 times daily

3. Acetazolamide250 mg Tablet

S01EC01000T1001XX

B Reduction of intraocularpressure in open-angleglaucoma, secondary glaucomaand peri-operatively in angle-closure glaucoma

250mg 1-4 times a day, the dosagebeing titrated according to patientresponse

4. Acetazolamide500 mg Injection

S01EC01000P4001XX

B Reduction of intra-ocularpressure in open-angleglaucoma, secondary glaucomaand peri-operatively in angle-closure glaucoma

Adult : 250-1000mg per 24hours,usually in divided doses for amountsover 250mg daily

5. Acetylcysteine200 mg/mlInjection

V03AB23520P3001XX

A* Antidote for paracetamolpoisoning

Diluted with dextrose 5% andinfused IV. Initial, 150 mg/kg IV in200 ml over 60 minutes, then 50mg/kg IV in 500 ml over 4 hours,followed by 100 mg/kg IV in 1000 ml

Page 1 of 296

No. Generic Name MDC Category Indications Dosageover 16 hours. Total dose: 300mg/kgin 20 hour

6. AcetylsalicylicAcid 100 mg,Glycine 45 mgTablet

B01AC06259T1001XX

B Prevention of myocardialinfarct, stroke, vascularocclusion and deep veinthrombosis. Transientischaemic attacks

1 tablet daily

7. AcetylsalicylicAcid 300 mgSoluble Tablet

N02BA01000T4001XX

C Mild to moderate pain 300 - 900 mg every 4 - 6 hours asrequired. Max 4 g daily. Use inchildren not recommended

8. Acitretin 10 mgCapsule

D05BB02000C1001XX

A* i) Severe form of psoriasisincluding erythrodermicpsoriasis and local orgeneralized pustular psoriasis.ii) Severe disorders ofkeratinization, such as -congenital ichthyosis -pityriasisrubra pilaris -Darier's disease -other disorders ofkeratinization which may beresistant to other therapies

ADULT: initially 25-30 mg daily for 2-4 weeks, then adjusted according toresponse, usually within range 25-50mg daily for further 6-8 weeks (max:75 mg daily). In disorders ofkeratinization, maintenance therapyof less than 20mg/day and shouldnot exceed 50mg/day CHILD:0.5mg/kg daily occasionally up to 1mg/kg daily to a max. 35 mg dailyfor limited periods

9. Acitretin 25 mgCapsule

D05BB02000C1002XX

A* i) Severe form of psoriasisincluding erythrodermicpsoriasis and local orgeneralized pustular psoriasis.ii) Severe disorders ofkeratinization, such as -congenital ichthyosis -pityriasisrubra pilaris -Darier's disease -other disorders ofkeratinization which may beresistant to other therapies

ADULT: initially 25-30 mg daily for 2-4 weeks, then adjusted according toresponse, usually within range 25-50mg daily for further 6-8 weeks (max:75 mg daily). In disorders ofkeratinization, maintenance therapyof less than 20mg/day and shouldnot exceed 50mg/day CHILD:0.5mg/kg daily occasionally up to 1mg/kg daily to a max. 35 mg dailyfor limited periods

10. Acriflavine 0.1%Lotion

D08AA03000L6001XX

C+ Infected skin, lesions, cuts,abrasions, wounds and burns.

Apply undiluted three times daily tothe affected part .

11. Actinomycin D(Dactinomycin)500 mcg/mlInjection

L01DA01110P4001XX

A i) For solid tumours;ii) Gestational trophoblasticdisease

i) ADULT: 500 mcg IV daily for maxof 5 days. CHILD: 1.5 mg/m2 onceevery 3 weeks (if weight less than 10kg, 50 mcg/kg) ii) 500 mcg IV onDays 2, 4, 6, 8, 10, repeat every 7 -10 days or 500 mcg IV bolus on Days1 and 2, repeat every 15 days

Page 2 of 296

No. Generic Name MDC Category Indications Dosage12. Acyclovir 200 mg

TabletJ05AB01000T1001XX

A/KK i) Mucocutaneous HerpesSimplex infection inimmunocompromised and AIDSpatientsii) Primary and recurrentVaricella Zoster infection inimmunocompromised and AIDSpatientsiii) Severe Kaposi VaricellaEruption (Eczema herpeticum)iv) Severe primary HSVinfections (eg. Neonatal herpes,encephalitis, eczemaherpeticum, genital herpes,gingival stomatitis, vaginaldelivery with maternal vulvaherpes)v) Severe and complicatedvaricella infection (eg.Encephalitis, purpurafulminans)vi) Severe zoster infection inpaediatrics (eg. Encephalitis,purpura fulminans,immunocompromised patientsand facial, sacral and motorzoster)

i) ADULT: initially 400 mg 5 timesdaily for 7 - 14 days. CHILD less than2 years: 200 mg 4 times daily, CHILDmore than 2 years: 400 mg 4 timesdaily ii), iii) and iv) ADULT: 200 - 400mg 4 times daily. CHILD: less than 2years, half adult dose; more than 2years, adult dose v) ADULT: 800 mg5 times daily for 7 days vi) ADULT:20 mg/kg (maximum: 800 mg) fourtimes daily for 5 days, CHILD 6 years:800 mg four times daily. CHILD lessthan 2 years; 400mg 4 times daily,more than 2 years; 800mg 4 timesdaily

13. Acyclovir 200mg/5 mlSuspension

J05AB01000L8001XX

A* i) Mucocutaneous HerpesSimplex infection inimmunocompromised and AIDSpatients.ii) Primary and recurrentVaricella Zoster infection inimmunocompromised and AIDSpatients.iii) Severe Kaposi VaricellaEruption (Eczema herpeticum).iv) Severe primary HSVinfections (eg. Neonatal herpes,encephalitis, eczemaherpeticum, genital herpes,gingival stomatitis, vaginaldelivery with maternal vulvaherpes).v) Severe and complicatedvaricella infection (eg.Encephalitis, purpurafulminans) vi) Severe zosterinfection in paediatrics(eg.Encephalitis, purpurafulminans,immunocompromised patientsand facial, sacral and motor

i) ADULT: initially 400 mg 5 timesdaily for 7 - 14 days. CHILD less than2 years: 200 mg 4 times daily, CHILDmore than 2 years: 400 mg 4 timesdaily.ii), iii) and iv) ADULT: 200 - 400 mg 4times daily. CHILD : less than 2years, half adult dose; more than 2years, adult dose.v) ADULT: 800 mg 5 times daily for 7days vi) ADULT: 20 mg/kg(maximum: 800 mg) four times dailyfor 5 days, CHILD 6 years: 800 mgfour times daily. CHILD: less than 2years; 400mg 4 times daily, morethan 2 years; 800 mg 4 times daily

Page 3 of 296

No. Generic Name MDC Category Indications Dosagezoster)

14. Acyclovir 250 mgInjection

J05AB01000P4001XX

A* Treatment and prophylaxis ofherpes simplex inimmunocompromised, severeinitial genital herpes andVaricella -Zoster

ADULT: 5 mg/kg by IV infusion 8hourly for 5 days doubled to10mg/kg every 8 hourly in varicella-zoster in the immunocompromisedand in simplex encephalitis (usuallygiven for at least 10 days inencephalitis; possibly for 14 - 21days). NEONATE & INFANT up to 3months with disseminated herpessimplex: 20mg/kg every 8 hourly for14 days (21 days in CNSinvolvement), varicella-zoster 10-20mg/kg every 8 hourly usually for 7days. CHILD, 3 months - 12 years:Herpes simplex or Varicella Zoster:250 mg/m2 8 hourly for 5 days,doubled to 500 mg/m2 8 hourly forvaricella-zoster in theimmunocompromised and insimplex encephalitis (usually givenfor 10 days in encephalitis)

15. Acyclovir 3% EyeOintment

S01AD03000G5101XX

A* Only for the treatment ofherpes simplex keratitis

Apply 1 cm 5 times daily. Continuefor at least 3 days after healing

16. Acyclovir 5%Cream

D06BB03000G1001XX

A* Herpes simplex infections of theskin, including initial andrecurrent labial and genitalherpes simplex infections

Apply every 4 hours for 5 - 10 days

17. Acyclovir 800 mgTablet

J05AB01000T1002XX

A/KK i) Mucocutaneous HerpesSimplex infection inimmunocompromised and AIDSpatients.ii) Primary and recurrentVaricella Zoster infection inimmunocompromised and AIDSpatients.iii) Severe Kaposi VaricellaEruption (Eczema herpeticum).iv) Severe primary HSVinfections (eg. Neonatal herpes,encephalitis, eczemaherpeticum, genital herpes,gingival stomatitis, vaginaldelivery with maternal vulvaherpes).v) Severe and complicatedvaricella infection (eg.Encephalitis, purpurafulminans).vi) Severe zoster infection inpaediatrics (eg. Encephalitis,purpura fulminans,immunocompromised patients

i) ADULT: initially 400 mg 5 timesdaily for 7 - 14 days. CHILD less than2 years: 200 mg 4 times daily, CHILDmore than 2 years: 400 mg 4 timesdaily ii), iii) and iv) ADULT: 200 - 400mg 4 times daily. CHILD: less than 2years, half adult dose; more than 2years, adult dose v) ADULT: 800 mg5 times daily for 7 days vi) ADULT:20 mg/kg (maximum: 800 mg) fourtimes daily for 5 days, CHILD 6 years:800 mg four times daily. CHILD lessthan 2 years; 400mg 4 times daily,more than 2 years; 800mg 4 timesdaily

Page 4 of 296

No. Generic Name MDC Category Indications Dosageand facial, sacral and motorzoster)

18. Adalimumab 40mg Injection

L04AB04000P5001XX

A* i) Third line treatment of: -Severe rheumatoid arthritis -Psoriatic arthritis - Ankylosingspondylitis after failure ofconventional DMARDs or otherbiologicsii)Treatment of adults withmoderate to severe chronicplaque psoriasis who have notresponded to, havecontraindication or are unableto tolerate phototherapyand/or systemic therapiesincluding acitretin,methotreaxate andcyclosporineiii) Crohn's Disease:a) For treatment of moderatelyto severely active Crohn’sDisease in adult patients whohave inadequate response toconventional therapyb) For treatment of moderatelyto severely active Crohn’sDisease in adult patients whohave lost response to or areintolerant to infliximabiv) Ulcerative Colitis - Fortreatment of moderately toseverely active ulcerative colitisin adult patients who have hadan inadequate response toconventional therapy includingcorticosteroids and 6-mercaptopurine orazathioprine, or who areintolerant to or have medical

i)Severe rheumatoid arthritis,Psoriatic arthritis, Ankylosingspondylitis : Subcutaneous 40 mgevery other week ii)Chronic plaquepsoriasis : Initial, 80 mg SC, followedby 40 mg SC every other weekstarting one week after the initialdose iii) & iv) Crohn?s disease &Ulcerative colitis: 160mg at week 0(dose can be administered as fourinjections in one day or as twoinjections per day for twoconsecutive days) and 80mg at week2. After induction treatment, therecommended maintenance dose is40mg every other week viasubcutaneous injection.

Page 5 of 296

No. Generic Name MDC Category Indications Dosagecontraindications for suchtherapies

19. Adapalene 0.1%Cream

D10AD03000G1001XX

A* Acne vulgaris wherecomedones, papules andpustules predominate in thosesensitive to benzoyl peroxide ortopical tretinoin [third linetreatment]

Apply once daily to the affectedareas after washing at bedtime

20. Adapalene 0.1%Gel

D10AD03000G3001XX

A* Acne vulgaris wherecomedones, papules andpustules predominate in thosesensitive to benzoyl peroxide ortopical tretinoin [third linetreatment]

Apply once daily to the affectedareas after washing at bedtime

21. Adefovir Dipivoxil10 mg Tablet

J05AF08000T1001XX

A* i) Treatment of chronic HBeAgpositive and HBeAg negativehepatitis B infection in adultswith compensated liverfunction (lamivudine should betried first)ii) Lamivudine-resistant chronichepatitis B virus infection witheither compensated ordecompensated hepatitisfunction (only by hepatologistand gastroenterologist forapproved indications)

Adult (18-65 years): 10mg OnceDaily Renal Dose Adjustment : 10mgevery 48hours (30-49ml/min); 10mgevery 72hours (10-29ml/min); 10mgevery 7 days (Hemodialysis)

22. Adenosine 3mg/ml Injection

C01EB10000P3001XX

B Rapid conversion of paroxysmalsupraventricular tachycardia tosinus rhythm

ADULT: Initially: 3 mg given as arapid IV bolus (over 2 seconds).Second dose: If the first dose doesnot result in elimination of thesupraventricular tachycardia with in1 or 2 minutes, 6 mg should begiven also as a rapid IV bolus. Thirddose: If the second dose does notresult in elimination of thesupraventicular tachycardia with in1-2 minutes, 12 mg should be givenalso as a rapid IV bolus

Page 6 of 296

No. Generic Name MDC Category Indications Dosage23. Adrenaline Acid

(Epinephrine)Tartrate 1 mg/mlInjection

C01CA24123P3001XX

B Cardiopulmonary resuscitation 1 mg by intravenous injectionrepeated every 3-5 minutesaccording to response

24. Aflibercept40mg/ml solutionvial for injection

S01LA05000P3001XX

A* Treatment of neovascular (wet)age-related maculardegeneration (wet AMD).

The recommended dose is 2mgaflibercept, equivalent to 0.05mL(50 μL) given as intra-vitrealinjection. Aflibercept treatment isinitiated with one injection permonth for three consecutive doses,followed by one injection every twomonths.

25. Agomelatine 25mg Tablet

N06AX22000T1001XX

A* Major depression The recommended dose is 25mgonce daily at bedtime, maybeincreased to 50mg once daily atbedtime.

26. Albendazole 200mg Tablet

P02CA03000T1001XX

C+ i) Single or mixed infestations ofintestinal parasites;ii) Strongyloides infection

i) Child 12-24months: 200mg as asingle doseii) Adult & Child above 2 years:400mg as a single dose for 3consecutive days; Child 12 -24months: 200mg as a single dosefor 3 consecutive days

27. Albendazole 200mg/5 mlSuspension

P02CA03000L8001XX

C+ i) Single or mixed infestations ofintestinal parasites;ii) Strongyloides infection

i) Child 12-24months: 200mg as asingle doseii) Adult & Child above 2 years:400mg as a single dose for 3consecutive days; Child 12 -24months: 200mg as a single dosefor 3 consecutive days

28. Alcohol 70%Solution

D08AX08000L9901XX

C+ Use as antiseptic anddisinfectant

Apply to the skin undiluted or whenneeded

29. AlendronateSodium 70 mgandCholecalciferol5600 IU Tablet

M05BB03972T1002XX

A* Osteoporosis inpostmenopausal women with ahistory of vertebral fracture andwhom oestrogen replacementtherapy is contraindicated.Review treatment after 2 yearsand if there is positiveresponse, treatment may becontinued up to 5 years andthen re-evaluate. Treatmentshould be stopped if there is nopositive response after 5 years.Otherwise, patient needs to begiven drug holiday for 1 to 2years and then continuetreatment shall the benefitoutweigh the risk.

1 tablet once weekly [70mg/5600IU]. Patient should receivesupplemental calcium or vitamin D,if dietary vitamin D inadequate. Thetablet should be taken at least halfand hour before the first food,beverage, or medication of the daywith plain water only. To facilitatedelivery to stomach and thus reducethe potential for esophagealirritation, it should only beswallowed upon arising for the daywith a full glass of water and patientshould not lie down for at least 30minutes and until after their firstfood of the day.

Page 7 of 296

No. Generic Name MDC Category Indications Dosage30. Alendronate

Sodium 70 mgTablet

M05BA04520T1001XX

A* Osteoporosis inpostmenopausal women with ahistory of vertebral fracture andwhom oestrogen replacementtherapy is contraindicated.Review treatment after 2 yearsand if there is positiveresponse, treatment may becontinued up to 5 years andthen re-evaluate. Treatmentshould be stopped if there is nopositive response after 5 years.Otherwise, patient needs to begiven drug holiday for 1 to 2years and then continuetreatment shall the benefitoutweigh the risk.

70 mg once weekly. Swallow thetablet whole with a full glass of plainwater only on an empty stomach atleast 30 minutes before breakfast(and any other oral medication);stand or sit upright for at least 30minutes and do not lie down untilafter eating breakfast

31. Alfacalcidol 0.25mcg Capsule

A11CC03000C1001XX

A/KK i) Renal osteodystrophy inpatients on haemodialysis;ii) Hypoparathyroidism andpseudohypoparathyroidism;iii) Adjunct to the managementof tertiaryhyperparathyroidism;iv) Rickets and osteomalacia;v) Osteoporosis

Initial dose ADULT and CHILD above20kg body weight: 1 mcg daily;CHILD under 20kg body weight:0.05mcg/kg/day. Maintenance dose: 0.25 mcg to 2 mcg daily

32. Alfacalcidol 1mcg Capsule

A11CC03000C1002XX

A/KK i) Renal osteodystrophy inpatients on haemodialysis;ii) Hypoparathyroidism andpseudohypoparathyroidism;iii) Adjunct to the managementof tertiaryhyperparathyroidism;iv) Rickets and osteomalacia;v) Osteoporosis

Initial dose ADULT and CHILD above20kg body weight: 1 mcg daily;CHILD under 20kg body weight:0.05mcg/kg/day. Maintenance dose: 0.25 mcg to 2 mcg daily

33. Alfacalcidol 2mcg/ml Drops

A11CC03000D5001XX

A* i) Renal osteodystrophy inpatients on haemodialysis;ii) Hypoparathyroidism andpseudohypoparathyroidism;iii) Adjunct to the managementof tertiaryhyperparathyroidism;iv) Rickets and osteomalacia;v) Osteoporosis

NEONATES : 0.1 mcg/kg/day

34. Alfacalcidol 2mcg/ml Injection

A11CC03000P3001XX

A* i) Renal osteodystrophy inpatients on haemodialysis;ii) Hypoparathyroidism andpseudohypoparathyroidism;iii) Adjunct to the managementof tertiaryhyperparathyroidism;iv) Rickets and osteomalacia;v) Osteoporosis

Adult: Initially, 1 mcg daily.Maintenance: 0.25-1 mcg daily.Child: Premature infants andneonates: 0.05-0.1 mcg/kg daily;<20 kg: 0.05 mcg/kg daily. Elderly:0.5 mcg daily.

Page 8 of 296

No. Generic Name MDC Category Indications Dosage35. Alfentanil HCl 0.5

mg/ml InjectionN01AH02110P3001XX

A* For use as short acting narcoticanalgesic in short proceduresand day-care surgicalprocedures

Initial dose: 20 - 40 mcg/kg.Supplemental dose: 15 mcg/kg orinfusion 0.5 - 1.0 mcg/kg/min

36. Alfuzosin HCl 10mg Tablet

G04CA01110T1001XX

A* Treatment of functionalsymptoms related with benignprostatic hypertrophy (BPH)

10 mg once a day pre bed

37. Alglucosidase alfa5 mg/ml Injection

A16AB07000P4001XX

A* Infantile-onset Pompe disease 20 mg/kg of body weightadministered once every 2 weeks asan intravenous infusion. MonitoringIt is suggested that patients bemonitored periodically for IgGantibody formation. Patients whoexperience Infusion-associatedreactions suggestive ofhypersensitivity may be tested forIgE antibodies to alglucosidase alfa.Treated patients who experience adecrease in benefit despitecontinued treatment withAlglucosidase Alfa, in whomantibodies are suspected to play arole, may be tested forneutralization of enzyme uptake oractivity.

38. Alkaline NasalDouche

R01A000999L5001XX

B To remove nasal plug To be diluted with an equal volumeof warm water before use

39. Allopurinol 100mg Tablet

M04AA01000T1002XX

A/KK i) Frequent and disablingattacks of gouty arthritis (3or more attacks/year).

ii) Clinical or radiographicsigns of erosive goutyarthritis.

iii) The presence oftophaceous deposits.

iv) Urate nephropathy.v) Urate nephrolithiasis.vi) Impending cytotoxic

chemotherapy orradiotherapy for lymphomaor leukaemia

Initial dose: 100-300 mg daily.Maintenance: 300-600 mg daily.Maximum: 900 mg daily

40. Allopurinol 300mg Tablet

M04AA01000T1001XX

A/KK i) Frequent and disablingattacks of gouty arthritis (3or more attacks/year).

ii) Clinical or radiographicsigns of erosive goutyarthritis.

iii) The presence oftophaceous deposits.

iv) Urate nephropathy.v) Urate nephrolithiasis.vi) Impending cytotoxic

chemotherapy or

Initial dose: 100-300 mg daily.Maintenance: 300-600 mg daily.Maximum: 900 mg daily

Page 9 of 296

No. Generic Name MDC Category Indications Dosageradiotherapy for lymphomaor leukaemia

41. All-Trans RetinoicAcid 10 mgCapsule

L01XX14000C1001XX

A* Acute promyelocytic leukaemia Induction: 45 mg/m2 daily for 30 -90 days. Maintenance: 45 mg/m2daily for 2 weeks every 3 months.Renal/or hepatic insufficiency:25mg/m2 daily for 30-90 days. Referto protocols

42. Alprazolam 0.25mg Tablet

N05BA12000T1001XX

A/KK Anxiety disorders 0.25 - 0.5 mg 3 times daily (elderlyor delibitated 0.25 mg 2-3 timesdaily), increased if necessary to atotal dose of 3 mg/day. Notrecommended for children

43. Alprazolam 0.5mg Tablet

N05BA12000T1002XX

A Anxiety disorders 0.25 - 0.5 mg 3 times daily (elderlyor delibitated 0.25 mg 2-3 timesdaily), increased if necessary to atotal dose of 3 mg/day. Notrecommended for children

44. Alprazolam 1 mgTablet

N05BA12000T1003XX

A Anxiety disorders 0.25 - 0.5 mg 3 times daily (elderlyor delibitated 0.25 mg 2-3 timesdaily), increased if necessary to atotal dose of 3 mg/day. Notrecommended for children

45. Alprostadil 500mcg/ml Injection

C01EA01000P3001XX

A* For treatment of congenitalheart diseases which are ductusarteriosus dependent

0.05 - 0.1 mcg/kg/min by continuousIV infusion, then decreased tolowest effective dose

46. Alteplase 50 mgper vial Injection

B01AD02000P4001XX

A* Thrombolytic treatment ofacute ischaemic stroke.

0.9 mg/kg (maximum of 90 mg)infused over 60 minutes with 10% ofthe total dose administered as aninitial intravenous bolus. Treatmentmust be started as early as possiblewithin 4.5 hours after onset ofstroke symptoms and afterexclusion of intracranialhaemorrhage by appropriateimaging technique.

47. Amantadine HCl100 mg Capsule

N04BB01110C1001XX

B Parkinson's disease Initial dose: 100 mg daily and isincreased to 100 mg twice daily (notlater than 4 p.m.) after a week.Elderly over 65 years: less than 100mg or 100 mg at intervals of morethan 1 day

48. Amikacin 125mg/ml Injection

J01GB06183P3003XX

A Infections due to susceptibleorganisms

ADULT: (IM or IV): 15 mg/kg/day 8 -12 hourly for 7 - 10 days. Maximum:1.5 g/day. CHILD: 15 mg/kg/day 8 -12 hourly. Maximum: 1.5 g/day.Neonates: Initial loading dose of 10mg/kg followed by 7.5 mg/kg/day

Page 10 of 296

No. Generic Name MDC Category Indications Dosage12 hourly. Maximum 15mg/kg/day

49. Amikacin250mg/mlInjection

J01GB06183P3002XX

A Infections due to susceptibleorganisms

ADULT: (IM or IV): 15 mg/kg/day 8 -12 hourly for 7 - 10 days. Maximum:1.5 g/day. CHILD: 15 mg/kg/day 8 -12 hourly. Maximum: 1.5 g/day.Neonates: Initial loading dose of 10mg/kg followed by 7.5 mg/kg/day12 hourly. Maximum 15mg/kg/day

50. Amiloride HCl 5mg &Hydrochlorothiazide 50 mg Tablet

C03EA01900T1001XX

B i) Diuretic as an adjunct to themanagement ofoedematous states

ii) Hypertension

i) Initially 1 - 2 tab daily adjustedaccording to response. Max: 4tabs daily.

ii) 1 -2 tabs daily as a single ordivided dose

51. Amino AcidsInjection

B05BA01910P3001XX

A Source of amino acids inpatients needing IV nutrition

Dose to be individualised. ADULTusually 500-2000 ml by IV. ADULTusual requirement for amino acid: 1-2 g/kg/day

52. Amino Acids withElectrolytesInjection

B05BA10910P3002XX

A Source of amino acids andelectrolytes in patients needingIV nutrition

Dose to be individualised. ADULTusual requirement for amino acid 1-2 g/kg/day

53. Amino Acids withGlucose withElectrolytesInjection

B05BA10910P3003XX

A Source of amino acids,carbohydrate and electrolytesin patients needing IV nutrition

Dose to be individualised. ADULTusual requirement for amino acid 1-2 g/kg/day, carbohydrate 4-6g/kg/day

54. Amino Acids,Glucose and Lipidwith ElectrolytesInjection

B05BA10910P3001XX

A Source of amino acids,carbohydrate, lipid andelectrolytes in patients needingIV nutrition

Dose to be individualised. ADULT:500 - 2000 ml daily given by IV.ADULT usual requirement for aminoacid 1-2 g/kg/ day, carbohydrate 4-6g/kg/day, lipid 2-3 g/kg/day

55. Aminophylline 25mg/ml Injection

R03DA05000P3001XX

B Reversible airways obstruction,acute severe brochospasm

Adult: Loading dose: 5 mg/kg (idealbody weight) or 250-500 mg (25mg/ml) by slow inj or infusion over20-30 min. Maintenance infusiondose: 0.5 mg/kg/hr. Max rate: 25mg/min. Child: Loading dose: sameas adult dose. Maintenance dose: 6mth-9 yr: 1 mg/kg/hr and 10-16 yr:0.8 mg/kg/hr.

56. Amiodarone 200mg Tablet

C01BD01110T1001XX

A* Arrhythmias 200 mg 3 times daily for 1 week,then reduced to 200 mg twice dailyfor another week. Maintenancedose, usually 200 mg daily or theminimum required to control thearrhythmia

57. Amiodarone 50mg/ml Injection

C01BD01110P3001XX

A* Arrhythmias when other drugsare contraindicated orineffective

Initial infusion of 5mg/kg via largevenous access over 20-120 minuteswith ECG monitoring; subsequentinfusion given if necessary according

Page 11 of 296

No. Generic Name MDC Category Indications Dosageto response up to a maximum of 1.2g in 24 hours

58. Amisulpride 100mg Tablet

N05AL05000T1001XX

A* Treatment of psychoses,particularly acute or chronicschizophrenia disorderscharacterized by positivesymptoms(e.g. delusion,hallucinations, thoughtdisorders) and/or negativesymptoms(e.g. bluntedemotions, emotional and socialwithdrawal) including when thenegative symptomspredominate

Predominantly negative episodes:50-300 mg once daily adjustedaccording to the patient?s response.Mixed episodes with positive andnegative symptoms: 400-800mg/day in 2 divided doses adjustedaccording to the patient?s response.Should be taken on an emptystomach (Preferably taken beforemeals)

59. Amisulpride 400mg Tablet

N05AL05000T1002XX

A* Treatment of psychoses,particularly acute or chronicschizophrenia disorderscharacterized by positivesymptoms(e.g. delusion,hallucinations, thoughtdisorders) and/or negativesymptoms(e.g. bluntedemotions, emotional and socialwithdrawal) including when thenegative symptomspredominate

Predominantly negative episodes:50-300 mg once daily adjustedaccording to the patient?s response.Mixed episodes with positive andnegative symptoms: 400-800mg/day in 2 divided doses adjustedaccording to the patient?s response.Should be taken on an emptystomach (Preferably taken beforemeals)

60. Amitriptyline HCl25 mg Tablet

N06AA09110T1001XX

B Depression Initially 25mg 3 times a day.Maintenance: 25-100mg daily individed doses. Hospitalized patient:100mg/day &gradually increase to200-300mg/day. ADOLESCENT andELDERLY: initially 20-30mg/day individed doses w/ gradualincrements. CHILD under 16 yearsare not recommended

61. Amlodipine 10mg Tablet

C08CA01000T1002XX

B Hypertension 5 mg once daily. Max: 10 mg oncedaily

62. Amlodipine 5 mgTablet

C08CA01000T1001XX

B Hypertension 5 mg once daily. Max: 10 mg oncedaily

63. AmmoniumBicarbonate,Tincture Ipecac,etc Mixture

R05CA04900L2101XX

C Cough Adults, the elderly and children over12 years: 10- 20ml, repeated after 4hours if required. Not more than 4doses to be taken in any 24 hours.

64. Amorolfine 5 %Nail Lacquer

D01AE16110L5001XX

A* Fungal nail infections Apply to affected nail once orsometimes twice a week after fillingand cleansing, allow to dry, treatfinger nail for 6 months, toe nail for9 - 12 months (review at intervals of3 months)

Page 12 of 296

No. Generic Name MDC Category Indications Dosage65. Amoxicillin &

Clavulanate 228mg/5 ml Syrup

J01CR02961F2102XX

A/KK Infections caused by susceptibleorganisms

Mild to Moderate infection:25mg/kg/day (based on Amoxicillindose) in 2 divided dose. Severeinfection: 45mg/kg/day (based onAmoxicillin dose) in 2 divided dose

66. Amoxicillin 1 g &Clavulanate 200mg Injection

J01CR02961P4002XX

A Infections caused by susceptibleorganisms. Respiratory tract,skin, soft tissue, GUT infection,septicaemia, peritonitis, post-operative infection &osteomyelitis

CHILD less than 3 months: 30mg/kg12 hourly. 3 months - 12 years:30mg/kg 6 - 8 hourly. ADULT: 1.2 gby IV or intermittent infusion 6 - 8hourly

67. Amoxicillin 250mg Capsule

J01CA04012C1001XX

B Infections caused by susceptiblestrains of gram positive andgram negative organisms

ADULT: 250 - 500 mg 3 times daily.CHILD: 20 - 40 mg/kg/day in divideddoses 8 hourly

68. Amoxicillin 500mg & Clavulanate125 mg Tablet

J01CR02961T1002XX

A/KK Infections due to beta-lactamase producing strainwhere amoxicillin alone is notappropriate. Respiratory tract,skin, soft tissue, GUT infection,septicaemia, peritonitis, post-operative infection &osteomyelitis

ADULT & CHILD more than 12 years:Mild to moderate infections: 625 mgtwice daily.

69. Amoxicillin 500mg andClavulanate 100mg Injection

J01CR02961P4001XX

A Infections caused by susceptibleorganisms. Respiratory tract,skin, soft tissue, GUT infection,septicaemia, peritonitis, post-operative infection andosteomyelitis

CHILD less than 3 months: 30mg/kg12 hourly. 3 months - 12 years: 30mg/kg 6 - 8 hourly. ADULT: 1.2 g byIV or intermittent infusion 6 - 8hourly

70. Amoxicillin 500mg Capsule

J01CA04012C1002XX

B Infections caused by susceptiblestrains of gram positive andgram negative organisms

ADULT: 250 - 500 mg 3 times daily.CHILD: 20 - 40 mg/kg/day in divideddoses 8 hourly

71. AmoxicillinTrihydrate 125mg/5 ml Syrup

J01CA04012F1001XX

B Infections caused by susceptiblestrains of gram positive andgram negative organisms

CHILD less than 10 years: 125 - 250mg 8 hourly. CHILD less than 20 kg:20 - 40 mg/kg/day in 3 - 4 divideddoses

72. Amphotericin B0.15% Eye Drops

S01A000801D2002XX

A Fungal infection of the cornea 1 drop hourly or 2 hourly

73. Amphotericin B0.25% Eye Drops

S01A000801D2003XX

A Fungal infection of the cornea 1 drop hourly or 2 hourly

74. Amphotericin B50 mg Injection

J02AA01801P4001XX

A Systemic fungal infections ADULT: 0.25 mg/kg/day by IVinfusion, gradually increase iftolerated to 1 mg/kg/day. Maximumin severe cases: 1.5 mg/kg daily oron alternate days. For neonates,lower doses are recommended

75. Ampicillin Sodium& SulbactamSodium 250 mg/5ml Suspension

J01CR01961F2101XX

A Treatment of susceptiblebacterial infections

ADULT: (1-) 2-6g daily CHILDREN:(25-) 50-100mg/kg dailyPREMATURE AND NEWBORNS: 25-50mg/kg daily

76. Ampicillin Sodium& SulbactamSodium 375 mgTablet

J01CR01961T1001XX

A/KK Treatment of susceptiblebacterial infections

ADULT: 375-750mg twice dailyCHILDREN AND INFANTS: 25-50mg/kg/day in 2 divided doses, if ≥30kg use an adult dose

Page 13 of 296

No. Generic Name MDC Category Indications Dosage77. Ampicillin Sodium

1g & SulbactamSodium 500mgInjection

J01CR01961P4002XX

A Treatment of susceptiblebacterial infections

ADULT: 1.5 - 12 g/day in divideddoses 6 - 8 hourly. Maximum: 4 gSulbactam. CHILD: 150-300mg/kg/day 6 - 8 hourly. Prophylaxisof surgical infections: 1.5 - 3 g atinduction of anaesthesia. May berepeated 6 - 8 hourly. NEONATES:First week of life, 75mg/kg/day individed doses every 12 hour

78. Ampicillin Sodium500 mg &SulbactamSodium 250 mgInjection

J01CR01961P4001XX

A Treatment of susceptiblebacterial infections

ADULT: 1.5 - 12 g/day in divideddoses 6 - 8 hourly. Maximum: 4 gSulbactam per day. CHILD: 150-300mg/kg/day 6 - 8 hourly.Prophylaxis: 1.5 -3 g at induction ofanaesthesia. May be repeated 6 - 8hourly

79. Ampicillin Sodium500 mg Injection

J01CA01520P4001XX

B Treatment of susceptiblebacterial infections (non beta-lactamase-producingorganisms); meningitis

250 - 500 mg IM/IV every 4 - 6hours. Maximum: 400 mg/kg/day.Meningitis: 2 g 6 hourly. CHILD: 150mg/kg/daily IV in divided doses.Usual children dose less than 10years, half adult dose

80. AmpicillinTrihydrate 125mg/5 mlSuspension

J01CA01012F2101XX

B Treatment of susceptiblebacterial infections (non beta-lactamase-producingorganisms)

CHILD: 50 - 100 mg/kg/day 4 timesdaily. Under 1 year: 62.5 - 125 mg 4times daily, 1 - 10 years: 125 - 250mg 4 times daily

81. Anastrozole 1 mgTablet

L02BG03000T1001XX

A* Treatment of hormoneresponsive metastatic or locallyadvanced breast cancer afterfailure of tamoxifen

1 mg daily

82. Anidulafungin100mg Injection

J02AX06000P3001XX

A* Treatment of invasivecandidiasis, includingcandidemia in adults whenintolerance or resistance toAmphotericin B or Fluconazole

Loading dose of 200 mg on day 1,then 100 mg once daily thereafterfor at least 14 days after the lastpositive culture.

83. Antazoline HCl,TetrahydrozolineHCl andBenzalkoniumCloride Eye Drops

S01GA52110D2001XX

A/KK Hay fever, conjunctivitis,allergic conjunctivitis, vernalkeratoconjunctivitis andeczematosa

ADULT: Instill 1 drop, 3 - 4 timesdaily, into the lower eyelid. CHILD 2- 12 years : Instill 1 drop daily ortwice daily

84. Anti RhD GammaGlobulin 300mcg/2 mlInjection (150mcg = 750 IU)

J06BB01000P3001XX

B Prevention of Rh(D)sensitisation to Rh(D)-negativewoman:i) Pregnancy/delivery of

Rh(D)-positive infantii) Abortion/threatened

abortion, ectopicpregnancy or hydatidiformmole

iii) iii) Transplacentalhaemorrhage resultingfrom antepartumhaemorrhage,

i) Antepartum prophylaxis: Therecommended dose is a singledose of 300mcg administeredby IV or IM injection

ii) Postpartum prophylaxis:300mcg should be administeredas soon as possible afterdelivery and no later than 72hours thereafter, by IV or IMroute. If the 72-hour limit isexceeded, anti-Rh(D)immunoglobulin must beadministered anyway.

Page 14 of 296

No. Generic Name MDC Category Indications Dosageamniocentesis, chorionicbiopsy or obstetricmanipulative procedurese.g. external version orabdominal trauma

85. Antilymphocyte/AntithymocyteImmunoglobulin(from Horse)Injection

L04AA03000P3001XX

A* i) To be used whenconventional anti-rejectiontherapy is not successful

ii) Treatment of aplasticanaemia not responding tooxymethalone after 3months, in which there ispersistent pancytopeniawith repeated attacks ofsepticaemia and bleeding.

iii) Severe aplastic anaemiawith the followingparameters: a) Granulocyteless than 0.5x109/L b)Platelet less than 20x109/Lc) Reticulocyte less than20x109/L

iv) As a conditioning regimeprior to transplant.

v) v) Graft-versus-hostdisease treatment

10 - 30 mg/kg body weight daily.Slow IV infusion (over at least 4hours) diluted in 250 - 500 mlNormal Saline. For Graft versus hostdisease treatment:40 mg/kg/day

86. AntirabiesImmunoglobulin(Human) 300iu/2ml

J06BB05000P3001XX

B Treatment of rabies, post-exposure

20 iu/kg; half by IM and half byinfiltration around the wound

87. AntithymocyteImmunoglobulin(from rabbit)Injection

L04AA04000P3001XX

A* i) Prophylaxis of acute graftrejection;

ii) Treatment of acute graftrejection;

iii) Prophylaxis of acute andchronic graft versus hostdisease;

iv) Treatment of steroid-resistant, acute graft versushost disease;

v) Treatment of aplasticanemia.

i) 1.0 - 1.5 mg/kg/day for 2 - 9days after transplantation of akidney, pancreas or liver, for 2 -5 days after hearttransplantation;

ii) 1.5 mg/kg/day for 3 - 14 days;iii) 2.5 - 5.0 mg/kg/day for 4 days;iv) 2.5 - 5.0 mg/kg/day for 5 days;v) 2.5 - 3.5 mg/kg/day for 5 days.

88. AntiveneneCobra Injection

J06AA03000P3002XX

B Treatment of patients whoexhibit manifestations ofsystemic envenoming followinga bite by Cobra (Naja kaouthia).

Initial dose of 100ml ofreconstituted antivenene given byslow intravenous infusion(2ml/min). Subsequent dose can begiven every 12 hours according tothe clinical symptoms. As productmay differ from batches andmanufacturer, it is stronglyrecommended to refer to theproduct insert on dosingrecommendation.

Page 15 of 296

No. Generic Name MDC Category Indications Dosage89. Antivenene Pit

Viper InjectionJ06AA03000P3001XX

B Treatment of patients whoexhibit manifestations ofsystemic envenoming followinga bite by Malayan Pit Viper(Calloselasma rhodostoma).

Initial dose of 30ml of reconstitutedantivenene given by slowintravenous infusion (2ml/min).Subsequent dose can be given every6 hours according to the clinicalsymptoms. As product may differfrom batches and manufacturer, it isstrongly recommended to refer tothe product insert on dosingrecommendation.

90. AntiveneneSerum (Seasnake) 1000 unitsInjection

J06AA03000P3003XX

B Treatment of patients whoexhibit manifestations ofsystemic envenoming followinga bite by sea snake.

1000 units by IV infusion over 1/2 to1 hour. In severe cases 3000 -10000units may be required

91. AntiveneneSerum SnakePolyvalentInjection

J06AA03000P3004XX

B Treatment of patients whoexhibit manifestations ofsystemic envenoming followinga bite by Indian Cobra (Najanaja), Common Krait (Bungaruscaeruleus), Russell's Viper(Daboia russelli) and Saw-scaledViper (Echis carinatus).

Recommended initial dose is 20mlby intravenous infusion. Theinjection should be given very slowlyas 5 minutes by direct slowintravenous route or 1hour byinfusion. If symptoms continue,further doses are administered asrequired until symptoms completelydisappear.

92. Apixaban 2.5mgfilm coatedtablet.

B01AF02000T3201XX

A* Prevention of stroke andsystemic embolism in adultpatients with non-valvular atrialfibrillation (NVAF), with one ormore risk factors, such as priorstroke or transient ischaemicattack (TIA); age ≥ 75 years;hypertension; diabetes mellitus;symptomatic heart failure(NYHA Class ≥ II). Restriction:Only for renal patients.

5 mg taken orally twice daily. Dosereduction: 2.5mg taken orally twicedaily in NVAF patients with at leasttwo of the following characteristics:age ≥80 years old, body weight≤60kg, or serum creatinine≥1.5mg/dL (133micromole/L).

93. Apixaban 5mgfilm coatedtablet.

B01AF02000T3202XX

A* Prevention of stroke andsystemic embolism in adultpatients with non-valvular atrialfibrillation (NVAF), with one ormore risk factors, such as priorstroke or transient ischaemicattack (TIA); age ≥ 75 years;hypertension; diabetes mellitus;symptomatic heart failure(NYHA Class ≥ II).Restriction: Only for renalpatients.

5 mg taken orally twice daily. Dosereduction: 2.5mg taken orally twicedaily in NVAF patients with at leasttwo of the following characteristics:age ≥80 years old, bodyweight≤60kg, or serumcreatinine≥1.5mg/dL(133micromole/L).

94. Aprepitant 125mg Capsule

A04AD12000C1002XX

A* In combination with otherantiemetic agents forprevention of delayed nauseaand vomiting associated withinitial and repeat course ofhighly emetogenicchemotherapy

125 mg 1 hour prior tochemotherapy on Day 1. To be givenas part of a 3-day regimen thatincludes a corticosteroid and a 5-HT3 antagonist

Page 16 of 296

No. Generic Name MDC Category Indications Dosage95. Aprepitant 80 mg

CapsuleA04AD12000C1001XX

A* In combination with otherantiemetic agents forprevention of delayed nauseaand vomitting associated withinitial and repeat course ofhighly emetogenicchemotherapy

80 mg once daily in the morning onDays 2 and Day 3. To be given aspart of a 3-day regimen thatincludes a corticosteroid & a 5-HT3antagonist

96. Aprotinin 10,000KIU/ml Injection

B02AB01000P3001XX

A* Only for Open Heart Surgery(extracorporeal circulation)

All patients should receive a 1 ml IVtest dose at least 10 minutes priorto loading dose. Initially 2 millionKIU bolus followed by 2 million KIUin heart-lung machine followed by aslow infusion of 500,000 KIU/hr untilend of surgery. CHILD: 20,000KIU/kg/day

97. Aqueous Cream D02AX00000G1001XX

C+ Dry skin As a soap or apply to the skin as anemollient cream

98. Aripiprazole10mg Tablet

N05AX12000T1001XX

A* i) Treatment of acute episodesof schizophrenia and formaintenance of clinicalimprovement duringcontinuation therapy. ii)Treatment of acute manicepisodes associated withbipolar I disorder

Schizophrenia: 10 or 15 mg/day.Maintenance dose: 15 mg/day.Bipolar mania: Starting dose: 15 or30 mg/day. Dose adjustment shouldoccur at intervals of not less than 24hour

99. Aripiprazole15mg Tablet

N05AX12000T1002XX

A* i) Treatment of acuteepisodes of schizophreniaand for maintenance ofclinical improvementduring continuationtherapy.

ii) Treatment of acute manicepisodes associated withbipolar I disorder

Schizophrenia: 10 or 15 mg/day.Maintenance dose: 15 mg/day.Bipolar mania: Starting dose: 15 or30 mg/day. Dose adjustment shouldoccur at intervals of not less than 24hour

100. Arsenic Trioxide 1mg/ml Injection

L01XX27550P3001XX

A* Relapsed acute promyelocyticleukaemia (APML). To beprescribed by consultanthaematologist only

Induction: 0.15 mg/kg/day IV untilbone marrow remission. Totalinduction dose ≤ 60 doses.Consolidation : 0.15 mg/kg/day IVfor 25 doses in 5 weeks (5 days perweek, followed by 2 daysinterruption; treatment shouldbegin 3-6 weeks after completion ofinduction therapy).

101. Artemether 20mg+ Lumefantrine120mg Tablet

P01BE52981T1001XX

B Acute uncomplicatedfalciparum malaria

ADULT and CHILD over 12 yearsweighing over 35 kg : 4 tablets as asingle dose at the time of initialdiagnosis, again 4 tablets after 8hours and then 4 tablets twice daily(morning and evening) on each ofthe following two days (total coursecomprises 24 tablets). INFANT andCHILD weighing 5 kg to less than 35kg : A 6 dose regimen with 1 to 3

Page 17 of 296

No. Generic Name MDC Category Indications Dosagetablets per dose, depending onbodyweight

102. Artesunate 100mg andMefloquine HCI220 mg Tablet

P01BF02000T1002XX

A Treatment of acuteuncomplicated Plasmodiumfalciparummalaria, resultingeither from P. falciparummono-infection or mixedinfection with P. vivax.

Weight 5-8kg, Age 6-11 months,Dose: One tablet 25/55mg OD x 3days Weight : 9-17kg, Age 1-6 years,Dose : Two tablet 25/55mg OD x 3days Weight :18-29kg, Age 7-12years, Dose :One tablet 100/220mgOD x 3 days Weight ≥30kg, Age ≥13years, Dose:Two tablet 100/220mgOD x 3 days

103. Artesunate 25 mgand MefloquineHCI 55 mg Tablet

P01BF02000T1001XX

A Treatment of acuteuncomplicated Plasmodiumfalciparummalaria, resultingeither from P. falciparummono-infection or mixedinfection with P. vivax.

Weight 5-8kg, Age 6-11 months,Dose: One tablet 25/55mg OD x 3days Weight : 9-17kg, Age 1-6 years,Dose : Two tablet 25/55mg OD x 3days Weight :18-29kg, Age 7-12years, Dose :One tablet 100/220mgOD x 3 days Weight ≥30kg, Age ≥13years, Dose:Two tablet 100/220mgOD x 3 days

104. Artesunate 60 mgInjection

P01BE03000P3001XX

A Treatment of severe malariacaused by Plasmodiumfalciparum in adults andchildren

2.4mg of artesunate/kg bodyweight, by intravenous (IV) orintramuscular (IM) injection, at 0, 12and 24 hours, then once daily untiloral treatment can be substituted.For adults and children with severemalaria or who are unable totolerate oral medicines, artesunate2.4 mg/kg body weight IV or IMgiven on admission (time = 0), thenat 12 hrs and 24 hrs, then once aday for 5-7 days is therecommended treatment.

105. Artificialtears/eyelubricantophthalmic gel

S01KA02000G32XXXX

B Symptomatic relief of severedry eye conditions and as lenslubricant during ophthalmicdiagnostic procedures

Instill 1-2 drops in affected eye(s) asneeded. Refer to productinformation leaflet.

106. Artificialtears/eyelubricantophthalmicointment

S01XA20900G51XXXX

A Keeping the eye lubricated andcomfortable during the night

Apply a small amount into the eye.Refer product information leaflet.

107. Artificialtears/eyelubricantophthalmic

S01XA20000D20XXXX

B Tear deficiency, ophthalmiclubricant; for relief of dry eyesand eye irritation

1 - 2 drops several times a day.Refer to product information leaflet.

Page 18 of 296

No. Generic Name MDC Category Indications Dosagesolution

108. Ascorbic Acid 100mg Tablet

A11GA01000T1002XX

C+ Vitamin C deficiency ADULT: 100-250 mg once or twicedaily CHILD: 100 mg three timesdaily for one week followed by100mg daily until symptoms abate.

109. Ascorbic Acid 500mg Tablet

A11GA01000T1003XX

C+ Vitamin C deficiency ADULT: 100-250 mg once or twicedaily CHILD: 100 mg three timesdaily for one week followed by100mg daily until symptoms abate.

110. Ascorbic Acid 500mg/2 ml Injection

A11GA01000P3001XX

B For prevention and treatmentof scurvy

Therapeutic: Not less than 250 mgdaily in divided doses

111. Asenapine 10mgSublingual Tablet

N05AH05253T7002XX

A* For second or third linetreatment in adult for:i) Schizophreniai) Bipolar Disorder -

Monotherapy: Acutetreatment of manic ormixed episodes associatedwith Bipolar I disorder. -Adjunctive therapy: Asadjunctive therapy witheither lithium or valproatefor the acute treatment ofmanic or mixed episodesassociated with Bipolar IDisorder.

i) Schizophrenia: - Acute treatmentin adults: Recommended startingand target dose of asenapine is 5mggiven twice daily. - Maintenancedose: 5mg twice daily. ii) BipolarDisorder: - Monotherapy: 10mgtwice daily. Adjunctive therapy: 5mgtwice daily with lithium or valproate.Dose can be increased to 10mgtwice daily based on clinicalresponse.

112. Asenapine 5mgSublingual Tablet

N05AH05253T7001XX

A* For second or third linetreatment in adult for:i) Schizophreniaii) Bipolar Disorder -

Monotherapy: Acutetreatment of manic ormixed episodes associatedwith Bipolar I disorder. -Adjunctive therapy: Asadjunctive therapy witheither lithium or valproatefor the acute treatment ofmanic or mixed episodesassociated with Bipolar IDisorder.

i) Schizophrenia: - Acute treatmentin adults: Recommended startingand target dose of asenapine is 5mggiven twice daily. - Maintenancedose: 5mg twice daily. ii) BipolarDisorder: - Monotherapy: 10mgtwice daily. Adjunctive therapy: 5mgtwice daily with lithium or valproate.Dose can be increased to 10mgtwice daily based on clinicalresponse.

113. Atenolol 100 mgTablet

C07AB03000T1002XX

B Hypertension, angina pectoris,myocardial infarction andarrhythmias

Hypertension and arrythmias; 50 -100 mg daily, Angina; 100 mg daily,Myocardial infarction; individualised

114. Atenolol 50 mgTablet

C07AB03000T1001XX

B Hypertension, angina pectoris,myocardial infarction andarrhythmias

Hypertension and arrythmias; 50 -100 mg daily, Angina; 100 mg daily,Myocardial infarction; individualised

Page 19 of 296

No. Generic Name MDC Category Indications Dosage115. Atomoxetine HCl

10 mg CapsuleN06BA09110C1001XX

A* Attention deficit hyperactivitydisorder (ADHD) in children 6years and older who do notrespond to methylphenidate orwho have intolerable effects orhave tics. Diagnosis should bemade according to DSM IVcriteria or the guidelines in ICD-10

CHILD and ADOLESCENTS up to 70kg: Initially 0.5 mg/kg/day for atleast 7 days, then increasedaccording to response.Maintenance: 1.2 mg/kg/day.ADULTS and ADOLESCENTS morethan 70 kg: Initially 40 mg/day for atleast 7 days then increasedaccording to response.Maintenance: 80 mg/day. Max 100mg/ day

116. Atomoxetine HCl18 mg Capsule

N06BA09110C1002XX

A* Attention deficit hyperactivitydisorder (ADHD) in children 6years and older who do notrespond to methylphenidate orwho have intolerable effects orhave tics. Diagnosis should bemade according to DSM IVcriteria or the guidelines in ICD-10

CHILD and ADOLESCENTS up to 70kg: Initially 0.5 mg/kg/day for atleast 7 days, then increasedaccording to response.Maintenance: 1.2 mg/kg/day.ADULTS and ADOLESCENTS morethan 70 kg: Initially 40 mg/day for atleast 7 days then increasedaccording to response.Maintenance: 80 mg/day. Max 100mg/ day

117. Atomoxetine HCl25 mg Capsule

N06BA09110C1003XX

A* Attention deficit hyperactivitydisorder (ADHD) in children 6years and older who do notrespond to methylphenidate orwho have intolerable effects orhave tics. Diagnosis should bemade according to DSM IVcriteria or the guidelines in ICD-10

CHILD and ADOLESCENTS up to 70kg: Initially 0.5 mg/kg/day for atleast 7 days, then increasedaccording to response.Maintenance: 1.2 mg/kg/day.ADULTS and ADOLESCENTS morethan 70 kg: Initially 40 mg/day for atleast 7 days then increasedaccording to response.Maintenance: 80 mg/day. Max 100mg/ day

118. Atomoxetine HCl40 mg Capsule

N06BA09110C1004XX

A* Attention deficit hyperactivitydisorder (ADHD) in children 6years and older who do notrespond to methylphenidate orwho have intolerable effects orhave tics. Diagnosis should bemade according to DSM IVcriteria or the guidelines in ICD-10

CHILD and ADOLESCENTS up to 70kg: Initially 0.5 mg/kg/day for atleast 7 days, then increasedaccording to response.Maintenance: 1.2 mg/kg/day.ADULTS and ADOLESCENTS morethan 70 kg: Initially 40 mg/day for atleast 7 days then increasedaccording to response.Maintenance: 80 mg/day. Max 100mg/ day

119. Atomoxetine HCl60mg Capsule

N06BA09110C1005XX

A* Attention deficit hyperactivitydisorder (ADHD) in children 6years and older who do notrespond to methylphenidate orwho have intolerable effects orhave tics. Diagnosis should bemade according to DSM IVcriteria or the guidelines in ICD-10

CHILD and ADOLESCENTS up to 70kg: Initially 0.5 mg/kg/day for atleast 7 days, then increasedaccording to response.Maintenance: 1.2 mg/kg/day.ADULTS and ADOLESCENTS morethan 70 kg: Initially 40 mg/day for atleast 7 days then increasedaccording to response.

Page 20 of 296

No. Generic Name MDC Category Indications DosageMaintenance: 80 mg/day. Max 100mg/ day

120. Atorvastatin 20mg Tablet

C10AA05000T1002XX

A/KK Hypercholesterolaemia andcoronary heart diseaseintolerant or not responsive toother forms of therapy

10 mg once daily. Maximum: 80 mgdaily

121. Atorvastatin 40mg Tablet

C10AA05000T1001XX

A/KK Hypercholesterolaemia andcoronary heart diseaseintolerant or not responsive toother forms of therapy

10 mg once daily. Maximum: 80 mgdaily

122. Atorvastatin 80mg Tablet

C10AA05000T1004XX

A/KK Hypercholesterolaemia andcoronary heart diseaseintolerant or not responsive toother forms of therapy

10 mg once daily. Maximum: 80 mgdaily

123. Atosiban 7.5mg/ml Injection

G02CX01122P3001XX

A* To delay imminent pretermbirth in pregnant women with:i) Regular uterine

contractions of at least 30seconds duration at a rateof ≥ 4 per 30 minutes;

ii) A cervical dilation of 1 to 3cm (0 - 3 nulliparas) andeffacement of ≥ 50%;

iii) Age ≥ 18 years;iv) A gestational age from 28

until 33 completed weeks;v) A normal foetal heart rate.

Initial intravenous bolus dose of6.75mg (using 7.5mg/ml solution forinjection). Immediately followed bya continuous high dose infusion(loading infusion 300 mcg/min using7.5mg/ml concentrate for solutionfor infusion) during three hours,followed by lower infusion of100mcg/min up to 45 hours.Duration of treatment should notexceed 48 hours. Total dose givenduring a full course should notexceed 330mg of the activesubstance.

124. AtracuriumBesylate 10 mg/ml in 2.5 mlInjection

M03AC04197P3001XX

A* Muscle relaxant in generalanaesthesia, Endotrachealintubation, Aid controlledventilation.

Adult & childn >2 mth 0.3-0.6 mg/kgIV. Endotracheal intubation dose:0.5-0.6 mg/kg. Supplementary dose:0.1-0.2 mg/kg as required.Continuous infusion rates of 0.3-0.6mg/kg/hr to maintainneuromuscular block during longsurgical procedure.

125. AtracuriumBesylate 10 mg/ml in 5 mlInjection

M03AC04197P3002XX

A* Muscle relaxant in generalanaesthesia, Endotrachealintubation, Aid controlledventilation.

Adult & childn >2 mth 0.3-0.6 mg/kgIV. Endotracheal intubation dose:0.5-0.6 mg/kg. Supplementary dose:0.1-0.2 mg/kg as required.Continuous infusion rates of 0.3-0.6mg/kg/hr to maintainneuromuscular block during longsurgical procedure.

126. AtropineSulphate 0.3%,Cocaine HCl 1.7%,Adrenaline Acid

S01F000183P3001XX

A Subconjunctival injection todilate pupils resistant to topicalmydriatics

1 - 2 drops

Page 21 of 296

No. Generic Name MDC Category Indications DosageTartrate 0.03%MydriaticInjection

127. AtropineSulphate 1% EyeDrops

S01FA01183D2001XX

B Determination of refraction,strabismus, iritis andiridocyclitis, after extra orintracapsular extraction of lens

PREOPERATIVE MYDRIASIS : onedrop of a 1% solution supplementedwith one drop of 2.5 or 10%phenylephrine prior to surgery.ANTERIOR UVEITIS orPOSTOPERATIVE MYDRIASIS : onedrop of a 1% or 2% solution up to 3times a day

128. AtropineSulphate 1mg/mlInjection

A03BA01183P3001XX

B i) Reduce vagalinhibition,salivary andbronchiol secretion inanaesthesia;

ii) Reversal of excessivebradycardia;

iii) Reversal of effect ofcompetitive musclerelaxants;

iv) Overdosage with othercompounds havingmuscarinic action;

v) Organophosphatepoisoning.

i) Adult: 300-600 mcg IM/SC 30-60 minutes before anaesthesia.Alternatively, 300-600 mcg IVimmediately before induction ofanaesthesia. Child: >20 kg: 300-600 mcg; 12-16 kg: 300 mcg; 7-9 kg: 200 mcg; >3 kg: 100 mcg.Doses to be given via IM/SCadmin 30-60 minutes beforeanaesthesia.

ii) Adult: 500 mcg every 3-5minutes. Total: 3 mg. MaxDosage: 0.04 mg/kg bodyweight.

iii) Adult 0.6-1.2 mg before or withanticholinesterase

iv) Adult: 0.6-1 mg IV/IM/SC,repeated every 2 hr.

v) v) Adult: 2 mg IV/IM, every 10-30 minutes until muscariniceffects disappear or atropinetoxicity appears. In severecases, dose can be given asoften as every 5 minutes. Inmoderate to severe poisoning,a state of atropinisation ismaintained for at least 2 daysand continued for as long assymptoms are present. Child:20 mcg/kg given every 5-10minutes.

129. AzacitidinePowder forsuspension forinjection100mg/vial

L01BC07000P4001XX

A* First line therapy forintermediate-2 and high riskMDS, CMMOL with 10-29%blasts with no transplant optionand elderly AML with 20-30%blasts and multilineagedysplasia.

Recommended starting dose for thefirst treatment cycle, for all patientsregardless of baseline haematologylaboratory values, is 75mg/m2 ofbody surface area. Injectedsubcutaneously. Daily for 7 days,followed by a rest period of 21 days(28 day treatment cycle)

Page 22 of 296

No. Generic Name MDC Category Indications Dosage130. Azathioprine 50

mg TabletL04AX01000T1001XX

A i) Prophylaxis of rejection inorgan and tissuetransplant;

ii) Auto-immune diseases;iii) Rheumatoid arthritis.

i) Adult: 1-5 mg/kg/day. Adjustdose according to clinicalresponse and haematologicaltolerance. Dose may also begiven via IV administration.

ii) Adult: 1-3 mg/kg/day.Discontinue treatment if thereis no improvement after 12week.

iii) Adult: Initially, 1 mg/kg/daygiven in 1-2 divided doses for 6-8 week may increase by 0.5mg/kg every 4 week untilresponse or up to 2.5mg/kg/day. Maintenance:Reduce dose gradually toachieve the lowest effectivedose.

131. Azelaic Acid 20%Cream

D10AX03000G1001XX

A* Acne vulgaris Apply twice daily (sensitive skin,once daily for 1st week). Treatmentshould not exceed 6 months

132. Azithromycin 200mg/5 ml Granules

J01FA10011F1001XX

A* Treatment of complicatedrespiratory tract infections notresponding to standardmacrolides

CHILD 36 - 45 kg: 400 mg, 26 - 35 kg:300mg, 15 - 25 kg 200 mg, less than15 kg: 10 mg/kg. To be taken dailyfor 3 days or to be taken as a singledose on day 1, then half the dailydose on days 2 - 5

133. Azithromycin 250mg Tablet

J01FA10011T1001XX

A* Category of prescriber A/KK isonly approved for indication (i):i) Adult treatment of

uncomplicated genitalinfections due toChlamydia trichomatis orsusceptible Neisseriagonorrhoea.

The following indication is stillunder category of prescriberA*:i) Treatment of complicated

respiratory tract infectionnot responding to standardmacrolides;

ii) Prophylaxis againstMycobacterium aviumcomplex in patients withadvanced HIV.

i) 1 g as a single dose;ii) 500 mg daily for 3 days;iii) 1 g weekly

134. Azithromycin 500mg Injection

J01FA10011P4001XX

A* Only for treatment of severeatypical pneumonia

500 mg IV as a single daily dose for aminimum of two days followed by500 mg oral dose as a single dailydose to complete a 7 - 10 dayscourse

Page 23 of 296

No. Generic Name MDC Category Indications Dosage135. Bacampicillin 400

mg TabletJ01CA06000T1001XX

B Infections caused by ampicillin-sensitive gram positive& gramnegative microorganisms

ADULT: 400 mg twice daily. Severeinfection: 800 mg twice daily. CHILDmore than 25 kg: 12.5 - 25 mg/kg 12hourly

136. Baclofen 10 mgTablet

M03BX01000T1001XX

B Spasticity of the skeletal muscle ADULT: 5 mg 3 times daily. Max: 80mg daily. CHILD: 0.75 - 2 mg/kg daily(more than 10 years, maximum: 2.5mg/kg daily)

137. Balanced SaltSolution

B05CB10907L5001XX

A For irrigation during ocularsurgery

Irrigate as directed

138. Balanced SaltSolution PLUS(fortified withsodiumbicarbonate,glucose &glutathione)

B05CB10905L5001XX

A For irrigation during intraocularsurgery especially in patientswith poor cornea endotheliumand poorly controlled diabetes

Irrigate as directed

139. Barium SulphateSuspension

V08BA01183L8001XX

B For x-ray examination of thealimentary tract: i) Oesophagusii) Stomach and duodenum iii)Colon

i) Up to 150 ml of a 50% - 200%suspension orally ii) Up to 300 ml ofa 30% - 200% suspension orally iii)Up to 2 litre of a 30% - 200%suspension orally

140. Basiliximab 20mg Injection

L04AC02000P3001XX

A* Prophylaxis of acute organrejection in de novo renaltransplantation.

ADULT & CHILD 2 years and above &35 kg or more: 20 mg /dose. 2 yearsor more but less than 35kg: 10mg/dose. First dose given within 2hours before start of transplantationand second dose 4th day aftertransplant

141. BCG 81 mg/3 ml L03AX03000P3001XX

A* Superficial bladder cancer 81 mg intravesically once weekly for6 weeks, followed by treatments at3, 6, 12, 18, and 24 months afterinitial treatment

142. BCG VaccineFreeze-DriedInjection

J07AN01000P4001XX

C+ For the prevention oftuberculosis

0.1 ml by intradermal injection.INFANT under 12 months: 0.05 ml

143. BeclomethasoneDipropionate 100mcg/dose Inhaler

R03BA01133A2101XX

B Prophylaxis of asthmaespecially if not fully controlledby bronchodilators

Adults: The usual maintenance doseis one to two inhalations (200-400mcg) twice daily.If needed,the dosecan be increased up to 1600mcg/day divided in two to fourdoses : Children 6-12 years old: Oneinhalation (200 mcg) two times dailyand dose may be increased up to800 mcg/day in divided two to fourdoses if necessary.

Page 24 of 296

No. Generic Name MDC Category Indications Dosage144. Beclomethasone

dipropionate100mcg andformoterolfumaratedihydrate 6mcgpressurizedinhalationsolution

R03AK07986A2101XX

A/KK Regular treatment of asthmawhere use of a combinationproduct (inhaled corticosteroidand long-acting beta2 agonist)is appropriate in:i) Patients not adequatelycontrolled with inhaledcorticosteroids and "as needed"inhaled short-acting beta2agonist, orii) Patients already adequatelycontrolled on both inhaledcorticosteroids and long-actingbeta2-agonists.

Based on treatment approach.i) Maintenance therapy (taken asregular maintenance treatment witha separate as needed rapid-actingbronchodilator): Doserecommendations for adults 18years and above: One or twoinhalations twice daily. Themaximum daily dose is 4 inhalations.ii) Maintenance and reliever therapy(taken as regular maintenancetreatment and as needed inresponse to asthma symptoms):Dose recommendations for adults18 years and above: Therecommended maintenance dose is1 inhalation twice daily (oneinhalation in the morning and oneinhalation in the evening). Patientsshould take 1 additional inhalationas needed in response to symptoms.If symptoms persist after a fewminutes, an additional inhalationshould be taken. The maximum dailydose is 8 inhalations.

145. BeclomethasoneDipropionate 200mcg/dose Inhaler

R03BA01133A2102XX

A/KK Prophylaxis of asthmaespecially if not fully controlledby bronchodilators

ADULT: 1 - 2 puff twice daily. Mayincrease to 2 puff 2 - 4 times dailyCHILD: 1 puff twice daily. Mayincrease to 1 puff 2 - 4 times daily

146. BeclomethasoneDipropionate 50mcg/dose NasalSpray

R01AD01133A4101XX

A/KK Prophylaxis and treatment ofperennial and seasonal allergicrhinitis and vasomotor rhinitis

ADULT and CHILD over 6 years :Apply 100 mcg (2 sprays) into eachnostril twice daily or 50 mcg (1spray) into each nostril 3 - 4times/day. Maximum 400 mcg daily(8 sprays). When symptomscontrolled, reduce dose to 50 mcg (1spray) into each nostril twice daily

147. BendamustineHydrochloride100mg/vialpowder forconcentrate forsolution forinfusion

L01AA09110P3302XX

A* Bendamustine is indicated formonotherapy in patients withindolent B-cell non-Hodgkin?slymphomas (iNHL) that hasprogressed during or within sixmonths of treatment withrituximab or a rituximab-containing regimen.

Monotherapy for iNHL refractory torituximab: 120mg/m2 body surfacearea bendamustine hydrochlorideon days 1 and 2; every 3 weeks.

148. BendamustineHydrochloride25mg/vialpowder forconcentrate forsolution forinfusion

L01AA09110P3301XX

A* Bendamustine is indicated formonotherapy in patients withindolent B-cell non-Hodgkin?slymphomas (iNHL) that hasprogressed during or within sixmonths of treatment withrituximab or a rituximab-containing regimen.

Monotherapy for iNHL refractory torituximab: 120mg/m2 body surfacearea bendamustine hydrochlorideon days 1 and 2; every 3 weeks.

Page 25 of 296

No. Generic Name MDC Category Indications Dosage149. Benzalkonium

0.01% CreamD08AJ01000G1001XX

B Prevention and treatment ofnappy rash

Wash and dry baby's bottom. Applyby spreading the cream evenlypaying particular attention to thefold of the skin, after every nappychange

150. BenzalkoniumChlorideDisinfectantSolution

V07AV00100L9908XX

C Low level disinfectant suitablefor general cleaning anddisinfection of hard surface

Cleaning purposes: Dilute 1 in 10.Disinfection, use undiluted

151. BenzathinePenicillin 2.4 MIU(1.8 g) Injection

J01CE08702P4001XX

B i) Treatment of mild tomoderately severe infectionsdue to Penicillin G-sensitiveorganisms ii) Treatment ofsyphillis

i) ADULT: 1.2 mega units IM ii) Forsyphillis: 2.4 mega units weekly for 1- 3 weeks

152. Benzhexol 2 mgTablet

N04AA01110T1001XX

B i) Parkinson's disease ii) Druginduced parkinsonism iii)Dystonias

ADULT: Initially 1 mg daily, increasegradually. Maintenance: 5 - 15 mgdaily in 3 - 4 divided doses. (Max15mg/day)

153. Benzoic AcidCompound HalfStrength (Paed)Ointment

D01AE12952G5001XX

C Tinea infections of the skin Apply sparingly to affected areaonce or twice daily

154. Benzoic AcidCompoundOintment

D01AE12952G5002XX

C Tinea infections of thickenedskin of palms and soles

Apply sparingly to affected areaonce or twice daily

155. BenzoinCompoundTincture

D08AX00000L5001XX

C Infected skin, lesions, cuts,abrasions, wounds and burns

Apply undiluted to the skin 1 or 2times daily. Duration of therapy,may be weeks to months dependingon the infection being treated

156. Benzoyl Peroxide10% Gel

D10AE01241G3002XX

B Mild to moderate acne vulgaris Apply 1-2 times daily preferablyafter washing with soap and water

157. Benzoyl Peroxide5% Gel

D10AE01241G3001XX

B Mild to moderate acne vulgaris Apply 1-2 times daily preferablyafter washing with soap and water

158. Benzydamine HCl0.15% Solution

A01AD02110M2001XX

B For relief of painful condition ofthe oral cavity

Used as a 30 seconds gargle or rinse,undiluted. ADULT 15 ml. CHILD less12 years 5-15 ml. Uninterruptedtreatment should not be more than7 days

159. BenzydamineHydrochloride 3.0mg/ml throatspray

A01AD02110A4201XX

A* Temporary relief of painfulconditions of the mouth andthroat including tonsillitis, sorethroat, radiation mucositis,aphthous ulcers, pharyngitis,swelling, redness, inflammatoryconditions, post-orosurgical andperiodontal procedures. (Forpediatric andotorhinolaringology use.Restrict to patients who are notable to gargle)

ADULTS and CHILDREN OVER 12YEARS: 2-4 sprays (1-2mg) directlyonto the sore/inflamed area andswallow gently. Repeat every 1 1/2to 3 hours as necessary. CHILDREN6-12 YEARS: 2 sprays (1mg) directlyonto sore/ inflamed area andswallow gently. Repeat every 11/2to 3 hours as necessary. CHILDRENUNDER 6 YEARS: Not recommended.Uninterrupted treatment should notexceed seven days, unless undermedical supervision

Page 26 of 296

No. Generic Name MDC Category Indications Dosage160. Benzyl Benzoate

12.5 % Emulsion(Child)

P03AX01252L2001XX

C Scabies - for child 2-12 years old After bath, apply over the wholebody, neck down and leave on for24 hours then wash off. Reapply foranother 24 hours, the first repeatapplication should be within 5 daysof the initial application, a thirdapplication may be required in somecases

161. Benzyl Benzoate25 % Emulsion(Adult)

P03AX01000L2002XX

C+ Scabies for adult and childrenmore than 12 years old.

After bath, apply over the wholebody, neck down and leave on for24 hours then wash off. Reapply foranother 24 hours, the first repeatapplication should be within 5 daysof the initial application, a thirdapplication may be required in somecases.

162. Benzylpenicillin 1mega unit (600mg) Injection

J01CE01702P4001XX

B i) Infections caused bysusceptible organismsii) Infective endocarditis

i) Adult: 600mg - 3600mg (1 - 6mega units) daily, divided into 4 to 6doses. Higher doses (24 mega units)in divided doses may be given inserious infections such asmeningitis. Child 1 month to 12years old: 100mg/kg/day in 4divided doses, not exceeding4g/day; Infants 1 -4 weeks:75mg/kg/day in 3 divided doses;Newborn Infants: 50mg/kg/day in 2divided dosesii) 7.2 to 12g (12 - 20 mega units)maybe given daily in divided doses

163. Benzylpenicillin10,000 units/mlEye Drops

S01AA14702D2002XX

B Eye infection 1-2 drops every 15 minutes oraccordingly to needs of the patient

164. Benzylpenicillin2,500 units/ml(1.5 mg/ml) EyeDrops

S01AA14702D2001XX

B Eye infection 1-2 drops every 15 minutes oraccordingly to needs of the patient

165. Benzylpenicillin 5mega units (3 g)Injection

J01CE01702P4002XX

B i) Infections caused bysusceptible organismsii) Infective endocarditis

i) ADULT: 600 - 1200 mg IM 4 timesdaily, increased if necessary in moreserious infections. CHILD: 50 - 100mg/kg body weight daily IV in 2 - 4divided dosesii) ADULT: 7.2 g daily by slow IVinfusion in 6 divided doses

166. BeractantIntratrachealSuspension (200mg phospholipidsin 8 ml vial)

R07AA02000L8001XX

A* Treatment of newborn babywith birth weight of 700 g orgreater undergoing mechanicalventilation for respiratorydistress syndrome, whose heartrate and arterial oxygenationare continuously monitored

100 mg/kg (4 ml/kg) body weightintratracheally up to 4 doses in 1st48 hr. Doses should not be givenmore frequently than 6 hrly. To beadministered as soon as possible.

Page 27 of 296

No. Generic Name MDC Category Indications Dosage167. Betahistine

Dihydrochloride16 mg Tablet

N07CA01110T1002XX

A/KK i) Meniere's Syndrome asdefined by the following coresymptoms: - Vertigo (withnausea/vomiting). - Hearingloss (Hardness of hearing). -Tinnitus (ringing in the ears)ii) Symptomatic treatment ofvestibular vertigo

Given in doses of 8 to 16 mg orally 3times daily (total 24 to 48 mg/day)preferably with food. CHILD notrecommended

168. BetahistineDihydrochloride24 mg Tablet

N07CA01110T1003XX

A* i) Meniere's Syndrome asdefined by the following coresymptoms: - Vertigo (withnausea/vomiting). - Hearingloss (Hardness of hearing). -Tinnitus (ringing in the ears)ii) Symptomatic treatment ofvestibular vertigo

24-48mg in divided doses daily

169. BetahistineDihydrochloride 8mg Tablet

N07CA01110T1001XX

A/KK i) Meniere's Syndrome asdefined by the following coresymptoms: - Vertigo (withnausea/vomiting). - Hearingloss (Hardness of hearing). -Tinnitus (ringing in the ears)ii) Symptomatic treatment ofvestibular vertigo

Given in doses of 8 to 16 mg orally 3times daily (total 24 to 48 mg/day)preferably with food. CHILD notrecommended

170. Betamethasone0.5 mg Tablet

H02AB01000T1001XX

A Suppression of inflammatoryand allergic disorders,congenital adrenal hyperplasia,cerebral oedema

0.5 - 9 mg daily in divided doses.CHILD: 0.5 - 7.5 mg/m2/day dividedevery 6 - 12 hours

171. Betamethasone17-Valerate 0.01-0.05% Cream

D07AC01256G1001XX

B Eczemas, prurigo nodularis,limited psoriasis in appropriatein sites

Apply sparingly to affected area 2 - 3times daily then reduced to oncedaily when improvement occurs

172. Betamethasone17-Valerate 0.01-0.05% Ointment

D07AC01256G5001XX

B Eczema, prurigo nodularis,limited psoriasis in appropriatein sites

Apply sparingly to affected area 2 - 3times daily then reduced to oncedaily when improvement occurs

173. Betamethasone17-Valerate 0.1%Cream

D07AC01256G1002XX

A Eczemas, prurigo nodularis,psoriasis (excluding widespreadplaque psoriasis)

Apply sparingly to affected area 2 - 3times daily then reduced to oncedaily when improvement occurs

174. Betamethasone17-Valerate 0.1%Ointment

D07AC01256G5002XX

A Eczema, prurigo nodularis,psoriasis (excluding widespreadplaque psoriasis)

Apply sparingly to affected area 2-3times daily then reduced to oncedaily when improvement occurs

175. BetamethasoneDisodiumPhoshate 0.1%Ear Drops

S03BA03162D1001XX

B Non-infected inflammatoryconditions

Apply 2 - 3 drops every 2 - 3 hours,reduce frequency when reliefobtained

176. BetamethasoneDisodiumPhoshate 0.5%Ear Drops

S03BA03162D1002XX

B Non-infected inflammatoryconditions

Apply 2 - 3 drops every 2 - 3 hours,reduce frequency when reliefobtained

177. BetamethasoneDisodiumPhosphate 0.1%Eye Drops

S01BA06162D2001XX

A Non-infected inflammatoryconditions of the eyes

1 - 2 drops every 1 - 2 hours untilcontrolled then reduce frequency

Page 28 of 296

No. Generic Name MDC Category Indications Dosage178. Betamethasone

DisodiumPhosphate 0.1%Eye Ointment

S01BA06162G5101XX

A Non-infected inflammatoryconditions of the eyes

2 - 4 times daily or at night whenused with eye drops

179. BetamethasoneDisodiumPhosphate andNeomycinSulphate 0.5%Ear Drops

S03CA06991D1001XX

B Allergic dermatosis in the ear Apply 2 - 3 drops 3 - 4 times daily,reduce frequency when reliefobtained

180. BetamethasoneDisodiumPhosphate andNeomycinSulphate EyeDrops

S01CA05991D2001XX

A Infected inflammatoryconditions of the eyes

2 - 3 drops every 2 - 3 hours

181. BetamethasoneSodiumPhosphate 4mg/ml Injection

H02AB01162P3001XX

B Pre-operative and in serioustrauma or illness, shock, asadjunctive therapy inrheumatoid disorders, ocular,dermatologic and respiratoryallergic and inflammatory states

Usual intravenous doses are up to 9mg/day of the sodium phosphatesalt only. CHILD: IM: 0.5 - 7.7 mgbase/m2/day divided every 6 - 12hours. ADOLESCENT and ADULT, IM:0.6 - 9 mg divided every 12 - 24hours

182. Betaxolol 0.25%Eye Suspension

S01ED02110D2001XX

A Chronic open-angle glaucoma,ocular hypertension

One to two drops in the affectedeye(s) twice daily

183. Bicalutamide 50mg Tablet

L02BB03000T1001XX

A* Advanced prostate cancer incombination with LHRHanalogue therapy or surgicalcastration.

50 mg once daily (morning orevening), with or without food. Takeon the same time each day. Adult:When used with gonadorelinanalogue: Usual dose: 50 mg oncedaily. May be started with or at least3 days before starting gonadorelinanalogue therapy.

184. Bimatoprost0.03%OphthalmicSolution

S01EE03000D2001XX

A* Lowering of intraocularpressure in patients with open-angle glaucoma and ocularhypertension who areintolerant of other intraocularpressure lowering medicationsor insufficiently responsive toanother intraocular pressurelowering medication

1 drop in affected eye(s) once dailyat evening

185. Bisacodyl 10 mgSuppository

A06AB02000S2002XX

C i) Constipationii) Bowel preparation forradiological procedures andsurgery

i) ADULT and CHILD over 10 years:10 mg, CHILD less than 10 years 5mg insert rectallyii) ADULT 10-20 mg, CHILD over 4years 5 mg the following morningbefore procedures insert rectally

186. Bisacodyl 5 mgSuppository

A06AB02000S2001XX

C i) Constipationii) Bowel preparation forradiological procedures andsurgery

i) ADULT and CHILD over 10 years:10 mg, CHILD less than 10 years 5mg insert rectallyii) ADULT 10-20 mg, CHILD over 4years 5 mg the following morning

Page 29 of 296

No. Generic Name MDC Category Indications Dosagebefore procedures insert rectally

187. Bisacodyl 5 mgTablet

A06AB02000T1001XX

C i) Constipationii) Bowel preparation forradiological procedures andsurgery

i) ADULT and CHILD over 10 years 5-10 mg, CHILD 4-10 years 5 mg. To betaken at night for effect on thefollowing morningii) ADULT 10-20 mg the night beforeprocedures, CHILD over 4 years 5mg the night before procedures

188. BismuthSubnitrate,Iodoform andLiquid ParaffinPaste

R01AX30984G6001XX

B As a mild antiseptic for woundsand abscesses. Sterile gauzeimpregnated with paste forpacking cavities afterotorhinological surgery

As directed for local application

189. BisoprololFumarate 2.5 mgTablet

C07AB07000T1001XX

B Treatment of stable moderateto severe congestive cardiacfailure in addition to ACEI's anddiuretics

1.25 mg once daily to 5 - 10 mg daily

190. BisoprololFumarate 5 mgTablet

C07AB07000T1002XX

B Treatment of stable moderateto severe congestive cardiacfailure in addition to ACEI's anddiuretics

1.25 mg once daily to 5 - 10 mg daily

191. Bleomycin HCl 15mg Injection

L01DC01110P4001XX

A Squamous cell carcinoma, germcell tumours, lymphomas.Routes: SC, IM, IV (either asbolus or as infusion over 24hours), intra-arterial, intra-pleural

15 - 30 mg weekly in divided dosesor 10 - 20 mg/m2 once or twiceweekly or 10 mg/m2 slow bolus in15 minutes D1 and D15. Totaldosage:should not exceed 300 mg.CHILD: 10 - 15 mg/m2 over 6 hoursevery 3 - 4 weeks

192. Boric Acid withSpirit 2% w/v EarDrops

S02AA03000D1001XX

C Perforated eardrum 3 drops instilled into affected ear 3 -4 times daily

193. Bortezomib 3.5mg Injection

L01XX32000P3001XX

A* i) Treatment of multiplemyeloma in patient who havereceived at least one priortherapy.ii) For use in combination withconventional therapy for thetreatment of previouslyuntreated multiple myelomapatients who are not eligible forhaematopoietic stem celltransplantation.

1.3 mg/ m2/dose given as IV bolusinjection twice weekly for twoweeks (days 1, 4, 8, and 11)followed by a 10- day rest period(days 12-21). At least 3 days shouldelapse between consecutive dosesof bortezomib

194. Bosentan 125 mgtablet

C02KX01000T1001XX

A* For the treatment of pulmonaryarterial hypertension (PAH) inpatients with WHO Class III orIV symptoms, to improveexercise ability and decreasethe rate of clinical worsening(To be used by those who aretrained and specialized intreating and managing PAH)

Initially 62.5 mg bd for 4 weeks,then increase to the maintenancedose of 125 mg bd

Page 30 of 296

No. Generic Name MDC Category Indications Dosage195. Brimonidine

Tartrate 0.15%Ophthalmic

S01EA05123D2001XX

A* Lowering of intraocularpressure in patients with open-angle glaucoma or ocularhypertension

1 drop in the affected eye(s) 3 timesdaily

196. Bromazepam 3mg Tablet

N05BA08000T1002XX

A Anxiety disorders Adult: Initially, 6-18 mg daily individed doses. Doses up to 60 mgdaily have been used. Elderly: Maxinitial dose: 3 mg daily

197. Bromhexine HCl 4mg/2 ml Injection

R05CB02110P3001XX

A Secretolytic therapy in acuteand chronic bronchopulmonarydiseases associated withabnormal mucous secretion andimpaired mucous transport

4 to 8 mg SC, IM or IV 2 - 3 timesdaily (maximum 24mg/ day). Elderly:Max initial dose: 3 mg daily.

198. Bromhexine HCl 4mg/5 ml Elixir

R05CB02110L1001XX

B Secretolytic therapy in acuteand chronic bronchopulmonarydiseases associated withabnormal mucous secretion andimpaired mucous transport

1) Adults: 10 ml three times aday.Can increase up to 15 ml fourtimes a day. 2)Children 5 to 12 years: 5 ml four times a day 3)Children 2to 5 years: 5 ml two times a day

199. Bromhexine HCl 8mg Tablet

R05CB02110T1001XX

B Secretolytic therapy in acuteand chronic bronchopulmonarydiseases associated withabnormal mucous secretion andimpaired mucous transport

ADULT and CHILD more than 12years : 8 mg 3 times daily, 6 - 12years : 4 mg 3 times daily, 2 - 6 years: 4 mg 2 times daily

200. BromocriptineMesilate 10 mgTablet

G02CB01196T1003XX

A/KK i) Hypogonadism orGalactorrhoeaii) Acromegaly

i) Initially 1 - 1.25 mg at bedtimeincreased gradually, usual dose: 7.5mg daily in divided doses. Max 30mg dailyii) 1.25 - 2.5 mg at bedtime for 3days and may be increased by 1.25 -2.5 mg every 3 - 7 days up to 30 mga day in divided doses

201. BromocriptineMesilate 2.5 mgTablet

G02CB01196T1001XX

A/KK i) Hypogonadism orGalactorrhoeaii) Acromegaly

i) Initially 1 - 1.25 mg at bedtimeincreased gradually, usual dose: 7.5mg daily in divided doses. Max 30mg daily ii) 1.25 - 2.5 mg at bedtimefor 3 days and may be increased by1.25 - 2.5 mg every 3 - 7 days up to30 mg a day in divided doses

202. BromocriptineMesilate 5 mgTablet

G02CB01196T1002XX

A/KK i) Hypogonadism orGalactorrhoeaii) Acromegaly

i) Initially 1 - 1.25 mg at bedtimeincreased gradually, usual dose: 7.5mg daily in divided doses. Max 30mg dailyii) 1.25 - 2.5 mg at bedtime for 3days and may be increased by 1.25 -2.5 mg every 3 - 7 days up to 30 mga day in divided doses

203. Budesonide 1mg/2 mlNebuliserSolution

R03BA02000A3002XX

B Maintenance treatment ofasthma as prophylactic therapyespecially if not fully controlledby bronchodilators

ADULT: Initially 1 - 2 mg twice daily.CHILD 3 months - 12 years of age :500 mcg - 1 mg. Maintenance dose :half of the above doses

Page 31 of 296

No. Generic Name MDC Category Indications Dosage204. Budesonide 100

mcg/dose InhalerR03BA02000A2101XX

B Maintenance treatment ofasthma as prophylactic therapyespecially if not fully controlledby bronchodilators

ADULT: 200 - 1600 mcg daily in 2 - 4divided doses. Maintenance withtwice daily dosing. CHILD more than7 years 200 - 800 mcg, 2 - 7 years200 - 400 mcg. To be taken orally in2 - 4 divided doses

205. Budesonide 160mcg andFormoterol 4.5mcg Inhalation

R03AKO7989A2101XX

A/KK i) Regular treatment of asthmawhere use of a combination(inhaled corticosteroid andlong-acting beta2-agonist) isappropriate:-

a. Patients notadequately controlledwith inhaledcorticosteroids and ‘asneeded’ inhaled short-acting beta2-agonists.or

b. Patients alreadyadequately controlledon both inhaledcorticosteroids andlong- acting beta2-agonists.

ii) Symptomatic treatment ofpatients with severe COPD(FEV1 <50% predicted normal)and a history of repeatedexacerbations, who havesignificant symptoms despiteregular therapy with long-actingbronchodilators.

Asthma Maintenance therapy Adult≥18 yr 160 mcg to 320 mcg bd.Some patients may require up to amax of 640 mcg bd. Adolescent 12-17 yr 160 mcg to 320 mcg bd. Childn6-11 yr 160 mcg bd, <6 yr Notrecommended. Maintenance &relief Adult ≥18 yr 320 mcg/dayeither as 160 mcg bd or 320 mcgeither morning or evening. For somepatients a maintenance dose of 320mcg bd may be appropriate.Patients should take 160 mcgadditional inhalation as needed inresponse to symptoms. If symptomspersist after a few minutes, anadditional inhalation should betaken. Not more than 960 mcgshould be taken on any singleoccasion. A total daily dose of morethan 1280 mcg is not normallyneeded, however a total daily doseof up to 1920 mcg could be used fora limited period. Patients usingmore than 1280 mcg daily shouldseek medical advice, should bereassessed & their maintenancetherapy reconsidered. Childn &adolescent <18 yr Notrecommended. COPD Adult ≥18 yr320 mcg bd.

206. Budesonide 200mcg/doseInhalation

R03BA02000A2102XX

B Maintenance treatment ofasthma as prophylactic therapyespecially if not fully controlledby bronchodilators

ADULT: 200 - 1600 mcg daily in 2 - 4divided doses. Maintenance withtwice daily dosing. CHILD more than7 years 200 - 800 mcg, 2 - 7 years200 - 400 mcg. To be taken orally in2 - 4 divided doses

Page 32 of 296

No. Generic Name MDC Category Indications Dosage207. Budesonide 320

mcg andFormoterol 9 mcgInhalation

R03AK07989A2102XX

A/KK i) Regular treatment of asthmawhere use of a combination(inhaled corticosteroid andlong-acting beta2-agonist) isappropriate:-

a. Patients notadequately controlledwith inhaledcorticosteroids and ‘asneeded’ inhaled short-acting beta2-agonists.or

b. Patients alreadyadequately controlledon both inhaledcorticosteroids andlong- acting beta2-agonists.

ii) Symptomatic treatment ofpatients with severe COPD(FEV1 <50% predicted normal)and a history of repeatedexacerbations, who havesignificant symptoms despiteregular therapy with long-actingbronchodilators.

Asthma; Maintenance therapy:Adult ≥18 yr 160 mcg to 320 mcg bd.Some patients may require up to amax of 640 mcg bd. Adolescent 12-17 yr 160 mcg to 320 mcg bd.Children 6-11 yr 160 mcg bd, <6 yrNot recommended. Maintenance &relief: Adult ≥18 yr 320 mcg/dayeither as 160 mcg bd or 320 mcgeither morning or evening. For somepatients a maintenance dose of 320mcg bd may be appropriate.Patients should take 160 mcgadditional inhalation as needed inresponse to symptoms. If symptomspersist after a few minutes, anadditional inhalation should betaken. Not more than 960 mcgshould be taken on any singleoccasion. A total daily dose of morethan 1280 mcg is not normallyneeded, however a total daily doseof up to 1920 mcg could be used fora limited period. Patients usingmore than 1280 mcg daily shouldseek medical advice, should bereassessed & their maintenancetherapy reconsidered. Children &adolescent less than 18 yr: Notrecommended. COPD; Adult morethan or equal to 18 yr: 320 mcg bd.

208. Budesonide 500mcg/2 mlNebuliserSolution

R03BA02000A3001XX

B Maintenance treatment ofasthma as prophylactic therapyespecially if not fully controlledby bronchodilators

ADULT: Initially 1 - 2 mg twice daily.CHILD 3 months - 12 years of age :500 mcg - 1 mg. Maintenance dose :half of the above doses

209. Budesonide64mcg NasalSpray

R01AD05000A4103XX

A Seasonal allergic, perennialrhinitis and nasal polyposis

ADULT and CHILD 6 years and older.Rhinitis: 2 spray into each nostrilonce daily in the morning or 1 sprayinto each nostril twice daily. Nasalpolyps : 2 spray twice daily

210. Bumetanide 0.5mg/ml Injection

C03CA02000P3001XX

A* Oedema used in furosemideallergic patient

IV injection: 1 - 2 mg repeated after20 mins. IV infusion: 2 - 5 mg over30 - 60 mins

211. Bumetanide 1 mgTablet

C03CA02000T1001XX

A* Oedema used in furosemideallergic patient

1 mg in the early evening. Up to 5mg daily in severe cases

212. Bupivacaine0.125% EpiduralInjection

N01BB01110P3004XX

A Epidural analgesia forpostoperative pain relief.

Infuse at 6 - 15 ml/hour. Not toexceed 2 mg/kg in a single dose.

213. Bupivacaine 0.5% Heavy Injection

N01BB01110P3003XX

A Used for spinal anaesthesia ADULT: 2 - 4 ml. Not to exceed 2mg/kg in a single dose

Page 33 of 296

No. Generic Name MDC Category Indications Dosage214. Bupivacaine 0.5

% InjectionN01BB01110P3002XX

B For peripheral sympatheticnerve and epidural (excludingcaudal) anaesthesia andobstetrics anaesthesia

Regional nerve block or epiduralblock: 15 - 30 ml. Nerve block offinger or toe: 2 - 6 ml. Maximum: 2mg/kg body weight in any 4 hoursperiod, equivalent to 25 - 30 ml inadults of average weight

215. Bupivacaine 0.5% withAdrenaline1:200,000Injection

N01BB51975P3001XX

B Regional nerve block orepidural block.

10 - 40 ml (0.25 %) or maximum : 2mg/kg body weight in any 4 hoursperiod, equivalent to 25 - 30 ml of0.5% solution

216. Buprenorphine10mcg/hrtransdermalpatch

N02AE01110M7001XX

A* Treatment of non-malignantpain of moderate intensitywhen an opioid is necessary forobtaining adequate analgesia.Not suitable for the treatmentof acute pain. Restrictions: Forelderly patients or patients withcomorbidities/difficult toswallow

Once weekly transdermal patch/forhospital use only. Patient aged 18years and over. Initial dose: 5mcg/hr For elderly: Renalimpairment. No special doseadjustments necessary in patientswith renal impairment Hepaticimpairment Patients with hepaticinsufficiency should be carefullymonitored during the treatmentwith buprenorphine patch.Alternate therapy should beconsidered. Patch should be usedwith cautions in severe hepaticimpairment patient

217. Buprenorphine5mcg/hrtransdermalpatch

N02AE01110M7003XX

A* Treatment of non-malignantpain of moderate intensitywhen an opioid is necessary forobtaining adequate analgesia.Not suitable for the treatmentof acute pain. Restrictions: Forelderly patients or patients withcomorbidities/difficult toswallow

Once weekly transdermal patch/forhospital use only. Patient aged 18years and over. Initial dose: 5mcg/hr For elderly: Renalimpairment. No special doseadjustments necessary in patientswith renal impairment Hepaticimpairment Patients with hepaticinsufficiency should be carefullymonitored during the treatmentwith buprenorphine patch.Alternate therapy should beconsidered. Patch should be usedwith cautions in severe hepaticimpairment patient

218. Busulfan 2 mgTablet

L01AB01000T1001XX

A i) Chronic myeloid leukaemia(CML) and othermyeloproliferative diseasesii) Haemopoietic stem celltransplant (HSCT)- refer tospecific protocols

i) ADULT: Initial: 2 - 4 mg daily.Maintenance: 0.5 - 2 mg daily. Stopwhen white blood cell less than 20 x109/L. CHILD: 60 mcg/kg bodyweight dailyii) CHILD: Induction 60 mcg/kg bodyweight daily (maximum 4 mg) ifleucocytes more than 20,000/mm3and platelets more than100,000/mm3. Maintenance 10 -30mcg/kg (maximum 2 mg daily)

Page 34 of 296

No. Generic Name MDC Category Indications Dosage219. Busulfan 6 mg/ml

InjectionL01AB01000P3001XX

A* For use in combination withcyclophosphamide as aconditioning regimen prior toallogeneic hematopoietic stemcell transplantation (HSCT) forchronic myelogenous leukemiain selected cases with high riskof liver toxicity and intoleranceto oral busulfan. To beprescribed by paediatriconcologist and consultanthaematologist trained intransplant only.

0.8 mg/kg of ideal body weight oractual body weight, whichever islower via central venous catheter asa 2-hour infusion on the basis ofevery 6 hours for 4 days, for a totalof 16 doses. For obese or severelyobese patients, IV Busulfan shouldbe administered based on adjustedideal body weight

220. Cabergoline 0.5mg Tablet

G02CB03000T1001XX

A* i) Treatment ofhyperprolactinaemic disordersii) Prevention of puerperallactation and suppression oflactation in HIV infectedmothers only

i) 0.5mg per week given in 1 or 2(one-helf of one 0.5mg tablet) dosesper weekii) HIV mothers only: Preventlactation 2 tab first day afterdelivery. Interruption of laction :0.25mg 12 hourly for 2 days

221. Calamine Cream D04AX00000G1001XX

C+ Soothes and relieves nappyrashes, prickly heat, minor skinirritations, insect bites andsunburn, Pruritic skinconditions.

Apply to the affected area asrequired, 1-3 times daily

222. Calamine Lotion D04AX00000L8001XX

C+ Soothes and relieves nappyrashes, prickly heat, minor skinirritations, insect bites andsunburn, Pruritic skinconditions.

Apply to the skin as required andallow to dry, 1-3 times daily

223. Calamine with0.25 - 0.5%Menthol Lotion

D04AX00952L6001XX

C Soothes and relieves nappyrashes, prickly heat, minor skinirritations, insect bites andsunburn, Pruritic skinconditions.

Apply to the skin as required andallow to dry, 1 - 3 times daily

224. Calamine with0.5% PhenolCream

D04AX00952G1001XX

C For use as a mild astringent Apply to the affected area asrequired

225. Calamine with 2 -6% PrecipitatedSulphur Lotion

D04AX00952L6002XX

C Acne vulgaris Apply to the skin as required andallow to dry, 1 - 3 times daily

226. Calcipotriol 50mcg/g Cream

D05AX02000G1001XX

A* Only for the treatment ofPsoriasis Vulgaris

ADULT Apply to the affected skinlesions twice daily. Maintenancetherapy may be achieved with lessfrequent application. The weeklydose should not exceed 100 g.CHILD over 6 years, apply twicedaily. 6-12 years maximum 50gmweekly, over 12 years maximum75gm weekly

Page 35 of 296

No. Generic Name MDC Category Indications Dosage227. Calcipotriol 50

mcg/g OintmentD05AX02000G5001XX

A* Only for the treatment ofPsoriasis Vulgaris

ADULT Apply to the affected skinlesions twice daily. Maintenancetherapy may be achieved with lessfrequent application. The weeklydose should not exceed 100 g.CHILD over 6 years, apply twicedaily. 6-12 years maximum 50gmweekly, over 12 years maximum75gm weekly

228. Calcipotriol 50mcg/ml ScalpSolution

D05AX02000L9901XX

A* Only for the treatment ofPsoriasis Vulgaris

Apply to scalp twice daily. Maximum60 mL weekly.

229. CalcipotriolHydrate 50 mcg/g&BetamethasoneDipropionate 0.5mg/g Ointment

D05AX52952G5001XX

A* Resistant plaque psoriasis Apply once daily up to 4 weeks withmaximum weekly dose of 100g andmaximum treatment area 30% ofbody surface

230. Calcipotriolmonohydrate 50mcg/g andBetamethasonedipropionate 0.5mg/g Gel

D05AX52952G3001XX

A* Topical treatment of scalp andnon-scalp plaque psoriasisvulgaris in adults

Should be applied to affected areasonce daily. The recommendedtreatment period is 4 weeks forscalp areas and 8 weeks for non-scalp areas. The body surface areatreated with calcipotriol containingproducts should not exceed 30%and maximum dose should notexceed 15g or 100g/ week

231. Calcitonin(syntheticSalmon) 100 IUInjection

H05BA01000P3002XX

A* Acute hypercalcaemia 5-10 IU per kg body weight in 500mLphysiological saline daily by i.v.infusion over at least 6 hours or byslow i.v. injection in 2-4 divideddoses spread over the day. Renalimpairment: Dosage adjustmentneeded.

232. Calcitonin(SyntheticSalmon) 50 IUInjection

H05BA01000P3001XX

A* Acute hypercalcaemia 5-10 IU per kg body weight in 500mLphysiological saline daily by i.v.infusion over at least 6 hours or byslow i.v. injection in 2-4 divideddoses spread over the day. Renalimpairment: Dosage adjustmentneeded.

233. Calcitriol 0.25mcg Capsule

A11CC04000C1001XX

A/KK i) Establishedpostmenopausalosteoporosis

ii) Renal osteodystrophy inpatients on haemodialysis

iii) Hypoparathyroidism andrickets

iv) Secondaryhyperparathyroidism inrenal failure

i) 0.25 mcg 2 times daily;ii) Initial dose 0.25 mcg. In patientswith normal or only slightly reducedserum calcium levels, doses of 0.25mcg every other day is sufficientiii) 0.25 mcg/day given in themorningiv) ADULT and CHILD 3 years andolder : Initially 0.25 mcg/ml. CHILDless than 3 years : 10 to 15ng/kg/day

Page 36 of 296

No. Generic Name MDC Category Indications Dosage234. Calcitriol 1

mcg/ml InjectionA11CC04000P3001XX

A* Management of hypocalcaemiaand/or secondaryhyperparathyroidism in patientsundergoing chronic renaldialysis

Initially dose, depending on severity,1 mcg (0.02 mg/kg) to 2 mcg 3 timesweekly, approximately every otherday

235. Calcitriol 2mcg/ml Injection

A11CC04000P3002XX

A* Management of hypocalcaemiaand/or secondaryhyperparathyroidism in patientsundergoing chronic renaldialysis

Initially dose, depending on severity,1 mg (0.02 mg/kg) to 2 mg 3 timesweekly, approximately every otherday

236. CalciumCarbonate 500mg Capsule

A12AA04121C1001XX

B To be used only for:a. Hyperphosphatemia

(phosphate binder) inchronic renal failurepatients

b. Calcium supplementation

a) Hyperphosphatemia:i) Stage 3 to 5 chronic kidney

disease, total dose of elementalcalcium from all sources (ie,dietary and calcium-basedphosphate binder) not toexceed 2,000 mg/day

ii) Stage 5 chronic kidney disease,total dose of elemental calciumfrom calcium-based phosphatebinder not to exceed 1,500mg/day

b) Calcium supplementation 1,000-2,500mg elemental calcium per dayin divided doses (500mg capsulecontains 200mg elemental calcium)

237. CalciumCarbonate 500mg Tablet

A12AA04121T1001XX

B To be used only for:a. Hyperphosphatemia

(phosphate bindingactivity) in patients withchronic renal failure

b. b) Calciumsupplementation

a) Hyperphosphatemia:iii) Stage 3 to 5 chronic kidney

disease, total dose of elementalcalcium from all sources (ie,dietary and calcium-basedphosphate binder) not toexceed 2,000 mg/day

iv) Stage 5 chronic kidney disease,total dose of elemental calciumfrom calcium-based phosphatebinder not to exceed 1,500mg/day

b) Calcium supplementation 1,000-2,500mg elemental calcium per dayin divided doses (500mg capsulecontains 200mg elemental calcium)

238. Calcium ChlorideDihydrate,Sodium Chloride,MagnesiumChlorideHexahydrate,Sodium AcetateTrihydrate,Potassium Chloride, andMalic AcidSolution

B05BB01905P6002XX

A Replacement of extracellularfluid losses in the case ofisotonic dehydration, whereacidosis is present or imminent.

The maximum infusion rate dependson the needs of the patient in fluidreplacement and electrolytes,patient’s weight, clinical condition,and biological status. Adults, elderly,adolescents:500ml-3L/24hr. Babies,children: 20ml to 100ml/kg/24 hr.

Page 37 of 296

No. Generic Name MDC Category Indications Dosage239. Calcium Disodium

Edetate 200 mgInjection

V03AB03999P3001XX

A Lead Poisoning IM (Lead encephalopathy): 1000mg/m(2)/day IM in divided equaldoses 8 to 12 hours apart, for 5days. Therapy is interrupted for 2 to4 days, and followed by anadditional 5-day course of therapy,if indicated. Do not exceed therecommended daily dosage. IV:1000 mg/m(2)/day administered IVover 8 to 12 hours for 5 days.Therapy is interrupted for 2 to 4days, and followed by an additional5-day course of therapy, if indicated.

240. CalciumGluconate 10%Injection

A12AA03000P3001XX

B i) Acute hypocalcaemiaii) Hypocalcaemic tetanyiii) Cardiac resuscitation

i) 1-2 g (2.25-4.5 mmol). CHILD 50mg/kg

ii) ADULT 1g (2.2 mmol) by slow IVinjection followed bycontinuous infusion of 4 g (8.8mmol) daily

iii) IV or intracardiac injection, 10ml

241. Calcium Lactate300 mg Tablet

A12AA05125T1001XX

C For prophylaxis of calciumdeficiency and treatment ofchronic hypocalcaemia

ADULT 1-5 g daily in divided doses

242. CalciumPolystyreneSulphonatePowder

V03AE01999F2101XX

A Hyperkalemia resulting fromacute or chronic renal failure

15 - 30g daily in 2-3 divided doses.Each dose should be suspended in30 - 50ml of water and administeredorally

243. Capecitabine 150mg Tablet

L01BC06000T1002XX

A* i) Metastatic breast cancer inelderly and poorperformance statuspatients and refractory totaxanes.

ii) Metastatic colon cancer,first line in elderly and poorperformance statuspatients.

iii) Colon cancer, adjuvanttherapy for stage III (Duke'sStage C) following surgery.

iv) First line treatment ofpatients with advancedgastric cancer incombination with aplatinum-based regimen

i) & ii) 1250 mg/m2 twice daily(morning and evening) for 2 weeks,every 21 days.iii) Recommended for a total of 24weeks (8 cycles of 2 weeks of drugadministration and 1 week restperiod.iv) In combination with platinum onday 1, give capecitabine 1250mg/m2 twice daily for 14 days.Repeated every 3 weeks for 8 cyclesor optimum number of cycles

Page 38 of 296

No. Generic Name MDC Category Indications Dosage244. Capecitabine 500

mg TabletL01BC06000T1001XX

A* i) Metastatic breast cancer inelderly and poorperformance statuspatients and refractory totaxanes;

ii) Metastatic colon cancer,first line in elderly and poorperformance statuspatients;

iii) Colon cancer, adjuvanttherapy for stage III (Duke'sStage C) following surgery;

iv) First line treatment ofpatients with advancedgastric cancer incombination with aplatinum-based regimen.

i) & ii) 1250 mg/m2 twice daily(morning and evening) for 2 weeks,every 21 days;iii) Recommended for a total of 24weeks (8 cycles of 2 weeks of drugadministration and 1 week restperiod;iv) In combination with platinum onday 1, give capecitabine 1250mg/m2 twice daily for 14 days.Repeated every 3 weeks for 8 cyclesor optimum number of cycles

245. Captopril 25 mgTablet

C09AA01000T1002XX

B i) Hypertensionii) Congestive heart failureiii) Post-myocardial infarctioniv) Diabetic nephropathy

i) Initially 12.5 mg twice daily.Maintenance: 25-50 mg 2 - 3times daily, may be increased tomaximum 450 mg/day individed doses;

ii) Initially 6.25 - 12.5 mg 3 timesdaily, increase after severaldays to 25 - 50 mg 3 times daily;

iii) Start 3 days after MI Initially6.25 mg daily, graduallyincreased to 37.5 mg daily individed doses. May increaseafter several week to 150mg/day in divided doses ifneeded and tolerated;

iv) 75 - 100 mg daily in divideddose.

246. Carbachol 0.01%IntraocularSolution

S01EB02100D2001XX

A For intraocular use for miosisduring surgery

Instill no more than 0.5 ml gentlyinto the anterior chamber

247. Carbamazepine100 mg/5 ml (2%w/v) Syrup

N03AF01000L9001XX

A Epilepsy ADULT: Initially, 100-200 mg once ortwice daily gradually increased byincrements of 100-200 mg every 2week. Maintenance: 0.8-1.2 g dailyin divided doses. CHILD: 10-15years: 0.6-1 g daily; 5-10 years: 400-600 mg daily; 1-5 years: 200-400 mgdaily; less than or equal to 1 year:100-200 mg daily. Alternatively, 10-20 mg/kg body weight daily individed doses. Max: Adult: 1.6 gdaily

Page 39 of 296

No. Generic Name MDC Category Indications Dosage248. Carbamazepine

200 mg CR TabletN03AF01000T5001XX

A Epilepsy ADULT: Initial, 200 mg twice dailyfor the first week, may increasedosage by 200 mg/day at weeklyintervals until optimal response isobtained. Maximum 1.6 g/day.CHILD: usual maximum dosage 1000mg/day in children 12-15 years ofage, 1200 mg/day in patients above15 years of age

249. Carbamazepine200 mg Tablet

N03AF01000T1001XX

B i) Epilepsyii) Trigeminal neuralgia

i) ADULT: 100 - 200 mg 1 - 3 timesdaily increased gradually tousual dose of 0.8 - 1.2 g daily individed doses. CHILD: Up to 1year: 100 - 200 mg daily; 1 - 5yrs: 200 - 400 mg daily; 5 - 10years: 400 - 600 mg daily; 10 -15 years: 0.6 - 1 g daily;

ii) The initial dosage of 200 to400mg should be slowly raiseddaily until freedom from pain isachieved (normally at 200mg 3to 4 times daily). The dosageshould then be graduallyreduced to the lowest possiblemaintenance level. In elderlypatients, an initial dose of100mg twice daily isrecommended.

250. Carbamazepine400 mg CR Tablet

N03AF01000T5002XX

A Epilepsy ADULT: Initial, 200 mg twice dailyfor the first week, may increasedosage by 200 mg/day at weeklyintervals until optimal response isobtained. Maximum 1.6 g/day.CHILD: usual maximum dosage 1000mg/day in children 12-15 years ofage, 1200 mg/day in patients above15 years of age

251. Carbamide (Urea)10 % Cream

D02AE01000G1001XX

B Contact irritant dermatitis,infantile eczemas, acute andchronic allergic eczemas,icthyosis, hyperkeratotic

Apply sparingly and rub intoaffected area 2 - 3 times daily andwhen required after cleansing skin

252. Carbetocin 100mcg/ ml Injection

H01BB03000P2001XX

A* Prevention of uterine atony andpostpartum hemorrhagefollowing elective cesareansection under epidural or spinalanaesthesia

A single IV dose of 100mcg (1ml) isadminitered by bolus injection,slowly over 1minute, only whendelivery of the infant has beencompleted by caesarean sectionunder epidural or spinalanaesthesia, before or after deliveryof the placenta.

Page 40 of 296

No. Generic Name MDC Category Indications Dosage253. Carbimazole 5 mg

TabletH03BB01000T1001XX

B Hyperthyroidism ADULT: Initially, 10-60mg daily individed doses given 8 hourly.Maintenance: 5 to 20mg daily.CHILDREN > 6 years: Initially 15mgdaily in divided doses. CHILDREN 1-6years: Initially 7.5mg daily in divideddoses

254. Carboplatin 150mg Injection

L01XA02000P4001XX

A* Adult solid tumours, paediatrictumours. Salvage therapy forlymphoma

360 - 400 mg/m2 BSA, by IV infusionover 15 mins to 1 hour on Day 1every 4 weeks. Alternatively,prescription may be based on AreaUnder Curve (AUC) calculations.CHILD: 500-600 mg/m2 over 1 houronce every 3 weeks. Salvageregimes in lymphomas - refer tospecific protocols. Starting dose inrenal impairment, please refer toproduct insert.

255. Carboplatin 450mg Injection

L01XA02000P4002XX

A* Adult solid tumours, paediatrictumours. Salvage therapy forlymphoma

360 - 400 mg/m2 BSA, by IV infusionover 15 mins to 1 hour on Day 1every 4 weeks. Alternatively,prescription may be based on AreaUnder Curve (AUC) calculations.CHILD: 500-600 mg/m2 over 1 houronce every 3 weeks. Salvageregimes in lymphomas - refer tospecific protocols. Starting dose inrenal impairment, please refer toproduct insert.

256. CarboprostTromethamine250 mcg Injection

G02AD04999P3001XX

A* Postpartum haemorrhagerefractory to oxytocin

Initially 250 mcg deep IM inj. Thedose may be repeated at intervals of15-90 min if necessary. Max totaldose: 2 mg.

257. CardioplegiasolutioncontainingPotassiumChloride,Magnesiumchloride &Procaine HClInjection

B05XA16934P3001XX

A* For myocardialpreservation(preventmyocardial damage) duringcardiac surgery

Dilute 20 ml to 1 L of Ringer solution(cooled to 2-8 ∞C prior to use).Initial rapid instillation into aorticroot at 300 ml/m≤ body surfacearea/min for 3 minutes. Shouldmyocardial activity persist or recurinstill at 300ml/m≤ body surfacearea/min for 2 minutes

258. Carvedilol 25 mgTablet

C07AG02000T1002XX

A/KK Treatment of stable moderateto severe congestive cardiacfailure in addition to ACEI's anddiuretics

3.125 mg twice daily for 2 weeks,then 6.25 mg twice daily for 2weeks, then 12.5 mg twice daily for2 weeks then 25 mg twice daily(titrated up to the highest toleratedlevel). Max: <85 kg: 25 mg bid; >85kg: 50 mg bid.

Page 41 of 296

No. Generic Name MDC Category Indications Dosage259. Carvedilol 6.25

mg TabletC07AG02000T1001XX

A/KK Treatment of stable moderateto severe congestive cardiacfailure in addition to ACEI's anddiuretics

3.125 mg twice daily for 2 weeks,then 6.25 mg twice daily for 2weeks, then 12.5 mg twice daily for2 weeks then 25 mg twice daily(titrated up to the highest toleratedlevel). Max: <85 kg: 25 mg bid; >85kg: 50 mg bid.

260. CaspofunginAcetate 50 mgInjection

J02AX04122P4001XX

A* i) Confirmed systemic fungalinfection in patients whoare refractory or intolerantto other fungal therapies.

ii) For pediatric patient (12month and older) for thefollowing indications :a. Empirical therapy for

presumed fungalinfections in febrile,neutropenic patients

b. Treatment of invasivecandidiasis, includingcandidemia and thefollowing Candidainfections ; intra-abdominal abscesses,peritonitis and pleuralspace infections

c. Treatment ofesophageal candidiasis

d. d) Treatment ofinvasive Aspergillosisin patients who arerefractory to orintolerant of otherstherapy (eg :Amphotericin B)

i) Invasive aspergillosis & invasivecandidiasis: ADULT: Initially, 70mg infused over 1 hourfollowed by subsequent dosesof 50 mg/day. Oesophagealcandidiasis: ADULT: 50 mg byslow IV infusion overapproximately 1 hour;

ii) For all indications, a loadingdose of 70mg/m2 on D1followed by maintenance doseof 50mg/m2 od.

261. CaspofunginAcetate 70 mgInjection

J02AX04122P4002XX

A* i) Confirmed systemic fungalinfection in patients whoare refractory or intolerantto other fungal therapies.

ii) For pediatric patient (12month and older) for thefollowing indications :a. Empirical therapy for

presumed fungalinfections in febrile,neutropenic patients

b. Treatment of invasivecandidiasis, includingcandidemia and thefollowing Candidainfections ; intra-abdominal abscesses,peritonitis and pleural

i) Invasive aspergillosis & invasivecandidiasis: ADULT: Initially, 70mg infused over 1 hourfollowed by subsequent dosesof 50 mg/day. Oesophagealcandidiasis: ADULT: 50 mg byslow IV infusion overapproximately 1 hour daily

ii) Child (12months to 17 years) :For all indication) A single70mg/m2 loading dose (not toexceed an actual dose of 70mg)by slow IV infusion over 1hour;followed by 50mg/m2 (not toexceed an actual dose of 70mg)

Page 42 of 296

No. Generic Name MDC Category Indications Dosagespace infections

c. Treatment ofesophageal candidiasis

d. d) Treatment ofinvasive Aspergillosisin patients who arerefractory to orintolerant of otherstherapy (eg :Amphotericin B)

262. Cefaclor 125mg/5 mlSuspension

J01DC04000F2101XX

A Infections caused by susceptibleorganisms includingStaphylococcus aureus and H.influenzae, treatment ofsinusitis and infections involvingthe respiratory tract, skin andskin structure, bone and joint,and urinary tract

CHILD :>1 mth: 20 mg/kg daily in 3divided doses, increased to 40mg/kg daily if necessary, <1 yr: 62.5mg tid, 1-5 yr: 125 mg tid, >5 yr: 250mg tid. Maximum: 1 g daily

263. Cefaclor 375 mgMR Tablet

J01DC04010T5001XX

A i) Adult pharyngitis,tonsillitis, skin& soft tissueinfections;

ii) Bronchitis;iii) Pneumonia;iv) Lower UTI.

i) 375 mg twice dailyii) 375 mg or 500 mg twice dailyiii) 750mg twice dailyiv) 375mg twice daily or 500 mg

once daily

264. Cefaclor 500 mgCapsule

J01DC04000C1002XX

A Infections caused by susceptibleorganisms includingStaphylococcus aureus and H.influenzae, treatment ofsinusitis and infections involvingthe respiratory tract, skin andskin structure, bone and joint,and urinary tract

ADULT: 250 mg 3 times daily for 10days. For severe infections, doublethe dosage. Maximum: 4 g daily.CHILD :>1 mth: 20 mg/kg daily in 3divided doses, increased to 40mg/kg daily if necessary, <1 yr: 62.5mg tid, 1-5 yr: 125 mg tid, >5 yr: 250mg tid . Maximum: 1 g daily

265. Cefazolin Sodium1 g Injection

J01DB04520P3001XX

A Infection caused by cefazolin-sensitive microorganism,infection of the respiratorytract, urogenital tract, skin andsoft tissue, bile duct, bones andjoint, endocarditis, systemicseptic infection, peri-operative/surgical prophylaxis

ADULT: Uncomplicated infections:500 - 1000 mg 2 - 3 times daily.Moderately severe and severeinfections: 500 - 1000 mg 3 - 4 timesdaily. Severe life-threateninginfections: 1 - 1.5 g 4 times daily.Rarely, dose up to 12 g daily.CHILDREN >1 month: 25-50mg/kg/day in 3-4 divided dose

266. Cefepime 1 gInjection

J01DE01110P4002XX

A* Febrile neutropenia,septicaemia, lower respiratorytract infection, urinary tractinfection, skin and skinstructure infections,gynaecologic and intra-abdominal infections

ADULT: 1 - 2 g twice daily for mostinfections. For severe infectionsincluding febrile neutropenia: 2 g 3times daily. CHILD:2 mth - 16 yr: ≤40kg: 50 mg/kg every 8-12 hr for 7-10days

267. Cefepime 500 mgInjection

J01DE01110P4001XX

A* Febrile neutropenia,septicaemia, lower respiratorytract infection, urinary tractinfection, skin and skinstructure infections,

ADULT: 1 - 2 g twice daily for mostinfections. For severe infectionsincluding febrile neutropenia: 2 g 3times daily. CHILD: 2 mth - 16 yr:≤40 kg: 50 mg/kg every 8-12 hr for

Page 43 of 296

No. Generic Name MDC Category Indications Dosagegynaecologic and intra-abdominal infections

7-10 days

268. CefoperazoneSodium 1 gInjection

J01DD12520P4002XX

A Infections due to gram-negativebacteria

ADULT: 1 - 2 g twice daily IM or IV.By IV, adult dose may be doubled.Maximum: 16 g daily in divideddoses. CHILD & INFANT: 50 - 200mg/kg/day in 2 - 4 divided doses.NEONATE less than 8 days: 50 - 200mg/kg/day 12 hourly

269. CefoperazoneSodium 2 gInjection

J01DD12520P4003XX

A Infections due to gram-negativebacteria

ADULT: 1 - 2 g twice daily IM or IV.By IV, adult dose may be doubled.Maximum: 16 g daily in divideddoses. CHILD & INFANT: 50 - 200mg/kg/day in 2 - 4 divided doses.NEONATE less than 8 days: 50 - 200mg/kg/day 12 hourly

270. CefoperazoneSodium 500 mg &SulbactamSodium 500 mgInjection

J01DD62000P4001XX

A i) Treatment of infectionsdue to multi-drugresistance pathogensproducing B-lactamase;

ii) Treatment of infectionscaused by Acinetobacterspecies

ADULT: 1 - 2 g twice daily. In severeor refractory infections the dailydosage of sulbactam/cefoperazonemay be increased up to 8g (4gcefopreazone activity) CHILD: 40 -80 mg/kg/day in 2 to 4 equallydivided doses; in serious orrefractory infections, may increaseto 160mg/kg/d in 2 - 4 equallydivided doses.

271. CefoperazoneSodium 500 mgInjection

J01DD12520P4001XX

A Infections due to gram-negativebacteria

ADULT: 1 - 2 g twice daily IM or IV.By IV, adult dose may be doubled.Maximum: 16 g daily in divideddoses. CHILD & INFANT: 50 - 200mg/kg/day in 2 - 4 divided doses.NEONATE less than 8 days: 50 - 200mg/kg/day 12 hourly

272. Cefotaxime 1 gInjection

J01DD01520P4002XX

A Infections due to gram-negativebacteria

ADULT: 1 g 12 hourly (up to 12g/day in severe cases). CHILD: 50 -180 mg/kg/day in 4 - 6 divided doses

273. Cefotaxime 500mg Injection

J01DD01520P4001XX

A Infections due to gram-negativebacteria

ADULT: 1 g 12 hourly (up to 12g/day in severe cases). CHILD: 50 -180 mg/kg/day in 4 - 6 divided doses

274. CeftarolineFosamil 600mgPowder forconcentrate forsolution forinfusion

J01D102000P4001XX

A* Treatment of complicated skinand soft tissue infections (cSSTI)in adults Restriction: Restrictedfor only complicated SSTI inpatients who are unable totolerate or not responding tovancomycin.

600mg administered every 12 hoursby intravenous infusion over 60minutes for 5-14 days. Doseadjustment in renal impairment: -CrCl > 30 to ≤50 ml/min : 400mg (IV)every 12 hours (over 60 minutes) -CrCl ≥ 15 ≤ 30 ml/min: 300mg (IV)every 2 hoours (over 60 minutes) -CrCl < 30ml/min includinghemodialysis*: 200mg (IV) every 12hours (over 60 minutes) *Ceftaroline is hemodialyzable, thusshould be administered afterhemodialysis.

Page 44 of 296

No. Generic Name MDC Category Indications Dosage275. Ceftazidime 1 g

InjectionJ01DD02520P4003XX

A Severe gram negative bacterialinfections

ADULT: 1 g 8 hourly or 2 g 12 hourly.In severe infections: 2 g 8 hourly.CHILD: 25 - 150 mg/kg/day in 2 - 3divided doses

276. Ceftazidime 2 gInjection

J01DD02520P4004XX

A Severe gram negative bacterialinfections

ADULT: 1 g 8 hourly or 2 g 12 hourly.In severe infections: 2 g 8 hourly.CHILD: 25 - 150 mg/kg/day in 2 - 3divided doses

277. Ceftazidime 250mg Injection

J01DD02520P4001XX

A Severe gram negative bacterialinfections

ADULT: 1 g 8 hourly or 2 g 12 hourly.In severe infections: 2 g 8 hourly.CHILD: 25 - 150 mg/kg/day in 2 - 3divided doses

278. Ceftazidime 500mg Injection

J01DD02520P4002XX

A Severe gram negative bacterialinfections

ADULT: 1 g 8 hourly or 2 g 12 hourly.In severe infections: 2 g 8 hourly.CHILD: 25 - 150 mg/kg/day in 2 - 3divided doses

279. Ceftriaxone 0.25g Injection

J01DD04520P4001XX

A/KK i) Gonorrhoeaii) Chancroid

i) 250 mg by deep IM injectionii) single IM injection 250 mg only.For severe infection up to 100mg/kg/day

280. Ceftriaxone 0.5 gInjection

J01DD04520P4002XX

A Infections caused by susceptibleorganisms

ADULT: 1 - 2 g once daily. Severeinfection: 4 g daily at 12 hourintervals. INFANT & CHILD, 3 weeks -12 years: 20 - 80 mg/kg body weightdaily. CHILD with body weight 50 kgor more: adult dose. NEONATE up to2 weeks: 20 - 50 mg/kg body weightdaily, not to exceed 50 mg/kg

281. Ceftriaxone 1gInjection

J01DD04520P4003XX

A Infections caused by susceptibleorganisms

ADULT: 1 - 2 g once daily. Severeinfection: 4 g daily at 12 hourintervals. INFANT & CHILD, 3 weeks -12 years: 20 - 80 mg/kg body weightdaily. CHILD with body weight 50 kgor more: adult dose. NEONATE up to2 weeks: 20 - 50 mg/kg body weightdaily, not to exceed 50 mg/kg

282. Cefuroxime Axetil125 mg Tablet

J01DC02233T1001XX

A/KK Upper and lower respiratorytract, genito-urinary tract, skin& soft tissue and urinary tractinfections (UTI)

ADULT: 250 mg twice daily; UTI: 125mg twice daily. CHILD:30 mg/kg/dayin 2 divided doses, up to 500 mgdaily

283. Cefuroxime Axetil125 mg/5 mlSuspension

J01DC02233F2101XX

A Infections caused by susceptibleorganisms

30 mg/kg/day in 2 divided doses, upto 500 mg daily.

284. Cefuroxime Axetil250 mg Tablet

J01DC02233T1002XX

A/KK Upper and lower respiratorytract, genito-urinary tract, skin& soft tissue and urinary tractinfections (UTI)

ADULT: 250 mg twice daily; UTI: 125mg twice daily. CHILD:30 mg/kg/dayin 2 divided doses, up to 500 mgdaily

285. CefuroximeSodium 1.5 gInjection

J01DC02520P4003XX

A Infections caused by susceptibleorganisms, surgical prophylaxis

ADULT: 750 mg every 6 - 8 hours asIM or IV. Severe infections: 1.5 gevery 6 - 8 hours as IV. CHILD: 30 -100 mg/kg/day in 3 - 4 divided dosesor 2-3 divided doses in neonates.Surgical prophylaxis: 1.5 g IV

Page 45 of 296

No. Generic Name MDC Category Indications Dosage286. Cefuroxime

Sodium 250 mgInjection

J01DC02520P4001XX

A Infections caused by susceptibleorganisms, surgical prophylaxis

ADULT: 750 mg every 6 - 8 hours asIM or IV. Severe infections: 1.5 gevery 6 - 8 hours as IV. CHILD: 30 -100 mg/kg/day in 3 - 4 divided dosesor 2-3 divided doses in neonates.Surgical prophylaxis: 1.5 g IV

287. CefuroximeSodium 750 mgInjection

J01DC02520P4002XX

A Infections caused by susceptibleorganisms, surgical prophylaxis

ADULT: 750 mg every 6 - 8 hours asIM or IV. Severe infections: 1.5 gevery 6 - 8 hours as IV. CHILD: 30 -100 mg/kg/day in 3 - 4 divided dosesor 2-3 divided doses in neonates.Surgical prophylaxis: 1.5 g IV

288. Celecoxib 200 mgCapsule

M01AH01000C1001XX

A i) Osteoarthritisii) Rheumatoid Arthritisiii) Acute painiv) Ankylosing Spondylitis

i) ADULTS: 200 mg once daily.May increase to 200 mg bid, ifnecessary. CHILD notrecommended.

ii) 100mg twice daily, increased ifnecessary to 200 mg 2 timesdaily; CHILD not recommended.

iii) 400mg as a single dose on firstday followed by 200mg oncedaily on subsequent days.

iv) iv) Initial, 200 mg once daily or100 mg twice daily; if no effectafter 6 weeks, may increase tomax. 400 mg daily in 1-2 divideddoses. If no response following2 weeks of treatment with 400mg/day, considerdiscontinuation and alternativetreatment.

289. Celecoxib 400 mgCapsule

M01AH01000C1002XX

A* i) Osteoarthritisii) Rheumatoid Arthritisiii) Acute painiv) Ankylosing Spondylitis

i) ADULTS: 200 mg once daily.CHILD not recommended.

ii) 100 mg twice daily, increased ifnecessary to 200 mg 2 timesdaily; CHILD not recommended.

iii) 400 mg as a single dose on firstday followed by 200 mg oncedaily on subsequent days.

iv) Initial, 200 mg once daily or 100mg twice daily; if no effect after6 weeks, may increase to max.400 mg daily in 1-2 divideddoses. If no response following2 weeks of treatment with 400mg/day, considerdiscontinuation and alternativetreatment

290. CephalexinMonohydrate125 mg/5 mlSyrup

J01DB01010F2101XX

B Respiratory tract infections, ear,nose and throat infections,urinary tract infections,obstetric and gynaecologicinfections

CHILD: 25 - 100 mg/kg/day every 6hourly. Maximum: 4 g daily

Page 46 of 296

No. Generic Name MDC Category Indications Dosage291. Cephalexin

Monohydrate250 mg Capsule

J01DB01010C1001XX

B i) Respiratory tract infection,urinary tract infection ii)Complicated, recurrent orchronic infections, bronchitis iii)Pneumonia

i) 250 mg 6 hourly ii) 250 - 500 mg 6hourly iii) 1 - 1.5 g 3 times daily or 4times daily. Maximum: 6 g/dayChild: 25-100 mg/kg daily in divideddoses. Max: 4 g daily.

292. CephalexinMonohydrate250 mg Tablet

J01DB01010T1001XX

B i) Respiratory tract infection,urinary tract infection ii)Complicated, recurrent orchronic infections, bronchitis iii)Pneumonia

i) 250 mg 6 hourly ii) 250 - 500 mg 6hourly iii) 1 - 1.5 g 3 times daily or 4times daily. Maximum: 6 g/dayChild: 25-100 mg/kg daily in divideddoses. Max: 4 g daily.

293. CephalexinMonohydrate500 mg Capsule

J01DB01010C1002XX

B i) Respiratory tract infection,urinary tract infection ii)Complicated, recurrent orchronic infections, bronchitis iii)Pneumonia

i) 250 mg 6 hourly ii) 250 - 500 mg 6hourly iii) 1 - 1.5 g 3 times daily or 4times daily. Maximum: 6 g/day

294. CephalexinMonohydrate500 mg Tablet

J01DB01010T1002XX

B i) Respiratory tract infection,urinary tract infection ii)Complicated, recurrent orchronic infections, bronchitis iii)Pneumonia

i) 250 mg 6 hourly ii) 250 - 500 mg 6hourly iii) 1 - 1.5 g 3 times daily or 4times daily. Maximum: 6 g/dayChild: 25-100 mg/kg daily in divideddoses. Max: 4 g daily.

295. Cetirizine HCl 10mg Tablet

R06AE07110T1001XX

A/KK Urticaria, allergic dermatoses(insect bites, atopic eczema),perennial rhinitis, allergicrhinitis

ADULT and CHILD over 6 years:10mg daily or 5 mg twice daily. Child 2-6 years: 5 mg once daily or 2.5 mgtwice daily

296. Cetrimide 1-2%Lotion.

D08AJ04000L6001XX

C+ As shampoo and cleansingagent

Apply to affected area

297. Cetrorelix 0.25mg Injection

H01CC02122P4001XX

A* Prevention of prematureovulation in patientsundergoing a controlled ovarianstimulation, followed by oocytepick-up and assistedreproductive techniques

Given by SC 0.25 mg/day, giveneither in the morning beginning onthe day 5 or 6 of ovarian stimulationor in the evening beginning on day5, and continued until ovulationinduction

298. Cetuximab 5mg/ml Solutionfor Infusion

L01XC06000P5002XX

A* For neo-adjuvant treatment ofKRAS wild type metastaticcolorectal cancer with the aimof liver resection with thefollowing conditions: i) Theprimary colorectal tumour hasbeen resected or is potentiallyresected. ii)The metastaticdisease is confined to the liverand is unresectable iii) Thepatient is fit enough to undergosurgery to resect the primarycolorectal tumour and toundergo liver surgery if themetastases become resectableafter treatment withcetuximab. iv)The treatment islimited to 16 weeks

Administered once a week. The veryfirst dose is 400mg cetuximab perm2 body surface area with arecommended infusion period of120 minutes. All subsequent weeklydoses are 250mg per m2 bodysurface area each with arecommended infusion period of 60minutes. The maximum infusionrate must not exceed 10mg/min.

Page 47 of 296

No. Generic Name MDC Category Indications Dosage299. Charcoal,

Activated 250 mgTablet

A07BA01000T1001XX

C i) Diarrhoea and food poisoningii) Reduce absorption of drugs,plant, inorganic poison andchemicals in poisoning cases

i) ADULT 0.5-1 g given 3-4 timesdaily. CHILD half adult dose. ii) Needto be dissolved in liquid (slurryconsistency). ADULT and CHILD over12 years: initial 30-100 g or 1-2 g/kg;repeat initial dose as soon aspossible or 20-50 g every 2-6 hours.CHILD over 1-12 years, 25-50 g or 1-2 g/kg; may repeat half the initialdose every 2-6 hour as needed.CHILD to 1 year of age, 1 g/kg; mayrepeat half the initial dose every 2-6hours as needed. For maximumefficacy administer within 1 hourafter ingestion of toxic compound

300. Charcoal,Activated 50 gGranules

A07BA01000F1001XX

A Emergency treatment of acuteoral poisoning and drugoverdose

ADULT:Acute poisoning: 50 - 100g insuspension. Severe poisoning: 50 -100g as an initial dose followed by20g every 4 - 6 hours. CHILDREN:1g/kg/dose

301. Chloral Hydrate200 mg/5 mlMixture

N05CC01010L2101XX

B Preoperative sedation ADULT : 0.5 - 1 g (max 2 g) withplenty of water at bedtime. CHILD :Neonate: 30-50 mg/kg; up to 100mg/kg may be used with respiratorymonitoring. 1 mth-12 yr: 30-50mg/kg (max: 1 g); up to 100 mg/kg(max: 2 g) may be used; 12-18 yr: 1-2 g. Doses to be taken 45-60minutes before procedure. May begiven rectally if oral route is notavailable.

302. Chlorambucil 2mg Tablet

L01AA02000T1001XX

A Low grade lymphoma, chroniclymphocytic leukaemia. Ovariancancer

General : Initial :0.1 -0.2 mg/kg bodyweight daily for 4 - 8 weeksmaintanance : given either byreduced daily dosage or intermittentcourse of treatment. ChronicLymphocytic Leukaemia: initial :0.15mg/kg/day untill total leukocytecount has fallen to 10,000peruL,then resumed treatment untill 4weeks after the end of the firstcourse then continued at a dosage0.1mg/kg/day.

303. Chloramphenicol0.5% Eye Drops

S01AA01000D2001XX

C Broad spectrum antibiotic insuperficial eye infections

Instill 1 drop of a 0.5% solutionevery 2 hr. Increase dosage intervalupon improvement. To continuetreatment for at least 48 hr aftercomplete healing

304. Chloramphenicol1% Eye Ointment

S01AA01000G5101XX

C Treatment of ocular infectionsinvolving the conjunctivaand/or cornea caused bychloramphenicol susceptibleorganisms

ADULT and CHILD : Apply to theconjunctiva, a thin strip(approximately 1 cm) of ointmentevery 3 hours or more frequently

Page 48 of 296

No. Generic Name MDC Category Indications Dosage305. Chloramphenicol

125 mg/5 mlSuspension

J01BA01126L8001XX

B Typhoid fever, salmonellainfections, meningitis, cholera,anaerobic and rickettsialinfections

CHILD: 25 - 50 mg/kg/day in 4divided doses. Severe infections,premature& full-term infants lessthan 2 weeks: 25mg/kg/day individed doses. Full-term infantsmore than 2 weeks: up to50mg/kg/day in divided doses

306. Chloramphenicol250 mg Capsule

J01BA01126C1001XX

B Treatment of typhoid,paratyphoid fevers,bronchopneumonia and entericinfection

ADULT: 500 mg 4 times daily or 50mg/kg/day in 4 divided doses.Maximum dose: 4 g/day. CHILD: 25 -100 mg/kg/day in 4 divided doses

307. Chloramphenicol5% w/v Ear Drops

S02AA01000D1001XX

C Acute otitis media, otitisexterna with perforation

Apply 2 - 3 drops into the ear 2 - 3times daily. Not to be used for longterm

308. ChloramphenicolSodium Succinate1 g Injection

J01BA01520P4001XX

B Treatment of typhoid,paratyphoid fevers,bronchopneumonia and entericinfection

Adult:50 to 100 mg/kg/day in 4divided doses. Premature and full-term neonates: 25 mg/kg/day in 4divided doses. Full-term infants >2wk: 50 mg/kg/day in 4 divideddoses. Children: 50-100 mg/kg/dayin 4 divided doses

309. Chlorhexidine1:200 in Alcoholwith Emollient(HandDisinfectant).

D08AC52137L9901XX

C+ To be used undiluted for handand skin disinfections

Pre-op surgical hand disinfection:Spread 5ml throughly over bothhands and forearms, rubbingvigorously. When dry apply a further5ml and repeat procedure.Antiseptic hand disinfection on theward: Spread 3ml throughly overthe hands and wrist rubbingvigorously until dry. Disinfection ofpatient's skin: Prior to surgery, applyto a sterile swab and rub thoroughlyover the operation site for aminimum of 2 mins

310. ChlorhexidineGluconate 0.2 %Mouthwash

R02AA05137M2001XX

C As a gargle Rinse mouth with 10 ml for about 1minute twice daily

311. Chlorhexidinegluconate 1%cream

D08AC02137G1001XX

C+ As a disinfectant cream. It canbe used for disinfection orlubricating duringgynaecological and obstetricprocedures or childbirth.

Clean the affected skin area andapply cream as required.

312. ChlorhexidineGluconate 2% inAlcohol 70%Solution

D08AC52137L9902XX

C Use as disinfectant in centralvenous catheter care bundle

Skin Preparation:Use ChlorhexidineGluconate 2% in Isopropyl Alcohol70% and allow to dry. Catheteracces:Apply to catheter ports orhubs prior to accessing the line foradministering fluids or injections

Page 49 of 296

No. Generic Name MDC Category Indications Dosage313. Chlorhexidine

Gluconate 4%Scrub

D08AC02137M9901XX

C+ Surgical handscrub/disinfection, pre-op skinpreparation

Surgical hand disinfection: Apply5ml to clean hands and forearms for1 min. Rinse and repeat withanother 5ml for a further 2 mins andthen rinse and dry. General skindisinfection: Apply appropriatequantity to wet area and scrub for 1min. Rinse thoroughly & dry

314. ChlorhexidineGluconate 5%Solution

D08AC02137L9901XX

C+ i) Preoperative skin disinfectionii) Wounds or burns iii)Emergency disinfection ofinstruments

i) & iii) 1 : 10 in 70 % Alcohol ii) 1 :100

315. Chlorinated LimePowder

V07AV00000F9901XX

C Antiseptic and disinfectants Not applicable

316. Chlorinated LimeSolution &Buffered AcetateSolution

D08A000999G9901XX

C Wound or ulcer Apply to affected areas undiluted asa cleansing agent

317. ChloroquinePhosphate 250mg Tablet (150mg Chloroquinebase)

P01BA01162T1001XX

C Treatment of malaria - acuteattack

ADULT 600 mg base stat, 300 mg 6 -8 hours later and a further 300 mgon each of 2 following days. CHILD 3- 4 years : 150 mg base stat, 75 mg 6hours later, then 75 mg daily for 2days. CHILD 5 - 8 years : 300 mg stat,150 mg 6 hours later, then 150 mgdaily for 2 days

318. Chlorpheniramine Maleate 10mg/ml Injection

R06AB04253P3001XX

B Allergic conditions 10 - 20 mg IM or SC, repeated ifrequired. Not to exceed 40 mg in 24hours. 10 - 20 mg over 1 minute byslow IV

319. Chlorpheniramine Maleate 2 mg/5ml Syrup

R06AB04253L9001XX

C Symptomatic treatment ofallergic conditions responsive toantihistamine

CHILD 2 - 5 years : 1 mg every 4 - 6hours (maximum 6 mg daily) 6 - 12years : 2 mg every 4 - 6 hours(maximum 12 mg daily)

320. Chlorpheniramine Maleate 4 mgTablet

R06AB04253T1001XX

C Symptomatic treatment ofallergic conditions responsive toantihistamines

ADULT : 4 mg every 4 - 6 hours.Maximum 24 mg daily. CHILD 2 - 5years : 1 mg every 4 - 6 hours(maximum 6 mg daily) 6 - 12 years :2 mg every 4 - 6 hours (maximum 12mg daily)

321. ChlorpromazineHCl 100 mgTablet

N05AA01110T1002XX

B Psychosis mania and agitation ADULT : Initial dose - 25 mg 3 timesdaily according to response up to 1 gdaily. PAEDIATRIC: Up to 5 years: 0.5mg/kg body weight every 4 - 6 hours(Maximum 40 mg daily). CHILD 6 -12 years: A third to half adult dose(Maximum 75 mg daily)

322. ChlorpromazineHCl 25 mg Tablet

N05AA01110T1001XX

B Psychosis mania and agitation ADULT : Initial dose - 25 mg 3 timesdaily according to response up to 1 gdaily. PAEDIATRIC: Up to 5 years: 0.5mg/kg body weight every 4 - 6 hours(Maximum 40 mg daily). CHILD 6 -12 years: A third to half adult dose

Page 50 of 296

No. Generic Name MDC Category Indications Dosage(Maximum 75 mg daily)

323. Chlortetracycline1% Eye Ointment

S01AA02000G5101XX

B Eye infections requiring a broadspectrum antibiotic

Apply thin strip (approximately 1cm) to the conjuctiva 2 to 4 hourlyor more frequently.

324. Chlortetracycline1-3 % Cream

D06AA02000G1001XX

B Bacterial skin infections Apply directly to affected area twicedaily as required for 1 - 2 weeks

325. Cholera Vaccine J07AE01000P3001XX

B Immunisation of cholera Prophylactic ADULT: First dose of0.5 ml SC/IM followed after 1 - 4weeks by a second dose of 1 ml.CHILD: 1 - 5 years: 0.1 ml (1st dose),0.3 ml (2nd dose). CHILD; 5 - 10years: 0.3 ml (1st dose), 0.5ml (2nddose). Booster: For optimum long-term protection, a booster dose isrecommended for adults after 2years. Children 2-6 years shouldreceive a booster dose after 6months.

326. CholestyramineResin 4 G

C10AC01000M4001XX

A i) Hypercholesterolemia ii)Familial hypercholesterolemia -heterozygous iii) Generalizedatherosclerosis iv) Diarrhoeadue to bile acid malabsorptionv) Pruritus of skin associatedwith partial biliary obstruction

Hypercholesterolemia: Adjunct:initial, 4 g orally 1-2 times daily,maintenance, 8 to 16 g in divideddoses, max 24 g daily CHILD: 50 -150 mg/ kg 6 - 8 hourly oral

327. Choline Salicylate8.7%,CetylkoniumChloride 0.01%Dental Gel

N02BA03900G3001XX

B For relief of the pain anddiscomfort in mouth ulcers andsores, infant teething anddenture irritation

Apply to area 4 times daily

328. Choriogonadotropin Alfa 250mcg/0.5 mlInjection inPrefilled Syringe

G03GA01000P5001XX

A* i)Women undergoingsuperovulation prior to assistedreproductive techniques suchas in-vitro fertilization (IVF)ii)Anovulatory or oligo-ovulatory women

250 mcg 24-48 hour after the lastadministration of an FSH or hMGpreparation, when optimalstimulation of follicular growth isachieved.

329. ChorionicGonadotrophinHuman (HCG)5000 IU Injection

G03GA01000P4001XX

A* i)Treatment of infertile womento induce ovulation ii) As aluteal support in controlledovarian hyperstimulation cycles

i) & ii)Induction of ovulation: 5000 -10,000 units one day following lastdose of menotropin. Up to 3 repeatinjections of 5000 units each may begiven within the following 9 days toprevent insufficiency corpus luteum

330. Ciclesonide160mcg Inhaler

R03BA08000A2101XX

A* Prophylactic treatment ofasthma in adults, adolescentsand children over 6 years(follow current indication) Notmeant for 6 yo)

For adults and adolescents over 12years of age with mild to moderateasthma is 160 to 640mcg per day:severe asthma dose may beincreased to 1280mcg per day.

Page 51 of 296

No. Generic Name MDC Category Indications Dosage331. Ciclosporin 100

mg CapsuleL04AD01000C1002XX

A* Only for: i) Patients in whomdonor specific transplantationcannot be carried out and inyoung children to minimiseside-effects of steroids ii)Follow-up cases of bonemarrow transplant iii) Patientswith severe rheumatoidarthritis not responding toother second line drugs iv)Patients with idiopathicnephrotic syndrome who aresteroid toxic or poor responseto cyclophosphamide v) Severeaplastic anemia, pure red cellaplasia vi) Cases of recalcitrantpsoriasis and atopic eczema vii)Treatment of chronic ocularinflammatory disorders/uveitis

i & ii) Initially 12.5 - 15 mg/kg/day,beginning on the day beforetransplant. Maintenance approx12.5 mg/kg/day for 3 - 6 monthsbefore being tapered off to zero by1 year of transplantation iii) 3mg/kg/day in 2 divided doses forfirst 6 weeks. May increasedgradually to maximum 5 mg/kg.Treatment withdrawn if no responseafter 3 months iv) ADULT: 5mg/kg/day in 2 divided doses.CHILD: 6 mg/kg/day in 2 divideddoses. Patients with permittedlevels of kidney failure, the startingdose must not more than 2.5mg/kg/day v) 12 mg/kg/day. vi) 2.5mg/kg/day in 2 divided dosesincreasing if there is noimprovement after 4 weeks by 0.5 -1 mg/kg/month up to maximum 5mg/kg/day vii) 5 mg/kg/day in 2divided doses, may increase to 7mg/kg/day in resistant cases.Maintenance: Less than 5mg/kg/day especially duringremission

332. Ciclosporin 100mg/ml DrinkSolution

L04AD01000L5002XX

A* Only for : i) Patients in whomdonor specific transplantationcannot be carried out and inyoung children to minimiseside-effects of steroids ii)Follow-up cases of bonemarrow transplant iii) Patientswith severe Rheumatoidarthritis not responding toother second line drugs iv)Patients with idiopathicnephrotic syndrome who aresteroid toxic or poor responseto cyclophosphamide v) Severeaplastic anaemia, pure red cellaplasia vi) Cases of recalcitrantpsoriasis and atopic eczema

i & ii) Initially 12.5 - 15 mg/kg/day,beginning on the day beforetransplant. Maintenance approx12.5 mg/kg/day for 3 - 6 monthsbefore being tapered off to zero by1 year of transplantation iii) 3mg/kg/day in 2 divided doses forfirst 6 weeks. May increasedgradually to maximum 5 mg/kg.Treatment withdrawn if no responseafter 3 months iv) ADULT: 5mg/kg/day in 2 divided doses.CHILD: 6 mg/kg/day in 2 divideddoses. Patients with permittedlevels of kidney failure, the startingdose must not more than 2.5mg/kg/day v) 12 mg/kg/day vi) 2.5mg/kg/day in 2 divided dosesincreasing if there is noimprovement after 4 weeks by 0.5 -1 mg/kg/month up to maximum 5mg/kg/day

Page 52 of 296

No. Generic Name MDC Category Indications Dosage333. Ciclosporin 25 mg

CapsuleL04AD01000C1001XX

A* Only for: i) Patients in whomdonor specific transplantationcannot be carried out and inyoung children to minimiseside-effects of steroids ii)Follow-up cases of bonemarrow transplant iii) Patientswith severe rheumatoidarthritis not responding toother second line drugs iv)Patients with idiopathicnephrotic syndrome who aresteroid toxic or poor responseto cyclophosphamide v) Severeaplastic anemia, pure red cellaplasia vi) Cases of recalcitrantpsoriasis and atopic eczema vii)Treatment of chronic ocularinflammatory disorders/uveitis

i & ii) Initially 12.5 - 15 mg/kg/day,beginning on the day beforetransplant. Maintenance approx12.5 mg/kg/day for 3 - 6 monthsbefore being tapered off to zero by1 year of transplantation iii) 3mg/kg/day in 2 divided doses forfirst 6 weeks. May increasedgradually to maximum 5 mg/kg.Treatment withdrawn if no responseafter 3 months iv) ADULT: 5mg/kg/day in 2 divided doses.CHILD: 6 mg/kg/day in 2 divideddoses. Patients with permittedlevels of kidney failure, the startingdose must not more than 2.5mg/kg/day v) 12 mg/kg/day vi) 2.5mg/kg/day in 2 divided dosesincreasing if there is noimprovement after 4 weeks by 0.5 -1 mg/kg/month up to maximum 5mg/kg/day vii) 5 mg/kg/day in 2divided doses, may increase to 7mg/kg/day in resistant cases.Maintenance: Less than 5mg/kg/day especially duringremission

334. Ciclosporin 50mg/ml Injection

L04AD01000P3001XX

A* i) Post bone marrow transplantii) Solid organ transplant

i) 3 - 5 mg/kg/day until tolerateorally ii) 2 - 3 mg/kg/day forrecipients who are unable to takeorally

335. Cilostazol 100 mgTablet

B01AC00000T1002XX

A* Improvement of the maximaland pain-free walking distancesin patients with intermittentclaudication, who do not haverest pain and who do not haveevidence of peripheral tissuenecrosis.

100 mg twice daily

336. CimicifugaRacemosaRhizome Extract20 mg Tablet

HG03WA5001T1001XX

A Traditionally used for the reliefof hot flushes, sweating,restlessness associated withmenopause

20 mg twice daily

Page 53 of 296

No. Generic Name MDC Category Indications Dosage337. Cinacalcet

Hydrochloride25mg tablet

H05BX01110T1001XX

A* Secondary hyperparathyroidismin patients undergoingmaintenance dialysis withhypercalcaemia. Restriction(s):For treatment of refractorysecondary hyperparathyroidismin patients with end-stage renaldisease (including those withcalciphylaxis) only in those: i)who have 'very uncontrolled'plasma levels of intactparathyroid hormone (definedas greater than 85pmol/L [800pg/mL] that are refractory tostandard therapy, and anadjusted serum calcium level atupper limit of normal or high,despite appropriate adjustmentof phosphate binders includingnon-calcium based phosphatebinders. ii) in whom surgicalparathyroidectomy iscontraindicated in that the risksof surgery are considered tooutweigh the benefits, or ifthere is likely to be a significantdelay for surgery. Response totreatment should be monitoredregularly and treatment shouldbe continued with doseescalation as appropriate. If areduction in the plasma levelsof intact parathyroid hormoneof 30% or more is not seenwithin 4 months of treatment,then consideration should begiven to stopping treatment.

The starting dose for adults is 25mgonce daily to be administered orally.Depends on the serum parathyroidhormone (PTH) and calcium levels,the dose may be adjusted within arange of 25-75mg once daily. If noimprovement in PTH, the dose maybe increased up to 100 mg oncedaily. Dose can be increased by25mg at a time at intervals of atleast 3 weeks. The safety ofcinacalcet in low birth weightinfants, newborns, sucklings, infantsand children has not beenestablished. Caution whencinacalcet is administered topatients aged 65 years or older. It isrecommended not to use cinacalcetin pregnant women or in womenwho may possibly be pregnant.Cinacalcet should be avoided innursing mothers.

338. Cinnarizine 25 mgTablet

N07CA02000T1001XX

B Vestibular disorders Adult: One tablet 3 times daily

339. Ciprofloxacin 100mg/50 mlInjection

J01MA02125P3001XX

A Treatment of infections due tosusceptible bacterial strains

ADULT: the dosage range is 100-400mg twice daily Gonorrhoea:100mg single dose Upper and LowerUrinary Tract Infection: 100mg bdUpper and Lower Respiratory TractInfection: 200mg bd-400mg twicedaily Cystic Fibrosis withpsuedomonal Lower RTI: 400mg bdOthers: 200-400mg bd inhalationAnthrax: 400mg bd

Page 54 of 296

No. Generic Name MDC Category Indications Dosage340. Ciprofloxacin 200

mg/100 mlInjection

J01MA02125P3002XX

A Treatment of infections due tosusceptible bacterial strains

Suggest to rephrase ADULT: thedosage range is 100-400mg twicedaily Gonorrhoea: 100mg singledose Upper and Lower Urinary TractInfection: 100mg bd Upper andLower Respiratory Tract Infection:200mg bd-400mg twice daily CysticFibrosis with psuedomonal LowerRTI: 400mg bd Others: 200-400mgbd inhalation Anthrax: 400mg bd

341. Ciprofloxacin 250mg Tablet

J01MA02110T1001XX

A Treatment of infections due tosusceptible bacterial strains

ADULT: 125-750 mg twice daily.Acute gonorrhoea: a single dose of250 mg

342. Ciprofloxacin 500mg Tablet

J01MA02110T1002XX

A Treatment of infections due tosusceptible bacterial strains

ADULT: 125-750 mg twice daily.Acute gonorrhoea: a single dose of250 mg

343. Ciprofloxacin HCl0.3% OphthalmicSolution

S01AX13110D2001XX

A* Treatment of bacterialinfections caused by susceptiblestrains in i) corneal ulcers ii)bacterial conjunctivitis

i) 2 drops every 15 minutes for thefirst 6 hours, then 2 drops every 30minutes for the rest of the first day.Second day : 2 drops every hour.Subsequent days (3rd - 14th day) : 2drops every 4 hours. Treatment maybe continued after 14 days if cornealre-epithelialization has not occuredii) 1 - 2 drops every 2 hours into theconjunctival sac while awake for 2days and 1-2 drops every 4 hourswhile awake for the next 5 days

344. CisatracuriumBesylate 2 mg/mlInjection

M03AC11197P3001XX

A* As an adjunct to generalanaesthesia to facilitateendotracheal intubation, toprovide skeletal musclerelaxation during surgery and tofacilitate mechanicalventilation. Restricted topatients with lung problemsuch as asthma.

Administered as bolus intravenousinjection. May be administered asinfusion in ICU patients at a rate of3mcg/kg/min. Adult dose: a)Induction: 0.15mg/kg over 5-10secs, b) Maintenance: 0.03 mg/kg.Children 2-12 years: a) Induction:0.1 mg/kg over 5-10 secs, b)Maintenance: 0.02 mg/kg

345. Cisplatin 10 mgInjection

L01XA01000P3001XX

A Germ cell tumours, ovariantumours, adult solid tumours,lymphomas

Germ cell tumours: 20 mg/m2 dailyfor 5 days every 3 weeks for 3 - 4courses. Ovarian tumours: 75mg/m2 once every 3 weeks as partof combination therapy withpaclitaxel or 50-60mg/m2 IV onceevery 3 weeks as a single agent.Baseline creatinine clearance,pretreatment hydration and forceddiuresis are mandatory. CHILD:100mg/m2 over 6 hours once every3 weeks. Lymphomas: Refer toprotocols CHILD: 100mg/m2 over 6hours once every 3 weeks.Lymphomas: Refer to protocols

Page 55 of 296

No. Generic Name MDC Category Indications Dosage346. Cisplatin 50 mg

InjectionL01XA01000P3002XX

A Germ cell tumours, ovariantumours, adult solid tumours,lymphomas

Germ cell tumours: 20 mg/m2 dailyfor 5 days every 3 weeks for 3 - 4courses. Ovarian tumours: 75mg/m2 once every 3 weeks as partof combination therapy or 100mg/m2 IV once every 3 weeks as asingle agent. Baseline creatinineclearance, pretreatment hydrationand forced diuresis are mandatory.CHILD: 100mg/m2 over 6 hoursonce every 3 weeks. Lymphomas:Refer to protocols CHILD:100mg/m2 over 6 hours once every3 weeks. Lymphomas: Refer toprotocols

347. Clarithromycin125 mg/5 mlGranules

J01FA09000F1001XX

A* Treatment of complicatedrespiratory tract infections notresponding to standardmacrolides

CHILD: 8 - 12 years: 30 - 40 kg 10mL, 4 - 8 years: 20 - 29 kg 7.5 mL, 2 -4 years: 12 - 19 kg 5 mL, 1 - 2 years:8 - 11 kg 2.5 mL, less than 8 kg: 7.5mg/kg. To be given twice daily.Maximum dose: 1g/day

348. Clarithromycin250 mg Tablet

J01FA09000T1001XX

A* Only for i) treatment ofcomplicated respiratory tractinfection not responding tostandard macrolides ii)eradication of Helicobacterpylori infection

i) 250 - 500 mg twice daily. Up to 6 -14 days ii) 500 mg twice daily withomeprazole & amoxicillin. Up to 2weeks

349. Clarithromycin500 mg Injection

J01FA09000P3001XX

A* Only for treatment ofcomplicated respiratory tractinfection not responding tostandard macrolides

Susceptible infections Adult: 500 mgbid for 2-5 days. Dose to be infusedover 60 minutes in a 0.2% solution;revert to oral therapy wheneverpossible. Child: 1 mth-12 yr: 7.5mg/kg every 12 hr. Dose to be givenvia infusion into proximal vein.Dosage Recommendation CrCl(ml/min)<30 : Half the dosage ordouble dosing interval

350. Clindamycin HCl300 mg Capsule

J01FF01110C1001XX

A* i) Skin and soft tissue infections,bone& joint infections ii)Cerebral toxoplasmosis iii)Children less than 8 yearsold:Treatment and prophylaxisof malaria in combination withquinine, as an alternative todoxycline

i) ADULT: 150 - 300 mg every 6hours; up to 450 mg every 6 hours insevere infections; Max: 1.8g/dayCHILD: 3 - 6 mg/kg every 6 hours.Children weighing <10 kg shouldreceive at least 37.5 mg every 8 hr.ii) 600 mg 6 hourly for 6 weeks iii)10mg/kg twice a day, incombination with quinine. Thecombination to be given for 7 days

351. ClindamycinPhosphate 150mg/ml Injection

J01FF01162P3001XX

A* i) Skin and soft tissue infections,bone & joint infections ii)Cerebral toxoplasmosis

i) ADULT: 0.6 - 2.7 g daily (in 2 - 4divided doses); up to 4.8 g daily;CHILD over 1 month, 20 - 40mg/kg/day or 350 mg/m2/day in 3 -4 divided doses ii) 1200 mg every 6hours for 3 weeks followed by 300

Page 56 of 296

No. Generic Name MDC Category Indications Dosagemg orally every 6 hours for another3 weeks

352. Clobazam 10 mgtablet

N05BA09000T1001XX

A* As adjunctive therapy inpatients with epilepsy notadequately stabilised with theirbasic medication.

The initial dose in adults andadolescents >15 yr should be low (5to15mg daily), if necessary,increased gradually to a maximumdaily dose of about 80mg. Doses ofup to 30mg may be taken as a singledose in the evening. The initial dosein children from 3 to15 yr isnormally 5mg. A maintenance doseof 0.3 to 1.0mg/kg body weight dailyis usually sufficient.

353. ClobetasolPropionate 0.05%Cream

D07AD01133G1001XX

A Short term treatment only ofmore resistant dermatoses eg.psoriasis, recalcitrant eczemas,lichen planus, discoid lupuserythematosus and otherconditions which do notrespond satisfactorily to lesspotent steroids

Apply sparingly once or twice daily,changing to lower potency therapyas soon as condition is controlled.For mild to moderate use maximumfor 2 weeks. For moderate to severemaximum duration 4 consecutiveweeks. Max: 50 g/week

354. ClobetasolPropionate 0.05%Ointment

D07AD01133G5001XX

A Short term treatment only ofmore resistant dermatoses eg.psoriasis, recalcitrant eczemas,lichen planus, discoid lupuserythematosus and otherconditions which do notrespond satisfactorily to lesspotent steroids

Apply sparingly once or twice daily,changing to lower potency therapyas soon as condition is controlled.For mild to moderate use maximumfor 2 weeks. For moderate to severemaximum duration 4 consecutiveweeks. Max:50 g/week

355. ClobetasoneButyrate 0.05%Cream

D07AB01255G1001XX

A/KK Eczema and dermatitis of alltypes

Apply up to four times daily untilcondition improves, then reducefrequency

356. ClobetasoneButyrate 0.05%Ointment

D07AB01255G5001XX

A Eczema and dermatitis of alltypes

Apply up to four times daily untilcondition improves, then reducefrequency

357. Clodronate 800mg Tablet

M05BA02011T1011XX

A* Treatment of hypercalcaemiadue to malignancy

2 tablets in single or two divideddoses

358. Clofazimine 100mg Capsule

J04BA01000C1002XX

B i) Previously untreated leprosypatients ii) Leprosy patientsresistant to sulphones iii)Suppression of lepra reactions

i) ADULT: 100 mg each other day or50 mg daily with 100mg Dapsone &300mg once a month with 600mgrifampicin under supervision.Maximum: 200 mg/day. CHILD: 10-14 yr: 50mg clofazimine on alternatedays with 50mg dapsone & 150 mgclofazimine with 450 mg rifampicinonce a month.Maximum: 100mg/day. ii) 100 mg daily iii) 200-300mg usually effective. Treatmentwith minimum suppression dosecontinued for at least 6 months

Page 57 of 296

No. Generic Name MDC Category Indications Dosage359. Clofazimine 50

mg CapsuleJ04BA01000C1001XX

B i) Previously untreated leprosypatients ii) Leprosy patientsresistant to sulphones iii)Suppression of lepra reactions

i) ADULT: 100 mg each other day or50 mg daily with 100mg Dapsone &300mg once a month with 600mgrifampicin under supervision.Maximum: 200 mg/day. CHILD: 10-14 yr: 50mg clofazimine on alternatedays with 50mg dapsone & 150 mgclofazimine with 450 mg rifampicinonce a month.Maximum: 100mg/day. ii) 100 mg daily iii) 200-300mg usually effective. Treatmentwith minimum suppression dosecontinued for at least 6 months

360. ClomipheneCitrate 50mgTablet

G03GB02136T1001XX

A Anovulatory infertility 50 mg daily from 2nd - 6th or 5th -9th day of menstrual cycle. Increasedose gradually by increments of 50mg if there is no response until adosage of 200 mg daily is achieved(starting as early as 30 days afer theprevious course). Further treatmentmay not be recommended ifpregnancy has not occurred after atotal of 6 treatment cycles.

361. ClomipramineHCI 25 mg Tablet

N06AA04110T1001XX

A Depression, obsessive-compulsive disorder.

Initially 10 mg daily, increasedgradually as necessary to 30 - 150mg daily in divided doses or as asingle dose at bedtime; max 250 mgdaily. ELDERLY initially 10 mg dailyincreased carefully overapproximately 10 days to 30 - 75 mgdaily;Child: ≥10 yr: Initially, 25 mgdaily, increased gradually over 2 wk.Max: 3 mg/kg/day or 100 mg daily,whichever is smaller. Give in divideddoses. Once titrated, dose may begiven as a single dose at bedtime.

362. Clonazepam 0.5mg Tablet

N03AE01000T1001XX

B i) Epilepsy ii) Non-epilepticmyoclonus

i) & ii) ADULT: Initial dose should notexceed 1.5mg/day divided into 3doses, may be increased inincrements of 0.5mg every 3 daysuntil seizures are controlled.Maintenance dose: 3-6mg/day.Maximum: 20mg/day. CHILD up to10 years: initial dose 0.01-0.03mg/kg/day in 2-3 divided doses,increased by no more than 0.25-0.5mg every third day, maximum0.2mg/kg/day. CHILD 10-16 years:initial dose 1-1.5mg/day in 2-3divided dose, may be increased by0.25-0.5mg every third day untilindividual maintenance dose of 3-6mg/day is reached.

Page 58 of 296

No. Generic Name MDC Category Indications Dosage363. Clonazepam 2 mg

TabletN03AE01000T1002XX

B i) Epilepsy ii) Non-epilepticmyoclonus

i) & ii) ADULT: Initial dose should notexceed 1.5mg/day divided into 3doses, may be increased inincrements of 0.5mg every 3 daysuntil seizures are controlled.Maintenance dose: 3-6mg/day.Maximum: 20mg/day. CHILD up to10 years: initial dose 0.01-0.03mg/kg/day in 2-3 divided doses,increased by no more than 0.25-0.5mg every third day, maximum0.2mg/kg/day. CHILD 10-16 years:initial dose 1-1.5mg/day in 2-3divided dose, may be increased by0.25-0.5mg every third day untilindividual maintenance dose of 3-6mg/day is reached.

364. Clonidine HCl0.025 mg Tablet

N02CX02110T1001XX

A Rapid opiod detoxificationcombination use withnaltrexone

Rapid detoxification in 4-5 days (usewith naltrexone): 6 mcg/kg ORALLYdivided in 3 doses 6 to 8 hours apartthe first day, increasing to 11mcg/kg divided in 3 doses given daytwo, tapering to 0.6 mcg/kg thethird day. Rapid opioiddetoxification for 7 days ( use withnaltrexone) : 0.1 to 0.2 mg every 4hours as needed

365. Clopidogrel 75mg Tablet

B01AC04192T1001XX

A* Prevention of myocardialinfarct, stroke or establishedperipheral arterial disease. Assecond/third line treatment inpatients who are sensitive toacetylsalicylic acid & intolerantto ticlopidine

75 mg once daily

366. ClostridiumBotulinum ToxinType A 100 units

M03AX01000P4001XX

A* i) Focal dystonias ii) Hemifacialspasm iii) Spasticity includingcerebral palsy

20 - 200 units 3 months once

367. ClostridiumBotulinum Type Atoxinhaemagglutinincomplex 300units/vial powderfor injection

M03AX01000P4003XX

A* i) Focal dystonias ii) Hemifacialspasm iii) Spasticity includingcerebral palsy

Initially 20 U/kg divided betweenboth calf muscles. May be titrated10-30 U/kg up to max of not >1000U/patient. Should only be used inchildren > 2 years of age. Repeatinjections given not less than 3months from previous injection.

368. Clostridiumbotulinum Type Atoxinhaemagglutinincomplex500U/vialpowder forinjection

M03AX01000P4002XX

A* i) Focal dystonias ii) Hemifacialspasm iii) Spasticity includingcerebral palsy

Initially 20 U/kg divided betweenboth calf muscles. May be titrated10-30 U/kg up to max of not >1000U/patient. Should only be used inchildren > 2 years of age. Repeatinjections given not less than 3months from previous injection.

Page 59 of 296

No. Generic Name MDC Category Indications Dosage369. Clotrimazole 1%

CreamD01AC01000G1001XX

B Cutaneous candidiasis, Tineacorporis, Tinea cruris, Tineapedis and Tinea versicolor

Rub in gently onto affected andsurrounding skin 2 or 3 times dailycontinuing for about 2 weeksbeyond the dissapearance of allsymptoms

370. Clotrimazole 1%Ear Drop

S02AA00000D1002XX

B Otomycosis; concomitanttherapy with antibiotics andcorticosteroid ear drops

4 to 5 drops 3 to 4 times daily

371. Clotrimazole 1%Solution

D01AC01000L6001XX

A Cutaneous candidiasis, tineaorporis, tinea cruris, tinea pedisand tinea versicolor

Apply gently onto affected andsurrounding skin area 2 or 3 timesdaily continuing for 2-4 weeks

372. Clotrimazole 200mg Vaginal Tablet

G01AF02000S1002XX

B Vaginal candidiasis 200 mg once daily, preferably atbedtime for three consecutive days

373. Clotrimazole 500mg Vaginal Tablet

G01AF02000S1003XX

B Vaginal candidiasis 500 mg as a single one-time dose

374. CloxacillinSodium 125 mg/5ml Suspension

J01CF02520L8001XX

B Treatment of susceptiblebacterial infections, notablypenicillinase-producingstaphylococci

Child: 50-100 mg/kg in divided dosesevery 6 hr

375. CloxacillinSodium 250 mgCapsule

J01CF02520C1001XX

B Treatment of susceptiblebacterial infections, notablypenicillinase-producingstaphylococci

ADULT: 250 - 500 mg every 6 hours.Child: 50-100 mg/kg in divided dosesevery 6 hr.

376. CloxacillinSodium 250 mgInjection

J01CF02520P4001XX

B Treatment of susceptiblebacterial infections, notablypenicillinase-producingstaphylococci infections

ADULT: 250 to 500 mg every 6 hoursdepending on type and severity ofinfection. CHILD less than 20 kg: 25to 50 mg/kg/day in equally divideddoses every 6 hours

377. CloxacillinSodium 500 mgCapsule

J01CF02520C1002XX

B Treatment of susceptiblebacterial infections, notablypenicillinase-producingstaphylococci

ADULT: 250 - 500 mg every 6 hours.Child: 50-100 mg/kg in divided dosesevery 6 hr.

378. CloxacillinSodium 500 mgInjection

J01CF02520P4002XX

B Treatment of susceptiblebacterial infections, notablypenicillinase-producingstaphylococci infections

ADULT: 250 to 500 mg every 6 hoursdepending on type and severity ofinfection. CHILD less than 20 kg: 25to 50 mg/kg/day in equally divideddoses every 6 hours

379. Clozapine 100 mgTablet

N05AH02000T1002XX

A Treatment of resistantschizophrenia

Initial dose : 12.5 mg ( once or twice) daily, increase slowly in steps of 25- 50 mg up to 300 mg daily within 2 -3 weeks. Maximum 900 mg/day

380. Clozapine 25 mgTablet

N05AH02000T1001XX

A Treatment of resistantschizophrenia

Initial dose : 12.5 mg ( once or twice) daily, increase slowly in steps of 25- 50 mg up to 300 mg daily within 2 -3 weeks. Maximum 900 mg/day

381. Coal Tar 1- 6 % inBetamethasone17 - Valerate 0.01% Ointment

D05AA00946G5003XX

B Dandruff, seborrhoeicdermatitis, atopic dermatitis,eczema and psoriasis

Apply to the affected areas sparingly1-2 times daily

Page 60 of 296

No. Generic Name MDC Category Indications Dosage382. Coal Tar 1-9%

OintmentD05AA00000G5001XX

B Dandruff, seborrhoeicdermatitis, atopic dermatitis,eczema and psoriasis. Used as amild astringent for the skin, as asoothing and protectiveapplication in eczema and as aprotective to slight excoriation

Apply sparingly to the affected area1-3 times daily starting with lowstrength preparations

383. Coal Tar 20%Solution

D05AA00000L5201XX

B Dandruff, seborrhoeicdermatitis, atopic dermatitis,eczema and psoriasis

Use 100 ml in a bath

384. Coal Tar andSalicylic Acid(variousconcentrations)Ointment

D05AA00946G5002XX

B Dandruff, seborrhoeicdermatitis, atopic dermatitis,eczema and psoriasis

Apply to the affected areas

385. Coal Tar withSalicylic Acid(variousconcentrations)Solution

D05AA00000L5202XX

B Dandruff, seborrhoeicdermatitis, atopic dermatitis,eczema and psoriasis

Apply to the affected areas or as inproduct leaflet

386. Cocaine 10%Solution

N01BC01110L5001XX

B To produce local anaesthesia orvasoconstriction duringendoscopic nasal surgery,turbinectomy septoplasty,polypectomy etc

Maximum total dose recommendedfor application to the nasal mucosain healthy adult is 1.5 to 2 mg/kg ofa 10% cocaine solution

387. Cocois Co.Ointment

D05AA00946G5001XX

B Scalp psoriasis and severeseborrhoeic dermatitis

Rub a small amount into the scalpgently

388. Colchicine 0.5 mgTablet

M04AC01000T1001XX

B i) Acute gout and prophylaxis ofrecurrent gout. ii)Leucocytoclastic Vasculitiseither cutaneous or systemicinvolvement, Behcet'ssyndrome, Urticarial vasculitis,Systemic sclerosis, Sweet'ssyndrome and severerecalcitrant aphthous stomatitis

i) Initial dose, 0.5-1.2 mg, then 0.5-0.6 mg every hour until relief of painis obtained or vomiting or diarrhoeaoccurs (Maximum : 8 mg). Thecourse should not be repeatedwithin 3 days. Prevention of attacksduring initial treatment withallopurinol or uricosuric drugs: 0.5mg 1-3 times daily. ii) 0.5 mg 1-3times daily depends on disease andseverity, up to a maximum of 3mg/day

Page 61 of 296

No. Generic Name MDC Category Indications Dosage389. Colistimethate

Sodium 1 millionIU per vial(Polymyxin E)

J01XB01520P4001XX

A* Intravenous administration forthe treatment of seriousinfections caused by Gramnegative bacteria, when morecommonly used systemicantibacterial agents may becontraindicated or may beineffective because of bacterialresistance.

A minimum of 5 days treatment isgenerally recommended. For thetreatment of respiratoryexacerbations in cystic fibrosispatients, treatment should becontinued up to 12 days. Childrenand adults (including elderly): Up to60kg: 50,000 units/kg/day to amaximum of 75,000 units/kg/day.The total daily dose should bedivided into three doses given atapproximately 8-hour intervals.Over 60kg: 1-2 million units threetimes a day. The maximum dose is 6million units in 24 hours. Renalimpairment: In moderate to severerenal impairment, excretion ofcolistimethate sodium is delayed.Therefore, the dose and doseinterval should be adjusted in orderto prevent accumulation. SuggestedDosage Adjustment in RenalImpairment (for over 60 kg bodyweight): - Mild (CrCl 20-50 ml/min):1-2 million units every 8 hr. -Moderate (CrCl 10-20 ml/min): 1million units every 12-18 hr. - Severe(CrCl <10 ml/min): 1 million unitsevery 18-24 hr.

390. Colloidal BismuthSubcitrate 120mg Tablet

A02BX05136T1001XX

A Eradication therapy forHelicobacter Pylori incombination with antibioticsand antisecretory drugs

240 mg twice daily for 1-2 weeks

391. CompoundSodium Lactate(HartmannsSolution)

B05XA30125P6001XX

C Replacement of extracellularlosses of fluid and electrolytes,as an alkaliniser agent

100-1000 ml by IV or according tothe needs of the patient

392. Conjugatedestrogens 0.3 mgTablet

G03CA57000T1003XX

A i) Osteoporosis associated withoestrogen deficiency ii) Femalehypoestrogenism iii) Vasomotorsymptoms associated withoestrogen deficiency iv)atrophicvaginitis and urethritis

i) 0.3 - 0.625 mg daily ii) 0.3- 1.25mgdaily for 3weeks, then off for 1 weekiii) & iv) 0.3mg-1.25mg daily

393. ConjugatedEstrogens 0.625mg &Medroxyprogesterone Acetate 2.5mg Tablet

G03FA12295T1002XX

A Management of moderate tosevere vasomotor symptomsassociated with menopause,prevention and management ofpostmenopausal osteoporosis,atropic vaginitis and atropicurethritis in post menopausalwoman with intact uterus

1 tablet daily

Page 62 of 296

No. Generic Name MDC Category Indications Dosage394. Conjugated

Oestrogens 0.625mg Tablet

G03CA57000T1001XX

A i) Osteoporosis associated withoestrogen deficiency ii) Femalehypoestrogenism iii) Vasomotorsymptoms associated withoestrogen deficiency iv)atrophicvaginitis and urethritis

i) 0.3 - 0.625 mg daily ii) 0.3- 1.25mgdaily for 3weeks, then off for 1 weekiii) & iv) 0.3mg-1.25mg daily

395. ConjugatedOestrogens 0.625mg/g Cream

G03CA57000G1001XX

A Atrophic vaginitis and postmenopausal atrophic urethritis

Intravaginally or topically 0.5-2gdaily depending on severity ofcondition. Administration should becyclic, with 3 weeks on conjugatedestrogens and one week off.Estrogens should be used for theshortest duration possible whentreating atrophic vaginitis. Every 3to 6 months attempts should bemade to taper or discontinuetherapy and conjugated estrogensshould be titrated to give the lowestpossible dosage to controlsymptoms

396. ContinuousAmbulatoryPeritonealDialysis (CAPD)Solutioncontaining 2.3%glucose (Calcium1.75mmol/L) &(Calcium1.25mmol/L)

B05DB00908H2504XX

B For chronic renal diseasesrequiring dialysis and acutetherapy-resistance renal failureeg. prior to transfer to a dialysiscentre

Dose depending on clinical cases

397. ContinuousAmbulatoryPeritonealDialysis Solutioncontaining 1.5%Dextrose

B05DB00908H2501XX

B For chronic renal diseasesrequiring dialysis and acutetherapy-resistance renal failureeg. prior to transfer to a dialysiscentre

Dose depending on clinical cases

398. ContinuousAmbulatoryPeritonealDialysis Solutioncontaining 2.5%Dextrose

B05DB00908H2502XX

B For chronic renal diseasesrequiring dialysis and acutetherapy-resistance renal failureeg. prior to transfer to a dialysiscentre

Dose depending on clinical cases

399. ContinuousAmbulatoryPeritonealDialysis Solutioncontaining 4.25%Dextrose

B05DB00908H2503XX

B For chronic renal diseasesrequiring dialysis and acutetherapy-resistance renal failureeg. prior to transfer to a dialysiscentre

Dose depending on clinical cases

400. Copper 250 mm2IntrauterineDevice

G02BA02000M9001XX

B Intrauterine contraception One unit intrauterine device to beinserted into the uterine cavity onthe last day of the menstrual flow orin the first days afterwards. It isadvised that the Multiload Cu 250

Page 63 of 296

No. Generic Name MDC Category Indications Dosagedevices are replaced every 3 years

401. Copper 375 mm2IntrauterineDevice

G02BA02000M9002XX

B Contraception One unit intrauterine device to beinserted into the uterine cavity onthe last day of the menstrual flow orin the first days afterwards. It isadvised that the Multiload Cu 375devices are replaced every 5 years

402. Copper SulphateCrystal

D08A000183F9901XX

C Wounds The tip of the crystal should bemoistened by dipping in water andapplied carefully to the lesion

403. CorifollitropinAlfa100mcg/0.5mlsolution forinjection

G03GA09000P5001XX

A* Controlled Ovarian Stimulation(COS) in combination with aGnRH antagonist for thedevelopment of multiplefollicles in woman participatingin an Assisted ReproductiveTechnology (ART) programRestriction: As second linetreatment alternative to otherrecombinant FSH

Women with Body Weight ≤60 kg: Asingle dose of 100 mcg should beadministered. Women with BodyWeight >60 kg: A single dose of 150mcg should be administered. Details: Refer to Product Information

404. CorifollitropinAlfa150mcg/0.5mlsolution forinjection

G03GA09000P5002XX

A* Controlled Ovarian Stimulation(COS) in combination with aGnRH antagonist for thedevelopment of multiplefollicles in woman participatingin an Assisted ReproductiveTechnology (ART) programRestriction: As second linetreatment alternative to otherrecombinant FSH

Women with Body Weight ≤60 kg: Asingle dose of 100 mcg should beadministered. Women with BodyWeight >60 kg: A single dose of 150mcg should be administered. Details: Refer to Product Information

405. Cortisone Acetate5 mg Tablet

H02AB10122T1002XX

B For salt losing congenitaladrenal hyperplasia in newbornand paediatric patients

20-30 mg/m2 daily. Doses may bedivided with two-thirds in themorning and one-third late in theafternoon

406. Crotamiton 10 %Cream

P03A000000G1001XX

B i) Pruritus ii) Scabies iii) Insectbite reactions

i) and iii) Massage into affected areauntil the medication is completelyabsorbed. Repeat as needed. Apply2 or 3 times daily ii) Apply to thewhole body from below the chin.2nd application is applied 24 hrlater. May need to use once daily forup to 5 days.

Page 64 of 296

No. Generic Name MDC Category Indications Dosage407. Cyanocobalamin

0.1 mg InjectionB03BA01000P3001XX

B i) Prophylaxis of anaemia ii)Uncomplicated perniciousanaemia or Vitamin B12malabsorption

i) Prophylaxis of anaemia: 250-1000mcg IM every month ii)Uncomplicated pernicious anaemiaor Vitamin B12 malabsorption:Initial 100 mcg daily for 5-10 daysfollowed by 100-200 mcg monthlyuntil complete remission isachieved. Maintenance: up to 1000mcg monthly. CHILD 30-50 mcg dailyfor 2 or more weeks (to a total doseof 1-5mg). Maintenance: 100 mcgmonthly to sustain remission OR ASPRESCRIBED.

408. Cyanocobalamin1 mg Injection

B03BA01000P3002XX

B i) Prophylaxis of anaemiaassociated with Vitamin B12deficiency ii) Uncomplicatedpernicious anaemia or VitaminB12 malabsorption

i) Prophylaxis of anaemia: 250-1000mcg IM every month ii)Uncomplicated pernicious anaemiaor Vitamin B12 malabsorption:Initial 100 mcg daily for 5-10 daysfollowed by 100-200 mcg monthlyuntil complete remission isachieved. Maintenance: up to 1000mcg monthly. CHILD 30-50 mcg dailyfor 2 or more weeks (to a total doseof 1-5mg). OR AS PRESCRIBED.

409. Cyanocobalamin50 mcg Tablet

B03BA01000T1002XX

B Vitamin B12 deficiency ofdietary origin

ADULT 50-150 mcg daily. CHILD 50-105 mcg daily in 1-3 divided doses

410. Cyclopentolate0.2% withPhenylephrine1% Eye Drops

S01GA55990D2001XX

A Dilating agent for prematurebabies

1 drop every 5 - 10 minutes; notexceeding three times to producerapid mydriasis. Observe infantsclosely for at least 30 minutes

411. Cyclopentolate1% Eye Drops

S01FA04000D2002XX

A Mydriasis and cycloplegia ADULT : 1 drop of solution in eye(s);may repeat after 5-10 minutes ifneeded. CHILD : 1 drop of solution ineye(s); may repeat after 5-10minutes if needed. Pre-treatmenton the day prior to examination isusually not necessary. If desirable, 1or 2 drops may be instilled theevening prior to examination.

Page 65 of 296

No. Generic Name MDC Category Indications Dosage412. Cyclophosphamid

e 1 g InjectionL01AA01000P4002XX

A i) Solid tumours (adult andpaediatric), leukaemia, non-Hodgkin's lymphoma, multiplemyeloma ii) Severe lupusnephritis (Class III and IV) iii)Other systemic vasculitis iv)Systemic lupus erythematosus,rheumatoid arthritis,polyarteritis nodosa, wegenergranulomatosis v) Pemphigusvulgaris

i) ADULT: 600 - 750 mg/m2 IV onceevery 3 weeks as part ofcombination regime. CHILD: Dosevariable depending on disease andprotocol. Range 600 mg/m2 to 2g/m2 infusion over 1 hour to 6hours (lower doses can be given asbolus). Care with pre and post-hydration. Mesna to be given withdoses more than 1 g/m2. Higherdoses are used in haematopoeticstem cell transplant-refer to specificprotocols ii) 750 mg/m2 BSAmonthly for 18 months iii) 750mg/m2 BSA monthly for 6 months.Dose can be adjusted up to 1,000mg/m2 BSA to achieve adequateleucocyte suppression iv) 500 - 1000mg intravenously (Regime variesaccording to indication). Startingdose may be given fortnightly thenat monthly intervals followed by 3monthly intervals v) 500 mg infusionon the 2nd day of thedexamethasone-cyclophosphamidepulsed regime, the cycle is repeatedevery 4 weeks up to 6 cycles or tillremission followed by oralcyclophosphamide

413. Cyclophosphamide 200 mgInjection

L01AA01000P4001XX

A i) Solid tumours (adult andpaediatric), leukaemia, non-Hodgkin's lymphoma, multiplemyeloma ii) Severe lupusnephritis (Class III and IV) iii)Other systemic vasculitis iv)Systemic lupus erythematosus,rheumatoid arthritis,polyarteritis nodosa, wegenergranulomatosis v) Pemphigusvulgaris

i) ADULT: 600 - 750 mg/m2 IV onceevery 3 weeks as part ofcombination regime. CHILD: Dosevariable depending on disease andprotocol. Range 600 mg/m2 to 2g/m2 infusion over 1 hour to 6hours (lower doses can be given asbolus). Care with pre and post-hydration. Mesna to be given withdoses more than 1 g/m2. Higherdoses are used in haematopoeticstem cell transplant-refer to specificprotocols ii) 750 mg/m2 BSAmonthly for 18 months iii) 750mg/m2 BSA monthly for 6 months.Dose can be adjusted up to 1,000mg/m2 BSA to achieve adequateleucocyte suppression iv) 500 - 1000mg intravenously (Regime variesaccording to indication). Startingdose may be given fortnightly thenat monthly intervals followed by 3monthly intervals v) 500 mg infusionon the 2nd day of the

Page 66 of 296

No. Generic Name MDC Category Indications Dosagedexamethasone-cyclophosphamidepulsed regime, the cycle is repeatedevery 4 weeks up to 6 cycles or tillremission followed by oralcyclophosphamide

414. Cyclophosphamide 50 mg Tablet

L01AA01000T1001XX

A i) Solid tumours, leukaemia,lymphoma, autoimmunedisorders, autoimmune bullousdiseases, connective tissuedisease, pyodermagangrenosum ii) For severelupus nephritis (Class III & IV),systemic vasculitis and steroidresistant/dependent nephroticsyndrome iii) Systemic lupuserythematosus (SLE),rheumatoid arthritis,polyarteritis nodosa, wegenergranulomatosis

i) ADULT: 50 - 100 mg/day. Monitorfull blood count (FBC), liver function,urine microscopy and renalfunction. CHILD, up to 1 year: 10 -20 mg daily, 1 - 5 years: 30 - 50 mgdaily, 6 - 12 years: 50 - 100 mg dailyii) 2 mg/kg/day for 3 - 4 months iii) 1- 1.5 mg/kg/day orally in divideddoses

415. Cycloserine 250mg Capsule

J04AB01000C1001XX

A* Multi-Drug ResistanceTuberculosis treatment failure.(For respiratory physicians)

ADULT: Initial: 250 mg every 12hours for 14 days, then administer0.5 - 1 g daily in 2 divided doses for18 - 24 months (maximum dailydose: 1 g). CHILD: 2-12 yr: 5 mg/kgbid; 12-18 yr: 250 mg bid for 2 wkthen adjusted to a max dose of 1 gdaily

416. CyclosporineOphthalmicEmulsion 0.05%

S01XA18000D2001XX

A* To increase tear production inpatients whose tear productionis presumed to be suppresseddue to ocular inflammationassociated withkeratoconjunctivitis sicca.Increased tear production wasnot seen in patients currentlytaking anti inflammatory drugsor using punctal plugs.

1 drop twice a day in each eyeapproximately 12 hours apart.

417. CyproteroneAcetate 2 mg &Ethinyloestradiol0.035 mg Tablet

G03HB01954T1001XX

A* Androgen dependent diseasesin women

1 tablet daily for 21 days on the firstday of the cycle, followed by 7 tabfree days. Starting on day 2 to 5 isallowed, but during the first cycle abarrier method is recommended forthe first 7days of tablet taking.

418. CyproteroneAcetate 50 mgTablet

G03HA01122T1001XX

A* Carcinoma of prostate i) After orchidectomy, 100 mg oncedaily or twice daily ii) If usedtogether with LHRH agonists, theinitial dose is 100 mg twice daily for5 to 7 days before the start of LHRHagonist, then 100 mg twice daily for3 to 4 weeks together with the LHRHagonist

Page 67 of 296

No. Generic Name MDC Category Indications Dosage419. Cytarabine 1 g

InjectionL01BC01000P4004XX

A i) Central nervous systemlymphoma ii) Meningealleukemia iii) Non Hodgkin'sLymphoma iv) High dosecytarabine as conditioning tocytoreduce the disease beforestem cell transplant forrelapsed or refractory leukemiav) As salvage for acutelymphocytic leukemia vi) Assalvage for acute myeloidleukemia vii) As palliativechemotherapy in elderly acutemyeloid leukemia/myelodysplastic syndrome

Standard doses 100 - 200 mg/m2daily over 5 - 10 days. Higher dosesfor intensification/consolidation:1000 - 3000 mg/m2 daily over 3 - 5days depending on specificprotocols. CHILD: Dose variabledepending on disease and protocol.Range from 100 mg/m2 to 3 g/m2twice daily. May be given as SC, IVbolus or infusion. Intrathecal dose:Less than 1 year: 15 mg, 1 - 2 years:20 mg, 2 - 3 years: 25 mg, more than3 years: 30 mg. (ENSURE THATPREPARATION IS SUITABLE FORINTRATHECAL USE)

420. Cytarabine 100mg Injection

L01BC01000P4002XX

A i) Central nervous systemlymphoma ii) Meningealleukemia iii) Non Hodgkin'sLymphoma iv) High dosecytarabine as conditioning tocytoreduce the disease beforestem cell transplant forrelapsed or refractory leukemiav) As salvage for acutelymphocytic leukemia vi) Assalvage for acute myeloidleukemia vii) As palliativechemotherapy in elderly acutemyeloid leukemia/myelodysplastic syndrome

Standard doses 100 - 200 mg/m2daily over 5 - 10 days. Higher dosesfor intensification/consolidation:1000 - 3000 mg/m2 daily over 3 - 5days depending on specificprotocols. CHILD: Dose variabledepending on disease and protocol.Range from 100 mg/m2 to 3 g/m2twice daily. May be given as SC, IVbolus or infusion. Intrathecal dose:Less than 1 year: 15 mg, 1 - 2 years:20 mg, 2 - 3 years: 25 mg, more than3 years: 30 mg. (ENSURE THATPREPARATION IS SUITABLE FORINTRATHECAL USE)

421. Cytarabine 500mg Injection

L01BC01000P4003XX

A i) Central nervous systemlymphoma ii) Meningealleukemia iii) Non Hodgkin'sLymphoma iv) High dosecytarabine as conditioning tocytoreduce the disease beforestem cell transplant forrelapsed or refractory leukemiav) As salvage for acutelymphocytic leukemia vi) Assalvage for acute myeloidleukemia vii) As palliativechemotherapy in elderly acutemyeloid leukemia/myelodysplastic syndrome

Standard doses 100 - 200 mg/m2daily over 5 - 10 days. Higher dosesfor intensification/consolidation:1000 - 3000 mg/m2 daily over 3 - 5days depending on specificprotocols. CHILD: Dose variabledepending on disease and protocol.Range from 100 mg/m2 to 3 g/m2twice daily. May be given as SC, IVbolus or infusion. Intrathecal dose:Less than 1 year: 15 mg, 1 - 2 years:20 mg, 2 - 3 years: 25 mg, more than3 years: 30 mg. (ENSURE THATPREPARATION IS SUITABLE FORINTRATHECAL USE)

Page 68 of 296

No. Generic Name MDC Category Indications Dosage422. Dabigatran

Etexilate 110 mgCapsule

B01AE07999C1002XX

A* i) Prevention of venousthromboembolic events inpatients who have undergonetotal knee replacement or totalhip replacement surgery. ii)Reduction of the risk of strokeand systemic embolism inpatients with non-valvular atrialfibrillation (AF). iii) Treatmentof deep vein thrombosis (DVT)and pulmonary embolism (PE)and prevention of recurrentDVT and PE in adults.

i) Following total knee replacement:Initially ADULT 110mg (ELDERLY, 75mg) within 1- 4 hours after surgery,then 220 mg (ELDERLY, 150 mg)once daily thereafter for 6-10 daysFollowing total hip replacement:Initially ADULT 110 mg (ELDERLY, 75mg) within 1- 4 hours after surgery,then 220 mg (ELDERLY, 150 mg)once daily thereafter for 28-35 daysii) Recommended daily dose is300mg taken orally as 150mg hardcapsule twice daily. Therapy shouldbe continued lifelong. iii)Recommended daily dose is 300mgtaken as one 150mg capsule BDfollowing treatment with aparenteral anticoagulant for at least5 days. The duration of therapyshould be individualized aftercareful assessment of the treatmentbenefit against the risk for bleeding.ii) & iii) For the following groups, therecommended daily dose is 220 mgtaken as one 110mg capsule twicedaily: - Patients aged 80 years orabove -Patients who receiveconcomitant verapamil Specialpatient population for renalimpairment : Renal function shouldbe assessed by calculating thecreatinine clearance (CrCl) prior toinitiation of treatment withDabigatran to exclude patients fortreatment with severe renalimpairment (i.e. CrCl < 30 ml/min).

423. DabigatranEtexilate 75 mgCapsule

B01AE07999C1001XX

A* Prevention of venousthromboembolic events inpatients who have undergonetotal knee replacement or totalhip replacement surgery

Following total knee replacement:Initially ADULT 110 mg (ELDERLY, 75mg) within 1- 4 hours after surgery,then 220 mg (ELDERLY, 150 mg)once daily thereafter for 6-10 daysFollowing total hip replacement:Initially ADULT 110 mg (ELDERLY, 75mg) within 1- 4 hours after surgery,then 220 mg (ELDERLY, 150 mg)once daily thereafter for 28-35 days

Page 69 of 296

No. Generic Name MDC Category Indications Dosage424. Dabigatran

Etexilate150 mgCapsule

B01AE07999C1003XX

A* i) Reduction of the risk of strokeand systemic embolism inpatients with non-valvular atrialfibrillation (AF). ii) Treatment ofdeep vein thrombosis (DVT) andpulmonary embolism (PE) andprevention of recurrent DVTand PE in adults.

i) Recommended daily dose is300mg taken orally as 150mg hardcapsule twice daily. Therapy shouldbe continued lifelong. ii)Recommended daily dose is 300mgtaken as one 150mg capsule BDfollowing treatment with aparenteral anticoagulant for at least5 days. The duration of therapyshould be individualized aftercareful assessment of the treatmentbenefit against the risk for bleeding.For the following groups, therecommended daily dose is 220 mgtaken as one 110mg capsule twicedaily: - Patients aged 80 years orabove -Patients who receiveconcomitant verapamil Specialpatient population for renalimpairment : Renal function shouldbe assessed by calculating thecreatinine clearance (CrCl) prior toinitiation of treatment withDabigatran to exclude patients fortreatment with severe renalimpairment (i.e. CrCl < 30 ml/min).

425. Dacarbazine 100mg Injection

L01AX04000P4001XX

A* i) Malignant melanoma,sarcomas, neuroblastomas andother childhood solid tumoursii) Hodgkin's Disease

i) 250 mg/m2 for 5 days, may berepeated every 3 weeks ii) 375mg/m2 IV every 2 weeks

426. Danazol 100 mgCapsule

G03XA01000C1001XX

A/KK i)Endometriosis andgynaecomastia ii)Menorrhagiaiii)Prophylaxis of hereditaryangioedema

i)200 - 800 mg daily for max of 9months ii)200 mg daily for 12 weeksii)400 mg daily. Reduce to 200 mgdaily after 2 months attack freeperiod

427. Danazol 200 mgCapsule

G03XA01000C1002XX

A/KK i)Endometriosis andgynaecomastia ii)Menorrhagiaiii)Prophylaxis of hereditaryangioedema

i)200 - 800 mg daily for max of 9months ii)200 mg daily for 12 weeksii)400 mg daily. Reduce to 200 mgdaily after 2 months attack freeperiod

428. Dapsone 100 mgTablet

J04BA02000T1001XX

B i)Leprosy ii) Dermatitisherpetiformis

i) ADULT: 6 - 10 mg/kg weekly/1.4mg/kg daily (around 50 - 100 mgdaily). CHILD: 1 - 2 mg/kg/day.Maximum: 100 mg/day ii) ADULT:50 - 300 mg daily

Page 70 of 296

No. Generic Name MDC Category Indications Dosage429. Darbepoietin alfa

120mcg/0.5mlinjection

B03XA02-000-P50-04-XXX

A* Treatment of anaemiaassociated with chronic renalfailure, including patients ondialysis and patients not ondialysis. (For naïve patients whoare eligible for long-actingErythropoietin StimulatingAgent)

Hemodialysis patients: Initial dose:20mcg IV once weekly Initial dosefor switched ESA-treated patient: 15– 60mcg IV once weeklyMaintenance dose: 15 – 60mcg IVonce weekly, then 30 – 120mcg IVbiweekly. Peritoneal dialysispatients and patients with chronickidney disease not on dialysis: Initialdose: 30mcg IV or SC biweekly Initialdose for switched ESA-treatedpatient: 30 – 120mcg IV or SCbiweekly Maintenance dose: 30 –120mcg IV or SC biweekly, then 60 –180mcg IV or SC once every fourweeks.

430. Darbepoietin alfa20mcg/0.5mlinjection

B03XA02-000-P50-01-XXX

A* Treatment of anaemiaassociated with chronic renalfailure, including patients ondialysis and patients not ondialysis. (For naïve patients whoare eligible for long-actingErythropoietin StimulatingAgent)

Hemodialysis patients: Initial dose:20mcg IV once weekly Initial dosefor switched ESA-treated patient: 15– 60mcg IV once weeklyMaintenance dose: 15 – 60mcg IVonce weekly, then 30 – 120mcg IVbiweekly. Peritoneal dialysispatients and patients with chronickidney disease not on dialysis: Initialdose: 30mcg IV or SC biweekly Initialdose for switched ESA-treatedpatient: 30 – 120mcg IV or SCbiweekly Maintenance dose: 30 –120mcg IV or SC biweekly, then 60 –180mcg IV or SC once every fourweeks.

431. Darbepoietin alfa40mcg/0.5mlinjection

B03XA02-000-P50-03-XXX

A* Treatment of anaemiaassociated with chronic renalfailure, including patients ondialysis and patients not ondialysis. (For naïve patients whoare eligible for long-actingErythropoietin StimulatingAgent)

Hemodialysis patients: Initial dose:20mcg IV once weekly Initial dosefor switched ESA-treated patient: 15– 60mcg IV once weeklyMaintenance dose: 15 – 60mcg IVonce weekly, then 30 – 120mcg IVbiweekly. Peritoneal dialysispatients and patients with chronickidney disease not on dialysis: Initialdose: 30mcg IV or SC biweekly Initialdose for switched ESA-treatedpatient: 30 – 120mcg IV or SCbiweekly Maintenance dose: 30 –120mcg IV or SC biweekly, then 60 –180mcg IV or SC once every fourweeks.

Page 71 of 296

No. Generic Name MDC Category Indications Dosage432. Daunorubicin HCl

20 mg InjectionL01DB02110P4001XX

A* i) Acute myeloblastic leukaemia(AML) ii) Acute lymphoblasticleukemia (ALL)

i) 45 - 60 mg/m2 IV daily for 3 - 5days ii) 25 - 45 mg/m2 once a weekfor first 4 weeks during inductionphase. Caution: Total cumulativedose of daunorubicin anddoxorubicin must not exceed 500mg/m2 due to risk of cardiotoxicity.CHILD: 30-45 mg/m2/dose infusionover 6 hours. Schedule depends onprotocol. Need to check cardiacfunction closely byechocardiography every cumulativedose of 100mg/m2 to max. 360mg/m2

433. Decitabine 50 mgInjection

L01BC08000P3001XX

A* Myelodysplastic syndromes(MDS) including: Previouslytreated and untreated de novoand secondary MDS of allFrench-American-Britishsubtypes (refractory anemia,refractory anemia with ringedsideroblasts, refractory anemiawith excess blasts, refractoryanemia with excess blasts intransformation, and chronicmyelomonocytic leukemia) andIntermediate-1, Intermediate-2,and High-Risk InternationalPrognostic Scoring System(IPSS) groups

15 mg/m2 by continuous IV infusionover 3 hours repeated every 8 hoursfor 3 days. Repeat this treatmentcycle every 6 weeks for a minimumof 4 cycles. However, complete orpartial response may take longerthan 4 cycles. Treatment may becontinued as long as there iscontinued

434. Deferasirox 125mg DispersibleTablet

V03AC03000T4001XX

A* Treatment of chronic ironoverload due to bloodtransfusions (transfusionalhaemosiderosis) in adult andpediatric patients aged 2 yearsand above.

Initial 20 mg/kg/day. Starting dosecan also be based on transfusionrate and existing iron burden. Inpatients not adequately controlledwith doses of 30mg/kg/day (e.gserum ferritin levels persistentlyabove 2,500 microgram/L and notshowing a decreasing trend overtime), doses up to 40mg/kg/daymay be considered.

435. Deferasirox 500mg DispersibleTablet

V03AC03000T4002XX

A* Treatment of chronic ironoverload due to bloodtransfusions (transfusionalhaemosiderosis) in adult andpediatric patients aged 2 yearsand above.

Initial 20 mg/kg/day. Starting dosecan also be based on transfusionrate and existing iron burden. Inpatients not adequately controlledwith doses of 30mg/kg/day (e.gserum ferritin levels persistentlyabove 2,500 microgram/L and notshowing a decreasing trend overtime), doses up to 40mg/kg/daymay be considered.

Page 72 of 296

No. Generic Name MDC Category Indications Dosage436. Deferiprone 500

mg TabletV03AC02000T1001XX

A* Treatment of iron overload inpatients with thalassemia majorfor whom desferrioxaminetherapy is contraindicated orinadequate. Add on therapy todesferrioxamine forthalassemia patients withcardiac complication

25 mg/kg 3 times a day for totaldaily dose of 75 mg/kg. Dosesgreater 100 mg/kg are notrecommended

437. Denosumab in1.0 mL solution(60 mg/mL)Pre‐filled syringe(subcutaneousinjection)

M05BX04000P4001XX

A* Post-Menopausal Osteoporosis.(To be used by OrthopaedicSpecialist, Rheumatologist andEndocrinologist)

A single subcutaneous injection of60 mg administered once every 6months. Patients should receivecalcium and vitamin D supplementswhilst undergoing treatment.

438. DesferrioxamineBMethanesulphonate 0.5 g Injection

V03AC01196P3001XX

A i) Acute iron poisoning inchildren ii) Investigation andtreatment ofhaemochromatosis iii)Diagnosis and treatment ofaluminium toxicity in patientswith renal failure and dialysis iv)Chronic iron toxicity or overload

i) 2 g by IM immediately and 5 g bymouth after gastric lavage ii) 0.5 -1.5 g by IM injection daily iii)Diagnosis: 5 mg per kg by slowintravenous infusion during the lasthour of haemodialysis. Treatment: 5mg per kg once a week by slowintravenous infusion during the lasthour of dialysis iv) 30 - 50 mg/kg

439. Desflurane Liquid N01AB07000L5001XX

A i) Induction and maintenance ofanaesthesia in adult ii)Maintenance of anaesthesia ininfants & children

ADULT: Induction , initially 3% inoxygen or nitrous oxide/oxygen andincreased by 0.5%-1% every 2-3breaths or as tolerated (up to 11%),until loss of consciousness.Maintenance: 2.5%-8.5% with orwithout concomitant nitrous oxideCHILD: maintenance, inhaled inconcentrations of 5.2%-10% with orwithout concomitant nitrous oxide

440. Desloratadine2.5mg/5ml syrup

R06AX27000L9001XX

A* Allergic rhinitis and chronicidiopathic urticaria. PrescribingRestriction(s): For use inchildren 1-2 years old only.

For children only: 1-5 yrs: 2.5mlonce a day (with or without meal) 6-11 yrs: 5ml once a day (with orwithout meal)

441. Desloratadine 5mg Tablet

R06AX27000T1001XX

A* Allergic rhinitis and chronicidiopathic urticaria

Adults and Adolescents (12 years ofage and older): 5mg once a dayregardless of mealtime.

442. Desmopressin 0.1mg Tablet

H01BA02122T1001XX

A i)Central diabetes insipidusii)Primary nocturnal enuresisiii)Treatment of nocturiaassociated with nocturnalpolyuria in adult

i)ADULT and CHILD : 0.1-0.2mg 3times daily, up to 0.1-1.2mg daily ii)ADULT & Child≥5 yr 0.2-0.4mg atnight iii)Initially 0.1 mg at night. Maybe increased to 0.2 mg and then to0.4 mg by means of weekly increase

443. Desmopressin 0.2mg Tablet

H01BA02122T1002XX

A i)Central diabetes insipidusii)Primary nocturnal enuresisiii)Treatment of nocturiaassociated with nocturnalpolyuria in adult

i)ADULT and CHILD : 0.1-0.2mg 3times daily, up to 0.1-1.2mg daily ii)ADULT & Child≥5 yr 0.2-0.4mg atnight iii)Initially 0.1 mg at night. Maybe increased to 0.2 mg and then to0.4 mg by means of weekly increase

Page 73 of 296

No. Generic Name MDC Category Indications Dosage444. Desmopressin

100 mcg/mlNasal Spray

H01BA02122A4101XX

A i) Diabetes Insipidus ii) Primarynocturnal enuresis

i) ADULT : 10 - 20 mcg 1-2 timesdaily. CHILD: 5 - 10mcg 1-2 timesdaily ii) 10-40 mcg nocte

445. DesmopressinAcetate 4 mcg/mlInjection

H01BA02122P3001XX

A Diabetes insipidus ADULT : 1 - 4 mcg IV daily. CHILD:0.4 mcg daily

446. Desogestrel0.075 mg Tablet

G03AC09000T1001XX

A* Contraception. Only for womenwho should not take combinedoral contraceptives (COCs) egObese, smoker, migraine,breast feeding

Tablets must be taken in the orderdirected on the package every dayat about the same time with someliquid as needed. One tablet is to betaken daily for 28 consecutive days.Each subsequent pack is startedimmediately after finishing theprevious pack.

447. Desogestrel 150mcg &Ethinylestradiol20 mcg Tablet

G03AA09954T1002XX

A/KK Oral contraception One tablet daily for 21 days startingon 1st day of menses followed by 7tablet-free days.

448. Desogestrel 150mcg &Ethinylestradiol30 mcg Tablet

G03AB05954T1001XX

C+ Contraception 1 tablet daily for 21 days,subsequent courses repeated after 7day interval (during whichwithdrawal bleeding occurs)

449. DesvenlafaxineSuccinate 50 mgExtended ReleaseTablet

N06AX23999T5002XX

A* Major depression Recommended dose is 50mg oncedaily, with or without food.

450. Dexamethasone0.5 mg Tablet

H02AB02000T1001XX

A i) Prophylaxis and managementof nausea and vomiting incancer chemotherapy, post-operation and palliative care, ii)Treatment of adrenocorticalfunction abnormalities, iii) Anyother treatment requiringcorticosteroid therapy.

0.5mg to 10mg daily is given for oraladministration, depending upon thedisease being treated. Up to 15 mgdaily in severe disease.

451. Dexamethasone4mg Tablet

H02AB02000T1003XX

A i) Prophylaxis and managementof nausea and vomiting incancer chemotherapy, post-operation and palliative care, ii)Treatment of adrenocorticalfunction abnormalities, iii) Anyother treatment requiringcorticosteroid therapy.

0.5mg to 10mg daily is given for oraladministration, depending upon thedisease being treated.

452. Dexamethasoneand NeomycinSulphate andPolymyxin B EyeOintment

S01CA01990G5101XX

A Treatment of ocularinflammation when concurrentuse of an antimicrobial isjudged necessary

Apply 1 - 1.5 cm 3 - 4 times daily,may be used adjunctively with dropsat bedtime

453. Dexamethasoneand NeomycinSulphate andPolymyxin BSulphateOphthalmic

S01CA01990D2001XX

A Treatment of ocularinflammation when concurrentuse of an antimicrobial isjudged necessary

1 - 2 drops hourly for severe casesand 4 - 6 hourly for mild infection

Page 74 of 296

No. Generic Name MDC Category Indications DosageSuspension

454. DexamethasoneSodiumPhosphate 0.1%Eye Drops

S01BA01162D2001XX

A Acute steroid responsiveinflammatory and allergicconditions

1 - 2 drops 4 - 6 times a day

455. DexamethasoneSodiumPhosphate 4mg/ml Injection

H02AB02162P3001XX

B i) Prophylaxis and managementof nausea and vomiting incancer chemotherapy, post-operation and palliative care, ii)Treatment of adrenocorticalfunction abnormalities, iii) Anyother treatment requiringcorticosteroid therapy.

Initially 0.5 - 9 mg IM, IV or infusiondaily, depending upon the diseasebeing treated

456. Dexchlorpheniramine Maleate 2mg Tablet

R06AB02253T1001XX

B Symptomatic treatment ofallergic rhinitis and allergicdermatoses

ADULT : 2 mg 3 times daily. CHILD :2 - 12 years : 2 mg 3 times daily

457. Dexchlorpheniramine Maleate 2mg/5 ml Syrup

R06AB02253L9001XX

B Symptomatic treatment ofallergic rhinitis

CHILD 2 - 5 years : 0.5 mg every 4 - 6hours; 6 - 11 years : 1 mg every 4 - 6hours

458. Dexmedetomidine HCl 100 mcg/mlInjection

N05CM18110P4001XX

A* i) Sedation of intubated andmechanically ventilated ICUpatients. For use only byspecialist anaesthetist ii) Forsedation of non-intubatedpatients prior to and/or duringsurgical and other procedures

i) Not to be infused for more than24 hours, 1 mcg/kg over 10 minutesas loading dose. Maintenance dose:0.2 - 0.7 mcg/kg/hr ii) Not to beinfused for more than 24 hours, 1mcg/kg over 10 minutes as loadingdose. Maintenance dose: 0.2 - 0.7mcg/kg/hr

459. Dextran 40Injection

B05AA05000P6001XX

A* Condition associated withperipheral local slowing of theblood flow, prophylaxis of postsurgical thromboembolicdisease

Initially 500-1000 ml by infusion,further doses are given according tothe patient's condition

460. Dextrose 10%Injection

B05BA03000P6002XX

B For parenteral replenishment offluid and minimal carbohydratecalories as required by theclinical condition of the patient

According to the needs of thepatient

461. Dextrose 20%Injection

B05BA03000P6003XX

B For parenteral replenishment offluid and minimal carbohydratecalories as required by theclinical condition of the patient

According to the needs of thepatient

462. Dextrose 30%Injection

B05BA03000P3004XX

B For parenteral replenishment offluid and minimal carbohydratecalories as required by theclinical condition of the patient

According to the needs of thepatient

463. Dextrose 5%Injection

B05BA03000P6001XX

B For parenteral replenishment offluid and minimal carbohydratecalories as required by theclinical condition of the patient

According to the needs of thepatient

464. Dextrose 50%Injection

B05BA03000P3005XX

B For parenteral replenishment offluid and minimal carbohydratecalories as required by theclinical condition of the patient

According to the needs of thepatient

Page 75 of 296

No. Generic Name MDC Category Indications Dosage465. Dextrose Powder V04CA02000

F2101XXB Use as a diagnostic agent for

diabetes75 g stat

466. DiatrizoateMeglumine andSodiumAmidotrizoateSolution

V08AA01254L9901XX

A i) Contrast medium for theradiological examination of thegastrointestinal tract (primarilyin cases in which bariumsulphate is contraindicated) ii)Computerised tomography inabdominal region iii) Treatmentof Mecolinium ileus

i) ADULT and CHILD more than 10year, ORALLY: 60 -100 ml RECTALLY,contrast medium should be dilutedwith 3-4 times its volume of water.ORALLY: CHILD less than 10 years,:15- 30 ml NEWBORN, INFANTcontrast medium should be dilutedwith 3 times its volume of water.RECTALLY: CHILD more than 5 years,contrast medium should be dilutedwith 4-5 times its volume of water.Younger patients a dilution with 5times its volume is recommended ii)Adult, orally, 25-77 mL in 1000 mLtap water 15-30 minutes prior toimaging

467. Diazepam 2 mgTablet

N05BA01000T1001XX

B i) Muscle spasm of variedaetiology, including tetanus ii)Anxiety disorders

i) ADULT: 2-10 mg 3-4 times daily.CHILD 6 months and older: 0.12 - 0.8mg/kg daily in divided doses, every6-8 hours ii) ADULT : 2 mg 3 timesdaily, increased in severe anxiety to15 - 30 mg daily in divided doses.ELDERLY (or delibitated) half adultdose. CHILD (night terrors), 1 - 5 mgat bedtime

468. Diazepam 5 mgRectal Solution

N05BA01000G2001XX

C Status epilepticus, skeletalmuscle spasm

Status epilepticus - ADULT: 0.5mg/kg repeated after 12 hours ifnecessary. CHILD (febrileconvulsions, prolonged orrecurrent): 0.5 mg/kg (maximum 10mg), repeated if necessary. Notrecommended for children below 2years

469. Diazepam 5 mgTablet

N05BA01000T1002XX

B i) Muscle spasm of variedaetiology, including tetanus ii)Anxiety disorders

i) ADULT: 2-10 mg 3-4 times daily.CHILD 6 months and older: 0.12 - 0.8mg/kg daily in divided doses, every6-8 hours ii) ADULT : 2 mg 3 timesdaily, increased in severe anxiety to15 - 30 mg daily in divided doses.ELDERLY (or delibitated) half adultdose. CHILD (night terrors), 1 - 5 mgat bedtime

Page 76 of 296

No. Generic Name MDC Category Indications Dosage470. Diazepam 5

mg/ml InjectionN05BA01000P3001XX

B i) Status epilepticus ii) Skeletalmuscle spasm iii) Anxietydisorders

i) Status epilepticus, by slow IV: 5-10every 10-15 minute (rate not morethan 5 mg/min), to a total dose of30 mg, may repeat in 2 hour ifneeded. Infants 30 days to 5 years,0.05-0.3 mg/kg/dose given over 2-3minutes, every 15-30 minutes to atotal dose of 5 mg, repeat in 2-4hours if necessary. CHILD more than5 years, 1 mg by slow IV, every 2-5minutes, maximum 10 mg, repeat in2-4 hours if necessary ii) Skeletalmuscle spasm, by slow IV or IM, 5-10 mg repeated if necessary in 3-4hours. CHILD (tetanus): 30 days - 5years, 1-2 mg IM or IV slowly every3-4 hours as needed. 5 years andabove, 5-10 mg IM or IV slowlyevery 3-4 hours if needed iii) Anxietydisorders, 2-10 mg by slow IV (notmore than 5 mg/min). Repeat ifnecessary every 3-4 hours

471. Diclofenac 1% Gel M02AA15520G3001XX

A Post-traumatic inflammation ofthe tendons,ligaments & joints.Localised forms of soft tissuerheumatism and degenerativerheumatism

Apply 3 - 4 times daily and gentlyrubbed in

472. Diclofenac 100mgSuppository

M01AB05520S2004XX

A Pain and inflammation inrheumatic disease and juvenilearthritis

Diclofenac Suppositories arenormally inserted one, two or threetimes a day up to a maximum totaldaily dose of 150 mg.

473. Diclofenac 12.5mg Suppository

M01AB05520S2001XX

A Pain and inflammation inrheumatic disease and juvenilearthritis

ADULT: 75 - 150 mg daily in divideddoses. CHILD 1-12 years, 12.5- 25mg daily

474. Diclofenac 25 mgSuppository

M01AB05520S2002XX

A Pain and inflammation inrheumatic disease and juvenilearthritis

ADULT: 75 - 150 mg daily in divideddoses. CHILD 1-12 years, 12.5- 25mg daily

475. Diclofenac 50 mgTablet

M01AB05520T1001XX

B Pain and inflammation inrheumatic disease

ADULTS: Initial dose of 150 mg daily.Mild or long term: 75 - 150 mg dailyin 2 to 3 divided doses after food.Maximum 200mg/day. PAEDS morethan 6 months : 1 - 3 mg/kg bodyweight daily in divided doses.Maximum 3mg/kg/day (Max150mg/day).

476. DiclofenacSodium 50 mgSuppository

M01AB05520S2003XX

A Pain and inflammation inrheumatic disease and juvenilearthritis

ADULTS: 75 - 150 mg daily in divideddoses. Maximum 150mg/day. PAEDSmore than 6 months : 1 - 3 mg/kgbody weight daily in divided doses.Maximum 3mg/kg/day (Max150mg/day).

Page 77 of 296

No. Generic Name MDC Category Indications Dosage477. Diclofenac

Sodium 75 mg/3ml Injection

M01AB05520P3001XX

A/KK Pain and inflammation inrheumatic disease

IM 75 mg once daily (2 times daily insevere cases) for not more than 2days. Max 150mg/day. Not suitablefor children.

478. Didanosine 100mg Tablet (ddI)

J05AF02000T1002XX

A* HIV infection, in combinationwith other antiretrovirals

ADULT less than 60 kg: 125 mg twicedaily or 250 mg once daily; morethan 60 kg: 400 mg once daily or200 mg twice daily. CHILD: 2 weeksto less than 3 months: 50mg/m2twice daily; 3-8 months: 100mg/m2twice daily

479. Didanosine 2 gOral Solution(ddI)

J05AF02000F2101XX

A* HIV infection, in combinationwith other antiretrovirals

ADULT less than 60 kg: 125 mg twicedaily or 250 mg once daily; morethan 60 kg: 400 mg once daily or200 mg twice daily. CHILD: 2 weeksto less than 3 months: 50mg/m2twice daily; 3-8 months: 100mg/m2twice daily

480. Didanosine 25 mgTablet (ddI)

J05AF02000T1001XX

A* HIV infection, in combinationwith other antiretrovirals

ADULT less than 60 kg: 125 mg twicedaily or 250 mg once daily; morethan 60 kg: 400 mg once daily or200 mg twice daily. CHILD: 2 weeksto less than 3 months: 50mg/m2twice daily; 3-8 months: 100mg/m2twice daily

481. Didanosine 250mg EntericCoated Capsule

J05AF02000C1001XX

A* HIV infection, in combinationwith other antiretrovirals

ADULT less than 60 kg: 250 mg oncedaily; 60 kg or greater: 400 mg oncedaily. Dose may varies if taken incombination with tenofovir

482. Didanosine 400mg EntericCoated Capsule

J05AF02000C1002XX

A* HIV infection, in combinationwith other antiretrovirals

ADULT less than 60 kg: 250 mg oncedaily; 60 kg or greater: 400 mg oncedaily. Dose may varies if taken incombination with tenofovir

483. Dienogest 2mgtablet

G03DB08000T1001XX

A/KK Treatment of endometriosis One tablet daily. Treatment can bestarted on any day of menstrualcycle. Tablets must be takencontinously without regard tovaginal bleeding.

484. Diethylcarbamazine Citrate 50 mgTablet

P02CB02136T1001XX

B i) Bancrofti filariasis,onchocerciasis, loasis, creepingeruption ii) Ascariasis iii)Tropical eosinophilia

i) 1 mg/kg on the first day andincreased gradually over 3 days to 6mg/kg daily in divided doses. Thisdosage is maintained for 21 days. ii)13 mg/kg once daily for 7 days.CHILD : 6 - 10 mg/kg 3 times dailyfor 7 days iii) 6 mg/kg/day in 3divided doses for 21 days

Page 78 of 296

No. Generic Name MDC Category Indications Dosage485. Digoxin 0.25 mg

TabletC01AA05000T1001XX

B Heart failure , with atrialfibrillation, supraventriculararrhythmias (particularly, atrialfibrillation)

Rapid digitalisation: 0.75 -1.5 mg individed doses over 24 hours; lessurgent digitalisation, 250 mcg-500mcg daily (higher dose may bedivided). Maintenance : 62.5mg -500 mcg daily (higher dose may bedivided) according to renal functionand , in atrial fibrillation, on heartrate response; usual range, 125-250mcg daily (lower dose may beappropriate in elderly)

486. Digoxin 250mcg/ml Injection

C01AA05000P3001XX

A Heart failure with atrialfibrillation, supraventriculararrhythmias (particularly atrialfibrillation)

Rapid digitilisation: ADULT & CHILDover 10 years, initially 0.75 - 1.5 mg,followed by 250 mcg 6 hourly untildigitilisation is complete

487. Digoxin 50mcg/ml Elixir

C01AA05000L1001XX

B Heart failure, supraventriculararrhythmias (particularly atrialfibrillation)

Rapid digitalization, give in divideddoses; PREMATURE: 20-30 mcg/kg;FULLTERM: 25-35 mcg/kg; CHILD 1-2years : 35 to 60 mcg/kg; CHILD 2-5years: 30-40 mcg/kg; CHILD 5-10years: 20- 35 mcg/kg; CHILD over 10years: 10-15 mcg/kg. For dailymaintenance doses or for gradualdigitalization, give 20% to 30% oforal digitalizing dose for prematureinfants or 25% to 35% of oraldigitalizing dose for all otherpediatric patients

488. Digoxin 62.5 mcgTablet

C01AA05000T1002XX

B Heart failure, with atrialfibrillation, supraventriculararrhythmias (particularly, atrialfibrillation)

Rapid digitalisation: 1-1.5 mg individed doses over 24 hours; lessurgent digitalisation, 250 mcg-500mcg daily (higher dose may bedivided). Maintenance: 62.5 - 500mcg dailly (higher dose may bedivided) according to renal fuction,and in atrial fibrillation, on heart-response; usual range :125 - 250mcg daily (lower doses may beappropriate in the elderly)

489. DihydrocodeineTartrate 30 mgTablet

N02AA08123T1001XX

B For the control of moderate tosevere chronic pain

ADULT: 30 - 60 mg every 4 - 6 hours.PAED, over 4 yrs: 0.5 - 1 mg/kg bodyweight every 4-6 hours

490. Dihydroergocristine or Co-dergocrineMesilate 1 mgTablet

C04AE01196T1001XX

A/KK Adjunct in elderly with mild tomoderate dementia, preventionof migraine and vascularheadache

3-6 mg daily in divided doses

491. Diltiazem HCl 30mg Tablet

C08DB01110T1001XX

B Treatment of angina pectoris inthe following cases: i)inadequate response orintolerance to beta-blockersand Isosorbide Dinitrate ii)contraindication to beta-

Initially 30mg tds, may increase to60mg tds (elderly initially twicedaily; increased if necessary to 360mg daily.

Page 79 of 296

No. Generic Name MDC Category Indications Dosageblockers iii) coronary arteryspasm

492. DimenhydrinateInjection10ml/vial(50mg/ml)

N07CA00000P2001XX

B Prevention and relief of motionsickness, treatment of vertigo,nausea or vomiting associatedwith electroshock therapy,anaesthesia and surgery;labyrinthine disturbances andradiation sickness.

Usual Adult & Adolescent Dose:Antiemetic; or Antivertigo agent ?Intramuscular, 50 mg repeatedevery four hours as needed.Intravenous, 50 mg in 10 mL of 0.9%sodium chloride injection,administered slowly over a period ofat least two minutes, repeatedevery four hours as needed. UsualPediatric Dose: Antiemetic; orAntivertigo agent ? Intramuscular,1.25 mg per kg of body weight or37.5 mg per square meter of bodysurface, every six hours as needed,not to exceed 300 mg per day.Intravenous, 1.25 mg per kg of bodyweight or 37.5 mg per square meterof body surface, in 10 ml of 0.9%sodium chloride injection,administered slowly over a period ofat least two minutes, every six hoursas needed, not to exceed 300 mgper day.

493. DimenhydrinateSyrup 15mg/5ml

N07CA00000L9003XX

B For prevention and treatmentof motion sickness. Also used asanti-emetic agent in irradiationsickness, postoperativevomiting, drug induced nauseaand vomiting, and forsymptomatic treatment ofnausea and vertigo due toMeniere`s disease and otherlabyrinthine disturbances.

ADULT: 50-100 mg every 4 hours asneeded. For motion sickness, takemedicine at least 30 minutes, andpreferably 1-2 hours beforetravelling. Usual adult prescribinglimit: Up to 400 mg daily. CHILD:Children 6-12 years: 25-50 mg every6-8 hours as needed (maximum of150 mg daily).

494. DimenhydrinateTablet 50mg

N07CA00000T1001XX

B Prevention and treatment ofthe nausea, vomiting anddizziness associated withmotion sickness. Symptomatictreatment of nausea andvertigo caused by Meniere'sdisease and other vestibulardisturbances.

ADULT: 50-100 mg every 4 hours asneeded. For motion sickness, takemedicine at least 30 minutes, andpreferably 1-2 hours beforetravelling. Usual adult prescribinglimit: Up to 400 mg daily. CHILD: 6-12 years: 25-50 mg every 6-8 hoursas needed (maximum of 150 mgdaily).

495. Dimercaprol 50mg/ml Injection

V03AB09000P3001XX

B Poisoning by antimony, arsenic,bismuth, gold, mercury,possibly thallium; adjunct (withcalcium disodium edetate) inlead poisoning

By IM: 2.5 - 3 mg/kg every 4 hoursfor 2 days, 2 - 4 times on the thirdday, then 1 - 2 times daily for 10days or until recovery. Forophthalmic use : instillation of 50mg/ml oily solution in conjunctivalsac, within 5 minutes ofcontamination

Page 80 of 296

No. Generic Name MDC Category Indications Dosage496. Dinoprostone

(Prostagladin E2)3 mg VaginalTablet

G02AD02000S1001XX

A Induction of labour 3 mg vaginal tablet to be insertedhigh into the posterior formix. Asecond 3 mg tablet may be insertedafter 6-8 hours if labour is notestablished. Max 6 mg

497. Diosmin 450 mgand Hesperidin50 mg Tablet

C05CA53931T1001XX

A/KK i) Haemorrhoids ii) Chronicvenous insufficiency

i) Acute attack: 6 tablets daily forthe first 4 days, then 4 tablets dailyin 2 divided doses for 3 days and 2tablets thereafter. Chronic: 2 tabletsdaily ii) 2 tab daily with meals

498. Diphenhydramine Hydrochloride10 mg/5 ml Oralsolution

R06AA02110L1001XX

C Cough and allergic rhinitis Allergic rhinitis 1) Adults & Childrenover 12 years of age : 25 to 50 mg 3to 4 times a day 2) Children 6 to 12years of age: 10 mg 3 to 4 times aday 3) Children 1 to 6 years of age: 5mg 3 to 4 times a day. Maximumdaily dosage <300 mg (adults andchildren) Cough and cold 1)Adults:25 mg every 4 hrs. Not to exceed150 mg in 24 hours 2) Children (6 to12years): 12.5 mg every 4 hours.Not to exceed 75 mg in 24 hours 3)Children (2 to 6 years): 6.25 mgevery 4 hours. Not to exceed 25 mgin 24 hours

499. Diphenhydramine Hydrochloride14 mg/5 mlExpectorant

R06AA52110L2101XX

C Cough ADULT : 5 - 10 ml 2 - 3 times daily.CHILD : 2.5 - 5 ml 2 - 3 times daily(not to be used in children less than2 years of age)

500. Diphenhydramine Hydrochloride 7mg/5 mlExpectorant

R06AA52110L9003XX

C Cough ADULT : 5 - 10 ml 2 - 3 times daily.CHILD : 2.5 - 5 ml 2 - 3 times daily(not to be used in children less than2 years of age)

501. DiphenoxylateHCl 2.5mg withAtropineSulphate0.025mg Tablet

A07DA01922T1001XX

B Acute diarrhoea ADULT initially 4 tablet followed by2 tablet 4 times daily until diarrhoeais controlled

502. Diphtheria andTetanus VaccineInjection

J07AM51963P3001XX

C+ Immunisation againstdiphtheria and tetanus

Prophylactic: 2 or 3 doses by deepSC or IM injection, 0.5 or 1 ml. Eachsecond dose at 4 - 6 weeks then 4 -6 months. Booster at 4 - 6 years

503. DiphtheriaAntitoxinInjection

J07AF01000P3001XX

B Diphtheria Therapeutic: 10,000 - 30,000 unitsby IM or IV. Increase to 40,000 -100,000 units in severe cases. Dosesup to 30,000 units may be given IM

504. Diphtheria,Pertussis,Tetanus andConjugatedHaemophilusType B 10 mcgVaccine

J07AG52000P3001XX

C Immunisation of childrenagainst Haemophilus Type Binfections, diphtheria, tetanusand pertussis

0.5 ml given by IM

Page 81 of 296

No. Generic Name MDC Category Indications Dosage505. Diphtheria,

Pertussis,Tetanus andHepatitis BVaccine

J07CA05963P3001XX

C+ Active immunisation againstdiphtheria, tetanus, pertussisand hepatitis B in infants from 6weeks onwards

Primary vaccination: 3 doses of 0.5ml each within the first 6 months oflife. Administer each dose atintervals of at least 4 weeks. Abooster dose can be administered inthe second year of life

506. Diphtheria,Pertussis,Tetanus VaccineInjection

J07AJ52963P3001XX

C Prophylactic immunisationagainst diphtheria, pertussisand tetanus

By deep SC or IM injection: 3 doseseach of 0.5 or 1 ml with intervals of6 - 8 weeks and 4 - 6 monthsrespectively between the doses.Booster 1 and 5 years after primaryimmunisation

507. Diphtheria,Tetanus, AcellularPertussis,Inactivated PolioVirus,HaemophilusInfluenza Type B(DTaP-IPV-HiB)Vaccine Injection(Single Dose)

J07CA06963P3001XX

C+ Immunisation of childrenagainst Diphtheria, Tetanus,Acellular Pertussis, Polio andHaemophilus Influenza Type Binfection

Primary : 0.5 ml by IM at 1 - 2months intervals Booster : Secondyear of life

508. Dipyridamole 75mg Tablet

B01AC07000T1001XX

B As an adjunct to oralanticoagulation/ antiplatelettherapy in the prophylaxis ofcerebrovascular events

75-150 mg 3 times daily to be taken1 hour before meals

509. DistigmineBromide 5 mgTablet

N07AA03320T1001XX

A i) Myasthenia gravis ii)Prevention and treatment ofpost-operative intestinal atony,urinary retention andneurogenic bladder

i) ADULT : 5 mg daily 30 minutesbefore breakfast. Increase atintervals of 3 - 4 days if necessary tomaximum of 20 mg daily. CHILD : Upto 10 mg daily according to age ii)Urinary retention : 5 mg daily 30minutes before breakfast.Neurogenic bladder : 5 mg daily oron alternate days 30 minutes beforebreakfast

510. Dithranol 0.1 - 5%in Vaseline/Ointment

D05AC01000G5001XX

A Short contact treatment forplaque psoriasis and alopeciaareata

For application to skin or scalp. 0.1-0.5% suitable for overnighttreatment. 1-2% for max 1 hour.

511. Dithranol 1 % inLassars Paste

D05AC01000G6001XX

A Treatment of quiescent orchronic psoriasis of the skin,scalp and alopecia areata

Apply liberally and carefully to thelesions with a suitable applicator. Adressing may be applied

512. Dobutamine 12.5mg/ml Injection

C01CA07110P3001XX

A Hypotension and heart failure Initial 0.5-1 mcg/kg/min by IV,maintenance 2.5-10mcg/kg/min.Frequently,doses up to20mcg/kg/min are required foradequate hemodynamicimprovement. On rareoccasions,infusion rates up to40mcg/kg/min

Page 82 of 296

No. Generic Name MDC Category Indications Dosage513. Docetaxel

40mg/mlInjection

L01CD02000P3002XX

A* i) Adjuvant treatment ofpatients with high risk node-positive breast cancer incombination with doxorubicinand cyclophosphamide ii)Breast cancer, locally advancedor metastatic, not previously oncytotoxic therapy, incombination with doxorubiciniii) First line therapy in nonsmall cell lung cancer in stage 3-4 and performance status 0-1,in combination with cisplatin iv)Inoperable locally advancedsquamous cell carcinoma ofhead and neck, in combinationwith cisplatin and 5-FU forinduction treatment v) Prostatecancer, in combination withprednisolone

i) 75 mg/m2 IV over 1 hour afterdoxorubicin 50 mg/m2 andcyclophosphamide 500 mg/m2every 3 weeks for 6 cycles ii) 75mg/m2 IV over 1 hour every 3 weekin combination with doxorubicin 50mg/m2 iii) Administer IV over 1 hourevery 3 weeks. Chemotherapy-naivepatients 75 mg/m2 immediatelyfollowed by 75 mg/m2 cisplatin over30-60 mins or carboplatin (AUC 6mg/mL/min) over 30-60 minutes.Monotherapy of non small cell lungcancer (NSCLC) after failure of priorplatinum-based chemotherapy 75mg/m2 iv) 75 mg/m2 as a 1 hourinfusion followed by cisplatin 75mg/m2 over 1 hour, on day one,followed by 5-fluorouracil as acontinuous infusion at 750 mg/m2per day for five days. This regimen isadministered every 3 weeks for 4cycles.

514. Dolutegravir50mg Tablet

J05AX12000T3201XX

A* Dolutegravir is indicated incombination with other anti-retroviral medicinal productsfor the treatment of HumanImmunodeficiency Virus (HIV)infected adults and adolescentsabove 12 years of age.Restriction: For patients whoare not able to tolerate orfailing treatment or resistanceto the first line therapy(efavirenz and nevirapine).

i) HIV-1 patients withoutdocumented or clinically suspectedresistance to the integrase class: 50mg (one tablet), once daily, orally. ii)HIV-1 patients with resistance to theintegrase class: 50 mg (one tablet),twice daily, orally.

515. Domperidone 1mg/mlSuspension

A03FA03000L8001XX

B Nausea, vomiting, dyspepsia,gastro-esophageal reflux

Chronic dyspepsia : CHILD 2.5 mL/10kg body weight 3 times daily andonce more in the evening ifnecessary. Dosage may be doubledin adults & childs over 1 year. Acuteand subacute conditions(particularly nausea and vomiting).CHILD: 5 mL/10 kg bodyweight. Allto be taken 3-4 times daily

516. Domperidone 10mg Tablet

A03FA03253T1001XX

B Nausea, vomiting, dyspepsia,gastro-esophageal reflux

Chronic dyspepsia ADULT 10 mg 3times daily. Acute and subacuteconditions (particularly nausea andvomiting):ADULT 20 mg 3-4 timesdaily

517. Donepezil HCl 10mg Tablet

N06DA02110T1002XX

A Treatment of mild to moderatedementia in Alzheimer'sdisease, as well as in patientswith severe Alzheimer's

5 - 10 mg once daily at bedtime.Maximum 10 mg daily

Page 83 of 296

No. Generic Name MDC Category Indications Dosagedisease. [psychiatrists andneurologists only]

518. Donepezil HCl 5mg Tablet

N06DA02110T1001XX

A Treatment of mild to moderatedementia in Alzheimer'sdisease, as well as in patientswith severe Alzheimer'sdisease.

5 - 10 mg once daily at bedtime.Maximum 10 mg daily

519. DonepezilHydrochloride10mgOrodispersibleTablet

N06DA02110T4002XX

A* Treatment of mild to moderatedementia in Alzheimer'sdisease, as well as in patientswith severe Alzheimer'sdisease. [psychiatrists andneurologists only]

Initiated at 5mg/day (one a daydosing), should be maintained for atleast 1 month in order to allow theearliest clinical responses and toallow steady state concentration tobe achieved. The maximumrecommended daily dose is 10 mg.

520. DonepezilHydrochloride5mgOrodispersibleTablet

N06DA02110T4001XX

A* Treatment of mild to moderatedementia in Alzheimer'sdisease, as well as in patientswith severe Alzheimer'sdisease. [psychiatrists andneurologists only]

Initiated at 5mg/day (one a daydosing), should be maintained for atleast 1 month in order to allow theearliest clinical responses and toallow steady state concentration tobe achieved. The maximumrecommended daily dose is 10 mg.

521. Dopamine HCl 40mg/ml Injection

C01CA04110P3001XX

B Non-hypovolemic hypotension Initial dose 2-5  mcg/kg/min withincremental changes of 5-10mcg/kg/min at 10-15 minutesintervals until adequate response isnoted. Most patients aremaintained at less than 20mcg/kg/min. If dosage exceeds50 mcg/kg/min, assess renalfunction frequently

522. DoripenemMonohydrate500 mg Injection

J01DH04000P4001XX

A* Ventilator-associatedpneumonia (VAP) patients atrisk or involving multidrugresistant pathogens especiallyPseudomonas aeruginosainfections

500mg every 8 hours as a one hourinfusion for 5 to 14 days accordingto severity, site of infection and thepatient's clinical response.

523. Dorzolamide HCl2% OphthalmicSolution

S01EC03110D2001XX

A* All glaucoma patients wherebeta-blockers arecontraindicated and whenintraocular pressure is not wellcontrolled by other drugs

Monotherapy : 1 drop 3 times daily.Adjunctive therapy with anophthalmic beta-blocker : 1 drop 2times daily. When substituting foranother ophthalmic antiglaucomaagent with this product, discontinuethe other agent after proper dosingon one day and start Trusopt on thenext day. If more than 1 topicalophthalmic drug is used, the drugsshould be administered at least 10mins apart

Page 84 of 296

No. Generic Name MDC Category Indications Dosage524. Dothiepin HCl 25

mg CapsuleN06AA16110C1001XX

A Depression of any aetiology Initially 75 mg (ELDERLY 50-75 mg)daily in divided doses or single doseat bedtime, increased gradually asnecessary to 150 mg daily (ELDERLY75 mg may be sufficient), up to 225mg daily in some circumstances.CHILD is not recommended

525. Dothiepin HCl 75mg Tablet

N06AA16110T1001XX

A Depression of any aetiology Initially 75 mg (ELDERLY 50-75 mg)daily in divided doses or single doseat bedtime, increased gradually asnecessary to 150 mg daily (ELDERLY75 mg may be sufficient), up to 225mg daily in some circumstances.CHILD is not recommended

526. DoxazosinMesilate 4 mg CRTablet

C02CA04196T5001XX

A* Benign Prostatic Hyperplasia 4 mg once daily to maximum8mg/day

527. Doxorubicin HCl10 mg Injection

L01DB01110P4001XX

A i) Solid tumours, leukaemia,non-Hodgkin's lymphoma ii)Leukaemia (ALL induction) iii)Multiple myeloma

i) 30 - 75 mg/m2 IV as a single doseat 21 day intervals ii) 25 - 45 mg/m2once a week for the first 4 weeksduring induction or re-inductionphase (refer to specific protocol.Caution: Total cumulative dose ofdoxorubicin must not exceed 550mg/m2 due to risk of cardiotoxicity.CHILD: 30 mg/m2/dose over 6 - 24hours for 1 - 2 days. Need to checkcardiac function closely byechocardiography every cumulativedose of 100 mg/m2 to maximum360 mg/m2 iii) 9 mg/m2 over 24hours infusion for 4 days at monthlyintervals

528. Doxorubicin HCl50 mg Injection

L01DB01110P4002XX

A i) Solid tumours, leukaemia,non-Hodgkin's lymphoma ii)Leukaemia (ALL induction) iii)Multiple myeloma

i) 30 - 75 mg/m2 IV as a single doseat 21 day intervals ii) 25 - 45 mg/m2once a week for the first 4 weeksduring induction or re-inductionphase (refer to specific protocol.Caution: Total cumulative dose ofdoxorubicin must not exceed 550mg/m2 due to risk of cardiotoxicity.CHILD: 30 mg/m2/dose over 6 - 24hours for 1 - 2 days. Need to checkcardiac function closely byechocardiography every cumulativedose of 100 mg/m2 to maximum360 mg/m2 iii) 9 mg/m2 over 24hours infusion for 4 days at monthlyintervals

529. Doxycycline 100mg Capsule

J01AA02000C1001XX

B Infections due to susceptibleorganisms

ADULT: 200 mg on the first dayfollowed by 100 mg daily. Severeinfections: 200 mg daily

Page 85 of 296

No. Generic Name MDC Category Indications Dosage530. Doxycycline 100

mg TabletJ01AA02000T1001XX

B Infections due to susceptibleorganisms

ADULT: 200 mg on the first dayfollowed by 100 mg daily. Severeinfections: 200 mg daily

531. D-Penicillamine0.25 g Capsule

M01CC01000C1001XX

A i) Treatment of severe leadpoisoning, it is used asadjunctive treatment followinginitial treatment with anotherchelating agent. May also beused as sole therapy in thetreatment of asymptomaticpatients with moderatelyelevated blood concentrationsii) Wilson's Disease: to aid inelimination of copper ions

i) Heavy metal poisoning: 900mg-1800mg daily. Duration oftreatment is dictated by the urinaryheavy metal excretion.Simultaneous oral vitamin B6replacement with at least 40mgdaily is essential ii) Wilson's disease:0.25g - 1.5g daily on an incrementalbasis. Maximal daily dose: 2g.Maintenance dose: 0.75g - 1g daily

532. Duloxetine 30 mgCapsule

N06AX21110C1001XX

A* Major depressive disorder,diabetic peripheral neuropathicpain

ADULT: 60 mg once daily up to amaximum dose of 120mg/day (individed doses) CHILD andADOLESCENT under 18 years notrecommended

533. Duloxetine 60 mgCapsule

N06AX21110C1002XX

A* Major depression, diabeticperipheral neuropathic pain

ADULT: 60 mg once daily up to amaximum dose of 120mg/day (individed doses) CHILD andADOLESCENT under 18 years notrecommended

534. Dutasteride 0.5mg Capsule

G04CB02000C1001XX

A* Benign prostatic hyperplasia inmen with an enlarged prostategland

0.5 mg daily

535. Dutasteride0.5mg andTamsulosin0.4mg Capsule

G04CA52953C1001XX

A* Combination therapy for thetreatment of moderate tosevere symptoms of BPH with:i) Large prostate (>30g) ii) Poorrisk or not fit for surgeryiii)Those who are awaiting theirturn for surgery

One capsule daily

536. Dydrogesterone10 mg Tablet

G03DB01110T1001XX

A/KK i) Dysmenorrhoea ii)Endometriosis iii) Dysfunctionaluterine bleeding (to arrest andto prevent bleeding) iv)Threatened abortion v) Habitualabortion vi) Post menopausalcomplaints (hormonereplacement therapy incombination with oestrogen)

i) 10 mg bd from day 5 - 25 of cycleii) 10 mg bd - tds from day 5 - 25 ofthe cycle or continuously iii) Toarrest bleeding :10 mg bd with anoestrogen once daily for 5 - 7 days,To prevent bleeding : 10 mg bd withan oestrogen once daily from day 11- 25 of the cycle iv) 40 mg at once,then 10mg 8hrly until symptomsremit v) 10 mg bd until 20th week ofpregnancy vi) 10-20 mg daily duringlast 12-14 days of each cycle

537. Ear Wax Softener S02DA30900D10XXXX

B Occlusion or partial occlusion ofthe external auditory meatus bysoft wax or wax plug

Instill 5 drops into the ears. Referproduct information leaflet

Page 86 of 296

No. Generic Name MDC Category Indications Dosage538. Edrophonium

Chloride 10mg/ml Injection

N07AA00100P3001XX

B i) For reversal of neuromuscularblock ii) Diagnosis ofmyasthenia gravis

i) Intravenous injection on overseveral minutes, 500 - 700 mcg/kg(after or with atropine sulphate 600mcg) ii) Intravenous injection 2 mgfollowed by 8 mg if no responseoccurs within 30 seconds. CHILD: 20mcg followed by 80 mcg/kg after 30seconds

539. Efavirenz 100 mgCapsule

J05AG03000C1002XX

A* Combination therapy for HIVinfections with a proteaseinhibitor and or NucleosideReverse Transcriptase Inhibitors(NRTIs)

ADULT: 600 mg once daily.ADOLESCENT & CHILD less than 17years, more than 40 kg: 600 mgonce daily, 32.5 - less than 40 kg:400 mg once daily, 25 - less than32.5 kg: 350 mg once daily, 20 - lessthan 25 kg: 300 mg once daily, 15 -less than 20 kg: 250 mg once daily,13 - less than 15 kg: 200 mg oncedaily. No studies in children lessthan 3 years or less than 13 kg.Formulation unsuitable for childrenless than 40 kg

540. Efavirenz 200 mgCapsule

J05AG03000C1003XX

A* Combination therapy for HIVinfections with a proteaseinhibitor and or NucleosideReverse Transcriptase Inhibitors(NRTIs)

ADULT: 600 mg once daily.ADOLESCENT & CHILD less than 17years, more than 40 kg: 600 mgonce daily, 32.5 - less than 40 kg:400 mg once daily, 25 - less than32.5 kg: 350 mg once daily, 20 - lessthan 25 kg: 300 mg once daily, 15 -less than 20 kg: 250 mg once daily,13 - less than 15 kg: 200 mg oncedaily. No studies in children lessthan 3 years or less than 13 kg.Formulation unsuitable for childrenless than 40 kg

541. Efavirenz 50 mgCapsule

J05AG03000C1001XX

A* Combination therapy for HIVinfections with a proteaseinhibitor and or NucleosideReverse Transcriptase Inhibitors(NRTIs)

ADULT: 600 mg once daily.ADOLESCENT & CHILD less than 17years, more than 40 kg: 600 mgonce daily, 32.5 - less than 40 kg:400 mg once daily, 25 - less than32.5 kg: 350 mg once daily, 20 - lessthan 25 kg: 300 mg once daily, 15 -less than 20 kg: 250 mg once daily,13 - less than 15 kg: 200 mg oncedaily. No studies in children lessthan 3 years or less than 13 kg.Formulation unsuitable for childrenless than 40 kg

Page 87 of 296

No. Generic Name MDC Category Indications Dosage542. Efavirenz 600 mg

TabletJ05AG03000T1001XX

A/KK Combination therapy for HIVinfections with a proteaseinhibitor and or NucleosideReverse Transcriptase Inhibitors(NRTIs)

ADULT: 600 mg once daily.ADOLESCENT & CHILD less than 17years, more than 40 kg: 600 mgonce daily, 32.5 - less than 40 kg:400 mg once daily, 25 - less than32.5 kg: 350 mg once daily, 20 - lessthan 25 kg: 300 mg once daily, 15 -less than 20 kg: 250 mg once daily,13 - less than 15 kg: 200 mg oncedaily. No studies in children lessthan 3 years or less than 13 kg.Formulation unsuitable for childrenless than 40 kg

543. EltrombopagOlamine 25 mgFilm-coatedTablet

B02BX05999T1001XX

A* Short term use in idiopathicthrombocytopenic purpurapatients as bridging therapy forsplenectomy or surgery and incases of severe bleeding.

Individualised dosage based on thepatient's platelet count. AdultInitially 50 mg once daily. East Asianpatient 25 mg once daily. Then,adjust dose to maintain plateletcount ≥50,000/microliter. Max: 75mg daily.

544. Empagliflozin10mg tablet

A10BK03-000-T32-01-XXX

A* Indicated in the treatment oftype 2 diabetes mellitus toimprove glycaemic control inadults as: Add-on combinationtherapy: In combination withother glucose–loweringmedicinal products includinginsulin, when these, togetherwith diet and exercise, do notprovide adequate glycaemiccontrol. Prescribing Restriction:The use of empagliflozin isrestricted to: 1. Secondaryprevention of cardiovasculardisease (patient that hasprevious cardiovascular event);2. HbA1c not more than 8.5%on dual combination anti-diabetic therapy; 3. BMI:30kg/m2 and above; 4.Creatinine clearance 60ml/minor EGFR 60ml/min/1.73m2 andabove.

Starting dose is 10 mg once daily. Inpatient with eGFR ≥60ml/min/1.73m2 who need tighterglycaemic control, the dose can beincreased up to 25 mg once daily(maximum).

Page 88 of 296

No. Generic Name MDC Category Indications Dosage545. Empagliflozin

25mg tabletA10BK03-000-T32-02-XXX

A* Indicated in the treatment oftype 2 diabetes mellitus toimprove glycaemic control inadults as: Add-on combinationtherapy: In combination withother glucose–loweringmedicinal products includinginsulin, when these, togetherwith diet and exercise, do notprovide adequate glycaemiccontrol. Prescribing Restriction:The use of empagliflozin isrestricted to: 1. Secondaryprevention of cardiovasculardisease (patient that hasprevious cardiovascular event);2. HbA1c not more than 8.5%on dual combination anti-diabetic therapy; 3. BMI:30kg/m2 and above; 4.Creatinine clearance 60ml/minor EGFR 60ml/min/1.73m2 andabove.

Starting dose is 10 mg once daily. Inpatient with eGFR ≥60ml/min/1.73m2 who need tighterglycaemic control, the dose can beincreased up to 25 mg once daily(maximum).

546. EmulsificantsOintment

D02AC00952G5001XX

C Xerosis and ichthyosis Use as a soap and emollient

547. Enalapril 10 mgTablet

C09AA02253T1002XX

B i) Hypertension ii) Congestiveheart failure

i) Initially 5 mg daily, (ELDERLY 2.5mg once daily), usual maintenancedose 10 - 20 mg daily. Maximum: 40mg/day in 1 - 2 divided doses ii)Initially 2.5 mg daily, usualmaintenance dose 20 mg daily in 1 -2 divided doses; maximum: 40mg/day

548. Enalapril 20 mgTablet

C09AA02253T1003XX

B i) Hypertension ii) Congestiveheart failure

i) Initially 5 mg daily, (ELDERLY 2.5mg once daily), usual maintenancedose 10 - 20 mg daily. Maximum: 40mg/day in 1 - 2 divided doses ii)Initially 2.5 mg daily, usualmaintenance dose 20 mg daily in 1 -2 divided doses; maximum: 40mg/day

549. Enalapril 5 mgTablet

C09AA02253T1001XX

B i) Hypertension ii) Congestiveheart failure

i) Initially 5 mg daily, (ELDERLY 2.5mg once daily), usual maintenancedose 10 - 20 mg daily. Maximum: 40mg/day in 1 - 2 divided doses ii)Initially 2.5 mg daily, usualmaintenance dose 20 mg daily in 1 -2 divided doses; maximum: 40mg/day

Page 89 of 296

No. Generic Name MDC Category Indications Dosage550. Enoxaparin

Sodium 20 mgInjection

B01AB05520P5001XX

A* i) Prevention of Deep VeinThrombosis(DVT) especially inperioperative and high risksurgical cases ii) Treatment ofDVT iii) Unstable angina andnon Q wave MyocardialInfarction

i) Prophylaxis fo DVT especially insurgical patients: moderate risk, 20mg SC approximately 2 hours beforesurgery then 20 mg every 24 hoursfor minimum 7 - 10 days, high risk(eg orthopaedic surgery, medicalpatients, 40mg every 24 hours for atleast 6 days until patient ambulant,max 14 days. ii) Treatment of DVT orpulmonary embolism, 1.5 mg/kgevery 24 hours, usually for 5 daysand until adequate oralanticoagulation established. iii)Unstable angina and non-ST-segment-elevation myocardialinfarction 1 mg/kg every 12 hours,usually for 2 - 8 days

551. EnoxaparinSodium 40 mgInjection

B01AB05520P5002XX

A* i) Prevention of Deep VeinThrombosis(DVT) especially inperioperative and high risksurgical cases ii) Treatment ofDVT iii) Unstable angina andnon Q wave MyocardialInfarction

i) Prophylaxis for DVT especially insurgical patients: moderate risk, 20mg SC approximately 2 hours beforesurgery then 20 mg every 24 hoursfor minimum 7 - 10 days, high risk(eg orthopaedic surgery, medicalpatients, 40mg every 24 hours for atleast 6 days until patient ambulant,max 14 days. ii) Treatment of DVT orpulmonary embolism, 1.5 mg/kgevery 24 hours, usually for 5 daysand until adequate oralanticoagulation established. iii)Unstable angina and non-ST-segment-elevation myocardialinfarction 1 mg/kg every 12 hours,usually for 2 - 8 days

552. EnoxaparinSodium 60 mgInjection

B01AB05520P5003XX

A* i) Prevention of Deep VeinThrombosis(DVT) especially inperioperative and high risksurgical cases ii) Treatment ofDVT iii) Unstable angina andnon Q wave MyocardialInfarction

i) Prophylaxis fo DVT especially insurgical patients: moderate risk, 20mg SC approximately 2 hours beforesurgery then 20 mg every 24 hoursfor minimum 7 - 10 days, high risk(eg orthopaedic surgery, medicalpatients, 40mg every 24 hours for atleast 6 days until patient ambulant,max 14 days. ii) Treatment of DVT orpulmonary embolism, 1.5 mg/kgevery 24 hours, usually for 5 daysand until adequate oralanticoagulation established. iii)Unstable angina and non-ST-segment-elevation myocardialinfarction 1 mg/kg every 12 hours,usually for 2 - 8 days

Page 90 of 296

No. Generic Name MDC Category Indications Dosage553. Entacapone 200

mg TabletN04BX02000T1001XX

A Parkinson's Disease. An adjunctto standardlevodopa/benserazide orlevodopa/carbidopa for use inpatients with parkinson'sdisease and end of dose motorfluctuations, who cannot bestabilised on thosecombinations

200 mg to be taken with each dailydose of levodopa/dopa-decarboxylase inhibitor. Max 2gdaily. May be taken with or withoutfood

554. Entecavir 0.5 mgTablet

J05AF10000T1001XX

A* First line treatment of ChronicHepatitis B in patients whosatisfy the criteria for treatmentand require long-term therapyor have a very high baselineviral load

0.5-1mg once daily. Renal DoseAdjustment: 0.5-1mg every 48hours(30-49ml/min); 0.5-1mg every72hours (10-29ml/min); 0.5mg-1mgevery 5-7 days (<10ml/min; HD orCAPD).

555. Eperisone HCl 50mg Tablet

M03BX09110T1001XX

A Myotonic symptoms associatedwith cervical syndrome,periarthritis of shoulder andlumbago spastic paralysis

50 mg 3 times daily

556. Ephedrine 0.5%w/v Nasal Drops

R01AA03110D6001XX

A/KK Decongestion of the upperrespiratory tract

2 drops 3 times daily. Maximum usefor 1 week

557. Ephedrine HCl 30mg/ml Injection

R03CA02110P3001XX

B Treatment of bronchial spasmin asthma, adjunct to correcthaemodynamic imbalances andtreat hypotension in epiduraland spinal anaesthesia

By IM, SC or IV. Severe, acutebronchospasm : 12.5-25 mg. Furtherdosage should be determine bypatient response. When used as apressor agent : ADULT 25 - 50 mgSC/IM. If necessary, a second IMdose of 50 mg or an IV dose of 25mg may be given. Direct IV injection,10 - 25 mg may be given slowly.Maximum parenteral ADULT dose :150 mg in 24 hours. CHILD : 3 mg/kgor 100 mg/m2 SC or IV daily, in 4 - 6divided doses

558. Epirubicin 10 mgInjection

L01DB03110P4001XX

A* Breast cancer, Non-Hodgkin'slymphoma, Leukaemia (ALLinduction), gastric cancer,ovarian cancer

i) 75 - 90mg/m2 body area injectedIV in 3 - 5 min, repeated at 21 dayintervals.Higher doses up to135mg/m2 as single agent and120mg/m2 as combination(effective in treatment of breastcancer) CHILD: 50 mg/m2 over 6hours. Schedule depends onprotocol.

559. Epirubicin 50 mgInjection

L01DB03110P4002XX

A* Breast cancer, Non-Hodgkin'slymphoma, Leukaemia (ALLinduction), gastric cancer,ovarian cancer

i) 75 - 90mg/m2 body area injectedIV in 3 - 5 min, repeated at 21 dayintervals.Higher doses up to135mg/m2 as single agent and120mg/m2 as combination(effective in treatment of breastcancer) CHILD: 50 mg/m2 over 6hours. Schedule depends onprotocol.

Page 91 of 296

No. Generic Name MDC Category Indications Dosage560. Erlotinib 100 mg

TabletL01XE03110T1003XX

A* Second line treatment ofpatients with locally advancedor metastatic non-small celllung cancer (NSCLC) who havepreviously failed one line ofchemotherapy, and who haveactivating mutations ofepidermal growth factorreceptor (EGFR). Prescribingrestrictions: - Adenocarcinomahistology - ECOG PerformanceStatus 0-1 - Must be prescribedby an oncologist or oncology-trained respiratory physician. -Must not have received priorTKI for this condition.

150 mg taken at least one hourbefore or two hours after theingestion of food once daily. Reducein steps of 50 mg when necessary.Continue treatment until diseaseprogression or unacceptable toxicityoccurs. May require dosemodifications when coadministeredwith strong CYP3A4 inhibitors orinducers; or in cigarette smokingpatients.

561. Erlotinib 150 mgTablet

L01XE03110T1002XX

A* Second line treatment ofpatients with locally advancedor metastatic non-small celllung cancer (NSCLC) who havepreviously failed one line ofchemotherapy, and who haveactivating mutations ofepidermal growth factorreceptor (EGFR). Prescribingrestrictions: - Adenocarcinomahistology - ECOG PerformanceStatus 0-1 - Must be prescribedby an oncologist or oncology-trained respiratory physician. -Must not have received priorTKI for this condition.

150 mg taken at least one hourbefore or two hours after theingestion of food once daily. Reducein steps of 50 mg when necessary.Continue treatment until diseaseprogression or unacceptable toxicityoccurs. May require dosemodifications when coadministeredwith strong CYP3A4 inhibitors orinducers; or in cigarette smokingpatients.

562. Ertapenem 1 gInjection

J01DH03520P4001XX

A* i) Patient with confirm ESBLproducing gram-negativeinfection. ii) Empiric treatmentfor severe community acquiredpneumonia or other infectionswhen Pseudomonas aeruginosais not suspected.

ADULT: 1 g once daily. CHILD 3month to 12 years: 15 mg/kg twicedaily. Not to exceed 1 g/ day

563. ErythromycinEthylsuccinate200 mg/5 mlSuspension

J01FA01238F2101XX

B Treatment of susceptiblebacterial infections

Child: 30-50 mg/kg daily, increasedto twice the usual dose in severecases. 2-8 yr: 1 g daily in divideddoses; <2 yr: 500 mg daily in divideddoses.

564. ErythromycinEthylsuccinate400 mg Tablet

J01FA01238T1001XX

B Treatment of susceptiblebacterial infections

Adult 400 mg 6 hrly or 800 mg 12hrly. Max: 4 g/day. Childn 30-50mg/kg in divided doses. Childn 2-8yr 1 g/day in divided doses in severecases. Infant & childn ≤2 yr 500mg/day in divided doses.

Page 92 of 296

No. Generic Name MDC Category Indications Dosage565. Erythromycin

Ethylsuccinate400 mg/5 mlSuspension

J01FA01238F2102XX

B Treatment of susceptiblebacterial infections

Child: 30-50 mg/kg daily, increasedto twice the usual dose in severecases. 2-8 yr: 1 g daily in divideddoses; <2 yr: 500 mg daily in divideddoses.

566. ErythromycinLactobionate 500mg Injection

J01FA01129P3001XX

A* Only for treatment of i) certainforms of meningitis ii)septicaemia not responding tousual antibiotics iii)mycoplasma pneumonia iv)infection with gram-positiveorganisms (e.g. tetanus,streptococcal infection)associated with Penicillinallergy, only when oralerythromycin cannot be given

Adult & Child: 25 - 50mg/kg /dayinfusion every 6 hours. Maximum: 4g/day.

567. ErythromycinStearate 250 mgTablet

J01FA01258T1001XX

B Infections due to susceptibleorganism

Child: 30-50 mg/kg daily, increasedto twice the usual dose in severecases. 2-8 yr: 1 g daily in divideddoses; <2 yr: 500 mg daily in divideddoses.

568. ErythropoietinHumanRecombinant10,000 IU/mlInjection

B03XA01000P5005XX

A* i) Treatment of anaemiaassociated with chronic renalfailure. Dialysis patients whoare haemoglobin less than 8 gor exhibiting symptoms ofanaemia although haemoglobinmore than 8 g and pre-transplant cases ii) Anaemia incancer (non-myeloidmalignancies) with concomitantchemotherapy

i) ADULT by IV injection over 1-5minutes, initially 50 units/kg 3 timesweekly adjusted according toresponse in step of 25 units/kg 3times weekly at interval of at least 4weeks. CHILD initially as for adult.Maintenance, bodyweight under 10kg usually 75-150 units/kg 3 timesweekly, bodyweight 10-30 kg usually60-150 units/kg 3 times weekly,bodyweight over 30 kg usually 30-100 units/kg 3 times weekly ii)ADULT by SC injection (max. 1 mlper injection site), initially 150units/kg 3 times weekly, increased ifappropriate rise in haemoglobin notachieved after 4 weeks to 300units/kg 3 times weekly. Discontinueif inadequate response after 4weeks at higher dose

Page 93 of 296

No. Generic Name MDC Category Indications Dosage569. Erythropoietin

HumanRecombinant1000 IU/0.5mlInjection

B03XA01000P5001XX

A* i) Treatment of anaemiaassociated with chronic renalfailure. Dialysis patients whoare haemoglobin less than 8 gor exhibiting symptoms ofanaemia although haemoglobinmore than 8 g and pre-transplant cases ii) Anaemia incancer (non-myeloidmalignancies) with concomitantchemotherapy

i) ADULT by IV injection over 1-5minutes, initially 50 units/kg 3 timesweekly adjusted according toresponse in step of 25 units/kg 3times weekly at interval of at least 4weeks. CHILD initially as for adult.Maintenance, bodyweight under 10kg usually 75-150 units/kg 3 timesweekly, bodyweight 10-30 kg usually60-150 units/kg 3 times weekly,bodyweight over 30 kg usually 30-100 units/kg 3 times weekly ii)ADULT by SC injection (max. 1 mlper injection site), initially 150units/kg 3 times weekly, increased ifappropriate rise in haemoglobin notachieved after 4 weeks to 300units/kg 3 times weekly. Discontinueif inadequate response after 4weeks at higher dose

570. ErythropoietinHumanRecombinant2000 IU/0.5mlInjection

B03XA01000P5002XX

A i) Treatment of anaemiaassociated with chronic renalfailure. Dialysis patients whoare haemoglobin less than 8 gor exhibiting symptoms ofanaemia although haemoglobinmore than 8 g and pre-transplant cases ii) Anaemia incancer (non-myeloidmalignancies) with concomitantchemotherapy

i) ADULT by IV injection over 1-5minutes, initially 50 units/kg 3 timesweekly adjusted according toresponse in step of 25 units/kg 3times weekly at interval of at least 4weeks. CHILD initially as for adult.Maintenance, bodyweight under 10kg usually 75-150 units/kg 3 timesweekly, bodyweight 10-30 kg usually60-150 units/kg 3 times weekly,bodyweight over 30 kg usually 30-100 units/kg 3 times weekly ii)ADULT by SC injection (max. 1 mlper injection site), initially 150units/kg 3 times weekly, increased ifappropriate rise in haemoglobin notachieved after 4 weeks to 300units/kg 3 times weekly. Discontinueif inadequate response after 4weeks at higher dose

Page 94 of 296

No. Generic Name MDC Category Indications Dosage571. Erythropoietin

HumanRecombinant3000 IU/0.3mlInjection

B03XA01000P5003XX

A* i) Treatment of anaemiaassociated with chronic renalfailure. Dialysis patients whoare haemoglobin less than 8 gor exhibiting symptoms ofanaemia although haemoglobinmore than 8 g and pre-transplant cases ii) Anaemia incancer (non-myeloidmalignancies) with concomitantchemotherapy

i) ADULT by IV injection over 1-5minutes, initially 50 units/kg 3 timesweekly adjusted according toresponse in step of 25 units/kg 3times weekly at interval of at least 4weeks. CHILD initially as for adult.Maintenance, bodyweight under 10kg usually 75-150 units/kg 3 timesweekly, bodyweight 10-30 kg usually60-150 units/kg 3 times weekly,bodyweight over 30 kg usually 30-100 units/kg 3 times weekly ii)ADULT by SC injection (max. 1 mlper injection site), initially 150units/kg 3 times weekly, increased ifappropriate rise in haemoglobin notachieved after 4 weeks to 300units/kg 3 times weekly. Discontinueif inadequate response after 4weeks at higher dose

572. ErythropoietinHumanRecombinant4000 IU Injection

B03XA01000P5004XX

A i) Treatment of anaemiaassociated with chronic renalfailure. Dialysis patients whoare haemoglobin less than 8 gor exhibiting symptoms ofanaemia although haemoglobinmore than 8 g and pre-transplant cases ii) Anaemia incancer (non-myeloidmalignancies) with concomitantchemotherapy

i) ADULT by IV injection over 1-5minutes, initially 50 units/kg 3 timesweekly adjusted according toresponse in step of 25 units/kg 3times weekly at interval of at least 4weeks. CHILD initially as for adult.Maintenance, bodyweight under 10kg usually 75-150 units/kg 3 timesweekly, bodyweight 10-30 kg usually60-150 units/kg 3 times weekly,bodyweight over 30 kg usually 30-100 units/kg 3 times weekly ii)ADULT by SC injection (max. 1 mlper injection site), initially 150units/kg 3 times weekly, increased ifappropriate rise in haemoglobin notachieved after 4 weeks to 300units/kg 3 times weekly. Discontinueif inadequate response after 4weeks at higher dose

573. Escitalopram 10mg Tablet

N06AB10124T1001XX

A* i) Major depression ii)Treatment of panic disorderwith or without agoraphobia

i) 10 mg once daily; may beincreased to max 20 mg daily. ii)Panic disorder with or withoutagoraphobia :Initially 5 mg for thefirst week, thereafter increased to10 mg daily. Max 20 mg daily,ELDERLY initially half the adult dose,lower maintenance dose may besufficient. CHILD and ADOLESCENTunder 18 years not recommended

574. Esmolol HCl 10mg/ml Injection

C07AB09110P3001XX

A* Tachycardia and hypertensionin perioperative period

By IV infusion usually within rangeof 50 - 200 mcg/kg/min

Page 95 of 296

No. Generic Name MDC Category Indications Dosage575. Esomeprazole 20

mg TabletA02BC05000T1002XX

A* i)Gastro-oesophageal refluxdisease ii)H. pylori eradication

i)20mg daily for 4-8 weeks ii)40mgdaily for 10 days in combinationwith amoxicillin 1g twice daily orclarithromycin 500mg twice daily

576. Esomeprazole 40mg Injection

A02BC05000P3001XX

A* i) Acute erosive/ ulcerativeoesophagitis ii) Non -varicealupper gastrointestinal bleed

i) 20- 40 mg once daily for 2-5 daysii) 80 mg by IV bolus followed by8mg/hour infusion for 72 hours

577. Esomeprazole 40mg Tablet

A02BC05000T1001XX

A* i)Gastro-oesophageal refluxdisease ii)H. pylori eradication

i)20mg daily for 4-8 weeks ii)40mgdaily for 10 days in combinationwith amoxicillin 1g twice daily orclarithromycin 500mg twice daily

578. EssentialPhospholipids,nicotinamide,cyanocobalamine, tocopheryl,pyridoxine,thiamine,riboflavinecapsule

A05BA00924C1001XX

A/KK Nutritional supplement in liverdisorders

Please refer to product leaflet

579. Estradiol 1 mg &Estradiol 1 mgwithDydrogesterone10 mg

G03FB08954T1001XX

A* Hormone Replacement Therapyfor women with disorders dueto natural or surgically inducedmenopause with intact uterus.

One tablet daily without pill-freeinterval, starting with 1 mg ofEstradiol for first 14 days, followedby 1mg Estradiol with 10 mgDydrogestrone daily for the next 14days

580. Estradiol 1 mg &NorethisteroneAcetate 0.5 mgTablet

G03FA01122T1001XX

A* Hormone replacement therapyfor oestrogen deficiencysymptoms in women more than1 year after menopause andprevention of osteoporosis inpost menopausal women

1 tablet per day withoutinterruption

581. Estradiol 1 mgwithDydrogesterone 5mg Tablet

G03FB08954T1002XX

A* i) Hormone replacementtherapy for the relief ofsymptoms due to oestrogendeficiency ii) Prevention ofpostmenopausal osteoporosisin women with a uterus

One tablet daily, taken continuouslywithout interruption. Should beused only in postmenopausalwomen more than 12 month aftermenopause

582. Estradiol Valerate1 mg Tablet

G03CA03256T1002XX

A* Oestrogen replacement therapy- only those who cannottolerate Premarin

1 mg daily continuously or 21 dayregimen with 1 week of tablet freeinterval

583. Estradiol Valerate2 mg andNorgestrel 500mcg withEstradiol Valerate2 mg Tablet

G03FB01953T1001XX

B Pre and post menopausalsyndrome, primary andsecondary amenorrhea,menstrual irregularities.Deficiency symptoms afteroophorectomy or radiologicalcastration fornoncarcinomatous disease

Start on the 5th day of menstrualcycle - 1 tab daily for 21 days thenstop for 7 days. If patient forgetsdose at usual time, it should betaken within following 12 hours

Page 96 of 296

No. Generic Name MDC Category Indications Dosage584. Etanercept 25 mg

InjectionL04AA11000P4001XX

A* i)Moderately to severerheumatoid arthritis asmonotherapy or in combinationwith methotrexate in patientswith inadequate response tomethotrexate alone. ii)Activepolyarticular-course juvenileidiopathic arthritis in children 2-17 years with inadequateresponse to, or who haveproved intolerant ofmethotrexate. iii)Psoriaticarthritis as monotherapy or incombination with methotrexatein patients inadequate responseto methotrexate alone.iv)Active ankylosing spondylitisin adults v)Moderate to severeplaque psoriasis who failed torespond to, or who have acontraindication to, or areintolerant to other systemictherapy including cyclosporine,methotrexate or PUVA

Adult & geriatric dose: Rheumatoidarthritis, psoriatic arthritis,ankylosing spondylitis; 50 mg SConce-weekly for once-weekly dosingor 25 mg SC twice weekly (individualdoses should be separated by 72 to96 hours) for twice-weekly dosing.Plaque psoriasis; Initial: 50 mg SCtwice weekly, 72 to 96 hours apart;maintain initial dose for 3 months(starting doses of 25 or 50 mg onceweekly have also been usedsuccessfully). Maintenance dose: 50mg SC once weekly. Paediatric dose(2 to 17 years): Juvenile idiopathicarthritis; 0.8 mg/kg (max. 25mg/dose) SC once weekly for once-weekly dosing or 0.4 mg/kg (max. 25mg/dose) SC twice weekly(individual doses should beseparated by 72 to 96 hours) fortwice-weekly dosing.

585. Etanercept 50 mgInjection

L04AB01000P4002XX

A* i) Moderately to severerheumatoid arthritis asmonotherapy or in combinationwith methotrexate in patientswith inadequate response tomethotrexate alone. ii) Activepolyarticular-course juvenileidiopathic arthritis in children 2-17 years with inadequateresponse to, or who haveproved intolerant ofmethotrexate. iii) Psoriaticarthritis as monotherapy or incombination with methotrexatein patients inadequate responseto methotrexate alone. iv)Active ankylosing spondylitis inadults v) Moderate to severeplaque psoriasis who failed torespond to, or who have acontraindication to, or areintolerant to other systemictherapy including cyclosporine,methotrexate or PUVA

Adult & geriatric dose: Rheumatoidarthritis, psoriatic arthritis,ankylosing spondylitis; 50 mg SConce-weekly for once-weekly dosingor 25 mg SC twice weekly (individualdoses should be separated by 72 to96 hours) for twice-weekly dosing.Plaque psoriasis; Initial: 50 mg SCtwice weekly, 72 to 96 hours apart;maintain initial dose for 3 months(starting doses of 25 or 50 mg onceweekly have also been usedsuccessfully). Maintenance dose: 50mg SC once weekly. Paediatric dose(2 to 17 years): Juvenile idiopathicarthritis; 0.8 mg/kg (max. 25mg/dose) SC once weekly for once-weekly dosing or 0.4 mg/kg (max. 25mg/dose) SC twice weekly(individual doses should beseparated by 72 to 96 hours) fortwice-weekly dosing.

586. Ethambutol HCl200 mg Tablet

J04AK02110T1001XX

B Tuberculosis Adult: 15-25mg/kg daily (max1200mg) or 50mg/kg biweekly(max2000mg). Children: 15-25mg/kgdaily or 50 mg/kg twice weekly.

Page 97 of 296

No. Generic Name MDC Category Indications Dosage587. Ethambutol HCl

400 mg TabletJ04AK02110T1002XX

B Tuberculosis Adult: 15-25mg/kg daily (max1200mg) or 50mg/kg biweekly(max2000mg). Children: 15-25mg/kgdaily or 50 mg/kg twice weekly.

588. Ether Solvent N01AA01000L9901XX

C To remove adhesive plasterfrom the skin

Dose depending on the route andprocedure

589. Ethinylestradiol20 mcg &Drospirenone 3mg Tablet

G03AA12954T1002XX

A* i)Oral contraceptionii)Treatment of acne vulgaris inwomen seeking oralcontraception. iii) Treatment ofsymptoms of premenstrualdysphoric disorder (PMDD) inwomen who choose to use anoral contraceptive as theirmethod of contraception.

1 tab daily for 28 consecutive daysstarting on 1st day of menstrualbleeding.

590. Ethinylestradiol20 mcg &Gestodene 75mcg Tablet

G03AA10954T1001XX

A/KK Oral contraception 1 tablet to be taken daily for 21executive days starting on the firstday of menses. Each subsequentpack is started after a 7 days tabletfree interval.

591. Ethinylestradiol20 mcg &Levonorgestrel100 mcg Tablet

G03AA07954T1002XX

A/KK i)Prevention of pregnancyii)Treatment of moderate acnevulgaris not controlled byconventional therapy (e.gtopical preparations and oralantibiotics) in post-menarchal,premenopausal women morethan or 14 years who acceptcontraception.

Beginning on day 1 of cycle, 1 tabletdaily for 21 days followed by 7tablet-free days.

592. Ethionamide 250mg Tablet

J04AD03000T1001XX

A* As second-line therapy in thetreatment of Multi DrugResistant Tuberculosis only incombination with otherefficacious agents and onlywhen therapy with isoniazid,rifampicin, or other first-lineagents has failed.

ADULT: 15-20mg/kg daily, in divideddoses if necessary; maximum dose1g/day. CHILD: 10-20mg/kg in 2-3divided doses or 15mg/kg/24hrs as asingle daily dose.

593. Ethosuximide 250mg/5 ml Syrup

N03AD01000L9001XX

B Absence seizures ADULT: Initially, 500 mg daily.Increased by 250 mg at intervals of4-7 days to usual dose of 1-1.5 gdaily. Maximum: Up to 2 g, understrict supervision. CHILD: Greaterthan or equal to 6 years: Same asadult dose; less than 6 years:Initially, 250 mg daily. Increasedgradually to usual dose of 20 mg/kgdaily. Maximum: Children greaterthan or equal to 6 years: Same asadult dose; less than 6 years: Up to1 g

Page 98 of 296

No. Generic Name MDC Category Indications Dosage594. Ethyl Chloride

100ml SprayN01BX01000A4001XX

C For minor surgical proceduresincluding lancing boils, incisionand drainage of smallabscesses, pain due to athleticinjuries and pain due toinjection administration

Spray to affected area at a distanceof about 30cm until a fine white filmis produced

595. Etomidate 20mg/10 mlInjection

N01AX07000P3001XX

A* Induction of generalanaesthesia forhaemodynamically unstablepatients

Adult: 300 mcg/kg given slowly over30-60 seconds into a large vein inthe arm. Child: Up to 30% more thanthe standard adult dose. Elderly:150-200 mcg/kg, subsequentlyadjusted according to effects.

596. Etonogestrel 68mg Implant

G03AC08000P1001XX

A/KK Contraception A single implant insertedsubdermally and can be left in placefor three years. The implant can beremoved at any time but not laterthan three years after the date ofinsertion.

597. Etoposide 100mg/5 ml Injection

L01CB01000P3001XX

A* i) For treatment of children withsolid tumours, juvenilemyelomonocytic leukemia(JMML) and Langerhan cellhistiocytosis ii) Leukaemia,lymphoma iii) Testicular cancer,lung cancer, gestationaltrophoblastic disease, gastriccancer, sarcoma

i) CHILD: 60-120 mg/m2/day by IVfor 3 - 5 days every 3 - 6 weeksdepending on protocols ii)Maintenance or palliativechemotherapy for elderly acutemyeloid leukemia, consolidationtherapy for acute lymphoblasticleukemia, stem cell mobilization(Refer to protocol) iii) 100 mg/m2 byIV every other day for 3 dosesrepeated every 3-4 weeks

598. Etoposide 50mgcapsule

L01CB01000C1003XX

A* Treatment of small cell lungcancer and malignantlymphomas

Normal adult dose is 175mg-200mgdaily for 5 consecutive days orally,followed by recession (withdrawal)interval of 3 weeks. Repeatadministration as necessary.Increase or reduce dose asappropriate, according to theparticular disease or symptoms.

599. Etoricoxib 120mg Tablet

M01AH05000T1002XX

A* i)Acute and chronic treatmentof signs and symptoms ofosteoarthritis (OA) andrheumatoid arthritis (RA)ii)Acute gouty arthritis iii)Acutepain

i) OA: 60 mg once daily. RA: 90 mgonce daily ii & iii) Acute goutyarthritis and acute pain: 120 mgonce daily (Given the exposure toCOX-2 inhibitors, doctors areadvised to use the lowest effectivedose for the shortest possibleduration of treatment)

600. Etoricoxib 60 mgTablet

M01AH05000T1003XX

A* i)Acute and chronic treatmentof signs and symptoms ofosteoarthritis (OA) andrheumatoid arthritis (RA)ii)Acute gouty arthritis iii)Acutepain

i) OA: 60 mg once daily. RA: 90 mgonce daily ii & iii) Acute goutyarthritis and acute pain: 120 mgonce daily (Given the exposure toCOX-2 inhibitors, doctors areadvised to use the lowest effectivedose for the shortest possibleduration of treatment)

Page 99 of 296

No. Generic Name MDC Category Indications Dosage601. Etoricoxib 90 mg

TabletM01AH05000T1001XX

A* i)Acute and chronic treatmentof signs and symptoms ofosteoarthritis (OA) andrheumatoid arthritis (RA)ii)Acute gouty arthritis iii)Acutepain

i) OA: 60 mg once daily. RA: 90 mgonce daily ii & iii) Acute goutyarthritis and acute pain: 120 mgonce daily (Given the exposure toCOX-2 inhibitors, doctors areadvised to use the lowest effectivedose for the shortest possibleduration of treatment)

602. Everolimus0.25mg tablet

L04AA18000T1001XX

A* Indicated for the prophylaxis oforgan rejection in adult patientsat low to moderateimmunological risk receiving anallogeneic renal or cardiactransplant in combination withciclosporin for microemulsionand corticosteroids.

An initial dose regimen of 0.75 mgb.i.d., which is recommended forthe general kidney and hearttransplant population. The dailydose of everolimus should always begiven orally in two divided doses(b.i.d.).

603. Everolimus0.75mg tablet

L04AA18000T1003XX

A* Indicated for the prophylaxis oforgan rejection in adult patientsat low to moderateimmunological risk receiving anallogeneic renal or cardiactransplant in combination withciclosporin for microemulsionand corticosteroids.

An initial dose regimen of 0.75 mgb.i.d., which is recommended forthe general kidney and hearttransplant population. The dailydose of everolimus should always begiven orally in two divided doses(b.i.d.).

604. Exemestane 25mg Tablet

L02BG06000T1001XX

A* Treatment of post-menopausalwomen with advanced breastcancer whose disease hasprogressed following tamoxifenand non-steroidal aromataseinhibitors

25 mg once daily

605. Ezetimibe 10 mg& Simvastatin 20mg Tablet

C10BA02000T1001XX

A* Primary hypercholesterolemia Usual starting dose: 10/20 mg/day

606. Ezetimibe 10 mgTablet

C10AX09000T1001XX

A* i) Co-administration with statinsfor patients who have chronicheart disease or are chronicheart disease equivalent orfamilial hypercholesterolaemiawith target LDL-C not achievedby maximum dose of statins ii)Monotherapy in patients withdocumented biochemicalintolerance to statins

10 mg once daily. Notrecommended for children less than10 years old

607. Ezetimibe 10mg/Simvastatin 40mgTablet

C10BA02000T1003XX

A* Primary hypercholesterolemia Usual starting dose: 10/20 mg/day

608. Factor IXInjection

B02BD04000P9901XX

A Prevention and control ofbleeding in patients with factorIX deficiency due tohaemophilia B

Dose varies according to the patientand the circumstances of thebleeding. i) Mild haemorrhage:initial dose of 30 units/kg bodyweight. ii) Moderate haemorrhage:initial dose of 50 units/kg iii) Majorhaemorrhage/surgery: Initial dose of

Page 100 of 296

No. Generic Name MDC Category Indications Dosage75 - 100 units/kg. Half of thesedoses may be repeated after 18-24hrs if necessary.

609. Factor IX, FactorII, Factor VII andFactor X InCombinationInjection

B02BD01000P4001XX

A* i) Treatment and perioperativeprophylaxis of bleeding inacquired deficiency of theprothrombin complexcoagulation factors, such asdeficiency caused by treatmentwith vitamin K antagonists, or incase of overdose of vitamin Kantagonists, when rapidcorrection of the deficiency isrequired. ii) Treatment andperioperative prophylaxis ofbleeding in congenitaldeficiency of any of the vitaminK dependent coagulationfactors only if purified specificcoagulation factor product isnot available.

Amount and frequency ofadministration should be calculatedon an individual patient basis.Individual dosage requirements canonly be identified on the basis ofregular determinations of theindividual plasma levels of thecoagulation factors of interest or onthe global tests of the prothrombincomplex levels (INR, Quick's test)and a continuous monitoring of theclinical condition of the patient. Anapproximate calculation is asfollows: Required dose (IU) = bodyweight (kg) x desired factor rise(IU/dl or % of normal) x reciprocal ofthe estimated recovery, i.e. Factor II= 53 Factor VII = 59 Factor IX = 77Factor X = 56 As product may differfrom one to another, it is stronglyadvised to refer to the manufacturer(product insert) in regards to dosingcalculation.

610. Factor VIIa(Recombinant)eptacog alfa(activated) 100KIU (2 mg)Injection

B02BD08000P4005XX

A* Treatment of bleeding episodesand prevention of excessivebleeding in connection withsurgery in patients withinherited or acquiredhaemophilia with inhibitors tocoagulation factors VIII or IX

Initially 4.5 KIU (90 mcg)/kg bodyweight IV bolus over 2-5 minutes,followed by 3-6 KIU (60-120 mcg)/kgbody weight depending on type &severity of haemorrhage or surgeryperformed. Dosing interval: initially2-3 hour to obtain haemostasis anduntil clinically improved. Ifcontinued therapy is needed, doseinterval can be increasedsuccessively to every 4, 6, 8 or 12hours

611. Factor VIIa(Recombinant)eptacog alfa(activated) 50 KIU(1 mg) Injection

B02BD08000P4004XX

A* Treatment of bleeding episodesand prevention of excessivebleeding in connection withsurgery in patients withinherited or acquiredhaemophilia with inhibitors tocoagulation factors VIII or IX

Initially 4.5 KIU (90 mcg)/kg bodyweight IV bolus over 2-5 minutes,followed by 3-6 KIU (60-120 mcg)/kgbody weight depending on type &severity of haemorrhage or surgeryperformed. Dosing interval: initially2-3 hour to obtain haemostasis anduntil clinically improved. Ifcontinued therapy is needed, doseinterval can be increasedsuccessively to every 4, 6, 8 or 12

Page 101 of 296

No. Generic Name MDC Category Indications Dosagehours

612. Factor VIII(Human bloodcoagulationfactor) & VonWillebrand factorInjection

B02BD06000P4002XX

A* i)The treatment and prophylaxisof haemorrhage or surgicalbleeding in Von WillebrandDisease (VWD) when 1-deamino-8-D-argininevasopressin (desmopressin,DDAVP) treatment alone isineffective or contraindicated.ii)The treatment andprophylaxis of bleedingassociated with factor VIIIdeficiency due to haemophiliaA.

i. Von Willebrand Disease:Spontaneous Bleeding Episodes:Initially, factor VIII 12.5-25 IU/kg andristocetin cofactor 25-50 IU/kgfollowed by factor VIII 12.5 IU/kgand ristocetin cofactor 25 IU/kgsubsequently every 12-24 hrs. MinorSurgery: Factor VIII 30 IU/kg andristocetin cofactor 60 IU/kg daily.Major Surgery: Initially, factor VIII30-40 IU/kg and ristocetin cofactor60-80 IU/kg followed by factor VIII15-30 IU/kg and ristocetin cofactor30-60 IU/kg subsequently every 12-24 hrs. Prophylaxis: Factor VIII 12.5-20 IU/kg and ristocetin cofactor 25-40 IU/kg 3 times weekly. ii.Hemophilia A therapy: Minorhaemorrage: 10-15 IU/kg every 12-24 hours. Moderate to severehaemorrhage: 15-40 IU/kg every 8to 24 hours. Minor surgery: Loadingdose 20-30 IU/kg, maintenance dose15-30 IU/kg. Major surgery: Loadingdose 40-50 IU/kg, maintenance dose10-40 IU/kg. Prophylaxis: 25-40IU/kg three times weekly As productmay differ from one to another, it isstrongly advised to refer to themanufacturer (product insert) inregards to dosing calculation.

613. Factor VIIIInhibitorBypassing ActivityInjection

B02BD03000P4001XX

A i)Treatment and prophylaxis ofhemorrhages in hemophilia Aand B patients with inhibitors.ii) Treatment and prophylaxis ofhemorrhages in non-hemophilicpatients who have developedinhibitors to Factors VIII, IX andXI. iii)Treatment of patientswith acquired inhibitors toFactors X and XIII. iv)In thecombination with Factor VIIIconcentrate for a long-termtherapy to achieve a completeand permanent elimination of

As a general guideline, a dose of 50to 100IU/kg body weight isrecommended, not exceeding anindividual dose of 100IU/kg bw anda maximum daily dose of 200IU/kgbw.

Page 102 of 296

No. Generic Name MDC Category Indications Dosagethe Factor VIII inhibitor so as toallow for regular treatmentwith Factor VIII concentrate asin patients without inhibitor.

614. Factor VIIIInjection

B02BD02999P9901XX

A Prevention and control ofbleeding in patients with factorVIII deficiency due to classicalhaemophilia A

Dose varies according to the patientand the circumstances of thebleeding. i) Mild to moderate:Usually a single dose of 10-15units/kg. ii) More serioushaemorrhage/minor surgery:Initially15-25 units/kg followed by 10-15units/kg every 8 - 12 hours ifrequired iii) Severehaemorrhage/major surgery: Initial :40 - 50 units/kg followed by 20 - 25units/kg every 8-12 hrs.

615. Fat Emulsion 10%for IV InfusionInjection

B05BA02000P6001XX

A Source of lipid in patientsneeding IV nutrition

Dose to be individualised. ADULTusual lipid requirement 2-3g/kg/day. INFANT 0.5 - 1 g/kg/day

616. Fat Emulsion 20%for IV InfusionInjection

B05BA02000P6002XX

A Source of lipid in patientsneeding IV nutrition

Dose to be individualised. ADULTusual lipid requirement 2-3g/kg/day. INFANT 0.5-1 g/kg/day

617. Felodipine 10 mgExtended ReleaseTablet

C08CA02000T1002XX

A/KK Hypertension Initiate at 5 mg once daily. Usualdose, 5 - 10 mg once daily in themorning

618. Felodipine 5 mgExtended ReleaseTablet

C08CA02000T1001XX

A/KK Hypertension Initiate at 5 mg once daily. Usualdose, 5 - 10 mg once daily in themorning

619. Fenofibrate 145mg tablet

C10AB05000T1002XX

A/KK As second line therapy afterfailed gemfibrozil in patients: i)Hypercholesterolemia andhypertriglyceridemia alone orcombined [type IIa,IIb,III and Vdysplipidemias] in patientsunresponsive to dietary andother non-pharmacologicalmeasures especially when thereis evidence of associated riskfactors ii) Treatment ofsecondaryhyperlipoproteinemias ifhyperlipoprotenemia persistsdespite effective treatment ofunderlying disease iii)

145mg once daily, with or withoutfood

Page 103 of 296

No. Generic Name MDC Category Indications DosageDyslipidemia in Type 2 DiabetesMellitus

620. Fentanyl12mcg/hTransdermalPatch

N02AB03136M7005XX

A* As a second line drug in themanagement of chronic severecancer pain not responding tonon-narcotic analgesic. Not tobe used in opiod naivepatients.The use is to berestricted to pain specialists,palliative medicine specialistsand oncologists

ADULT and CHILD over 2 yearspreviously treated with a strongopioid analgesic, initial dose basedon previous 24-hour opioidrequirement (consult productliterature). If necessary dose shouldbe adjusted at 72-hour intervals insteps of 12-25 mcg/hr

621. Fentanyl 25mcg/hTransdermalPatch

N02AB03136M7001XX

A* As a second line drug in themanagement of chronic cancerpain. The use is to be restrictedto pain specialists, palliativemedicine specialists andoncologists.

Patients who have not previouslyreceived a strong opioid analgesic,initial dose , one 25 mcg/hour patchto be replaced after 72 hours.Patients who have received a strongopioid analgesic, initial dose basedon previous 24 hours opioidrequirement (oral morphinesulphate 90 mg over 24 hours = one25 mcg/hour patch). Notrecommended in children.

622. Fentanyl 50mcg/hTransdermalPatch

N02AB03136M7002XX

A* As a second line drug in themanagement of chronic cancerpain. The use is to be restrictedto pain specialists, palliativemedicine specialists andoncologists

Patients who have not previouslyreceived a strong opioid analgesic,initial dose , one 25 mcg/hour patchto be replaced after 72 hours.Patients who have received a strongopioid analgesic, initial dose basedon previous 24 hours opioidrequirement (oral morphinesulphate 90 mg over 24 hours = one25 mcg/hour patch). Notrecommended in children.

Page 104 of 296

No. Generic Name MDC Category Indications Dosage623. Fentanyl Citrate

50 mcg/mlInjection

N01AH01136P3001XX

A Short duration analgesia duringpre-medication induction andmaintenance of anaesthesia,and in the immediate post-operative period.

Dose should be individualizedaccording to age, body weight,physical status, underlyingpathological conditions and type ofsurgery and anaesthesia. ADULT:Premedication: IM 50 - 100 mcg, 30- 60 mins prior to surgery. Adjunctto general anaesthesia: Induction IV50 - 100mcg, repeat 2 - 3 minsintervals until desired effect isachieved. IV/IM 25 - 50mcg inelderly and poor risk patients.Maintenance: IV/IM 25 - 50mcg.Adjunct to regional anaesthesia:IM/slow IV 50 - 100mcg whenadditinal analgesia is required. Post-operatively (recovery room): IM 50 -100mcg for pain control,tachypnoea and emergencydelirium. May be repeated in 1- 2hours as needed. CHILD (2 - 12years): Induction & maintenance: 2 -3 mcg/kg.

624. FerricAmmoniumCitrate 800mg/10 mlPaediatricMixture

B03AB06136L2101XX

C Prevention and treatment ofiron-deficiency anaemias

CHILD up to 1 year 5 ml, 1 - 5 years10 ml, taken well diluted with water

625. Ferrouscontrolledrelease 500 mg,Vitamin B1,Vitamin B2,Vitamin B6,Vitamin B12,Vitamin C,Niacinamide,CalciumPantothenate,Folic Acid 800mcg Tablet

B03AE10903T1001XX

A/KK Anemia due to iron deficiency,megaloblastic anemia wherethere is an associateddeficiency of Vitamin C andVitamin B-complex particularlyin pregnancy. In primary healthclinic, the indication isrestricted to anemia due to irondeficiency in pregnant womenONLY.

One tablet daily

626. Ferrous Fumarate200 mg Tablet

B03AA02138T1001XX

C+ Prevention and treatment ofiron-deficiency anaemias

Adult: Usual dose range: Up to 600mg daily. May increase up to 1.2 gdaily if necessary. Child: As syrupcontaining 140 mg(45 mg iron)/5ml.Preterm neonate: 0.6-2.4 ml/kgdaily; up to 6 years old: 2.5-5mltwice daily

Page 105 of 296

No. Generic Name MDC Category Indications Dosage627. Filgrastim (G-CSF)

30 MU/mlInjection

L03AA02000P3001XX

A* i) Reduction in the duration ofneutropenia and incidence offebrile neutropenia in cytotoxicchemotherapy for malignancyexcept chronic myeloidleukemia and myelodysplasticsyndrome ii) Haemopoeiticstem cell transplantation(HSCT)/stem cell harvesting

i) Adult: SC or IV 5 mcg/kg/day.Initiation: 24 - 72 hours afterchemotherapy. Duration: Until aclinically adequate neutrophilrecovery is achieved (absoluteneutrophil count of at least 1 x109/L on 2 consecutive days) ii)Refer to protocol

628. Filgrastim 30 MUin 0.5 ml Injection

L03AA02000P5001XX

A* i) Reduction in the duration ofneutropenia and incidence offebrile neutropenia in cytotoxicchemotherapy for malignancyexcept chronic myeloidleukemia and myelodysplasticsyndrome ii) Haemopoeiticstem cell transplantation(HSCT)/stem cell harvesting

i) ADULT: 5 mcg/kg/day by SC or IV.Initiation: 24 - 72 hours afterchemotherapy. Duration: Until aclinically adequate neutrophilrecovery is achieved (absoluteneutrophil count of at least 1 x109/L on 2 consecutive days) ii)Refer to protocol

629. Finasteride 5 mgTablet

G04CB01000T1001XX

A* Treatment and control ofbenign prostatic hyperplasia

5 mg a day as a single dose. Clinicalresponses occur within 12 weeks - 6months of initiation of therapy.Long-term administration isrecommended for maximalresponse

630. Fingolimod 0.5mgCapsule

L04AA27110C1001XX

A* Treatment of patients withrelapsing forms of multiplesclerosis to reduce thefrequency of clinicalexacerbations and to delay theaccumulation of physicaldisability

0.5mg orally once daily

631. Flavoxate HCl 100mg Tablet

G04BD02110T1001XX

A Urinary frequency andincontinence, dysuria, urgency,bladder spasm due tocatheterisation

ADULT: 200 mg 3 times daily. CHILDunder 12 years not recommended

632. FlecainideAcetate 100 mgTablet

C01BC04122T1001XX

A* i) Sustained monomorphicventricular tachycardias ii)Preexcited atrial fibrillationassociated with Wolff-Parkinson White Syndrome iii)Reciprocating Atrio-Ventriculartachycardias (AVT) associatedwith Wolff-Parkinson WhiteSyndrome iv) Supraventriculartachycardias due to Intra-AtrioVentricular Nodul Reentry

Ventricular arrhythmias: 100 mgtwice daily, maximum 400 mg/day(usually reserved for rapid control orin heavily built patients), reducedafter 3 - 5 days if possible.Supraventricular arrhythmias: 50 mgtwice daily, increased if required tomaximum of 150 mg twice daily

Page 106 of 296

No. Generic Name MDC Category Indications Dosage633. Fluconazole 100

mg CapsuleJ02AC01000C1002XX

A i) Oropharyngeal candidiasis,atrophic oral candidiasisassociated with dentures, othercandidal infections of mucosa ii)Tinea pedis, corporis, cruris,versicolor and dermalcandidiasis iii) Invasive candidal& cryptococcal infections(including meningitis) iv)Prevention of relapse ofcryptococcal meningitis in AIDSpatients after completion ofprimary therapy v) Preventionof fungal infections inimmunocompromised patientsconsidered at risk as aconsequence of HIV infectionsor neutropenia followingcytotoxic chemotherapy,radiotherapy or bone marrowtransplant

i) Oropharyngeal candidiasis: 50 -100 mg daily for 7 - 14 days(Maximum 14 days) except inseverely immunocompromisedpatients, treatment can becontinued for longer periods.Atrophic oral candidiasis associatedwith dentures: 50 mg daily for 14days. Other candidal infections ofmucosa: 50 - 100 mg daily for 14 -30 days. CHILD: 3 - 6 mg/kg on firstday then 3 mg/kg daily (every 72hours in NEONATE up to 2 weeksold, every 48 hours in NEONATE 2 -4 weeks old) ii) 50 mg daily for 2 - 4weeks, maximum 6 weeks iii) 400mg initially then 200 - 400 mg dailyfor 6 - 8 weeks. CHILD: 6 - 12 mg/kgdaily (every 72 hours in NEONATEup to 2 weeks old, every 48 hours inNEONATE 2 -4 weeks old) iv) 100 -200 mg daily v) 50 - 400 mg daily.CHILD: 3 - 12 mg/kg daily (every 72hours in NEONATE up to 2 weeksold, every 48 hours in NEONATE 2 -4 weeks old)

634. Fluconazole 2mg/ml Injection

J02AC01000P9901XX

A i) Oropharyngeal candidiasis,atrophic oral candidiasisassociated with dentures, othercandidal infections of mucosa ii)Tinea pedis, corporis, cruris,versicolor and dermalcandidiasis iii) Invasivecandidal& cryptococcalinfections (including meningitis)iv) Prevention of relapse ofcryptococcal meningitis in AIDSpatients after completion ofprimary therapy v) Preventionof fungal infections inimmunocompromised patientsconsidered at risk as aconsequence of HIV infectionsor neutropenia followingcytotoxic chemotherapy,radiotherapy or bone marrowtransplant

i) 50 - 100 mg daily for 7 - 14 days(Maximum 14 days) except inseverely immunocompromisedpatients, treatment can becontinued for longer periods.Atrophic oral candidiasis associatedwith dentures: 50 mg daily for 14days. Other candidal infections ofmucosa: 50 - 100 mg daily for 14 -30 days. CHILD: 3 - 6 mg/kg on firstday then 3 mg/kg daily (every 72hours in NEONATE up to 2 weeksold, every 48 hours in NEONATE 2 -4 weeks old) ii) 50 mg daily for 2 - 4weeks, maximum 6 weeks iii) 400mg initially then 200 - 400 mg dailyfor 6 - 8 weeks. CHILD: 6-12 mg/kgdaily (every 72 hours in NEONATEup to 2 weeks old, every 48 hours inNEONATE 2 - 4 weeks old) iv) 100 -200 mg daily v) 50 - 400 mg daily.CHILD: 3 - 12 mg/kg daily (every 72hours in NEONATE up to 2 weeksold, every 48 hours in NEONATE 2 -4 weeks old)

Page 107 of 296

No. Generic Name MDC Category Indications Dosage635. Fluconazole 50

mg CapsuleJ02AC01000C1001XX

A i) Oropharyngeal candidiasis,atrophic oral candidiasisassociated with dentures, othercandidal infections of mucosa ii)Tinea pedis, corporis, cruris,versicolor and dermalcandidiasis iii) Invasive candidal& cryptococcal infections(including meningitis) iv)Prevention of relapse ofcryptococcal meningitis in AIDSpatients after completion ofprimary therapy v) Preventionof fungal infections inimmunocompromised patientsconsidered at risk as aconsequence of HIV infectionsor neutropenia followingcytotoxic chemotherapy,radiotherapy or bone marrowtransplant

i) Oropharyngeal candidiasis: 50 -100 mg daily for 7 - 14 days(Maximum 14 days) except inseverely immunocompromisedpatients, treatment can becontinued for longer periods.Atrophic oral candidiasis associatedwith dentures: 50 mg daily for 14days. Other candidal infections ofmucosa: 50 - 100 mg daily for 14 -30 days. CHILD: 3 - 6 mg/kg on firstday then 3 mg/kg daily (every 72hours in NEONATE up to 2 weeksold, every 48 hours in NEONATE 2 -4 weeks old) ii) 50 mg daily for 2 - 4weeks, maximum 6 weeks iii) 400mg initially then 200 - 400 mg dailyfor 6 - 8 weeks. CHILD: 6 - 12 mg/kgdaily (every 72 hours in NEONATEup to 2 weeks old, every 48 hours inNEONATE 2 -4 weeks old) iv) 100 -200 mg daily v) 50 - 400 mg daily.CHILD: 3 - 12 mg/kg daily (every 72hours in NEONATE up to 2 weeksold, every 48 hours in NEONATE 2 -4 weeks old)

636. Flucytosine 2.5g/250 mlInjection

J02AX01000P9901XX

A* Treatment of systemic fungalinfection

ADULT: 100 - 200 mg/kg daily in 4divided doses by IV infusion over 20- 40 minutes not more than 7 days

637. Flucytosine 500mg Tablet

J02AX01000T1001XX

A* Only for the treatment of fungalmeningitis

ADULT: 50 - 150 mg/kg/day in 4divided doses

638. FludarabinePhosphate 10 mgTablet

L01BB05162T1001XX

A* B-cell chronic lymphocyticleukemia who have notresponded to or whose diseasehad progressed during or aftertreatment with at least onestandard alkylating-agentcontaining regimen

40 mg /m2 given daily for 5consecutive days every 28 days.Courses may be repeated every 28days, usually for up to 6 cycles.Duration of treatment depends ontreatment success and tolerability ofthe drug

639. FludarabinePhosphate 50 mgInjection

L01BB05162P4001XX

A* B-cell chronic lymphocyticleukaemia who have notresponded to or whose diseasehad progressed during or aftertreatment with at least onestandard alkylating-agentcontaining regimen

25 mg/m2 daily for 5 consecutivedays every 28 days. May beadministered up to the achievementof a maximal response (usually 6cycles) and then the drug should bediscontinued. Reduce dose by up to50% in patients with mild tomoderate renal impairment (30-70ml/min)

640. FludrocortisoneAcetate 0.1 mgTablet

H02AA02122T1001XX

A As an adjunct to glucocorticoidsin the management of primaryadrenocortical insufficiency inAddison's disease andtreatment of salt-losingadrenogenital syndrome

Adrenocorticoid insufficiency(chronic): ADULT 1 tablet daily. Salt-losing adrenogenital syndrome:ADULT 1 - 2 tablets daily. CHILD andINFANT 0.5 - 1 tablet daily

Page 108 of 296

No. Generic Name MDC Category Indications Dosage641. Flumazenil 0.1

mg/ml InjectionV03AB25000P3001XX

B i) Diagnosis and/ormanagement of benzodiazepineoverdose due to self-poisoningor accidental overdose ii)Reversal of sedation followinganaesthesia withbenzodiazepine

i) Initial, 0.2 mg IV over 30 seconds;if desired level of consciousness notobtained after an additional 30seconds, give dose of 0.3 mg IV over30 seconds; further doses of 0.5 mgIV over 30 seconds may be given at1-minutes intervals if needed tomaximum total dose of 3 mg;patients with only partial responseto 3 mg may require additional slowtitration to a total dose of 5 mg; ifno response 5 minutes afterreceiving total dose of 5 mg,overdose is unlikely to bebenzodiazepine and furthertreatment with flumazenil will nothelp ii) 0.2 mg IV over 15 seconds; ifdesired level of consciousness is notobtained after waiting 45 seconds, asecond dose of 0.2 mg IV may begiven and repeated at 60-secondsintervals as needed (up to amaximum of 4 additional times) to amaximum total dose of 1 mg; mostpatients respond to doses of 0.6 to 1mg; in the event of resedation,repeated doses may be given at 20-minutes intervals if needed; forrepeat treatment, no more than 1mg (given as 0.5 mg/minute) shouldbe given at any one time and nomore than 3 mg should be given inany one hour

642. Flunarizine HCl 5mg Capsule

N07CA03110C1001XX

B i) Migraine prophylaxis ii)Maintenance treatment ofvestibular disturbances and ofcerebral and peripheraldisorders

i) ADULT: 5 - 10 mg daily preferablyat night. ELDERLY more than 65years: 5 mg at night. Maintenance 5-day treatment at the same dailydose ii) 5 - 10 mg at night. If noimprovement after 1 month,discontinue treatment

643. Fluorescein 1 mgOphthalmic Strip

S01JA01520M9901XX

B Diagnostic fluoresceinangiography or angioscopy ofthe fundus and of the irisvasculature

Moisten tip with tear fluid fromlower fornix, sterile water orophthalmic solution and gentlystroke across the conjunctiva

644. FluoresceinSodium 10% in 5ml Injection

S01JA01520P3001XX

A Diagnostic fluoresceinangiography or angioscopy ofthe fundus and of the irisvasculature

500 mg IV

645. Fluorometholone0.1% OphthalmicSuspension

S01BA07000D2001XX

A* Treatment of steroid responsiveocular inflammation

1-2 drops qds. During the initial 24-48 hr, dose may be increased to 2drops 2 hrly.

Page 109 of 296

No. Generic Name MDC Category Indications Dosage646. Fluorouracil 1

g/20 ml InjectionL01BC02000P4002XX

A* Cancers of gastro-intestinaltract, breast and pancreas,head and neck. Ophtalmologicalindication: trabeculectomy

500 - 600 mg/m2 IV in combinationwith other cytotoxic agents,repeated every 3 weeks or 300 - 450mg/m2 IV slow bolus daily for 5 daysin combination with biologicalresponse modifiers, repeated every4 weeks or 3000 - 3750 mg/m2 as acontinuous infusion over 5 days incombination with a platinumcompound every 3 to 4 weeks

647. Fluorouracil 100mg Tablet

L01BC02000T1001XX

A Colorectal cancer 15 mg/kg (max: 1 g/day), may begiven once weekly for maintenance.Max: 1 g/week.

648. Fluorouracil 50mg / ml in 5 mlInjection

L01BC02000P4001XX

A* Cancers of gastro-intestinaltract, breast and pancreas,head and neck. Ophtalmologicalindication: trabeculectomy

Intravenous Infusion: 15 mg/kgbodyweight (to a maximum of 1 gdaily) diluted in 300-500mL of 5%glucose given over a period of 4hours. 12 mg/kg bodyweight dailyfor 3 consecutive days. Providingthere are no signs of toxic effects,the patient may then be given6mg/kg I.V. on the 5th, 7th and 9thdays. If after the 9th day there is stillno sign of toxicity, the patient maybe placed on maintenance therapy.Maintenance Therapy: 5 - 10mg/kgbodyweight by I.V. injection once aweek.

649. Fluoxetine HCl 20mg Capsule

N06AB03110C1001XX

A i) Depression ii) Obsessive-compulsive disorder

i) 20 mg once daily increased after 3weeks if necessary, usual dose 20 -60 mg (ELDERLY 20 - 40 mg) oncedaily max 80 mg once daily (ELDERLYmax 60 mg once daily). ii) Initially 20mg once daily increased after 2weeks if necessary, usual dose 20 -60 mg (ELDERLY 20 - 40 mg) oncedaily, max 80 mg (ELDERLY max 60mg) once daily, discontinue if noimprovement within 10 weeks.CHILD and ADOLESCENT under 18years are not recommended

650. FlupenthixolDecanoate20mg/mllnjection

N05AF01135P2001XX

B Chronic psychoses By deep IM, initial test dose of 5-20mg, then after at least 7 days. 20 -40 mg repeated at intervals of 2 - 4weeks. Maximum 400 mg weekly.Usual maintenance dose 50 mgevery 4 weeks to 300 mg every 2weeks. ELDERLY, initially quarter tohalf adult dose. CHILD notrecommended. Deep IMrecommended. Not for IV use

Page 110 of 296

No. Generic Name MDC Category Indications Dosage651. Fluphenazine

Decanoate 25mg/ml Injection

N05AB02135P3001XX

B Long term management ofpsychotic disorders

By deep IM : Test dose 12.5 mg(6.25 mg in ELDERLY), then after 4-7days 12.5 mg-100 mg repeated atintervals of 14-35 days, adjustedaccording to response. CHILD notrecommended

652. Flutamide 250mg Tablet

L02BB01000T1001XX

A* Metastatic prostatic carcinoma 250 mg 3 times daily

653. FluticasoneFuroate 27.5mcg/dose NasalSpray

R01AD08139A4101XX

A* Treatment of nasal symptoms(rhinorrhea, nasal congestion,nasal itching and sneezing) andocular symptoms(itching/burning,tearing/watering, and rednessof the eye) of seasonal andperennial allergic rhinitis.

Adults/Adolescents (≥12 years) : 1-2sprays (27.5 mcg/spray) in eachnostril once daily. Children (2-11years) : 1-2 sprays (27.5 mcg/spray)in each nostril once daily

654. Fluticasonepropionate &formoterolfumaratedihydrate(125/5mcg) peractuationpressurizedinhalation,suspension

R03AK11989A2101XX

A/KK Indicated in the regulartreatment of asthma where theuse of a combination product(an inhaled corticosteroid and along-acting β2 agonist) isappropriate: ? For patients notadequately controlled withinhaled corticosteroids and ?asrequired? inhaled short-actingβ2 agonist. ? For patientsalready adequately controlledon both an inhaledcorticosteroid and a long-actingβ2 agonist.

Two inhalations (puffs) twice dailynormally taken in the morning andin the evening.

655. Fluticasonepropionate &formoterolfumaratedihydrate(250/10mcg) peractuationpressurizedinhalation,suspension

R03AK11989A2102XX

A/KK Indicated in the regulartreatment of asthma where theuse of a combination product(an inhaled corticosteroid and along-acting β2 agonist) isappropriate: I) For patients notadequately controlled withinhaled corticosteroids and 'asrequired' inhaled short-actingβ2 agonist. II) For patientsalready adequately controlledon both an inhaledcorticosteroid and a long-actingβ2 agonist.

Two inhalations (puffs) twice dailynormally taken in the morning andin the evening.

Page 111 of 296

No. Generic Name MDC Category Indications Dosage656. Fluticasone

Propionate 125mcg/dose Inhaler

R03BA05133A2101XX

B Prophylactic treatment forasthma

ADULT and CHILD more than 16years i) Mild asthma : 100 mcg - 250mcg twice daily ii) Moderate asthma: 250 - 500 mcg twice daily iii)Severe asthma : 500 mcg - 1000 mcgtwice daily. Alternatively, thestarting dose of fluticasonedipropionate may be gauged at halfthe total daily dose ofbeclomethasone dipropionate orequivalent administered byinhalation. CHILD 4 - 11 years, 50mcg twice daily (maximum 100 mcgtwice daily), CHILD 1-4 years, 50-100mcg microgram twice daily

657. Fluvoxamine 100mg Tablet

N06AB08253T1002XX

B Depression For depression, initially 50 - 100 mgdaily in the evening, increased ifnecessary to 300 mg daily (over 150mg in divided doses); usualmaintenance dose 100 mg daily.CHILD and ADOLESCENT under 18years not recommended

658. Fluvoxamine 50mg Tablet

N06AB08253T1001XX

B Depressive disorder For depression, initially 50 - 100 mgdaily in the evening, increased ifnecessary to 300 mg daily (over 150mg in divided doses); usualmaintenance dose 100 mg daily.CHILD and ADOLESCENT under 18years not recommended

659. Folic Acid 5 mgTablet

B03BB01000T1001XX

C+ i) For the prevention andtreatment of folate deficiencystates ii) For the prevention ofneural tube defect in the foetus

i) ADULT initially 10-20mg mg dailyfor 14 days or until haematopoieticresponse obtained. Dailymaintenance: 2.5 mg-10mg .CHILDup to 1 year:250 mcg/kg daily; 1 to 5years:2.5mg/day;6-12 years:5mg/day ii) 5 mg daily startingbefore pregnancy and continuedthrough the first trimester

660. Follitropin Alpha(RecombinantHuman FSH) 300IU/0.5 mlInjection

G03GA05000P3002XX

A* i) Infertility treatment inanovulatory women who havebeen unresponsive totreatment with clomiphenecitrate ii) Stimulation offollicular development for intra-uterine cycles iii) Stimulation offollicular development inassisted reproductivetechnology in the managementof infertility

i) 75 - 150 IU daily, shouldcommence within the first 7 days ofthe menstrual cycle and increasedby 37.5 IU or 75 IU at 7 or 14 daysinterval. Max daily dose 225 IU ii)150 - 225 IU daily commencing ondays 2 or 3 of the cycle. Max dailydose 450 IU

Page 112 of 296

No. Generic Name MDC Category Indications Dosage661. Follitropin Alpha

(RecombinantHuman FSH) 75IU Injection

G03GA05000P3001XX

A* i) Infertility treatment inanovulatory women who havebeen unresponsive totreatment with clomiphenecitrate ii) Stimulation offollicular development for intra-uterine cycles iii) Stimulation offollicular development inassisted reproductivetechnology in the managementof infertility

i) 75 - 150 IU daily, shouldcommence within the first 7 days ofthe menstrual cycle and increasedby 37.5 IU or 75 IU at 7 or 14 daysinterval. Max daily dose 225 IU ii)150 - 225 IU daily commencing ondays 2 or 3 of the cycle. Max dailydose 450 IU

662. Follitropin Beta(RecombinantHuman FSH) 300IU Injection

G03GA06000P3002XX

A* Infertility treatment inanovulatory women who havebeen unresponsive totreatment with clomiphenecitrate. Stimulation of folliculardevelopment for intra-uterineinsemination cycles andassisted reproductivetechnology in the managementof infertility.

To be individualized. Give inmultiples of 50 IU. Starting dose canbe 50 IU - 200 IU daily. It can be astep-up regime or a step-down,depending on the protocol and theovarian response

663. Follitropin Beta(RecombinantHuman FSH) 50IU Injection

G03GA06000P3001XX

A* Infertility treatment inanovulatory women who havebeen unresponsive totreatment with clomiphenecitrate. Stimulation of folliculardevelopment for intra-uterineinsemination cycles andassisted reproductivetechnology in the managementof infertility.

To be individualized. Give inmultiples of 50 IU. Starting dose canbe 50 IU - 200 IU daily. It can be astep-up regime or a step-down,depending on the protocol and theovarian response

664. FondaparinuxSodium 12.5mg/ml Injectionin PrefilledSyringe

B01AX05520P5002XX

A* i) Treatment of acute Deep VeinThrombosis (DVT). ii) Treatmentof Pulmonary Embolism (PE)

The recommended dose to beadministered by SC injection oncedaily is: 5mg for body weight lessthan 50kg, 7.5mg for body weight50 to 100kg, 10mg for body weightgreater than 100kg. Treatmentshould be continued for at least 5days and until adequate oralanticoagulation is established (INR 2to 3). Concomitant treatment withvitamin K antagonists should beinitiated as soon as possible, usuallywithin 72 hours. The usual durationof treatment is 5 to 9 days

Page 113 of 296

No. Generic Name MDC Category Indications Dosage665. Fondaparinux

Sodium 2.5mg/0.5 mlInjection

B01AX05520P5001XX

A* i) Prevention of venousthromboembolic events (VTE)in orthopedic surgery (e.g. hipfracture, major knee or hipreplacement surgery),abdominal surgery in patientsat risk of thromboemboliccomplication. ii) Treatment ofunstable angina or non-STsegment elevation myocardialinfarction [UA/NSTEMI] inpatients for whom urgentinvasive management (PCI) isnot indicated. iii) Treatment ofST segment elevationmyocardial infarction (STEMI) inpatients managed withthrombolytics or are notreceiving other forms ofreperfusion therapy

i) 2.5 mg once daily given by SC,administered 6 hr following surgicalclosure provided homeostasis hasbeen established. Usual duration oftherapy is 5 to 9 days; for hipfracture patients, an extendedcourse of up to 24 days isrecommended. ii) ADULT more than18 years: 2.5 mg once daily given bySC, initiated as soon as possibleafter diagnosis and continued for upto 8 days or until hospital discharge.If patient needs to undergo PCI,unfractionated heparin to be adminas per local practice protocol, takinginto account the patient's bleedingrisk and time of last dose offondaparinux. Fondaparinux may berestarted no earlier than 2 hr aftersheath removal. iii) ADULT morethan 18 years: 2.5 mg once daily;first dose to be given IV (directlythrough an existing IV line or asinfusion in 25 or 50 ml of 0.9% salineover 1-2 min), subsequent doses tobe given SC. Treatment to beinitiated as soon as diagnosis ismade and continued up to a max of8 days or until hospital discharge,whichever comes earlier. If patientneeds to undergo non-primary PCI,unfractionated heparin to be adminas per local practice protocol, takinginto account the patient's bleedingrisk and time of last dose offondaparinux. Fondaparinux may berestarted no earlier than 3 hr aftersheath removal

666. FramycetinSulphate 0.5%,Dexamethasone0.05% andGramicidin0.005% Ear Drops

S01CA01991D1001XX

A/KK Otitis externa Apply 2 - 3 drops 3 to 4 times daily

667. Frusemide 10mg/ml Injection

C03CA01000P3001XX

B Pulmonary oedema Initially 20 -40 mg IM or slow IV(rate not exceeding 4 mg/min).CHILD: 0.5 - 1.5 mg/kg. Max: 20 mgdaily

Page 114 of 296

No. Generic Name MDC Category Indications Dosage668. Frusemide

10mg/ml oralsolution

C03CA01000L9001XX

B Pulmonary oedema ADULT: The usual initial oral dose is40mg once daily, adjusted asnecessary according to response.Mild cases may respond to 20mgdaily or 40mg on alternate days.Some patients may need doses of80mg or more daily given as one ortwo doses daily; or intermittently.Severe cases may require gradualtitration of the frusemide dosage upto 600mg daily. Children: The usualdose is 1 to 3mg/kg daily up to amaximum dose of 40mg daily.

669. Frusemide 40 mgTablet

C03CA01000T1001XX

B Pulmonary oedema ADULT: Initial 40 - 80 mg onmorning if required, can beincreased to a max of 1 g/day incertain cases especially in chronicrenal failure. CHILD : 1 - 3 mg/kgdaily

670. Fuller's EarthPowder

V03AB00000F2101XX

C Adsorbent in pesticidepoisoning

Adult: 100-150g every 2-4 hours.Child: 1-2g/kg. (100g of Fuller'sEarth is mixed with 200ml water.Repeat until Fuller's Earth is seen instool (normally between 4-6 hours)

671. Fusidate, Sodium250 mg Tablet

J01XC01520T1001XX

A* Treatment of infections causedby susceptible organismsespecially Staphylococcalinfections including MethicillinResistant Staphylococcusaureus (MRSA)

ADULT: 500 mg 3 times daily, skinand soft tissue infection: 250 - 500mg twice daily

672. Fusidic Acid 1%Eye Drops

S01AA13000D2001XX

A For staphylococcal infections 1 drop in conjunctival sac 12 hourly.To be continued for 2 days after theeye appears normal. On the first dayof treatment, may be applied morefrequently : 1 drop 4 hourly. Surgicalprophylaxis : 1 drop every 12 hours,24 - 48 hours before operation

673. Fusidic Acid 2%Cream

D06AX01000G1001XX

A Skin infections caused bystaphylococci, streptococci,corynebacterium minutissumunand other sodium fusidate-sensitive organisms

Apply to affected area 2 - 3 timesdaily

674. Fusidic Acid 2% inBetamethasoneValerate 0.1%Cream

D07CC01948G1001XX

A/KK Inflammatory dermatosis wherebacterial infection is likely tooccur eg atopic eczema, discoideczema, stasis eczema,seborrhoic dermatitis, contactdermatitis, lichen simplexchronicus, psoriasis, discoidlupus erythematosus

Uncovered lesion- Apply 2 to 3times daily. Covered lesions- Lessfrequent applications may beadequate

Page 115 of 296

No. Generic Name MDC Category Indications Dosage675. Fusidic Acid 50

mg/mlSuspension

J01XC01000L8001XX

A* Treatment of infections causedby staphylococcal especiallyMethicillin ResistantStaphylococcus aureus (MRSA)

ADULT : 15 ml 3 times daily. CHILD 1- 5 years: 5 ml 3 times daily; 5 - 12years: 10 ml 3 times daily. INFANT :1 ml/kg body weight daily in 3 - 4divided doses

676. Fusidic Acid 500mg Injection

J01XC01520P4001XX

A* Treatment of severestaphylococcal infectionsespecially Methicillin ResistantStaphylococcus aureus (MRSA).To be used in combinationtherapy only

ADULT : 500 mg 3 times daily dilutedto 250 - 500 ml infused slowly over 2hours. Maximum : 2 g daily. CHILDand INFANT : 20 mg/kg/day dividedinto 3 equal doses infused slowlyover 2 - 4 hours

677. Gabapentin 100mg Tablet

N03AX12000T1002XX

A* i) Add-on therapy forintractable partial epilepsy,refractory to standard anti-epileptic drugs ii) Treatment ofvarious types of neuropathicpain, both peripheral (whichincludes diabetic neuropathy,post-herpetic neuralgia,trigeminal neuralgia) in adultmore than 18 years

ADULT & CHILD > 12 yrs: 900-3600mg/day. Therapy may beinitiated by administering 300mgTDS on day 1, or by titrating thedose as: 300mg once on day 1,300mg BD on day 2, 300mg TDS onday 3. Thereafter, then dose may beincreased in 3 equally divided dosesup to max 3600mg/day.CHILD 3-12yr: Initially 10-15 mg/kg/day in 3divided dose. Effective dose: CHILD3 to less than 5 yrs: 40mg/kg/day in3 divided doses, CHILD 5-12 yrs: 25-35mg/kg/day in 3 divided doses ii)ADULT: 900mg/day in 3 equallydivided doses. Max 3600mg/day

678. Gabapentin 300mg Capsule

N03AX12000C1001XX

A* i) Add-on therapy forintractable partial epilepsy,refractory to standard anti-epileptic drugs ii) Treatment ofvarious types of neuropathicpain, both peripheral (whichincludes diabetic neuropathy,post-herpetic neuralgia,trigeminal neuralgia) in adultmore than 18 years

ADULT & CHILD > 12 yrs: 900-3600mg/day. Therapy may beinitiated by administered 300mgTDS on day 1, or by titrating thedose as: 300mg once on day 1,300mg BD on day 2, 300mg TDS onday 3. Thereafter, may be increasedin 3 equally divided doses up to max3600mg/day.CHILD 3-12 yr: Initially10-15 mg/kg/day in 3 divided dose.Effective dose: CHILD 3 to less than5 yrs: 40mg/kg/day in 3 divideddoses, CHILD 5-12 yrs: 25-35mg/kg/day in 3 divided doses ii)ADULT: 900mg/day in 3 equallydivided doses. Max 3600mg/day

Page 116 of 296

No. Generic Name MDC Category Indications Dosage679. Gabapentin 600

mg TabletN03AX12000T1001XX

A* i) Add-on therapy forintractable partial epilepsy,refractory to standard anti-epileptic drugs ii) Treatment ofvarious types of neuropathicpain, both peripheral (whichincludes diabetic neuropathy,post-herpetic neuralgia,trigeminal neuralgia) in adultover 18 years

ADULT & CHILD > 12 yrs: 900-3600mg/day. Therapy may beinitiated by administered 300mgTDS on day 1, or by titrating thedose as: 300mg once on day 1,300mg BD on day 2, 300mg TDS onday 3. Thereafter, may be increasedin 3 equally divided doses up to max3600mg/day.CHILD 3-12 yr: Initially10-15 mg/kg/day in 3 divided dose.Effective dose: CHILD 3 to less than5 yrs: 40mg/kg/day in 3 divideddoses, CHILD 5-12 yrs: 25-35mg/kg/day in 3 divided doses ii)ADULT: 900mg/day in 3 equallydivided doses. Max 3600mg/day

680. GadobenateDimeglumineInjection Solution

V08CA08996P3001XX

A* i) MRI of the liver for thedetection of focal liver lesionsin patients with known orsuspected primary liver cancer(e.g. Hepatocellular carcinoma)or metastatic disease; ii) MRI ofthe brain and spine where itimproves the detection oflesion and provides diagnosticinformation additional to thatobtained with unenhanced MRI;iii) Contrast-enhanced MR-angiography where it improvesthe diagnostic accuracy fordetecting clinically significantsteno-occlusive vascular diseasein patients with suspected orknown vascular disease of theabdominal or peripheralarteries.

i) MRI of liver: 0.05ml/kg bodyweight. This corresponds to0.1ml/kg of the 0.5M solution ii)MRI of brain & spine: 0.1mmol/kgbody weight. This corresponds to0.2ml/kg of the 0.5M solution iii)MRA: 0.1mmol/kg body weight. Thiscorresponds to 0.2ml/kg of the0.5M solution

681. Gadobutrol 1mmol/mlinjection

V08CA09000P3001XX

A* In adults, adolescents andchildren aged 2 years and olderwith diagnostic difficultyespecially in patients with renalimpairment for: i) Contrastenhancement in cranial andspinal magnetic resonanceimaging (MRI). ii) Contrastenhanced MRI of liver orkidneys in patients with highsuspicion or evidence of havingfocal lesion to classify theselesions as benign or malignant.iii)Contrast enhancement inMagnetic ResonanceAngiography (CE-MRA).

A single intravenous injection of 0.1mmol/kg (equivalent to 0.1 ml/kgbody weight). Max: 0.3 mmol/kg(equivalent to 0.3 ml/kg bodyweight)

Page 117 of 296

No. Generic Name MDC Category Indications Dosage682. Gadopentetate

Dimeglumine 469mg/ml

V08CA01000P3001XX

A i) Cranial and spinal magneticresonance imaging ii) Wholebody magnetic resonanceimaging

The usual dose in adults, children,and neonates is 0.2 mL/kg (0.1mmol/kg) intravenously. For cranialand spinal imaging, a further dose of0.2 mL/kg (0.1 mmol/kg) may begiven within 30 minutes ifnecessary; in adults this seconddose may be 0.4 mL/kg (0.2mmol/kg). For whole body imagingin adults and children over 2 years, adose of 0.4 mL/kg (0.2 mmol/kg)may be needed in some cases toproduce adequate contrast and inspecial circumstances a dose of 0.6mL/kg (0.3 mmol/kg) may be used inadults

683. GadoterateMeglumine(Gadoteric Acid)0.5 mmol/ mlInjection

V08CA02254P3001XX

A High risk patients undergoingMagnetic Resonance Imagingfor cerebral and spinal disease,diseases of the vertebralcolumn and other whole bodypathology

The recommended dose is 0.1mmol/kg (equivalent to 0.2 mL/kg inadults, children and infants. Inangiography, depending on theresults of the examination beingperformed, a second injection maybe administered during the samesession if necessary

684. Gadoxetic aciddisodium 0.25mmol/ml solutionfor injection(10ml pre-filledsyringe)

V08CA10520P3001XX

A* For use in adults for theenhancement of magneticresonance imaging (MRI) offocal liver lesions

0.1ml/kg body weight (equivalent to25 µmol per kg body weight). Notrecommended for patients youngerthan 18 years

685. Gamma BenzeneHexachloride 0.1% Lotion

P03AB02100L6001XX

B For treatment of head lice Leave lotion on hair for exactly 4minutes. Then wash off of the hairand skin with warm water.

686. Gamma BenzeneHexachloride 1%Cream/Lotion

P03AB02100G1002XX

A/KK Only for scabies in adultweighing more than 50kg. Useshould be restricted to patientswho have failed treatment withor cannot tolerate othermedications that pose less risk

Only for single application. Adult:Apply a thin layer of 1% topicalpreparation onto all skin areas fromthe neck to toes. Completely washoff from the body with warm waterafter 8-12 hr.

687. GanciclovirSodium 50 mg/ml Injection

J05AB06520P3001XX

A* Treatment of cytomegalovirus(CMV) disease inimmunocompromised patients,prevention of CMV diseaseduring immunosuppressivetherapy following organtransplantation

Initial: 5 mg/kg infused over 1 hour12 hourly for 14 - 21 days (CMVretinitis treatment) or 7 - 14 days(CMV disease prevention). Longterm maintenance: 6 mg/kg daily for5 days/week or 5 mg/kg daily for 7days/week

688. Ganirelix 0.25mg/0.5 mlInjection

H01CC01000P2001XX

A* Prevention of prematureluteinizing hormone surges inwomen undergoing controlledovarian hyperstimulation forassisted reproductiontechnique

Given by SC 0.25 mg once daily,starting on day 6 of ovarianstimulation and continued untilovulation induction

Page 118 of 296

No. Generic Name MDC Category Indications Dosage689. Gefitinib 250 mg

tabletL01XE02000T1001XX

A* i) First line treatment of adultpatients with locally advancedor metastatic Non Small CellLung Cancer (NSCLC) who haveactivating mutations of theEGFR TK. PrescribingRestriction: - Adenocarcinomahistology - Patient's ECOGPerformance Status 0-1 - Mustbe prescribed by an oncologistor oncology-trained respiratoryphysician. ii) For second linetreatment of patients withlocally advanced or metastaticnon-small cell lung cancer(NSCLC) who have previouslyfailed chemotherapy, and whohave activating mutation ofepidermal growth factorreceptor (EGFR). PrescribingRestriction: - Adenocarcinomahistology - Patient's ECOGPerformance Status 0-1 - Mustbe prescribed by an oncologistor oncology-trained respiratoryphysician. - Must not havereceived prior TKI for thiscondition.

250mg tablet once a day, taken withor without food

690. Gemcitabine HCl1 g Injection

L01BC05110P4002XX

A* i) Locally advanced ormetastatic non-small cell lungcancer ii) Locally advanced ormetastatic pancreatic cancer iii)In combination with carboplatinin the treatment of patientswith recurrent epithelialovarian carcinoma, who haverelapsed more than six months,following platinum-basedtherapy iv) In combination withpaclitaxel for treatment ofpatients with metastatic breastcancer who have relapsedfollowing adjuvant/neoadjuvant chemotherapy.Prior chemotherapy shouldhave included an anthracyclineunless clinically contraindicated

i) Alone or with cisplatin: 1000mg/m2 day 1 & 8 every 3 weeks or1000 mg/m2 day 1, day 8, day 15every 4 weeks ii) Initially 1000mg/m2 weekly for 7 weeks followedby 1 week rest. Subsequent cycles1000 mg/ m2 weekly for 3 weeksfollowed by 1 week rest iii)Gemcitabine 1000 mg/m2 as 30minutes IV infusion day 1 & 8 ofeach 21-day cycle followed bycarboplatin on day 1 to attain atarget AUC of 4 mg/ml/minute iv)1250 mg/m2 on days 1 and 8 ofeach 21-day cycle with paclitaxel175 mg/m2 given as a 3-hourinfusion before gemcitabine on day1 of each 21-day cycle

Page 119 of 296

No. Generic Name MDC Category Indications Dosage691. Gemcitabine HCl

200 mg InjectionL01BC05110P4001XX

A* i) Locally advanced ormetastatic non-small cell lungcancer ii) Locally advanced ormetastatic pancreatic cancer iii)In combination with carboplatinin the treatment of patientswith recurrent epithelialovarian carcinoma, who haverelapsed more than six months,following platinum-basedtherapy iv) In combination withPaclitaxel, for treatment ofpatients with metastatic breastcancer who have relapsedfollowing adjuvant/neoadjuvant chemotherapy.Prior chemotherapy shouldhave included an anthracyclineunless clinically contraindicated

i) Alone or with cisplatin: 1000mg/m2 day 1 & 8 every 3 weeks or1000 mg/m2 day 1, day 8, day 15every 4 weeks ii) Initially 1000mg/m2 weekly for 7 weeks followedby 1 week rest. Subsequent cycles1000 mg/ m2 weekly for 3 weeksfollowed by 1 week rest iii)Gemcitabine 1000 mg/m2 as 30minutes IV infusion day 1 & 8 ofeach 21-day cycle followed bycarboplatin on day 1 to attain atarget AUC of 4 mg/ml/minute iv)1250 mg/m2 on days 1 and 8 ofeach 21-day cycle, with paclitaxel175 mg/m2 given as a 3-hourinfusion before gemcitabine on day1 of each 21-day cycle

692. Gemeprost(Prostagladin E1SyntheticAnalogue) 1 mgPessary

G02AD03000S1001XX

A Inducing abortion in the firsttrimester

Cervical dilatation: 1 pessary 3hourly before surgery to a max of 5pessaries over 24 hours

693. Gemfibrozil 300mg Capsule

C10AB04000C1001XX

A/KK Treatment ofhyperlipoprotinaemias (TYPESIIA, IIB, III, IV, V)

ADULT: 1200 mg/day in 2 divideddoses, 30 minutes before breakfastand dinner. Dose range from 0.9-1.5g daily

694. Gentamicin 0.1%Cream

D06AX07183G1001XX

A* For localised infections Apply 2 - 3 times daily

695. Gentamicin 0.3%Eye Drops

S01AA11183D2001XX

A/KK Broad spectrum antibiotic insuperficial eye infections andalso for Pseudomonasaeruginosa

1 - 2 drops every 4 hours, in severeinfection dosage may be increasedup to 2 drops every hour

696. Gentamicin 0.3%Eye Ointment

S01AA11183G5101XX

A/KK Conjunctivitis, blepharitis,blepharo-conjunctivitis,keratitis, keratoconjunctivitis,episcleritis, dacrocystitis,corneal ulcers, styes andinfected eye socket

Apply into the conjunctival sac 3 - 4times daily

697. Gentamicin 3%Fortified EyeDrops

S01AA11183D2002XX

A Broad spectrum antibiotic insuperficial eye infections andalso for Pseudomonasaeruginosa

Dose according to the needs of thepatient

698. Gentamicin 7.5mg Beads

J01GB03183P1001XX

A Treatment of chronicosteomyelitis of post-traumatic,post-operative orhematogenous origin

7.5 - 22.5 mg chains to fill affectedcavity

699. GentamicinSulphate 10mg/ml Injection

J01GB03183P3002XX

B Infections due to susceptibleorganisms

ADULT: 3 - 5 mg/kg/day 8 hourly IMor IV. CHILD up to 2 weeks: 3mg/kgevery 12 hours; 2 weeks - 12 years:2 mg/kg 8 hourly

Page 120 of 296

No. Generic Name MDC Category Indications Dosage700. Gentamicin

Sulphate 40mg/ml Injection

J01GB03183P3003XX

B Infections due to susceptibleorganisms

ADULT: 3 - 5 mg/kg/day 8 hourly IMor IV. CHILD up to 2 weeks: 3mg/kgevery 12 hours; 2 weeks - 12 years:2 mg/kg 8 hourly

701. GentamicinSulphate andBetamethasoneDisodiumPhosphate EyeDrops

S01CA05990D2001XX

A/KK Inflammatory and allergicconditions involving superficialeye structures and whenbacterial infection is present :conjunctivitis, blepharitis,keratitis, episcleritis,dacryocystitis, hordeolum,meibomianitis, injuriesinvolving anterior segment ofthe eye

2 drops 3 - 4 times daily

702. GentamicinSulphate andBetamethasoneDisodiumPhosphate EyeOintment

S01CA05990G5101XX

A Inflammatory and allergicconditions involving superficialeye structures and whenbacterial infection is present :conjunctivitis, blepharitis,keratitis, episcleritis,dacryocystitis, hordeolum,meibomianitis, injuriesinvolving anterior segment ofthe eye

Thin coating of ointment 3 - 4 timesdaily

703. Glibenclamide 5mg Tablet

A10BB01000T1001XX

B Diabetes mellitus type 2.Restriction : Use only in patientunder 65 years old

Range: 2.5 - 15 mg daily (with orimmediately after breakfast).Initially 2.5 mg daily increasing by2.5 mg required for metaboliccontrol. Max: 20mg daily.

704. Gliclazide 30 mgModified ReleaseTablet

A10BB09000T5002XX

B Diabetes mellitus type 2 Initially, 30mg daily at breakfasttime, may increase in successivesteps to 60, 90 or 120mg daily at 1month intervals. Max daily dose:120mg

705. Gliclazide 60 mgModified ReleaseTablet

A10BB09000T5001XX

B Diabetes mellitus type 2 Initially, 30mg daily at breakfasttime, may increase in successivesteps to 60, 90 or 120mg daily at 1month intervals (except in patientswhose blood glucose level was notreduced after 2 weeks oftreatment). Max daily dose: 120mg

706. Gliclazide 80 mgTablet

A10BB09000T1001XX

B Diabetes mellitus type 2 Initially 40-80mg daily. A single doseshould not exceed 160mg and whenhigher doses are required, a twicedaily split dosage is advised andshould be divided. Maximum dailydose: 320mg. For elderly, startingdose should be 40mg twice daily.

707. Glucagon(Lyophilised) 1mg/ml Injection

H04AA01000P4001XX

B Management of hypoglycaemia Adult, children > 20kg: 1mg by SC,IM or IV. Children < 20kg : 0.5mg. Ifpatient does not respond within 10minutes, administer IV glucose.Repeat in 20 minutes if necessary.

Page 121 of 296

No. Generic Name MDC Category Indications Dosage708. Glutaraldehyde

Solution 2%V07AV00000L9905XX

A 2% formulation - High leveldisinfection for heat sensitiveequipments such asendoscopes

20 minutes or more immersion isrecommended for endoscopesbefore the session and betweenpatients after thorough cleaningbased on manufacturerrecommendation

709. Glycerin A06AX01000L5001XX

C+ As a lubricant and osmoticdehydrating agent

Apply to area when required

710. Glycerin 25% andSodium Chloride15% Enema

A06AG20921G2001XX

C+ Constipation 1 enema as required

711. Glycerine 25%w/w in aqueouscream

D02AX000G1001XX

C For topical application to theskin, as an emollient for thesymptomatic relief of dry skinconditions and as soap-substitute for skin-washing.

Adults, children and elderly: Applysparingly to the affected area asrequired or as directed by yourpharmacist or doctor.

712. GlycerylTrinitrate 0.5 mgSublingual Tablet

C01DA02221T1001XX

C Prophylaxis and treatment ofangina and left ventricularfailure

0.5-1 mg sublingually may berepeated every 5 minutes until reliefis obtained. Seek physician if thepain persists after a total of 3 tabletsin a 15 minutes period.

713. GlycerylTrinitrate 5mg/ml Injection

C01DA02221P3001XX

A Prophylaxis and treatment ofangina, left ventricular failure.Not for direct IV injection.

Initial 5 mcg/min delivered viainfusion pump. Subsequent titrationmust be adjusted to clinical situationwith dose increment becomingmore cautious as partial response isseen.

714. GlycerylTrinitrate AerosolSpray 400mcg(metered dose)

C01DA02221A1001XX

B Prophylaxis and treatment ofangina and left ventricularfailure

At the onset of an attack, one ortwo metered sprays should beadministered on or under thetongue. A spray maybe repeatedapproximately every 5 minutes asneeded. No more than 3 meteredsprays are recommended within 15minute period. If chest pain persistsafter a total of 3 sprays, promptmedical attention is recommended.Aerosol may be usedprophylactically 5 to 10 minutesbefore engaging in activities thatmight precipitate an acute attack

715. Glycine 1.5%Irrigating Solution

B05CX03000H3001XX

A Bladder irrigation duringgenitourinary surgery

The dosage depends on the extentof the procedure and its duration

716. Glycopyrrolate200 mcg/mlInjection

A03AB02320P3001XX

A* i) To reduce secretions(respiratory tract) for certaintypes of surgery ii) Reversal ofneuromuscular block in patientswhere atropine iscontraindicated

i) Pre-op: 4 mcg/kg via IMadministration 30-60 mins beforeprocedure. Intraoperative: 0.1 mgvia IV administration, repeat at 2-3min intervals when needed. Max:400 mcg/dose. ii) 0.2 mg by IV foreach 1 mg of neostigmine or 5 mgpyridostigmine

Page 122 of 296

No. Generic Name MDC Category Indications Dosage717. Glycopyrronium

50mcg, InhalationPowder HardCapsules

R03BB06320A2001XX

A/KK For maintenancebronchodilator treatment torelieve symptoms in adultpatients with chronicobstructive pulmonary disease(COPD). COPD diagnosis isconfirmed by spirometry.

One capsule daily. Therecommended dose is the inhalationof the content of one capsule oncedaily using inhaler. It isrecommended to be administered,at the same time of the day eachday. No relevant use ofglycopyrronium in pediatricpopulation (<18 years) for COPD.

718. Golimumab 50mg(0.5ml) solutionfor injection in apre-filled syringe

L04AB06000P5001XX

A* i) Rheumatoid arthritis (RA): Incombination with methotrexate(MTX), is indicated for: - Thetreatment of moderate tosevere active rheumatoidarthritis in adult patients whenthe response to DMARDtherapy including MTX has beeninadequate. - The treatment ofactive, severe and progressiverheumatoid arthritis in adultpatients not previously treatedwith MTX. ii) Psoriatic arthritis(PsA): Golimumab alone or incombination with MTX, isindicated for: The treatment ofactive psoriatic arthritis in adultpatients when the response toprevious DMARD therapy hasbeen inadequate. iii) Ankylosingspondylitis (AS):Golimumab(used alone) isindicated for: The treatment ofactive ankylosing spondylitis inadult patients when theresponse to conventionaltherapy has been inadequate.

i) Rheumatoid arthritis 50mg givenas a subcutaneous injection once amonth, on the same date eachmonth. ii)Psoriatic arthritis 50mggiven as a subcutaneous injectiononce a month, on the same dateeach month. iii) Ankylosingspondylitis 50mg given as asubcutaneous injection once amonth, on the same date eachmonth.

719. Goserelin 10.8mg DepotInjection

L02AE03000P2002XX

A Prostatecancer,endometriosis,leiomyoma uteri and assisstedreproduction,breast cancer inpremenopausal andperimenopausal womensuitable for hormonalmanipulation

One 10.8mg depot injectedsubcutaneously into the anteriorabdominal wall, every 12 weeks.

720. Goserelin 3.6 mgDepot Injection

L02AE03000P2001XX

A Prostatecancer,endometriosis,leiomyoma uteri and assisstedreproduction,breast cancer inpremenopausal andperimenopausal womensuitable for hormonalmanipulation

3.6 mg depot injection every 28days

Page 123 of 296

No. Generic Name MDC Category Indications Dosage721. Granisetron HCl 1

mg TabletA04AA02110T1001XX

A Prevention and treatment ofnausea and vomiting associatedwith chemotherapy andradiotherapy

ADULT 1 mg twice daily or 2 mgonce daily with the first dose to beadministered within 1 hour prior tocytostatic therapy and can be givenfor up to 1 week followingradiotherapy. Maximum 9 mg/day

722. Granisetron HCl 1mg/ml Injection

A04AA02110P3001XX

A i) Prevention and treatment ofnausea and vomiting associatedwith chemotherapy andradiotherapy ii) Post-operativenausea and vomiting

i) ADULT 1-3 mg as an IV bolus notnot less than 30 seconds; maximum9 mg/day. CHILD over 2 years; singledose of 10-40 mcg/kg as an IVinfusion; maximum 3 mg/day ii)ADULT 1 mg by slow IV injectionover 30 seconds prior to inductionof anaesthesia

723. Griseofulvin(Ultramicrosize125 mg = 250 mgMicrosize) Tablet

D01BA01000T1001XX

B Dermatophyte infections of theskin, scalp, hair and nails, wheretopical therapy has failed orinappropriate

ADULT: 500 mg daily up to 1 g dailyin divided doses, 2-8 wk in hair andskin infections, 6 mth in fingernailinfections and 12 mth or more fortoenail infections. CHILD: 10 mg/kgdaily in divided doses or as a singledose

724. HaemodialysisConcentrate withAcetate

B05ZA00908H1001XX

A For acute renal failure, chronicrenal failure, overhydration,intoxication, adjustment ofacid-base and electrolytebalance

Dose depending on clinical cases

725. HaemodialysisConcentrate withBicarbonate

B05ZA00908H1002XX

A For acute renal failure, chronicrenal failure, overhydration,intoxication, adjustment ofacid-base and electrolytebalance

Dose depending on clinical cases

726. HaemophilusInfluenza Type BConjugateVaccine Injection(Single Dose)

J07AG01000P4001XX

C Immunisation of infants againstHaemophilus Influenzae Type B

0.5 ml IM

727. Haloperidol 1.5mg Tablet

N05AD01000T1001XX

B Schizophrenia and otherpsychoses

Adult:†0.5-5 mg bid/tid, mayincrease up to 100 mg daily insevere or resistant cases. Usualmaintenance: 3-10 mg daily.†Child:>3 yr: Initially, 25-50 mcg/kg daily in2 divided doses, increased graduallyif necessary. Max: 10 mg/day.

728. Haloperidol 5 mgTablet

N05AD01000T1002XX

B Schizophrenia and otherpsychoses

Adult:†0.5-5 mg bid/tid, mayincrease up to 100 mg daily insevere or resistant cases. Usualmaintenance: 3-10 mg daily.†Child:>3 yr: Initially, 25-50 mcg/kg daily in2 divided doses, increased graduallyif necessary. Max: 10 mg/day.

Page 124 of 296

No. Generic Name MDC Category Indications Dosage729. Haloperidol 5

mg/ml InjectionN05AD01000P3001XX

B Acute psychoses and mania ADULT: IM or IV , 2 mg - 10 mg thenevery 4 - 8 hours according toresponse to total maximum 18 mgdaily. Use in child is notrecommended

730. Heparin 1000units/ml Injection

B01AB01520P3001XX

B i) Prophylaxis and treatment ofvenous thrombosis andpulmonary embolism. ii)Treatment of myocardialinfarction and arterialembolism. iii) Prevention ofclotting in arterial and heartsurgery and for prevention ofcerebral thrombosis

i) By IV injection, loading dose of5000 units (10,000 units in severepulmonary embolism) followed bycontinuous infusion of 15-25units/kg/hr. By SC injection (forDVT) of 15,000 units every 12 hours(laboratory monitoring on dailybasis essential to adjust dose). Smalladult or child, lower loading dosethen, 15-25 units/kg/hr by IVinfusion, or 250 units/kg every 12hours by SC injection. ii) As i), forunstable angina and acuteperipheral arterial occlusion. iii)Prophylaxis in general surgery, by SCinjection, 5000 units 2 hour beforesurgery, then every 8-12 hours for 7days or until patient is ambulant,during pregnancy (with monitoring),5000-10000 units every 12 hours.An adjusted dose regimen may beused for major orthopaedic surgeryor low molecular weight heparinmay be selected

731. Heparin 5000units/ml Injection

B01AB01520P3002XX

B i) Prophylaxis and treatment ofvenous thrombosis andpulmonary embolism. ii)Treatment of myocardialinfarction and arterialembolism. iii) Prevention ofclotting in arterial and heartsurgery and for prevention ofcerebral thrombosis

i) By IV injection, loading dose of5000 units (10,000 units in severepulmonary embolism) followed bycontinuous infusion of 15-25units/kg/hr. By SC injection (forDVT) of 15,000 units every 12 hours(laboratory monitoring on dailybasis essential to adjust dose). Smalladult or child, lower loading dosethen, 15-25 units/kg/hr by IVinfusion, or 250 units/kg every 12hours by SC injection. ii) As i), forunstable angina and acuteperipheral arterial occlusion. iii)Prophylaxis in general surgery, by SCinjection, 5000 units 2 hour beforesurgery, then every 8-12 hours for 7days or until patient is ambulant,during pregnancy (with monitoring),5000-10000 units every 12 hours.An adjusted dose regimen may beused for major orthopaedic surgeryor low molecular weight heparinmay be selected

Page 125 of 296

No. Generic Name MDC Category Indications Dosage732. Heparin Sodium

50 units inSodium ChlorideInjection

B01AB01930P3001XX

B To maintain patency ofperipheral venous catheters

Flush with 5 ml (50 units) every 4hours or as required

733. Hepatitis A,InactivatedVaccine 160antigen unitsInjection

J07BC02000P5001XX

A Vaccination against hepatitis Aespecially in those at risk ofexposure to hepatitis A virussuch as: i) Visitors ii) Chronichepatitis B and C patient iii)Those requiring vaccinationagainst hepatitis A

0.5 ml per injection. ADULT andCHILD more than 15 years: A singleprimary dose followed by a boosterdose 6 - 12 months later. CHILD 2 -15 years: A single primary dosefollowed by a booster dose 6 - 12months later

734. Hepatitis BImmunoglobulin(Human)Injection

J06BB04000P3001XX

A i) For post-exposure prophylaxisof hepatitis B ii) Prophylaxisagainst recurrence of hepatitisB infection in chronic hepatitisB post liver transplantation

i) Adults: Recommended Dose:1000-2000 IU IM and if necessary,the dose should be increased orrepeated. Children: Inject 32-48IU/kg of body weight, should beadministered within 7 days afterexposure to HBsAg (preferablywithin 48 hrs). Neonates:Recommended Initial Dose: 100-200IU. The 1st dose should beadministered within 5 days afterbirth (preferably within 48 hrs) andbooster dose should be 32-48 IU/kgbody weight. The booster doseshould be administered between 2and 3 months after the 1stadministration. ii) Differentregimens depending on hepatitis Bvirus (HBV) DNA positivity

735. Hepatitis BVaccine Injection

J07BC01000P4001XX

C+ Immunisation against infectionscaused by Hepatitis B virus

Dose depends on the products used.Please refer to package insert.Example: 1. Euvax-B Adult (from 16years old) - 20mcg/dose Neonates,infants & children up to andincluding 15 years - 10mcg/dose 2.Engerix-B Adult (from 20 years old) -20mcg/dose Neonates, infants &children up to and including 19years - 10mcg/dose Second dose tobe given after 1 month and boosterdose after 6 months

736. Homatropine 2%Eye Drops

S01FA05330D2003XX

B i) Mydriasis and cycloplegia forrefraction ii) Treatment ofanterior segment inflammation

i) Adult: Instill 1 or 2 drops of 2%solution immediately before theprocedure, repeat at 5-10-minuteintervals if necessary. Child: Instill 1drop of 2% soln immediately beforethe procedure, repeat at 10-minintervals if necessary. ii) Adult: Instill1-2 drops of 2% bd-tds up to every3-4 hr as needed. Child: 3 mth- 2 yr:instill 1 drop of 0.5% soln once dailyor on alternate days. >2 yr: instill 1

Page 126 of 296

No. Generic Name MDC Category Indications Dosagedrop of 1% or 2% soln bd.

737. Human AlbuminInjection

B05AA01000P3001XX

B i) Acute hypovolemic shock ii)Hypoproteinaemia iii) Neonatalhyperbilirubinaemia

i) ADULT 25 g. CHILD 0.6 g/kg bodyweight ii) Maximum daily dose is 2giii) 1 g/kg before exchangetransfusion. Dose is given at rate of1 ml of 25% solution per minute

738. Human NormalGlobulin Injection

J06BA02000P3001XX

A i) Hypogammaglobulinaemiaand other deficiency states ii)Severe refractory idiopathicthrombocytopenia purpura(platelet less than 20,000) withinternal bleeding, particularlycentral nervous system iii)Septicaemia inimmunocompromised patientsor patients not responding toantibiotics iv) Chroniclymphocytic leukaemia notresponding to conventionaltherapy

i) 50 mg/kg body weight daily for 5days, then 25 - 50 mg/kg weekly formaintenance according to theseverity of the condition ii) 400mg/kg daily for 5 days with a furtherdose of 400 mg/kg as required iii)Septicaemia inimmunocompromised patients orpatients not responding toantibiotics iv) 250 mg/kg per monthDose varies depending on brandused

739. HumanPapillomavirus(Types 16, 18)Vaccine Injection

J07BM02000P3001XX

C+ For the prevention of cervicalcancer due to papilloma virus.To be used as part of the publichealth program only

Given by IM into deltoid region.ADULT and CHILD 10 - 25 years, 3doses of 0.5 mL, at 0, 1 and 6months

740. HumanPapillomavirus(Types 6, 11, 16,18) VaccineInjection

J07BM01000P3001XX

C+ For the prevention of cervicalcancer due to papilloma virus.To be used as part of the publichealth program only

Given by IM into deltoid region orhigher anterolateral thigh. ADULTand CHILD 9 - 26 years, 3 doses of0.5 mL, at 0, 2 and 6 months

741. Hydralazine HCl20 mg Injection

C02DB02110P3001XX

B Hypertensive crisis in pregnancy i) Slow IV injection, ADULT: 5-10 mgdiluted with 10ml sodium chloride0.9%. May be repeated after 20-30minutes if necessary. ii) IV infusion200-300 mcg/minutes. Maintenancedose 50-150 mcg/minutes

742. Hydrochlorothiazide 25 mg Tablet

C03AA03000T1001XX

B Diuretic, hypertension ADULT: Diuretics; 25-200 mg daily.Hypertension 12.5-25 mg dailyCHILD: Oedema and hypertension;Adjunct; 1 to 2 mg/kg ORALLY dailyin single or two divided doses;Children 2-12 years old MAX dose,not to exceed 100 mg ORALLY daily;Infants less than 6 months old, mayrequire doses up to 3 mg/kg ORALLYdaily in two divided doses, Infantsup to 2 yrs old: MAX dose, not toexceed 37.5 mg ORALLY daily

Page 127 of 296

No. Generic Name MDC Category Indications Dosage743. Hydrochlorothiazi

de 50 mg TabletC03AA03000T1002XX

B Diuretic, hypertension ADULT: Diuretics; 25-200 mg daily.Hypertension 12.5-25 mg dailyCHILD: Oedema and hypertension;Adjunct; 1 to 2 mg/kg ORALLY dailyin single or two divided doses;Children 2-12 years old MAX dose,not to exceed 100 mg ORALLY daily;Infants less than 6 months old, mayrequire doses up to 3 mg/kg ORALLYdaily in two divided doses, Infantsup to 2 yrs old: MAX dose, not toexceed 37.5 mg ORALLY daily

744. Hydrocortisone1% & Neomycin0.5% Cream

D07CA01952G1001XX

B Inflammatory and pruriticmanifestations of corticosteroidresponsive dermatoses

Apply to affected part 2-3 timesdaily (occasionally may causesensitisation to Neomycin)

745. Hydrocortisone1% Cream

D07AA02000G1001XX

B Inflammatory and pruriticmanifestations of corticosteroidresponsive dermatoses

Apply sparingly to affected area 2 - 3times daily until condition improve,then reduce frequency

746. Hydrocortisone1% Ointment

D07AA02000G5001XX

B Inflammatory and pruriticmanifestations of corticosteroidresponsive dermatoses

Apply sparingly to affected area 2 - 3times daily until condition improve,then reduce frequency

747. Hydrocortisone10 mg Tablet

H02AB09000T1001XX

B Glucocorticoid replacementtherapy in primary or secondaryadrenal insufficiencies and longterm management ofcongenital adrenal hyperplasiain children

ADULT: 20 - 30 mg daily in divideddoses. CHILD: 10 - 30 mg daily individed doses

748. HydrocortisoneEnema 0.1%

A07EA02000G2001XX

B Adjunctive treatment forulcerative colitis and proctitis

ADULT 100 mg 1-2 times/day for 2-3weeks. If used for longer than 3weeks, taper treatment over 2-3weeks

749. HydrocortisoneSodium Succinate100 mg Injection

H02AB09520P4001XX

C Conditions responsive tosystemic or local glucocorticoidinjection therapy especially inemergencies

Initially 100 - 500 mg IV over 30seconds to more than 10 minutes.Dose may be repeated at intervalsof 2, 4 or 6 hours

750. HydrogenPeroxide 1.5%Ear Drops

S02AA06241D1001XX

C To soften impacted ear wax Instill 1 - 2 drops into the ear asrequired (leave for a few minutess)

751. HydrogenPeroxide 20volume Solution

D08AX01241L9901XX

C Skin disinfection, particularlycleansing and deodorisingwounds and ulcers

Hydrogen Peroxide 6% (=approx. 20vol) shall be dispensed. Forcleansing wounds: 1.5% to 6%solution apply 2-3 times daily orwhen nescessary. As a mouthwash:rinse the mouth for 2-3 minuteswith 15ml of hydrogen peroxide 6%diluted in half a tumblerful of warmwater 2-3 times daily. Disinfectingcleaned equipment: immersion for30 minutes in 6% solution. As eardrop for removal of wax: hydrogenperoxide 6% diluted with 3 parts ofwater preferably just before use

Page 128 of 296

No. Generic Name MDC Category Indications Dosage752. Hydroxychloroqui

ne Sulphate 200mg Tablet

P01BA02183T1001XX

A i) SLE and mixed connectivetissue disease for skin, joint andserosa ii) Second line therapyfor acute rheumatoid arthritis

i) Initially 400 mg daily in divideddose. Maintenance : 200 - 400 mgdaily ii) ADULT : 400 - 600 mg daily.Maintenance: 200 - 400 mg daily.CHILD : up to 6.5 mg/kg daily(maximum 400mg daily)

753. HydroxyethylCellulose Jelly

V07AY00250G4001XX

B For lubricating purpose Apply sufficiently for lubricatingpurpose

754. HydroxyethylStarch 6%Injection

B05AA07000P9901XX

B Therapy and prophylaxis ofhypovolaemia and shock inconnection with surgerytrauma, infections and burns

ADULT daily dose up to 20ml/kg/day. Normally 500-1500 ml.The rate of infusion may approach20 ml/kg/hour in acutehaemorrhagic shock, slower rates inburns and septic shock. CHILD under10 years do not exceed 15 ml/kg/hour.

755. Hydroxyprogesterone Caproate250 mg/mlInjection

G03DA03128P2001XX

A Habitual and threatenedabortion

250 - 500 mg once weekly by IMinjection

756. Hydroxyurea 500mg Capsule

L01XX05000C1001XX

A i)Solid tumours ii) Chronicmyelocytic leukaemia andmyeloproliferative diseaseiii)Severe psoriasis eg. Extensiveplaque psoriasis, erythrodermicpsoriasis, pustular psoriasis -asthird line therapy.

i)Intermittent therapy : 80 mg/kgorally as a single dose every 3rd day.Continuous therapy : 20 - 30 mg/kgorally as a single dose dly.Concomitant therapy withirradiation : 80 mg/kg orally as asingle dose every 3rdday.(administration of hydroxyureashould be started at least 7 daysbefore initiation of irradiation andcontinued during radiotherapy aswell). ii)Continuous therapy (20 - 30mg/kg orally as a single dose daily,therapy should be interrupted if thewhite blood cell count drops below2500/mm3, or the platelet countbelow 100,000/mm3. iii) 500 mgtds.

757. Hydroxyzine HCl25 mg Tablet

N05BB01110T1001XX

A Allergic pruritus Initially 25 mg at night, increased ifnecessary up to 25 mg 3-4 timesdaily. ADULT and CHILD more than10 years : 50 - 75 mg; 6 - 10 years:25 - 50 mg; 2 - 5 years: 12.5 - 25 mg;to be taken daily in divided doses

758. HyoscineHydrobromide400 mcg/mlInjection

A04AD01330P3001XX

B To reduce oral secretionsbefore surgery

200-600 mcg given as SC or IM 60minutes before induction ofanaesthesia. CHILD: 15 mcg/kg

759. Hyoscine N-Butylbromide 1mg/ml Liquid

A03BB01320L5001XX

B Gastrointestinal tract andgenito-urinary tract spasm,dyskinesia of the biliary system

ADULT 10-20mg, 3-4 times a day.CHILD 6-12 years old: 10mg 3 timesa day.

760. Hyoscine N-Butylbromide 10

A03BB01320T1001XX

B Gastrointestinal tract andgenito-urinary tract spasm,

ADULT 10-20mg, 3-4 times a day.CHILD 6-12 years old: 10mg 3 times

Page 129 of 296

No. Generic Name MDC Category Indications Dosagemg Tablet dyskinesia of the biliary system a day.

761. Hyoscine N-Butylbromide 20mg/ml Injection

A03BB01320P3001XX

B Gastrointestinal tract andgenito-urinary tract spasm,dyskinesia of the biliary system

20 mg IM/IV repeated after 30 minif needed. Max: 100 mg daily.

762. Ibandronic Acid150 mg Tablet

M05BA06000T1003XX

A* Treatment of postmenopausalosteoporosis to reduce the riskof fracture. Review treatmentafter 2 years and if there ispositive response, treatmentmay be continued up to 5 yearsand then re-evaluate.Treatment should be stopped ifthere is no positive responseafter 5 years. Otherwise,patient needs to be given drugholiday for 1 to 2 years andthen continue treatment shallthe benefit outweigh the risk.

150 mg once monthly

763. Ibuprofen 200 mgTablet

M01AE01000T1001XX

B Pain and inflammation inrheumatic disease

Dosage: ADULT : 200 - 400 mg 3times daily after food, maximum 3.2g daily. CHILD : 30-50 mg/kg bodyweight daily in divided doses,maximum 2.4g daily. Lowesteffective dose for the shortestpossible duration.

764. IchthammolGlycerin 10% EarDrops

S02AA30000D1001XX

C Ear wick for otitis externa withoedema

2 - 3 drops 3 - 4 times daily and inear wick for otitis externa

765. Idarubicin 10 mgInjection

L01DB06110P4002XX

A* i) Acute promyelocyticleukaemia ii) Relapse Acutemyeloid leukemia (with siblingmatch) iii) Acute myeloidleukemia, acute lymphoblasticleukemia (salvage therapy)

i) Induction phase: 12 mg/m2 IVslow bolus on Days 3, 5 and 7.Consolidation phase, month 1: 12mg/m2 IV on Days 1 and 2. Repeatmonthly for 3 courses ii) 12 mg/m2D1-3 iii) 12 mg/m2 D1-3 as part ofFLAG-IDA regimen. Children:10mg/m2 IV daily for 3 days

766. Idarubicin 5 mgInjection

L01DB06110P4001XX

A* i) Acute promyelocyticleukaemia ii) Relapse Acutemyeloid leukemia (with siblingmatch) iii) Acute myeloidleukemia, acute lymphoblasticleukemia (salvage therapy)

i) Induction phase: 12 mg/m2 IVslow bolus on Days 3, 5 and 7.Consolidation phase, month 1: 12mg/m2 IV on Days 1 and 2. Repeatmonthly for 3 courses ii) 12 mg/m2D1-3 iii) 12 mg/m2 D1-3 as part ofFLAG-IDA regimen. Children:10mg/m2 IV daily for 3 days

767. Idursulfase 2mg/ml Injection

A16AB09000P3001XX

A* Hunter syndrome(Mucopolysaccharidosis II, MPSII).

0.5 mg/kg of body weightadministered every week as anintravenous infusion.

Page 130 of 296

No. Generic Name MDC Category Indications Dosage768. Ifosfamide 1 g

InjectionL01AA06000P4001XX

A* i) Solid tumours ii) Leukaemiaiii) Lymphoma

i) 1.2 - 2.4 g/m2/day for 3 - 7 days asa 30 - 120 minutes infusion.Alternatively, can also be given as asingle high dose, eg. 5 g/m2 in a 24hour infusion. Cycles may berepeated every 3 - 4 weeks ii) CHILD:400 - 3000 mg/m2/day for 3 - 5 daysaccording to protocol iii) Refer toprotocols

769. ImatinibMesylate 100 mgTablet

L01XE01196T1001XX

A* i) ADULT and CHILD:Philadelphia positive (Ph+)chronic myeloid leukaemia inchronic phase and in earlyacceleration after failure ofinterferon therapy ii) Treatmentof patients with unresectableand/or metastatic malignantgastrointestinal stromaltumours (GIST) who are positivefor CD117/c-kit

i) ADULT: Chronic phase chronicmyeloid leukemia: 400 mg oncedaily. Accelerated phase or blastcrisis chronic myeloid leukemia: 600mg once daily. CHILD more than 2years, chronic and advanced phasechronic myeloid leukemia: 340mg/m2 daily. Max: 800 mg/day ii)ADULT : 400mg/day

770. ImatinibMesylate 400 mgTablet

L01XE01196T1002XX

A* i) ADULT and CHILD:Philadelphia positive (Ph+)chronic myeloid leukaemia inchronic phase and in earlyacceleration after failure ofinterferon therapy ii) Treatmentof patients with unresectableand/or metastatic malignantgastrointestinal stromaltumours (GIST) who are positivefor CD117/c-kit

i) ADULT: Chronic phase chronicmyeloid leukemia: 400 mg oncedaily. Accelerated phase or blastcrisis chronic myeloid leukemia: 600mg once daily. CHILD more than 2years, chronic and advanced phasechronic myeloid leukemia: 340mg/m2 daily. Max: 800 mg/day ii)ADULT : 400mg/day

771. Imiglucerase 400IU Injection

A16AB02000P4002XX

A* Non-neuronopathic (Type 1) orchronic neuronopathic (Type 3)Gaucher disease and whoexhibit clinically significant non-neurological manifestations ofthe disease. The non-neurological manifestations ofGaucher disease include one ormore of the followingconditions: - anemia, afterexclusion of other causes, suchas iron deficiency -thrombocytopenia - bonedisease, after exclusion of othercauses, such as Vitamin Ddeficiency - hepatomegaly orsplenomegaly

Dosage should be individualized toeach patient. Initial dosages rangefrom 2.5 units/kg of body weight 3times a week to 60 units/kg onceevery 2 weeks. Administered byintravenous infusion over 1-2 hours.

Page 131 of 296

No. Generic Name MDC Category Indications Dosage772. Imipenem 500

mg and Cilastatin500 mg Injection

J01DH51961P4002XX

A* Severe infections caused bysusceptible pathogensespecially useful in infectionsinvolving ESBL organisms. Notto be used for prophylaxis

Based on type or severity ofinfection, susceptibility ofpathogen(s) and patient conditionincluding body weight and renalfunction. ADULT: 1 - 2 g/day in 3 - 4divided doses. Maximum: 4 g/day or50 mg/kg/day. Infusion rate: lessthan 500 mg dose: over 20 - 30minutes, more than 500 mg: doseover 40 - 60 minutes. CHILDREN: ≥40kg body weight should receiveadult doses. CHILDREN ANDINFANTS: <40kg body weight shouldreceive 15mg/kg at six hourintervals. The total daily dose shouldnot exceed 2g.

773. Imipramine HCI25 mg Tablet

N06AA02110T1001XX

B Depression Initially up to 75 mg daily in divideddoses increased gradually to 150 -200 mg (up to 300 mg in hospitalpatients); up to 150 mg may begiven as a single dose at bedtime.ELDERLY initially 10 mg daily;increased gradually to 30 - 50 mgdaily; CHILD is not recommended

774. Imiquimod 5 %w/w Cream

D06BB10000G1001XX

A* Treatment of external genitaland perianal warts orcondyloma acuminata in adults

Apply to affected area at bedtimefor 3 times a week for up to 16weeks; leave on skin for 6-10 hours

775. ImmunoglobulinTetanus Human250 Units/VialInjection

J06BB02000P3001XX

B Passive immunization againsttetanus

Prophylaxis of tetanus: IM 250 units.Treatment of tetanus: IM 30 - 300units/kg

776. IndacaterolMaleate 150 mcgInhalationCapsule

R03AC18253C9901XX

A* Maintenance bronchodilatortreatment of airflowobstruction in adult patientswith chronic obstructivepulmonary disease (COPD).

Once-daily inhalation of the contentof one 150/300 microgram capsule.Maximum dose is 300 microgramonce-daily.

777. IndacaterolMaleate 300 mcgInhalationCapsule

R03AC18253C9902XX

A* Maintenance bronchodilatortreatment of airflowobstruction in adult patientswith chronic obstructivepulmonary disease (COPD).

Once-daily inhalation of the contentof one 150/300 microgram capsule.Maximum dose is 300 microgramonce-daily.

778. Indacaterolmaleate andglycopyrroniumbromide (fixeddosecombination)110/50mcg,inhalationpowder hardcapsules

R03AL04989C1101XX

A* As a once-daily maintenancebronchodilator treatment torelieve symptoms in adultpatients with chronicobstructive pulmonary disease(COPD).

One capsule inhalation daily.

Page 132 of 296

No. Generic Name MDC Category Indications Dosage779. Indomethacin

100 mgSuppository

M02AA23000S2001XX

B Pain and inflammation inrheumatic arthritis

Adult: As supp: 100 mg to beinserted at night and repeated inthe morning if necessary.

780. Indomethacin 25mg Capsule

M01AB01000C1001XX

B Pain and inflammation inrheumatic disease

50 - 200 mg daily in divided doses,with food. Child not recommended.

781. Infliximab 100 mgInjection

L04AB02000P4001XX

A* i) Rheumatoid arthritis(moderate to severe), incombination with methotrexateii) Ankylosing spondylitis inpatients with active diseasedespite treatment withmethotrexate iii) Crohn'sDisease in patients who have aninadequate response toconventional therapies. iv)Fistulizing Crohn's Disease inpatients who have aninadequate response toconventional therapies v)Ulcerative Colitis in patientswho have an inadequateresponse to conventionaltherapies

i) Rheumatoid arthritis: ADULT over18 years old: 3 mg/kg at 0, 2, 6weeks, then every 8 weeks; Mayincrease to 10 mg/kg or increasedosing frequency to 4 weekly forpatients with incomplete response.Discontinue if no response by 12weeks of initial infusion or afterdose adjustment ii) Ankylosingspondylitis: ADULT over 18 years: 5mg/kg IV over 2 hour given at week0, 2, and 6 then every 6-8 weeks.Discontinue if no response by 6weeks of initial infusion. iii), iv) & v)5mg/kg given as an intravenousinfusion over a 2-hour periodfollowed by additional 5 mg/kginfusion doses at 2 and 6 weeksafter the first infusion, then every 8weeks thereafter

782. Influenza Vaccine(Inactivated)Injection

J07BB02963P30XXXX

B i) Prophylaxis of influenza forfrontliners (KKM staff andessential services personnel). ii)Prophylaxis of influenza in highrisk groups, particularlyindividuals who have chroniccardiovascular, pulmonary,metabolic or renal disease, orwho are immunocompromisedand elderly patients. Refer tocurrent recommendation byWHO for selection of product ofinactivated influenza vaccines.

CHILD 6-35 months: Single dose of0.5 ml IM or deep SC; 3-8 years: 1-2doses of 0.5 ml IM ADULT & CHILDmore than 9 years: Single dose of0.5 ml IM

783. Insulin Aspart100 IU/mlInjection

A10AB05000P3001XX

A* Diabetic Type 1 and 2 inpatients that still experiencedhypoglycaemia with use ofhuman insulin

Dose to be individualised. Theaverage daily insulin requirement isbetween 0.5 to 1.0 units/kg bodyweight

784. Insulin Aspart30% andProtaminatedInsulin Aspart70% 100 U/mlInjection

A10AD05000P3001XX

A/KK Diabetic type 1 and 2 inpatients that still experiencedhypoglycaemia with use ofhuman insulin

Dose to be individualised. Theaverage daily insulin requirement isbetween 0.5 to 1.0 units/kg bodyweight

Page 133 of 296

No. Generic Name MDC Category Indications Dosage785. Insulin Detemir

100 IU/mlInjection inPrefilledsyringe/cartridge

A10AE05000P5001XX

A/KK i)Type 1 Diabetes patients onbasal bolus regimen, whomexperience hypoglycemia withconventional insulin, to be usedin combination with rapid orshort-acting insulin. ii)Type 2Diabetes patients on oral anti-diabetics and basal insulinregimen or basal bolus insulinregimen whom experiencehypoglycemia withconventional basal insulin.

Individualized dose given via SConce or twice daily. Initiate at a doseof 10IU or 0.1-0.2IU/kg. For twicedaily dosing, the evening dose canbe administered either with theevening meal, at bedtime, or 12hours after the morning dose.

786. Insulin Glargine300IU/3mlPrefilled Pen forInjection

A10AE04000P5001XX

A/KK i) Diabetes mellitus type I inadults and child over 6 years ii)Diabetes mellitus type II inadult

ADULT and CHILD over 6 years:individualised dose given by SC,once daily at the same time everyday. Adult patients who are insulinnaÔve may be initiated with 10IUdaily.

787. Insulin Glulisine100u/ml solutionfor injection inpre-filled pen 3ml

A10AB06000P5001XX

A* Treatment of adults,adolescents and children 6years or older with diabetesmellitus, where treatment withinsulin is required.

Glulisine should be given shortly (0-15 min) before or soon after meals.Apidra should be used in regimensthat include an intermediate or longacting insulin or basal insulinanalogue and can be used with oralhypoglycaemic agents. The dosageof Apidra should be individuallyadjusted.

788. Insulin Lispro 100IU/ml Injection inPrefilledsyringe/cartridge

A10AB04000P5001XX

A* i) As initial therapy in childrenwith Type 1 diabetes ii)Type 1diabetes patients on basal bolusregimen, not controlled orexperience hypoglycaemia withconventional insulin, to be usedin combination with long-actinginsulin iii)Type 2 diabetespatients on basal bolus orpremixed regimen, notcontrolled or experiencehypoglycaemia withconventional insulin, to be usedin combination withintermediate-acting insulin orlong-acting insulin iv)Patientswith diabetes in pregnancy withpoor postprandial control orexperience hypoglycaemia withconventional short-actinginsulin

Dose to be individualized. Theaverage daily insulin requirement isbetween 0.5 to 1.0 units/kg bodyweight, given within 15 minutesbefore meal.

789. Insulin Lispro25% & InsulinLispro Protamine75% 100 U/mlSuspension for

A10AD04000P5001XX

A* Patients with Type 2 diabeteswhom experiencehypoglycemia with the use ofhuman premixed insulin.

Dose to be individualized. Theaverage daily insulin requirement isbetween 0.5 to 1.0 units/kg bodyweight

Page 134 of 296

No. Generic Name MDC Category Indications DosageInjection inPrefilledSyringe/Cartridge

790. Insulin Lispro50% & InsulinLispro Protamine50% 100U/mlSuspension forInjection inPrefilledSyringe/Cartridge

A10AD04000P5002XX

A* Patients with Type 2 diabeteswhom experiencehypoglycemia with the use ofhuman premixed insulin.

Dose to be individualized. Theaverage daily insulin requirement isbetween 0.5 to 1.0 units/kg bodyweight.

791. InsulinRecombinantNeutral HumanShort Acting 100IU/ml Injection in10ml vial

A10AB01000P3001XX

B Diabetes mellitus Dose to be individualised. Theaverage daily insulin requirement isbetween 0.3-1.0 units/kg bodyweight/day. Daily insulinrequirement may be higher inpatients with insulin resistance, andlower in patients with residual,endogenous insulin production.

792. InsulinRecombinantNeutral HumanShort-acting100IU/ml Penfilland Refill

A10AB01000P5001XX

B Diabetes mellitus Dose to be individualised. Theaverage daily insulin requirement isbetween 0.3-1.0 units/kg bodyweight/day. Daily insulinrequirement may be higher inpatients with insulin resistance, andlower in patients with residual,endogenous insulin production.

793. InsulinRecombinantSynthetic HumanIntermediate-Acting 100IU/mlin Vial forInjection

A10AC01000P3001XX

B Diabetes mellitus Dose to be individualised. The dailyinsulin requirement is usuallybetween 0.3 and 1.0IU/kg /day

794. InsulinRecombinantSynthetic HumanPremixed100IU/ml in Vialfor Injection

A10AD01000P3001XX

B Diabetes mellitus Dose to be individualised. Theaverage daily insulin requirement isbetween 0.3-1.0 units/kg bodyweight/day. Daily insulinrequirement may be higher inpatients with insulin resistance, andlower in patients with residual,endogenous insulin production.

795. InsulinRecombinantSynthetic Human,Intermediate-Acting 100 IU/mlPenfill and Refill

A10AC01000P5001XX

B Insulin dependent diabetesmellitus, non insulin dependentdiabetes unresponsive totreatment to diet or oralhypoglycaemics, hyperkalaemiato assure proper utilisation ofglucose and reduce glucosuriain non diabetic patientsreceiving parenteral nutrition

Dose to be individualised. The dailyinsulin requirement is usuallybetween 0.3 and 1.0IU/kg /day

Page 135 of 296

No. Generic Name MDC Category Indications Dosage796. Insulin

RecombinantSynthetic Human,Premixed 100IU/ml Penfill andRefill

A10AD01000P5001XX

B Insulin dependent diabetesmellitus, non insulin dependentdiabetes unresponsive totreatment to diet or oralhypoglycaemics, hyperkalaemiato assure proper utilisation ofglucose and reduce glucosuriain non diabetic patientsreceiving parenteral nutrition

Dose to be individualised. Theaverage daily insulin requirement isbetween 0.5-1.0 units/kg bodyweight

797. Interferon Alfa -2a 3 MIUInjection

L03AB04000P3001XX

A* For the treatment of i) Hairy cellleukaemia ii) Chronicmyelogenous leukaemia iii)AIDS related Kaposi's Sarcomaiv) Chronic hepatitis B v)Chronic hepatitis C vi) Advancedrenal cell carcinoma

i) Initial : 3 MIU SC daily. Ifintolerant, 1.5 MIU daily or 3 MIU 3times a week or 1.5 MIU 3 times aweek. Maintenance : 1.5-3 MIU SC 3times a week ii) Patient > 18 years :3 MIU daily (days 1-3), 6 MIU daily(days 4-6), 9 MIU daily (days 7-84)iii) Patient > 18 years : Initiallyescalating dose to 18-36 MIU SC/IMfor 10-12 weeks. Maintenance: upto 36 MIU 3 times a week iv)2.5-5MIU/m2 SC 3 times a week for 4-6months. CHILD: up to 10 MIU/m2BSA v) Monotherapy : Initial : 3 - 6MIU SC 3 times a week for 6months. Maintenance : 3 MIU 3times a week for an additional 6months. vi) As an adjunct tocytotoxic chemotherapy: Anescalating dose of 3 MIU 3 times aweek for 1 week, then 9 MIU 3times a week for 1 week, then 18MIU 3 times a week thereafter for 3-12 months SC

798. Interferon Alfa-2b 18 MIUInjection

L03AB05000P5001XX

A For the treatment of i) Hairy cellleukaemia ii) Chronicmyelogenous leukaemia iii)AIDS related Kaposi's sarcomaiv) Chronic hepatitis B v)Chronic hepatitis C vi) Advancedrenal cell carcinoma

i) 2 MIU SC or IM 3 times a week ii)Patient more than 18 years: 3 - 9MIU 3 - 5 times a week or dailydepending on response iii) Patientmore than 18 years. Initiallyescalating dose to 18-36 MIU SC/IMfor 10-12 weeks. Maintenance: upto 36 MIU 3 times weekly iv) 2.5-5MIU/m2 SC 3 times weekly for 4-6month. CHILD: up to 10 MIU/m2BSA v) 3 MIU for 12 months vi) As anadjunct to cytotoxic chemotherapy:An escalating dose of 3 million IU 3times/week for 1 week, then 9million IU 3 times/week for 1 week,then 18 million IU 3 times/weekthereafter for 3-12 month SC or IM

Page 136 of 296

No. Generic Name MDC Category Indications Dosage799. Interferon Alfa-

2b 30 MIUMultidoseInjection Pen

L03AB05000P5002XX

A For the treatment of i) Hairy cellleukaemia ii) Chronicmyelogenous leukaemia iii)AIDS related Kaposi's sarcomaiv) Chronic hepatitis B v)Chronic hepatitis C vi) Advancedrenal cell carcinoma

i) 2 MIU SC or IM 3 times a week ii)Patient more than 18 years: 3 - 9MIU 3 - 5 times a week or dailydepending on response iii) Patientmore than 18 years. Initiallyescalating dose to 18-36 MIU SC/IMfor 10-12 weeks. Maintenance: upto 36 MIU 3 times weekly iv) 2.5-5MIU/m2 SC 3 times weekly for 4-6month. CHILD: up to 10 MIU/m2BSA v) 3 MIU for 12 months vi) As anadjunct to cytotoxic chemotherapy:An escalating dose of 3 million IU 3times/week for 1 week, then 9million IU 3 times/week for 1 week,then 18 million IU 3 times/weekthereafter for 3-12 month SC or IM

800. Interferon Alpha -2a 4.5 MIUInjection

L03AB04000P3002XX

A* For the treatment of i) Hairy cellleukaemia ii) Chronicmyelogenous leukaemia iii)AIDS related Kaposi's Sarcomaiv) Chronic hepatitis B v)Chronic hepatitis C vi) Advancedrenal cell carcinoma

i) 2 MIU SC or IM 3 times a week ii)Patient more than 18 years: 3 - 9MIU 3 - 5 times a week or dailydepending on response iii) Patientmore than 18 years. Initiallyescalating dose to 18-36 MIU SC/IMfor 10-12 weeks. Maintenance: upto 36 MIU 3 times weekly iv) 2.5-5MIU/m2 SC 3 times weekly for 4-6month. CHILD: up to 10 MIU/m2BSA v) 3 MIU for 12 months vi) As anadjunct to cytotoxic chemotherapy:An escalating dose of 3 million IU 3times/week for 1 week, then 9million IU 3 times/week for 1 week,then 18 million IU 3 times/weekthereafter for 3-12 month SC or IM

801. Interferon Alpha2b 3 MIUInjection

L03AB05000P3001XX

A* For the treatment of i) Hairy cellleukaemia ii) Chronicmyelogenous leukaemia iii)AIDS related Kaposi's sarcomaiv) Chronic hepatitis B v)Chronic hepatitis C vi) Advancedrenal cell carcinoma

i) 2 MIU/m2 SC or IM 3 times a weekii) 4 - 5 MIU/m2 SC daily. Treatmentmust be discontinued after 8 to 12weeks of treatment if at least apartial haematological remission ora clinically meaningful cytoreductionhas not been achieved iii) Patient >18 years : 30 MIU/m2 SC or IM threetimes a week until diseaseprogression or maximal responsehas been achieved after 16 weeks oftreatment. iv) 5 MIU daily or 10 MIUthree times a week for 16 weeks.CHILD : 3 MIU/m2 three times aweek for the first week of therapyfollowed by dose escalation to 6MIU/m2 (maximum of 10MIU) threetimes a week SC for a total durationof 16 to 24 weeks v) 3 MIU SC or IM

Page 137 of 296

No. Generic Name MDC Category Indications Dosage3 times a week.

802. Interferon beta -1b 250mcg(8MIU) Injection

L03AB08000P4001XX

A* i)Relapsing-remitting multiplesclerosis (RRMS): Reduction offrequency and degree ofseverity of clinical relapses inambulatory patientscharacterized by at least twoattacks of neurologicaldysfunction over the precedingtwo year period, followed bycomplete or incompleterecovery ii)Secondaryprogressive multiple sclerosis(SPMS):Reduction of frequencyand severity of clinical relapsesand for slowing the progressionof disease

0.25 mg (8 MIU) by SC injectionevery other day

803. Interferon Beta-1a 22 mcg

L03AB07000P5001XX

A* Multiple sclerosis of therelapsing remitting type with 2or more relapses within the last2 years

22 mcg 3 times weekly

804. Interferon Beta-1a 44 mcg

L03AB07000P5002XX

A* Multiple sclerosis of therelapsing remitting type with 2or more relapses within the last2 years

44 mcg 3 times weekly

805. IodamideInjection

V08AA03000P3001XX

A For hysterosalpingography According to the procedure androute of administration

806. Iodine andPotassium IodideSolution

H03CA00200L9901XX

B i) Pre-operative treatment ofthyrotoxicosis ii) Thyrotoxicosiscrisis

i) 1 ml daily in divided doses ii) 2 - 3ml daily

807. Iodixanol 320 mgI/ml Injection

V08AB09000P3001XX

A X-ray contrast medium forcardioangiography, cerebralangiography, peripheralarteriography, abdominalangiography, uroloraphy,venography, CT enhancement,lumbar, thoracic and cervicalmyelography

Depending on type of examination

Page 138 of 296

No. Generic Name MDC Category Indications Dosage808. Iohexol Injection V08AB02000

P3001XXA X-ray contrast medium for use

in adults and children forcardioangiography,arteriography, urography,phlebography and CT-enhancement. Lumbar,thoracic, cervical myelographyand computed tomography ofthe basal cisterns, followingsubarachnoid injection.Arthrography, endoscopicretrograde pancreatography(ERCP), herniography,hysterosalpingography,sialography and studies of thegastrointestinal tract

Dose depending on the route andprocedure

809. IopamidolInjection

V08AB04000P3001XX

A i) Neuroradiology :myeloradiculography,cisternography andventriculography ii) Angiograph: cerebral arteriography,thoracic aortography,abdominal aortography,angiocardiography, selectivevisceral arteriography,peripheral arteriography,venography, digital subtractionangiography (DSA), DSA ofcerebral arteries, DSA ofperipheral arteries, DSA ofabdominal arteries iii)Urography : intravenousurography iv) Contrastenhancement in CT Scanning,arthrography, fistulography

For angiography and cardiac cases-dose depending on the route andprocedure. For selected vascularexamination - bottles of 30 ml and100 ml; dose depending on theroute and procedure

810. Iopromide 300mginjection (623 mgof iopromidewith 300 mg ofiodine per mL)

V08AB05000P3001XX

A i) For angiography, urography,aortography and thevisualization of body cavities ii)Contrast enhancement duringcomputerized tomography iii)To check functioning of adialysis shunt

Dose depending on the route andprocedure

811. Iopromide 370mginjection (769 mgof iopromidewith 370 mg ofiodine per mL)

V08AB05000P3002XX

A i) For angiography, urography,aortography and thevisualization of body cavities ii)Contrast enhancement duringcomputerized tomography iii)To check functioning of adialysis shunt

Dose depending on the route andprocedure

Page 139 of 296

No. Generic Name MDC Category Indications Dosage812. Ipratropium

Bromide 0.0125%NebulisingSolution (125mcg/ml)

R03BB01320A3001XX

B Only for treatment of : i)Patients with ischaemic heartdisease who developextrasystole with salbutamol orterbutaline ii) Patients withchronic bronchitis who haveairway obstruction and who donot respond to salbutamol orterbutaline. Reversible airwaysobstruction, particularly inchronic obstructive pulmonarydisease

ADULT : 500 mcg up to 4 times daily.CHILD 5 - 12 years : 125 - 250 mcgup to 4 times daily, 12 years : 250 -500 mcg up to 4 times daily

813. IpratropiumBromide 0.025%InhalationSolution (250mcg/ml)

R03BB01320A3002XX

B Only for treatment of : i)Patients with ischaemic heartdisease who may developextrasystole with salbutamol orterbutaline ii) Patients withchronic bronchitis who haveairway obstruction and who donot respond to salbutamol orterbutaline. Reversible airwaysobstruction, particularly inchronic obstructive pulmonarydisease

ADULT : 500 mcg up to 4 times daily.CHILD 5 - 12 years : 125 - 250 mcgup to 4 times daily, 12 years : 250 -500 mcg up to 4 times daily

814. IpratropiumBromide 0.5 mgand Salbutamol2.5 mg per UDV

R03AK04320A3001XX

B Management of reversiblebronchospasm associated withobstructive airway diseases

Acute attacks : 1 unit dose vial. Insevere cases not relieved by 1 unitdose vial, 2 unit dose vials mayrequire, patient should consult adoctor immediately. Maintenance :1 unit dose vial 3 - 4 times daily

815. IpratropiumBromide 20 mcgand Fenoterol 50mcg/dose Inhaler

R03AK03986A2101XX

B Management of symptoms inchronic obstructive airwaydisorders with reversiblebronchospasm such asbronchial asthma and chronicbronchitis with or withoutemphysema

ADULT & CHILD more than 6 years;Acute asthma 2 puffs. Severe cases:if breathing has not noticeablyimproved after 5 mins, 2 furtherpuffs may be taken. Intermittentand long-term treatment 1-2 puffsfor each administration, up to max 8puffs/day (average: 1-2 puffs threetimes daily)

816. IpratropiumBromide 20 mcgand Salbutamolbase 100mcg/doseInhalation

R03AK04320A1001XX

B Management of reversiblebronchospasm associated withobstructive airway diseases

ADULT and ELDERLY : 2 inhalations 4times daily. Maximum : 12inhalations daily. CHILD under 12years not recommended

817. IpratropiumBromide 20mcg/doseInhalation

R03BB01320A1001XX

B Only for treatment of : i)Patients with chronic bronchitiswho have airway obstructionand who do not respond toSalbutamol or Terbutaline ii)Patients with ischaemic heartdisease who developextrasystole with Salbutamol or

20 - 40 mcg 3 - 4 times daily. In theearly treatment, up to 80 mcg 3 - 4times daily. CHILD up to 6 years : 20mcg 3 times daily, 6 - 12 years : 20 -40 mcg 3 times daily

Page 140 of 296

No. Generic Name MDC Category Indications DosageTerbutaline

818. Irbesartan 150mg andHydrochlorothiazide 12.5 mgTablet

C09DA04000T1003XX

A/KK Hypertension in patients whocannot tolerate ACE inhibitorsbecause of cough

1 tablet daily

819. Irbesartan 150mg Tablet

C09CA04000T1001XX

A/KK Hypertension, diabeticnephropathy (in patients whocannot tolerate ACE inhibitorsbecause of cough)

150 mg to 300 mg daily

820. Irbesartan 300mg &Hydrochlorothiazide 12.5 mgTablet

C09DA04000T1001XX

A/KK Hypertension in patients whocannot tolerate ACE inhibitorsbecause of cough

1 tablet daily

821. Irbesartan 300mg Tablet

C09CA04000T1002XX

A/KK Hypertension, diabeticnephropathy (in patients whocannot tolerate ACE inhibitorsbecause of cough)

150 mg to 300 mg daily

822. Irinotecan HClTrihydrate 20mg/ml Injection

L01XX19110P3002XX

A* Only for patients withcolorectal cancer who: i) haverelapsed within 6 months afterthe end of adjuvantchemotherapy with 5-fluorouracil-based regime ii)have progressive diseasedespite 5-fluorouracilchemotherapy for advanceddisease iii) good performancestatus (WHO of 2 or less) Thetreatment must be given in atertiary oncology centre or haveclearance in writing by anoncologist

In combination therapy (forpreviously untreated patients): 180mg/m2 once every 2 weeks as an IVinfusion over 90 mins followed byinfusion with folinic acid and 5-fluorouracil. In monotherapy (forpreviously treated patients): 350mg/m2 administered as anintravenous infusion over 90minutes period once every 3 weeks

823. Irinotecan HClTrihydrate 40mg/2 ml Injection

L01XX19110P3001XX

A* Only for patients withcolorectal cancer who: i) haverelapsed within 6 months afterthe end of adjuvantchemotherapy with 5-fluorouracil-based regime ii)have progressive diseasedespite 5-fluorouracilchemotherapy for advanceddisease iii) good performancestatus (WHO of 2 or less) Thetreatment must be given in atertiary oncology centre or haveclearance in writing by anoncologist

In combination therapy (forpreviously untreated patients): 180mg/m2 once every 2 weeks as an IVinfusion over 90 mins followed byinfusion with folinic acid and 5-fluorouracil. In monotherapy (forpreviously treated patients): 350mg/m2 administered as anintravenous infusion over 90minutes period once every 3 weeks

Page 141 of 296

No. Generic Name MDC Category Indications Dosage824. Iron (III)

hydroxidesucrose complex20mg/ml solutionfor injection

B03AC02250P3001XX

B Treatment of iron deficiencyanaemia: a) where there is aclinical need for rapid ironsupply b) in patients whocannot tolerate oral irontherapy or who are non-compliant c) in activeinflammatory bowel diseasewhere oral iron preparationsare ineffective

Individualised dosage. ADULT andELDERLY: Cumulative dose is to beadministered in single doses of 100 -200 mg of iron 2 - 3 times weeklydepending on Hb level. By IV dripinfusion, slow IV injection or directlyinto the venous limb of the dialyser.Total cumulative dose: 1000 mg

825. Iron (III)PolymaltoseComplex 10mgiron/ml syrup

B03AB05000L9001XX

A Treatment of latent irondeficiency and iron deficiencyanaemia (manifest irondeficiency).

Infants (up to 1 year): 2.5-5ml daily(25-50mg iron) Children (1-12 yearsold): 5-10ml daily (50-100mg iron)Children (>12 years), adults: 10-30ml daily (100-300mg iron) Pregnantwoman 20-30ml daily (200-300mgiron)

826. Iron (III)-hydroxidepolymaltosecomplex (IPC)100mg iron and0.35mg folic acidchewable tablet

B03AD04250T2001XX

A/KK Treatment of latent andmanifest iron deficiency andprevention of iron and folic aciddeficiency before, during afterpregnancy (during lactation)

Dosage and duration of therapy aredependent upon the extent of irondeficiency. Manifest iron deficiency:1 chewable tablet two to threetimes daily until a normalization ofthe hemoglobin value is achieved.Afterwards the therapy should becontinued with 1 chewable tabletdaily at least until the end ofpregnancy to replenish the ironstores. Latent iron deficiency andprevention of iron and folic aciddeficiency: 1 chewable tablet daily

827. Iron Dextran 50mg Fe/mlInjection

B03AC06000P3001XX

B Severe iron deficiency anaemia An initial test dose of 0.5 ml shouldbe given over the desired route. Forsevere iron deficiency anaemia, 1-2ml daily given by deep IM. Dosage isindividualized according to total irondeficit

828. Isoflurane Liquid N01AB06000L5001XX

B i) Induction and ii) Maintenanceof anaesthesia

i) Induction- Initiate at aconcentration of 0.5 % ii)Maintenance- 1 - 2.5 % in oxygen ornitrous oxide mixture. 0.5 - 0.75 %with oxygen and nitrous oxide forCaesarian section

829. Isoniazid 100 mgTablet

J04AC01000T1001XX

B i) Tuberculosis ii)Tuberculousmeningitis

i) & ii) ADULT 5-8mg/kg daily (Max300mg) or 15-20mg/kg biweekly(max 1200mg)

830. Isoniazid 400 mgTablet

J04AC01000T1002XX

B i) Tuberculosis ii)Tuberculousmeningitis

i) & ii) ADULT 5-8mg/kg daily (Max300mg) or 15-20mg/kg biweekly(max 1200mg)

Page 142 of 296

No. Generic Name MDC Category Indications Dosage831. Isoprenaline HCl

0.2 mg/mlInjection

C01CA02110P3001XX

B Complete heart block (third-degree artrioventricular block)not responding to atropine,while waiting for cardiac pacing

If given as IM: Initially 0.2 mg (1 mlof 1:5000 solution), followed by0.02-1 mg depending on clinicalresponse. If given as SC: 0.2 mg (1ml of 1:5000 solution), followed by0.15-0.2 mg depending on clinicalresponse. If given as IV : 1-2 mg in500 ml of dextrose 5%, infused at arate of 0.5-2 ml/min while thepatient's EKG is being monitored.The dose should be titrated toproduce the desired clinicalresponse

832. Isoprenaline HCl1 mg/5 mlInjection

C01CA02110P3002XX

B Complete heart block (third-degree artrioventricular block)not responding to atropine,while waiting for cardiac pacing

If given as IM: Initially 0.2 mg (1 mlof 1:5000 solution), followed by0.02-1 mg depending on clinicalresponse. If given as SC: 0.2 mg (1ml of 1:5000 solution), followed by0.15-0.2 mg depending on clinicalresponse. If given as IV : 1-2 mg in500 ml of dextrose 5%, infused at arate of 0.5-2 ml/min while thepatient's EKG is being monitored.The dose should be titrated toproduce the desired clinicalresponse

833. IsosorbideDinitrate 1 mg/mlInjection

C01DA08221P3001XX

A Treatment for angina pectorisand left ventricular failure

2-10 mg/hour IV infusion afterdilution, higher doses up to 20mg/hour may be required

834. IsosorbideDinitrate 10 mgTablet

C01DA08221T1001XX

B Prophylaxis and treatment for:i) Angina ii) Left ventricularfailure

i) 30 - 120 mg daily in divided dosesii) 40 - 160 mg, up to 240 mg ifrequired

835. IsosorbideMononitrate 50mg SR Capsule

C01DA14221C2001XX

A Prophylaxis and treatment ofangina pectoris

50 mg daily

836. Isosorbide-5-Mononitrate 30mg SR Tablet

C01DA14221T5001XX

A Prophylaxis and treatment ofangina pectoris

Initiate at 30 mg for 1st 2-4 days toavoid headache. Usual dose: 60 mgonce daily, may be increased to 120mg once daily

837. Isosorbide-5-Mononitrate 60mg SR Tablet

C01DA14221T5002XX

A Prophylaxis and treatment ofangina pectoris

60mg once daily, increase to 120 mgdaily

838. Isotretinoin 10mg Capsule

D10BA01000C1001XX

A* Only for treatment of i) Severenodulo-cystic acne ii) Acneconglobata iii) Acne fulminansiv) Severe acne vulgaris failingconventional treatment.

0.5-1 mg/kg of body weight per day(in two divided doses) for 15 to 20weeks; the maximum recommendeddose is 2mg/kg of body weight perday. After about 4 weeks, therefore,dosage for the maintenancetreatment should be adjusted withinthe range 0f 0.1-1mg/kg daily tomeet individual need. Treatmentusually lasts a total of 16 weeks.There should be an interval of at

Page 143 of 296

No. Generic Name MDC Category Indications Dosageleast 8 weeks before re-startingtreatment.

839. Isotretinoin 20mg Capsule

D10BA01000C1002XX

A* Only for treatment of i) Severenodulo-cystic acne ii) Acneconglobata iii) Acne fulminansiv) Severe acne vulgaris failingconventional treatmentWARNING: THIS DRUG ISTERATOGENIC

0.5-1 mg/kg of body weight per day(in two divided doses) for 15 to 20weeks; the maximum recommendeddose is 2mg/kg of body weight perday. After about 4 weeks, therefore,dosage for the maintenancetreatment should be adjusted withinthe range 0f 0.1-1mg/kg daily tomeet individual need. Treatmentusually lasts a total of 16 weeks.There should be an interval of atleast 8 weeks before re-startingtreatment.

840. Itopride HCl 50mg Tablet

A03FA00110T1001XX

A* Treatment of gastrointestinalsymptoms of functional, non-ulcer dyspepsia (chronicgastritis) i.e sensation ofbloating, early satiety, upperabdominal pain or discomfort,anorexia, heartburn, nauseaand vomiting

50 mg 3 times daily before meal

841. Itraconazole 10mg/ml OralSolution

J02AC02000L9901XX

A* Treatment of: i) oral and/oroesophageal candidiasis ii)fluconazole resistant and/oroesophageal candidiasis

i) 200 mg daily for 1 week. If noresponse after 1 week, continuetreatment for another week ii) 100 -200 mg twice daily for 2 weeks. If noresponse after 2 weeks, continuetreatment for another 2 weeks. The400 mg daily dose should not beused for more than 14 days if thereare no signs of improvement

842. Itraconazole 100mg Capsule

J02AC02000C1001XX

A/KK i) Dermatomycosis includingpityriasis versicolor ii) Oralcandidiasis iii) Palmar tineamanus and plantar tinea pedisiv) Fingernail onychomycosis v)Toenail onychomycosis vi)Vulvovaginal candidiasis

i) 200 mg once daily for 7 days ii)100 mg daily for 15 days iii) 200 mgtwice daily for 7 days iv) 200mgtwice daily for 1 week per month for2 months v) 200 mg twice daily for 1week per month for 3 months vi)200mg morning and evening for 1 dayor 200 mg once daily for 3 days

Page 144 of 296

No. Generic Name MDC Category Indications Dosage843. Ivabradine 5 mg

TabletC01EB17110T1001XX

A* i) Symptomatic treatment ofchronic stable angina pectorisin patients with normal sinusrhythm, who have acontraindication or intoleranceto beta blockers ii) Treatmentof coronary artery disease.Symptomatic treatment ofchronic stable angina pectorisin coronary artery diseasepatients with normal sinusrhythm. Ivabradine is indicated: - in patients unable to tolerateor with a contraindication tothe use of beta-blockers - or incombination with beta-blockersin patients inadequatelycontrolled with an optimalbeta-blocker dose and whoseheart rate is > 60 bpm.Treatment of chronic heartfailure. Ivabradine is indicatedin chronic heart failure NYHA IIto IV class with sinus rhythmand whose heart rate is≥75bpm, in combination withstandard beta-blocker therapyor when beta- blocker therapyis contraindicated or nottolerated.

Initial dose 5 mg twice daily. Mayincrease dose after 3-4 weeks to 7.5mg twice daily depending onresponse. ELDERLY, initial dose 2.5mg twice daily and titrate to amaximum of 7.5 mg twice daily

844. Ivabradine 7.5mg Tablet

C01EB17110T1002XX

A* i) Symptomatic treatment ofchronic stable angina pectorisin patients with normal sinusrhythm, who have acontraindication or intoleranceto beta blockers ii) Treatmentof coronary artery disease.Symptomatic treatment ofchronic stable angina pectorisin coronary artery diseasepatients with normal sinusrhythm. Ivabradine is indicated: - in patients unable to tolerateor with a contraindication tothe use of beta-blockers - or incombination with beta-blockersin patients inadequatelycontrolled with an optimalbeta-blocker dose and whoseheart rate is > 60 bpm.Treatment of chronic heartfailure. Ivabradine is indicatedin chronic heart failure NYHA II

Initial dose 5 mg twice daily. Mayincrease dose after 3-4 weeks to 7.5mg twice daily depending onresponse. ELDERLY, initial dose 2.5mg twice daily and titrate to amaximum of 7.5 mg twice daily

Page 145 of 296

No. Generic Name MDC Category Indications Dosageto IV class with sinus rhythmand whose heart rate is≥75bpm, in combination withstandard beta-blocker therapyor when beta- blocker therapyis contraindicated or nottolerated.

845. Kanamycin 1 gInjection

J01GB04183P4001XX

A* i) Treatment of gonorrhoea andneonatal meningitis ii)Treatment of TB patients whorequire reserved second linedrugs but have no pre-existingrenal complications

i) ADULT: 1 - 2 g daily IM in 1 - 2equally divided doses. CHILD: 30 - 50mg/kg/day in 1 - 2 divided doses ii)ADULT: 2 g daily IM in 2 equallydivided doses twice a week or 1 gonce daily 3 days a week

846. Ketamine 10mg/ml Injection

N01AX03110P3001XX

B Sole anaesthetic for shortprocedures or induction ofanaesthesia in certain types ofpatients (e.g in shock states)

IV Initially, 1-4.5 mg/kg IV, a dose of2 mg/kg produces anesth for 5-10mins. IM Initially, 6.5-13 mg/kg IM, adose of 10 mg/kg produces anesthfor 12-25 mins.

847. Ketamine 50mg/ml Injection

N01AX03110P3002XX

B Sole anaesthetic for shortprocedures or induction ofanaesthesia in certain types ofpatients (e.g in shock states)

IV Initially, 1-4.5 mg/kg IV, a dose of2 mg/kg produces anesthesia for 5-10 mins. IM Initially, 6.5-13 mg/kgIM, a dose of 10 mg/kg producesanesthesia for 12-25 mins.

848. Ketoconazole 2%Shampoo

D01AC08000L5201XX

A/KK Resistant dandruff only Apply twice weekly for 2 - 4 weeks.Prophylaxis: Once every 1 - 2 weeks

849. Ketoconazole 200mg Tablet

J02AB02000T1001XX

A/KK i) Pityriasis versicolor ii)Systemic mycosis (other skinmycoses) iii) Nail infections

i) 200 mg with meal once daily for10 days ii) 200 - 400 mg daily for 4weeks - 6 months iii) 200 - 400 mgdaily for 6 - 12 months.

850. Ketoprofen 2.5%Gel

M02AA10000G3001XX

A As a short term treatment fortraumatic lesions, sprains,tendinitis, oedema, bruises

Apply onto affected areas 2-4 timesdaily up to 10 days.

851. Ketoprofen 200mg Slow ReleaseCapsule

M01AE03000C2002XX

A/KK Pain and inflammation inrheumatic disease

200mg in the morning or evening.Should be taken with food: Takeimmediately after meals.

852. Ketoprofen 30mg TransdermalPlaster

M02AA10000M7001XX

A Treatment of signs & symptomsof arthritis deformans,periarthritis humero-scapularis,tendinitis, peritendinitis, soremuscle, swelling, pain resultingfrom trauma (eg. contusion,distorsion, sprain).

Apply 1 plaster to the affected areatwice daily

853. Ketoprofen 50mg/ml Injection

M01AE03000P3001XX

A* To be used only in treatment ofacute inflammatory conditions

By deep IM into gluteal muscle, 50-100 mg every 4 hours. Maximum200 mg in 24 hours for up to 3 days.Child not recommended

854. KetorolacTromethamine 30mg/ml Injection

M01AB15239P3001XX

A* Short term management ofmoderate to severepostoperative pain

ADULT : 60mg as a single dose viaIM inj or 30mg as a single IV dose.Alternatively, 30mg every 6 hr viaIM or IV admin up to a max of120mg daily.

Page 146 of 296

No. Generic Name MDC Category Indications Dosage855. Labetalol HCl 100

mg TabletC07AG01110T1001XX

B Hypertension (including inpregnancy)

ADULT: 100 mg daily with food,increased at intervals of 14 days tousual dose of 200 mg twice daily, upto 800 mg twice daily (3 - 4 divideddoses if higher dose). Max: 2.4 gdaily

856. Labetalol HCl 200mg Tablet

C07AG01110T1002XX

B Hypertension (including inpregnancy)

ADULT: 100 mg daily with food,increased at intervals of 14 days tousual dose of 200 mg twice daily, upto 800 mg twice daily (3 - 4 divideddoses if higher dose). Max: 2.4 gdaily

857. Labetalol HCl 5mg/ml Injection

C07AG01110P3001XX

B Hypertension crisis ADULT: 20mg injected slowly for atleast 2 min, followed by 40-80mgdose every 10 min, if necessary upto300 mg. Patient should remainsupine during and 3 hr after theprocedure.

858. Lactobacillusacidophilus 100million viablecells and estriol0.03mg vaginaltablet

G03CC06953T1001XX

A/KK i)Atrophic vaginitis due toestrogen deficiency duringmenopause and post-menopause, or as co-medication to systemichormone replacement therapyii)Restoration of theLactobacillus flora after localand/or systemic treatment withanti-infective agents orchemotherapeutic agents

Atrophic vaginitis : 1 vaginal tabletdaily for 6-12 days followed by amaintenance dose of 1 vaginaltablet for 1-2 days per weekRestoration therapy: 1-2 vaginaltablet daily for 6-12 daysAdministration The vaginal tabletsshould be inserted deeply into thevagina in the evenings beforebedtime. ?In cases of a very dryvagina, vaginal tablet can bemoistened with 1 or 2 drops ofwater before insertion into thevagina. ?During menstruation,treatment should be interruptedand resumed afterwards Should notuse vaginal douches or rinses duringtreatment

859. Lactulose 3.35g/5 ml Liquid

A06AD11000L5001XX

C+ i) Constipation ii) Hepaticencephalopathy

i) ADULT 15 ml twice daily adjustedto patient's need. CHILD 0.5ml/kg/dose once or twice daily ii)30-50 ml 3-4 times daily, doseadjusted to produce 2-3 soft stoolsdaily. CHILD 1 ml/kg/dose 3-4 timesdaily

860. Lamivudine 10mg/ml OralSolution

J05AF05000L9901XX

A* HIV infection in combinationwith other antiretroviral agents

ADULT: 150 mg twice daily or 300mg once daily. INFANT under 1month: 2 mg/kg twice daily. CHILD 3month or over: 4 mg/kg twice daily.Maximum 300 mg daily

861. Lamivudine 100mg Tablet

J05AF05000T1001XX

A* Management of chronichepatitis B infection associatedwith evidence of hepatitis Bviral replication and active liverinflammation

Adult:†100 mg once daily. Forpatients withconcomitant†HIV†infection: 300 mgonce daily or in 2 divideddoses.†Child: >2 yr: 3 mg/kg once

Page 147 of 296

No. Generic Name MDC Category Indications Dosagedaily. Max: 100 mg/day.

862. Lamivudine 150mg Tablet

J05AF05000T1002XX

A/KK HIV infection in combinationwith other antiretroviral agents

ADULT: 150 mg twice daily or 300mg once daily. INFANT under 1month: 2 mg/kg twice daily. CHILD 3month or over: 4 mg/kg twice daily.Maximum 300 mg daily

863. Lamotrigine 100mg Tablet

N03AX09000T1002XX

A i) Adjunctive or monotherapyfor partial seizures andgeneralised tonic-clonicseizures not satisfactorilycontrolled with otherantiepileptic drugs ii)Prevention of mood episodes inadult 18 years and above withbipolar disorder, predominatelyby preventing depressiveepisodes

i) Up to 200 mg daily in single ordivided dosage ii) 25- 200 mg daily

864. Lamotrigine 25mgDispersible/Chewable Tablet

N03AX09000T2001XX

A Add-on therapy in intractablepartial seizures

25 mg daily - 50 mg twice daily

865. Lamotrigine 5 mgDispersible/Chewable Tablet

N03AX09000T2002XX

A Management of seizures inchildren aged 2 - 12 years

a) Add-on therapy in patients nottaking Valproate: week 1 and 2: 2mg/kg/day twice daily, week 3 and4: 5 mg/kg/day twice daily.Maintenance: 5 - 15 mg/kg/daytwice daily b) Add-on therapy inpatients taking Valproate or otheranti-epileptic drugs, week 1 and 2:0.2 mg/kg/day as a single dose(children less than 25 kg may take 5mg on alternate days), week 3 and4: 0.5 mg/kg/day as a single dose.Maintenance dose: 1 -5 mg/kg/dayonce daily or twice daily

866. Lamotrigine 50mg Tablet

N03AX09000T1001XX

A i) Adjunctive or monotherapyfor partial seizures andgeneralised tonic-clonicseizures not satisfactorilycontrolled with otherantiepileptic drugs ii)Prevention of mood episodes inadult 18 years and above withbipolar disorder, predominatelyby preventing depressiveepisodes

i) Up to 200 mg daily in single ordivided dosage ii) 25- 200 mg daily

Page 148 of 296

No. Generic Name MDC Category Indications Dosage867. Lansoprazole 30

mg TabletA02BC03000T1001XX

A* i) Peptic ulcer disease ii) Refluxoesophagitis iii) Zollinger-EllisonSyndrome iv) For eradication ofHelicobacter pylori incombination with antibiotic

i) 30mg daily in the morning for upto 4 weeks (duodenal ulcer) or up to8 weeks (gastric ulcer).Maintenance: 15mg/day.ii) 30mgOD in the morning for up to 8 weeksif not healed. Maintenance: 15mgOD. iii) Initially 60mg OM & adjust asrequired. Daily doses >120mgshould be given in 2 divided doses.iv) 30 mg twice daily in combinationwith any of the 2 antibiotics(clarithromycin 500 mg twice daily ,amoxicillin 1 g twice daily ormetronidazole 400 mg twice daily)for 1-2 weeks

868. LanthanumCarbonate1000mgChewable Tablet

V03AE03130T2004XX

A* Phosphate binding agent forthe treatment ofhyperphosphataemia in dialysispatients with sustainedhypercalcaemia of more thanthree months and secondaryhyperparathyroidism

Initial: 750 to 1500 mg/day individed doses with meals, thentitrate in increments of 750 mg/dayat intervals of 2 to 3 weeks.Maintenance: 1500-3000 mg/day individed doses. Max: 3750 g/day

869. Laronidase 2.9mg/5ml Injection

A16AB05000P3001XX

A* Hurler and Hurler-Scheie formsof Mucopolysaccharidosis I(MPS I) and for patients withthe Scheie form who havemoderate to severe symptoms

0.58 mg/kg of body weightadministered once-weekly as anintravenous infusion

870. L-Asparaginase10,000 IUInjection

L01XX02000P3001XX

A* i) Acute lymphoblastic leukemiaii) Non-hodgkin's lymphoma

i) 5,000 iu/m2 for 10 days duringinduction, 10,000 iu/m2 also usedwith high dose methotrexate rescuein consolidation phase of acutelymphoblastic leukemia ii) CHILD:5,000 - 25,000 iu/m2 per dosedepending on protocol

871. Latanoprost0.005% andtimolol maleate0.5% eye drops

S01ED51990D2004XX

A* For reduction of IntraocularPressure (IOP) in patients withOpen-angle Glaucoma (OAG)and Ocular Hypertension (OH)who are insufficientlyresponsive to topical beta-blocker.

1 drop in the affected eye(s) oncedaily

872. Latanoprost0.005% Eye Drops

S01EE01000D2001XX

A* Reduction of elevatedintraocular pressure in patientswith open-angle glaucoma

The recommended dosage is onedrop (1.5 µg) in the affected eye(s)once daily in the evening. If morethan one topical ophthalmic drug isbeing used, the drugs should beadministered at least five (5)minutes apart

873. Leflunomide 10mg Tablet

L04AA13000T1001XX

A* i) Persistent active rheumatoidarthritis ii) Active psoriaticarthritis

Loading dose: 100 mg once daily for3 days. Maintenance: 10-20 mgonce daily

874. Leflunomide 20mg Tablet

L04AA13000T1002XX

A* i) Persistent active rheumatoidarthritis ii) Active psoriatic

Loading dose: 100 mg once daily for3 days. Maintenance: 10-20 mg

Page 149 of 296

No. Generic Name MDC Category Indications Dosagearthritis once daily.

875. Lenalidomide 10mg Capsule

L04AX04000C1002XX

A* In combination withdexamethesone is indicated forthe treatment of multiplemyeloma patients who havereceived at least one priortherapy

Recommended starting dose: 25 mgonce daily on days 1 to 21 ofrepeated 28 day cycle withdexamethasone 40 mg once daily ondays 1 to 4, 9 to 12 and 17 to 20 ofeach 28 day cycle for the first 4cycles of therapy, thereafterdexamethasone 40 mg once daily onday 1 to 4 every 28 day cycle

876. Lenalidomide 15mg Capsule

L04AX04000C1003XX

A* In combination withdexamethesone is indicated forthe treatment of multiplemyeloma patients who havereceived at least one priortherapy

Recommended starting dose: 25 mgonce daily on days 1 to 21 ofrepeated 28 day cycle withdexamethasone 40 mg once daily ondays 1 to 4, 9 to 12 and 17 to 20 ofeach 28 day cycle for the first 4cycles of therapy, thereafterdexamethasone 40 mg once daily onday 1 to 4 every 28 day cycle

877. Lenalidomide 25mg Capsule

L04AX04000C1004XX

A* In combination withdexamethesone is indicated forthe treatment of multiplemyeloma patients who havereceived at least one priortherapy

Recommended starting dose: 25 mgonce daily on days 1 to 21 ofrepeated 28 day cycle withdexamethasone 40 mg once daily ondays 1 to 4, 9 to 12 and 17 to 20 ofeach 28 day cycle for the first 4cycles of therapy, thereafterdexamethasone 40 mg once daily onday 1 to 4 every 28 day cycle

878. Lenalidomide 5mg Capsule

L04AX04000C1001XX

A* In combination withdexamethesone is indicated forthe treatment of multiplemyeloma patients who havereceived at least one priortherapy

Recommended starting dose: 25 mgonce daily on days 1 to 21 ofrepeated 28 day cycle withdexamethasone 40 mg once daily ondays 1 to 4, 9 to 12 and 17 to 20 ofeach 28 day cycle for the first 4cycles of therapy, thereafterdexamethasone 40 mg once daily onday 1 to 4 every 28 day cycle

879. Letrozole 2.5 mgTablet

L02BG04000T1001XX

A* i) Treatment of hormoneresponsive metastatic or locallyadvance breast cancer afterfailure of tamoxifen ii) Adjunctfor node positivepostmenopausal women withearly breast cancer (positive orunknown oestrogen or positiveprogesterone receptor status /receptor status) who havereceived 5 years of adjuvanttamoxifen therapy

2.5 mg once daily

880. LeucovorinCalcium (CalciumFolinate) 15 mg

V03AF03390T1001XX

A Treatment of folic acidantagonist overdose

15 mg every 6 hours for the next 48- 72 hours

Page 150 of 296

No. Generic Name MDC Category Indications DosageTablet

881. LeucovorinCalcium (CalciumFolinate) 3 mgInjection

V03AF03237P3001XX

A i) Biochemical modulator for 5-Fluorouracil in the treatment ofcolorectal cancer ii) As rescuefor high dose methotrexate iii)Megaloblastic anaemias due todeficiency of folic acid

i) 200mg/m2 by slow IV injectionover a minimum 3 minutes,followed by 5-Fluorouracil or20mg/m2 IV followed by 5-Fluorouracil. In both cases,treatment is repeated daily for 5days; may repeat at 4-weekintervals for 2 courses then 4- to 5-week intervals ii) 15 mg(approximately 10mg/m2) every 6hours for 10 doses, starting 24 hoursafter the beginning of themethotrexate infusion iii) Up to 1mg daily

882. LeucovorinCalcium (CalciumFolinate) 50 mgInjection

V03AF03237P3002XX

A i) Biochemical modulator for 5-Fluorouracil in the treatment ofcolorectal cancer ii) As rescuefor high dose methotrexate iii)Gestational trophoblasticdisease

i) 200mg/m2 by slow IV injectionover a minimum 3 minutes,followed by 5-Fluorouracil or20mg/m2 IV followed by 5-Fluorouracil. In both cases,treatment is repeated daily for 5days; may repeat at 4-weekintervals for 2 courses then 4- to 5-week intervals ii) 15 mg(approximately 10mg/m2) every 6hours for 10 doses, starting 24 hoursafter the beginning of themethotrexate infusion iii) 6 - 12 mgexactly 30 hours after each dose ofmethotrexate. In EMA-CO regimefor high risk gestationaltrophoblastic disease, use 30 mg IM

883. Leuprolide22.5mg injection

L02AE02122P2001XXX

A* Hormonal therapy in advancedprostate cancer.

22.5mg SC every 3 months

884. LeuprolideAcetate 11.25 mgInjection

L02AE02122P5002XX

A* i) Endometriosis ii) Hormonaltherapy in advanced prostatecancer

11.25 mg every 3 months

885. LeuprolideAcetate 3.75 mgInjection

L02AE02122P5001XX

A* i) Endometriosis ii) Hormonaltherapy in advanced prostatecancer

i) 3.75 mg monthly for 3 - 6 monthsii) 3.75 mg IM or SC injectionmonthly

Page 151 of 296

No. Generic Name MDC Category Indications Dosage886. Levetiracetam

100 mg/mlInjection

N03AX14000P3001XX

A* i) Monotherapy therapy in thetreatment of partial onsetseizures with or withoutsecondary generalization inpatients from age 16 years ofage with newly diagnosedepilepsy ii) Adjunctivetreatment in partial onsetseizures with or withoutsecondary generalization inadults and children from 4years of age with epilepsy;juvenile myoclonic epilepsy andidiopathic generalized tonicclonic epilepsy from 12 years ofage. To be initiated whenconventional IV antiepilepticdrugs failed to achieve control,or oral form is temporarily notfeasible in seizure emergencies

i) ADULTS and ADOLESCENT (from16 years): Starting dose: 250 mgtwice daily, Increase dose to 500 mgtwice daily after 2 week. Dose canbe further increased by 250 mgtwice daily every 2 weeks dependingupon the clinical response. Max:1500 mg twice daily. ii) ADULT morethan 18 years and ADOLESCENT (12to 17 years) more than or equal to50 kg: Initially 500 mg twice dailymay be increased up to 1500 mgtwice daily. Dose changes can bemade in 500 mg twice dailyincrements or decrements 2 to 4weekly. CHILD (4 to 11 years) andADOLESCENT (12 to 17 years) lessthan 50 kg : Initially 10 mg/kg twicedaily, may be increased up to 30mg/kg twice daily. Dose changesshould not exceed increments ordecrements of 10 mg/kg twice dailyevery 2 weeks. CHILD more than orequal to 50 kg: Adult dose

887. Levetiracetam100 mg/ml OralSolution

N03AX14000L9901XX

A* As adjunctive therapy in thetreatment of partial onsetseizures with or withoutsecondary generalization inadults and children from 4years of age with epilepsy

CHILD: 4-11 years and adolescent(12-17 years) less than 50 kg:Initially 10 mg/kg twice daily, maybe increased up to 30 mg/kg twicedaily. Dose changes should notexceed increments or decrements of10 mg/kg two times daily twiceweekly

888. Levetiracetam250 mg Tablet

N03AX14000T1001XX

A* i) Monotherapy therapy in thetreatment of partial onsetseizures with or withoutsecondary generalization inpatients from age 16 years ofage with newly diagnosedepilepsy ii) Adjunctivetreatment in partial onsetseizures with or withoutsecondary generalization inadults and children from 4years of age with epilepsy;juvenile myoclonic epilepsy andidiopathic generalized tonicclonic epilepsy from 12 years ofage

i) Monotherapy ADULTS andADOLESCENT (from 16 years) :Starting dose: 250 mg twice daily,Increase dose to 500 mg twice dailyafter 2 week. Dose can be furtherincreased by 250 mg twice dailyevery 2 week depending upon theclinical response. Max: 1500 mgtwice daily. ii) ADULT more than 18years and ADOLESCENT (12-17years) more than or equal to 50 kg:Initially 500 mg twice daily may beincreased up to 1500 mg twice daily.Dose changes can be made in 500mg twice daily increments ordecrements 2-4 weekly. CHILD (4-11years) and ADOLESCENT (12-17years) less than 50 kg : Initially 10mg/kg twice daily, may be increasedup to 30 mg/kg twice daily. Dosechanges should not exceed

Page 152 of 296

No. Generic Name MDC Category Indications Dosageincrements or decrements of 10mg/kg twice daily every 2 weeks.CHILD more than or equal to 50 kg:Adult dose

889. Levetiracetam500 mg Tablet

N03AX14000T1002XX

A* i) Monotherapy therapy in thetreatment of partial onsetseizures with or withoutsecondary generalization inpatients from age 16 years ofage with newly diagnosedepilepsy ii) Adjunctivetreatment in partial onsetseizures with or withoutsecondary generalization inadults and children from 4years of age with epilepsy;juvenile myoclonic epilepsy andidiopathic generalized tonicclonic epilepsy from 12 years ofage

i) Monotherapy ADULTS andADOLESCENT (from 16 years) :Starting dose: 250 mg twice daily,Increase dose to 500 mg twice dailyafter 2 week. Dose can be furtherincreased by 250 mg twice dailyevery 2 week depending upon theclinical response. Max: 1500 mgtwice daily. ii) ADULT more than 18years and ADOLESCENT (12-17years) more than or equal to 50 kg:Initially 500 mg twice daily may beincreased up to 1500 mg twice daily.Dose changes can be made in 500mg twice daily increments ordecrements 2-4 weekly. CHILD (4-11years) and ADOLESCENT (12-17years) less than 50 kg : Initially 10mg/kg twice daily, may be increasedup to 30 mg/kg twice daily. Dosechanges should not exceedincrements or decrements of 10mg/kg twice daily every 2 weeks.CHILD more than or equal to 50 kg:Adult dose

890. Levobupivacaine5mg/ml Injection

N01BB10110P3001XX

A Production of local or regionalanesthesia for surgery andobstetrics, and forpostoperative painmanagement

Surgical anesthesia : Lumberepidural : 10 - 20 ml (50 - 150 mg) ,caesarean section : 15 - 30 ml (75 -150 mg), intrathecal: 3 ml (15 mg),peripheral nerve block : 1 - 40 ml,ilioinguinal/iliohypogastric block.CHILD : 0.25 - 0.5 ml/kg (1.25-2.5mg/kg)

891. LevocetirizineDihydrochloride 5mg Tablet

R06AE09110T1001XX

A* Symptomatic treatment ofallergic rhinitis (includingpersistent allergic rhinitis) andchronic idopathic urticaria

Children above 12 years and adults:5 mg orally once daily (Swallowwhole, do not chew/crush).

892. Levodopa 100 mgand Benserazide25 mg DispersibleTablet

N04BA02977T4001XX

A* Parkinson's Disease Initially 1 cap tds. Max initial dose: 6caps/day. Patients previously onimmediate-releaseLevodopa/Benserazidepreparations: Initially dose shouldsubstitute every 100mg of Levodopawith 1 controlled-released cap,given at same dosage frequency asbefore. Increase every 2-3 days.

Page 153 of 296

No. Generic Name MDC Category Indications Dosage893. Levodopa 100 mg

and Carbidopa 25mg Tablet

N04BA02000T1001XX

B Parkinson's disease Patients not receiving Levodopabefore, initially 100 - 125 mg 3 - 4times daily adjusted according toresponse. Maintenance: 0.75 - 2 g individed doses. In patients previouslytreated with Levodopa the doseshould be about 20 - 25% of thedose previously being taken

894. Levodopa 100mg, Benserazide25 mg HBScapsule

N04BA02977C1001XX

B Parkinson's Disease Initial: 100/25 mg 1-2 times/day,increase every 3-4 days untiltherapeutic effect, optimal dosage:400/100 mg to 800/200 mg/daydivided into 4-6 doses. Dose: 200/50mg used only when maintenancetherapy is reached and not toexceed levodopa 1000-1200mg/benserazide 250-300 mg per day

895. Levodopa 100mg, Carbidopa 25mg andEntacapone 200mg Tablet

N04BA03977T1002XX

A* Idiopathic Parkinson's disease The optimum daily dosage must bedetermined by careful titration oflevodopa in each patient. The dailydose should preferably be optimisedusing 1 of the 4 available tabletstrengths (50/12.5/200mg,100/25/200mg, 150/37.5/200mg or200/50/200mglevodopa/carbidopa/entacapone).Patients should be instructed totake only 1 tablet/doseadministration. While theexperience with total daily dosage>200 mg carbidopa is limited, themaximum recommended daily doseof entacapone is 2000 mg andtherefore the maximum dose, forthe strengths of 50/12.5/200 mg,100/25/200 mg and 150/37.5/200mg, is 10 tablets/day. Ten (10)tablets of the strength 150/37.5/200mg equals carbidopa 375 mg/day.Therefore, using a maximumrecommended daily dose ofcarbidopa 375 mg, the maximumdaily dose of 200/50/200 mg is 7tablets per day. The maximum totaldaily levodopa dose administeredshould not exceed 1500 mg.

Page 154 of 296

No. Generic Name MDC Category Indications Dosage896. Levodopa 150

mg, Carbidopa37.5 mg andEntacapone 200mg Tablet

N04BA03977T1003XX

A* Idiopathic Parkinson's disease The optimum daily dosage must bedetermined by careful titration oflevodopa in each patient. The dailydose should preferably be optimisedusing 1 of the 4 available tabletstrengths (50/12.5/200mg,100/25/200mg, 150/37.5/200mg or200/50/200mglevodopa/carbidopa/entacapone).Patients should be instructed totake only 1 tablet/doseadministration. While theexperience with total daily dosage>200 mg carbidopa is limited, themaximum recommended daily doseof entacapone is 2000 mg andtherefore the maximum dose, forthe strengths of 50/12.5/200 mg,100/25/200 mg and 150/37.5/200mg, is 10 tablets/day. Ten (10)tablets of the strength 150/37.5/200mg equals carbidopa 375 mg/day.Therefore, using a maximumrecommended daily dose ofcarbidopa 375 mg, the maximumdaily dose of 200/50/200 mg is 7tablets per day. The maximum totaldaily levodopa dose administeredshould not exceed 1500 mg.

897. Levodopa 200mg, Benserazide50 mg Tablet

N04BA02977T1001XX

B Parkinson's Disease Initial: 100/25 mg 1-2 times/day,increase every 3-4 days untiltherapeutic effect, optimal dosage:400/100 mg to 800/200 mg/daydivided into 4-6 doses. Dose: 200/50mg used only when maintenancetherapy is reached and not toexceed levodopa 1000-1200mg/benserazide 250-300 mg per day

Page 155 of 296

No. Generic Name MDC Category Indications Dosage898. Levodopa 200

mg, Carbidopa 50mg & Entacapone200 mg Tablet

N04BA03977T1004XX

A* Idiopathic Parkinson's disease The optimum daily dosage must bedetermined by careful titration oflevodopa in each patient. The dailydose should preferably be optimisedusing 1 of the 4 available tabletstrengths (50/12.5/200mg,100/25/200mg, 150/37.5/200mg or200/50/200mglevodopa/carbidopa/entacapone).Patients should be instructed totake only 1 tablet/doseadministration. While theexperience with total daily dosage>200 mg carbidopa is limited, themaximum recommended daily doseof entacapone is 2000 mg andtherefore the maximum dose, forthe strengths of 50/12.5/200 mg,100/25/200 mg and 150/37.5/200mg, is 10 tablets/day. Ten (10)tablets of the strength 150/37.5/200mg equals carbidopa 375 mg/day.Therefore, using a maximumrecommended daily dose ofcarbidopa 375 mg, the maximumdaily dose of 200/50/200 mg is 7tablets per day. The maximum totaldaily levodopa dose administeredshould not exceed 1500 mg.

899. Levodopa 250 mgand Carbidopa 25mg Tablet

N04BA02000T1002XX

B Parkinson's disease Patients not receiving Levodopabefore, initially 100 - 125 mg 3 - 4times daily adjusted according toresponse. Maintenance: 0.75 - 2 g individed doses. In patients previouslytreated with Levodopa the doseshould be about 20 - 25% of thedose previous being taken

Page 156 of 296

No. Generic Name MDC Category Indications Dosage900. Levodopa 50 mg,

Carbidopa 12.5mg & Entacapone200 mg Tablet

N04BA03977T1001XX

A* Idiopathic Parkinson's disease The optimum daily dosage must bedetermined by careful titration oflevodopa in each patient. The dailydose should preferably be optimisedusing 1 of the 4 available tabletstrengths (50/12.5/200mg,100/25/200mg, 150/37.5/200mg or200/50/200mglevodopa/carbidopa/entacapone).Patients should be instructed totake only 1 tablet/doseadministration. While theexperience with total daily dosage>200 mg carbidopa is limited, themaximum recommended daily doseof entacapone is 2000 mg andtherefore the maximum dose, forthe strengths of 50/12.5/200 mg,100/25/200 mg and 150/37.5/200mg, is 10 tablets/day. Ten (10)tablets of the strength 150/37.5/200mg equals carbidopa 375 mg/day.Therefore, using a maximumrecommended daily dose ofcarbidopa 375 mg, the maximumdaily dose of 200/50/200 mg is 7tablets per day. The maximum totaldaily levodopa dose administeredshould not exceed 1500 mg.

901. Levofloxacin 0.5%ophthalmicsolution

S01AX19000D2001XX

A* For the treatment of bacterialconjunctivitis caused bysusceptible strains of thedesignated microorganisms.

Adult dose: 1 drop a time 3 timesdaily. The dosage may be adjustedaccording to the patient?ssymptoms. Route of administration:ophthalmic use only.

902. Levofloxacin 250mg Tablet

J01MA12000T1001XX

A* Community acquiredpneumonia

500 mg daily for 7 - 14 days

903. Levofloxacin 500mg Injection

J01MA12000P3001XX

A* Community AcquiredPneumonia

500 mg daily for 7 - 14 days

904. Levofloxacin 500mg Tablet

J01MA12000T1002XX

A* Community acquiredpneumonia

500 mg daily for 7 - 14 days

905. Levonorgestrel1.5 mg Tablet

G03AC03000T1001XX

A* Emergency contraceptionwithin 72 hours of unprotectedsexual intercourse for thefemale victim of sexual violenceto prevent unwantedpregnancy

1.5 mg as a single dose as soon aspossible after coitus [preferablywithin 12 hours but no later thanafter 72 hours]

906. Levonorgestrel150 mcg andEthinyloestradiol30 mcg Tablet

G03AA07954T1001XX

C+ Contraception 1 tablet daily for 21 days from firstday of the cycle, followed by 7 tabfree days

Page 157 of 296

No. Generic Name MDC Category Indications Dosage907. Levonorgestrel

52 mgIntrauterineSystem

G02BA03000P1001XX

A* i) Contraception (Initial releaserate of 20 mcg/24 hours). ii)Idiopathic menorrhagia

i) & ii):One unit intrauterine deviceto be inserted into the uterine cavitywithin 7 days of the onset ofmenstruation or immediately afterfirst trimester abortion. Postpartuminsertion should be postponed until6 weeks after delivery.Can beinserted at any time of amenorrheicwoman. One unit IUD is effective for5 years

908. LevothyroxineSodium 100 mcgTablet

H03AA01520T1001XX

B Hypothyroidism Start at low dose and increase at 2-4weeks interval. Adult: Initially, 50-100 mcg/day may increase by 25-50mcg at approximately 3 to 4 weeksintervals until the thyroid deficiencyis corrected. Maintenance: 100-200mcg/day. CHILD; 0 - 3 months: 10 -15 mcg/kg/day; 3 - 6 months: 8 - 10mcg/kg/day; 6 - 12 months: 6 - 8mcg/kg/day; 1 - 5 years: 5 - 6mcg/kg/day; 6 - 12 years: 4 - 5mcg/kg/day; more than 12 years: 2 -3 mcg/kg/day

909. LevothyroxineSodium 25 mcgTablet

H03AA01152T1003XX

B Hypothyroidism Start at low dose and increase at 2-4weeks interval. Usual recommendeddose for i) Treatment of benigneuthyroid goitre: 75-200mcg. ii)Prophylaxis of relapse after surgeryfor euthyroid goitre: 75-200mcg iii)Substitution therapy inhypothyroidism: ADULT Initially, 25-50mcg/day. Maintenance: 100-200mcg/day. CHILDREN Initially12.5-50mcg/day, Maintenance: 100-150mcg/m2 body surface area iv)Concomitant supplementationduring anti-thyroid drug treatmentof hyperthyroidism: 50-100mcg v)Suppression therapy in thyroidcancer: 150-300mcg

910. LevothyroxineSodium 50 mcgTablet

H03AA01520T1002XX

B Hypothyroidism Start at low dose and increase at 2-4weeks interval. Usual recommendeddose for i) Treatment of benigneuthyroid goitre: 75-200mcg. ii)Prophylaxis of relapse after surgeryfor euthyroid goitre: 75-200mcg iii)Substitution therapy inhypothyroidism: ADULT Initially, 25-50mcg/day. Maintenance: 100-200mcg/day. CHILDREN Initially12.5-50mcg/day, Maintenance: 100-150mcg/m2 body surface area iv)Concomitant supplementation

Page 158 of 296

No. Generic Name MDC Category Indications Dosageduring anti-thyroid drug treatmentof hyperthyroidism: 50-100mcg v)Suppression therapy in thyroidcancer: 150-300mcg

911. Lidocaine 25mgand Prilocaine25mg Cream

N01BB52974G1001XX

A Used for painlessvenepunctures, radial arterycannulations beforeextradural/spinal and otherregional blocks in childrenabove 1 year old and adults.Also used in chronic renalfailure patients for insertion ofA-V fistulas and shunts forhaemodialysis.

Apply a thick layer under occlusivedressing at least 1 hour before theprocedure

912. LidocaineMedicatedPlaster 5% w/w

N01BB02110M6001XX

A* Indicated for the symptomaticrelief of neuropathic painassociated with previous herpeszoster infection (post-herpeticneuralgia, PHN). Restrictions: i)For elderly patients withpolymedication status whomcertain treatment wascontraindicated or nottolerated. ii)Prescribed by painspecialist only.

1 patch /day (Adults & elderly.Cover the painful area once daily forup to 12 hr w/in 24-hr period.Subsequent plaster-free interval: Atleast 12 hr. Not more than 3 plastersshould be used at the same time)

913. Lignocaine 10 %w/w Spray

N01BB02110A4001XX

B For surface anaesthesia indental practice, inotorhinolaryngology andparacentesis

Spray to affected part

914. Lignocaine 2 %with Adrenaline(1:80,000)Injection

N01BB52974P3001XX

B For local anaesthesia includinginfiltration, nerve and plexusblocks

By infiltration: 0.5 - 1 ml; not toexceed 7 mg/kg body weight

915. Lignocaine 2%Jelly

N01BB02110G4001XX

B Use for endotracheal tubes andinstruments, painful proceduresin the ear, nose and throat,burns, wounds, abrasions,lacerations; catheterisation ofthe male and female urethraand for symptomatic treatmentof cystitis and urethritis

Apply to affected area 10 minsbefore catheterization, etc

916. Lignocaine 2%Viscous Solution

N01BB02110L5001XX

A For post-tonsilectomy, sorethroat, dumping syndrome,hiccough, reflux vomiting,painful lesions of the mouth,cardiospasm, instrumentationof the respiratory and digestivetract

As 2% soln: For pain: 300 mg rinsedand ejected for mouth and†throatpain; or gargled and swallowed ifnecessary for pharyngeal pain. Notto be used more frequently thanevery 3 hr. Max (topical oral soln):2.4 g/day.

Page 159 of 296

No. Generic Name MDC Category Indications Dosage917. Lignocaine 2%

withChlorhexidine0.05% Gel

N01BB52974G3001XX

B To provide local anaesthesiaand lubrication duringcatheterization, exploration bysound and other endourethraloperations and examinations,cytoscopy and symptomatictreatment of painful cystitis andurethritis

Adult Male†Instil 20 mL slowly intothe urethra until it reaches externalsphincter, proximal to the prostrate.Subsequently, apply compression atthe corona for several mins. Fill thelength of the urethra w/ theremaining gel.†Sounding procedureor cytoscopy†Instill 40 mL (in 3-4portions) into the insertion areathen allow 5-10 mins for anaesth totake effect.†Adult Female†Prior tourological procedure, instill 5-10 mLin small portions to fill the wholeurethra & allow anaesth to takeeffect in 3-5 mins.Childn <12 yr†Upto 6 mg/kg.

918. Lignocaine 4 %Solution

N01BB02110L5002XX

B For anaesthesia of mucousmembranes of theoropharyngeal, tracheal andbronchial areas eg. inlaryngoscopy and bronchoscopy

Bronchoscopy, 2 - 3 ml with suitablespray; biopsy in mouth, 3 - 4 ml withsuitable spray or swab (withadrenaline if necessary); maximum7.5 ml

919. Lignocaine HCl(Lidocaine) 100mg/ml Injection

C01BB01110P3002XX

B Ventricular tachycardia andventricullar fibrillation. To bediluted before use

50-100 mg IV as a bolus, repeatedafter 5 minutes if necessary.Maintenance : 1-4 mg/min by IVinfusion under ECG monitoring

920. Lignocaine HCl(Lidocaine) 2%Injection

N01BB02110P3001XX

B For local or regionalanaesthesia and nerve block.Not for IV use.

Local anesthesia: ADULT Maximum:100 mg; CHILD Maximum: 3 mg/kg

921. Lignocaine HCl(Lidocaine) 20mg/ml Injection

C01BB01110P3001XX

B Ventricular tachycardia andventricular fibrillation. For IVuse. To be diluted before use

50-100 mg IV as a bolus, repeatedafter 5 minutes if necessary.Maintenance : 1-4 mg/min by IVinfusion under ECG monitoring

922. Lignocaine HCl1% Injection

N01BB02110P3002XX

C+ Local or regional anaesthesiafor episiotomy repairs

According to patients weight andnature of procedures, maximum200mg. For most obstetricprocedures, the preparation isdiluted to 0.5%, which gives themaximum effect with the leasttoxicity. [lignocaine 1%, 1 part andnormal saline or sterile distilledwater, 1 part]

923. Lignocaine HCl5% andPhenylephrineHCl 0.5% NasalSpray

N01BB02984A4101XX

A* Preparation of nasal mucosa forsurgery (eg. Cautery to Little?sarea), aid the treatment ofacute nose bleeds and removalof foreign bodies from the nose,topical anaesthesia of thepharynx prior to direct orindirect laryngoscopy, topicalanaesthesia and localvasoconstriction prior toendoscopy of the upper airways

Adults and children over 12 years : 5squirts per nostril. Children: 8 to 12years 3 squirts per nostril, 4 to 8years 2 squirts per nostril, 2 to 4years 1 squirt per nostril. Doses areto be administered once only.

Page 160 of 296

No. Generic Name MDC Category Indications Dosage924. Lignocaine,

AluminiumAcetate, ZincOxide andHydrocortisoneOintment

C05AX03931G5001XX

A/KK Anorectal pain, pruritis,inflammation and irritation

Apply once or twice daily. Not forprolonged use

925. Lignocaine,AluminiumAcetate, ZincOxide andHydrocortisoneSuppository

C05AX03931S2001XX

B Anorectal pain, pruritis,inflammation and irritation

1 suppository to be used once ortwice daily. Not for prolonged use

926. Linagliptin 5 mgtablet

A10BH05000T1001XX

A* FUKKM restriction: As add-ontherapy for patient who failedtherapy and/orcontraindicated/unable totolerate metformin and/orsulphonylurea. - Managementof diabetes in patients withrenal failure wheremetformin/sulphonylurea iscontraindicated/untoleratedand elderly with multiple comorbidities that alwaysexperience hypoglycemia withother antidiabetic. Not to beused in diabetic patient whoseHBA1c is more than 9%.

Adults: 5 mg once daily. Whenlinagliptin is added to metformin,the dose of metformin should bemaintained and linagliptinadministered concomitantly.

927. Linezolid 2 mg/mlInjection

J01XX08000P3001XX

A* MRSA patient with severesepsis requiring intensive careand not clinically responding tovancomycin

ADULT: 600 mg twice daily for 10 -14 days. CHILD: 10 mg/kg 3 timesdaily. PREMATURE NEONATES lessthan 7 days: 10 mg/kg twice daily

928. Linezolid 20mg/mlSuspension

J01XX08000L8001XX

A* MRSA patients with severesepsis requiring intensive careand not clinically responding tovancomycin

CHILD: 10 mg/kg 3 times daily.PREMATURE NEONATES less than 7days: 10 mg/kg twice daily

929. Linezolid 600 mgTablet

J01XX08000T1001XX

A* MRSA patient with severesepsis requiring intensive careand not clinically responding tovancomycin.

ADULT: Above 12 years 600 mgevery 12 hours for 10-14 days.CHILD :10 mg/kg 3 times daily.PREMATURE NEONATES less than 7days: 10 mg/kg twice daily

930. Liquid Paraffin A06AA01000L5001XX

C Constipation ADULT 10-30 ml daily at night butshould not be taken immediatelybefore going to bed. CHILD notrecommended

931. LithiumCarbonate 300mg Tablet

N05AN01121T1001XX

A i) Prophylaxis and treatment ofacute mania and hypomaniaepisodes ii)Prophylaxis of manicdepression in bipolar illness orbipolar depression andrecurrent depression

Dose depends on the preparationused. Doses should be adjusted toproduce a serum-lithiumconcentration of 0.4-1 mmol/l.

Page 161 of 296

No. Generic Name MDC Category Indications Dosage932. Loperamide 2 mg

CapsuleA07DA03110C1001XX

B Adjunct to rehydration in acutediarrhoea in adult also inchronic diarrhoea in adult

Acute diarrhoea: ADULT: 4 mg stat,followed by 2 mg after eachunformed stool (up to 5 days). Usual6- 8 mg daily. Max: 16 mg daily.Chronic diarrhoea: Initially 4-8 mgdaily in divided doses, adjustaccording to response. Max: 16 mgdaily

933. Lopinavir 100 mgand Ritonavir 25mg Tablet

J05AE06964T1002XX

A As second line proteaseinhibitor if intolerant toindinavir/ ritonavir as part ofHAART regimen.

Adult: (Therapy-naive patients)400/100 mg bd or 800/200 mg oncedaily; (Therapy-experiencedpatients): 400/100 mg bd.Concomitant therapy (efavirenz,nevirapine, amprenavir,fosamprenavir or nelfinavir)400/100 mg bd. Children >40 kg orw/ BSA >1.4 m2 as adult dose.

934. Lopinavir 200 mgand Ritonavir 50mg Tablet

J05AE06964T1001XX

A As second line proteaseinhibitor if intolerant toindinavir/ ritonavir as part ofHAART regimen

Adult: (Therapy-naive patients)400/100 mg bd or 800/200 mg oncedaily; (Therapy-experiencedpatients): 400/100 mg bd.Concomitant therapy (efavirenz,nevirapine, amprenavir,fosamprenavir or nelfinavir)400/100 mg bd. Children >40 kg orw/ BSA >1.4 m2 as adult dose.

935. Lopinavir80mg/Ritonavir20mg (per ml)Oral Solution

J05AE06964L9901XX

A Management of patients withasymptomatic and symptomatic(early or advanced) HIVInfection with CD4 cell counts<50 cubic mm

Tab Adult Therapy-naive patients400/100 mg bd or 800/200 mg oncedaily. Therapy-experienced patients400/100 mg bd. Concomitanttherapy (efavirenz, nevirapine,amprenavir, fosamprenavir ornelfinavir) 400/100 mg bd. Can beused w/ no dose adjustment. Childn>40 kg or w/ BSA >1.4 m2 Adultdose. Oral Soln Childn 6 mth-12 yr,15-40 kg 10/2.5 mg/kg bd; 7 to <15kg 12/3 mg/kg bd. Max: 5 mL bd inchildn >40 kg. W/ efavirenz ornevirapine 15-45 kg 11/2.75 mg/kgbd; 7 to <15 kg 13/3.25 mg/kg.

936. Loratadine 1mg/ml Syrup

R06AX13000L9001XX

A Allergic rhinitis, chronicurticaria and other allergicdermatological disorders

ADULT and CHILD over 6 years : 10mg once daily. CHILD 2 - 6 years: 5mg once daily

937. Loratadine 10 mgTablet

R06AX13000T1001XX

B Allergic rhinitis and allergicdermatoses

ADULT and CHILD over 6 years 10mg once daily. CHILD 2 - 6 years: 5mg once daily

938. Loratadine 5 mgandPseudoephedrineSulphate 120 mgTablet

R01BA52988T1001XX

A/KK For treatment of allergic rhinitisand allergic dermatoses

ADULT and CHILD over 12 years 1tablet twice daily

Page 162 of 296

No. Generic Name MDC Category Indications Dosage939. Lorazepam 1 mg

TabletN05BA06000T1001XX

A/KK i) Severe anxiety ii) Insomnia i) 1 - 4 mg increase to 10 mg daily individed doses. ELDERLY (ordelibitated) half adult dose ii) 1 - 2mg at bedtime Not recommended inchildren

940. Losartan 50 mgTablet

C09CA01500T1001XX

B Patients intolerant of ACEinhibitors, only in the treatmentof i) Hypertensive patient withleft ventricular hypertrophy ii)Hypertension in diabetics withproteinuria or nephropathy

Hypertension: Usual starting andmaintenance dose: 50 mg oncedaily. Maximum increasing the doseto 100 mg once daily. Patients withintravascular volume-depletionstarting dose of 25 mg once daily.Renal protection in Type 2 diabeticpatients with proteinuria andhypertension, starting dose: 50 mgonce daily, may be increased to 100mg once daily based on bloodpressure response

941. LosartanPotassium 100mg &Hydrochlorothiazide 25 mg Tablet

C09DA01935T1004XX

A* Hypertension in patients whocannot tolerate ACE inhibitorsbecause of cough, hypertensivepatient with left ventricularhypertrophy

Fixed dose combination is notindicated for initial therapy. i. Usualstarting & maintenance dose: 1 tabof losartan & HCTZ 50/12.5 mg oncedaily. May be increased to 2 tab oflosartan & HCTZ 50/12.5 mg or 1 tabof losartan & HCTZ 100/25mg oncedaily if blood pressure remainuncontrolled after about 3 weeks ofcombination therapy with losartan& HCTZ 50/12.5mg. Max: 1 tab oflosartan & HCTZ 100/25mg oncedaily or 2 tab of Losartan & HCTZ50/12.5 mg once daily. ii. Usualstarting dose: 50 mg losartan oncedaily, may be titrated with acombination of losartan 50mg &HCTZ 12.5 mg, maybe substitutedwith losartan 100mg & HCTZ12.5mg, followed by losartan 100mg & HCTZ 25 mg once daily.

942. LosartanPotassium 100mg andHydrochlorothiazide 12.5 mgTablet

C09DA01935T1003XX

A* Hypertension in patients whocannot tolerate ACE inhibitorsbecause of cough, hypertensivepatient with left ventricularhypertrophy

Fixed dose combination is notindicated for initial therapy. i. Usualstarting & maintenance dose: 1 tabof losartan & HCTZ 50/12.5 mg oncedaily. May be increased to 2 tab oflosartan & HCTZ 50/12.5 mg or 1 tabof losartan & HCTZ 100/25mg oncedaily if blood pressure remainuncontrolled after about 3 weeks ofcombination therapy with losartan& HCTZ 50/12.5mg. Max: 1 tab oflosartan & HCTZ 100/25mg oncedaily or 2 tab of Losartan & HCTZ50/12.5 mg once daily. ii. Usualstarting dose: 50 mg losartan once

Page 163 of 296

No. Generic Name MDC Category Indications Dosagedaily, may be titrated with acombination of losartan 50mg &HCTZ 12.5 mg, maybe substitutedwith losartan 100mg & HCTZ12.5mg, followed by losartan 100mg & HCTZ 25 mg once daily.

943. LosartanPotassium 100mg Tablet

C09CA01500T1002XX

B Patients intolerant of ACEinhibitors, only in the treatmentof: i) Hypertensive patient withleft ventricular hypertrophyii)Hypertension in diabeticswith proteinuria ornephropathy

Usual starting dose: 50 mg oncedaily. May be increased to 100 mgonce daily.

944. LosartanPotassium 50 mgandHydrochlorothiazide 12.5 mgTablet

C09DA01935T1001XX

A/KK Hypertension in patients whocannot tolerate ACE inhibitorsbecause of cough, hypertensivepatient with left ventricularhypertrophy

1 tablet once daily, may increase tomaximum dose losartan 100 mg/hydrochlorothiazide 25 mg oncedaily

945. MagnesiumSulphate 45%Paste

D11AX05183G6001XX

C Inflammatory skin conditionssuch as boils and carbuncles

Apply under dressing

946. MagnesiumSulphate 50%Injection

B05XA05183P3001XX

C i)Treatment and prophylaxis ofacute hypomagnesaemia ii)Prevention and treatment oflife-threatening seizures in thetreatment of toxemias ofpregnancy (pre-eclampsia andeclampsia)

i)Mild hypomagnesemia (ADULT):1gm magnesium sulphate (8mEq)IM every 6 hours for 4 doses. Severehypomagnesemia (ADULT): 0.25g/kg IM over 4 hours. Alternativedose of 5g may be given by slowintravenous infusion over 3 hours ii)Toxemia of pregnancy: An initialintravenous dose of 4gm ofmagnesium sulphate isrecommended. Followed by anintramuscular dose of 4-5gm intoeach buttock. This may be followedby a dose of 4-5gm into alternatebuttocks every 4 hours as needed.Alternatively, the initial dose IV dosemay be followed by an infusion of 1-2gm/hr

947. MagnesiumTrisilicateMixture

A02AA10912L2101XX

C Heartburn, dyspepsia 10-20 ml 3-4 times daily beforemeals

Page 164 of 296

No. Generic Name MDC Category Indications Dosage948. Magnesium

Trisilicate TabletA02AA10912T1001XX

C Heartburn, dyspepsia ADULT 1-2 tablet to be chewed upto 6 times a day before meals. CHILDover 6 years one tablet to be taken3-4 times a day

949. Magnesium,AluminiumHydroxide andSimethiconeSuspension

V07AB00900L8001XX

C As a buffering agent forreconstituting didanosinepowder for oral administrationso as to prevent aciddegradation of didanosinewhich is used for the treatmentof paediatric patients (morethan 6 months old) withsymptomatic HIV infection

DDI should be mixed with water anddiluted with the appropriate dose ofantacids to a final concentration of10 mg per ml

950. Malathion 1 %Shampoo

P03AX03000L5201XX

C+ Lice infestation Wet hair, apply shampoo and workup lather. Leave for 15 minutes andrinse, comb. Repeat if necessaryafter 7 - 9 days

951. Mannitol 10%Injection (10g/100 ml)

B05BC01000P3001XX

A Cerebral oedema 0.25- 2 g/kg IV of a 15% to 25%solution over 30-60 minutes. Safetyand efficacy not established inchildren under 12 years of age

952. Mannitol 20%Injection (20g/100 ml)

B05BC01000P3002XX

A Cerebral oedema 0.25- 2 g/kg IV of a 15% to 25%solution over 30-60 minutes. Safetyand efficacy not established inchildren under 12 years of age

953. Measles andRubella VirusVaccine Live,Attenuated(Freeze-dried) 10doses/vial

J07BD52963P4002XX

C For active immunization againstmeasles and rubella in infants,children, adolescents and youngadults at risk. Immunization ofsusceptible non-pregnantadolescent and adult females isindicated if certain precautionsare observed. The vaccine canbe safely and effectively givensimultaneously with DTP, DT,TT, Td, BCG, Polio Vaccine (OPVand IPV), Haemophilusinfluenza type B, Hepatitis B,Yellow fever vaccine andvitamin A supplementation.

The vaccine should be reconstitutedonly with the diluent supplied(sterile water for injection) using asterile syringe and needle. Withgentle shaking the dried cake iseasily dissolved. After reconstitutionthe vaccines should be usedimmediately. A single dose of 0.5mlshould be administered by deep SCinjection into the anterolateralaspect of upper thigh in infants andupper arm in older children. If thevaccines is not used immediatelythen it should be stored in the darkat 20C and 80C for no longer than 6hours.

954. Measle's VaccineInjection (10doses)

J07BD01000P4001XX

C+ Prophylaxis against measles andto prevent development ofinfection (if given within 72hours of contact)

By SC or IM injection, 0.5 ml as asingle dose at 12 - 15 months of age

955. Measles, Mumpsand Rubella(MMR) VaccineInjection (SingleDose)

J07BD52963P4001XX

C+ For immunisation of childrenagainst measles, mumps andrubella

Subcutaneous or by intramuscularinjection, 0.5 ml

956. Mebeverine HCl135 mg Tablet

A03AA04110T1002XX

B Irritable bowel syndrome 135 mg 3 times daily

Page 165 of 296

No. Generic Name MDC Category Indications Dosage957. Meclozine HCl 25

mg andPyridoxine 50 mgTablet

R06AE55919T1001XX

B Nausea and vomiting ofpregnancy

1 - 2 tablet 2 - 3 times daily in severecases

958. Mecobalamin500 mcg Tablet

M09AX00000T1001XX

B Peripheral neuropathies 1 tablet 3 times daily. The dosageshould be adjusted according to ageof patient and severity of symptoms

959. Medroxyprogesterone Acetate 10mg Tablet

G03DA02122T1002XX

B i) Secondary amenorrhoea ii)Abnormal uterine bleeding dueto hormonal imbalance

i) 5-10 mg daily for 5-10 days startedanytime during cycle ii) 5-10 mgdaily for 5-10 days on day 16-21 ofmenstrual cycle. Optimum secretorytransformation 10 mg daily for 10days from day 16 of the cycle

960. Medroxyprogesterone Acetate 100mg Tablet

L02AB02122T1002XX

A Breast carcinoma, endometrialcarcinoma, renal carcinoma

200-500 mg orally daily

961. Medroxyprogesterone Acetate 5mg Tablet

G03DA02122T1001XX

B i) Secondary amenorrhoea ii)Abnormal uterine bleeding dueto hormonal imbalance

i) 5-10 mg daily for 5-10 days startedanytime during cycle ii) 5-10 mgdaily for 5-10 days on day 16-21 ofmenstrual cycle. Optimum secretorytransformation 10 mg daily for 10days from day 16 of the cycle

962. Medroxyprogesterone Acetate 50mg/ml Injection

G03AC06122P3001XX

B Prevention of pregnancy and toprovide long termcontraception

150mg to be administered onceevery 3 month

963. Medroxyprogesterone Acetate 500mg Tablet

L02AB02122T1001XX

A Breast carcinoma, endometrialcarcinoma, renal carcinoma

200-500 mg orally daily

964. Mefenamic Acid250 mg Capsule

M01AG01000C1001XX

B Mild to moderate pain ADULT: 250 - 500 mg 3 times dailyafter meals. CHILD over 6 months:6.5 - 25 mg/kg daily 3 - 4 times dailyfor not longer than 7 days except injuvenile arthritis

965. Mefenamic Acid250 mg Tablet

M01AG01000T1001XX

B Mild to moderate pain ADULT: 250 - 500 mg 3 times dailyafter meals. CHILD over 6 months:6.5 - 25 mg/kg daily 3 - 4 times dailyfor not longer than 7 days except injuvenile arthritis

966. Mefloquine HCl250 mg Tablet

P01BC02110T1001XX

A* For multi-drug resistant cases ofmalaria only

Treatment of malaria : ADULT andCHILD 25 mg/kg usually given over2-3 days. Prophylaxis of malaria :ADULT 250 mg once a week. CHILDover 5 kg : 5 mg/kg once a week;prophylaxis should start 1-3 weeksbefore departure and continue for 4weeks after last exposure

967. Meloxicam 7.5mg Tablet

M01AC06000T1001XX

A/KK Only for patients notresponding to other NSAIDs inthe treatment of i) painfulosteoarthritis ii) rheumatoidarthritis

i) initially 7.5 mg daily. May beincreased to 15 mg daily ii) initially15 mg daily. May be reduced to 7.5mg daily. Maximum 15 mg daily.Child under 12 years notrecommended

Page 166 of 296

No. Generic Name MDC Category Indications Dosage968. Melphalan 2 mg

TabletL01AA03000T1001XX

A i) Multiple myeloma ii)Neuroblastoma,rhabdomyosarcoma iii)Recurrent neuroblastoma(palliative)

i) 8 - 10 mg/m2 for 4 days every 4weeks ii) 10 - 35 mg/m2 once everymonth For dose regimes, refer toprotocols

969. Melphalan 50 mgInjection

L01AA03000P4001XX

B High dose conditioning therapyfor stem cell transplantation inmultiple myeloma

200 mg/ m2 IV infusions in divideddoses for Day 1 to day 3 followed byIV infusions of autologous stem cells

970. Memantine HCI10 mg Tablet

N06DX01110T1001XX

A* As monotherapy or asadjunctive therapy withcholinesterase inhibitors for thesymptomatic treatment ofpatients with moderate tosevere Alzheimer?s disease.

Adult Initially 5 mg/day on the 1stweek, 5mg twice a day on the 2ndweek, then 15 mg/day (10mg in themorning and 5mg in the evening) onthe 3rd week. From the 4th weekon, continue treatment withmaintenance dose of 20 mg/day(10mg twice a day). Max: 20mg/day.

971. Memantine HCl20 mg Tablet

N06DX01110T1002XX

A* As monotherapy or asadjunctive therapy withcholinesterase inhibitors for thesymptomatic treatment ofpatients with moderate tosevere Alzheimer?s disease.

Adult Initially 5 mg/day on the 1stweek, 5mg twice a day on the 2ndweek, then 15 mg/day (10mg in themorning and 5mg in the evening) onthe 3rd week. From the 4th weekon, continue treatment withmaintenance dose of 20 mg/day(10mg twice a day). Max: 20mg/day.

972. Meningococcal A,C, Y, W 135Vaccine Injection

J07AH04000P4001XX

B Immunisation againstmeningococcal diseases causedby Neisseria meningitis GroupA, Group C, Group Y or GroupW-135

Prophylaxis: 0.5 ml intramuscularinjection.

Page 167 of 296

No. Generic Name MDC Category Indications Dosage973. Menotrophin

(highly purified,multidose) 600 IUinjection

G03GA02-000-P40-01-XXX

A* Anovulation in women whohave been unresponsive totreatment with clomiphenecitrate or stimulation of folliclegrowth as part of an assistedreproductive technology (ART)

Anovulation in women who havebeen unresponsive to treatmentwith clomiphene citrate: Therecommended initial dose is 75-150IU daily, which should bemaintained for at least 7 days. Thesubsequent dosing should beadjusted according to individualpatient response. Adjustments indose should not be made morefrequently than every 7 days. Therecommended dose increment is37.5 IU per adjustment and shouldnot exceed 75 IU. The maximumdaily dose should not be higher than225 IU. If a patient fails to respondadequately after 4 weeks oftreatment, that cycle should beabandoned and the patient shouldrecommence treatment at a higherstarting dose than in the abandonedcycle. When an optimal response isobtained, a single injection of 5,000IU to 10,000 IU of Human ChorionicGonadotrophin (hCG) should begiven 1 day after the lastmenotrophin injection, The patientis recommended to have coitus onthe day of and the day followinghCG administration. Stimulation offollicle growth as part of an assistedreproductive technology (ART): Therecommended initial dose is 150-225IU daily injection for at least thefirst 5 days of treatment. Based onclinical monitoring subsequentdosing should be adjusted accordingto individual patient response andshould not exceed more than 150IUper adjustment. The maximum dailydose should not be higher than 450IU. In most cases, dosing beyond 20days is not recommended.

974. Menotrophin,Highly Purified 75IU Injection(FollicleStimulatingHormone 75 IUand LuteinizingHormone 75 IU)

G03GA02954P4003XX

A* Anovulation in women whohave been unresponsive totreatment with clomiphenecitrate or stimulation of folliclegrowth as part of an assistedreproductive technology (ART)

The recommended initial dose ofMENOPUR is 75-150 IU daily. Thesubsequent dosing should beadjusted according to individualpatient response. Adjustments indose should not be made morefrequently than every 7 days. Therecommended dose increment is37.5 IU per adjustment and shouldnot exceed 75 IU. The maximum

Page 168 of 296

No. Generic Name MDC Category Indications Dosagedaily dose should not be higher than225 IU.

975. Menthol 1.6% inIndustrialMethylated SpiritInhalation

R01AX30000A9901XX

C Decongestion of the upperrespiratory tract

As directed for local use

976. Mepivacaine HCl2% withAdrenaline(1:100,000)Injection

N01BB53974P3001XX

B For local anaesthesia includinginfiltration and nerve blocks

Adult: Single site in the jaw: 36 mg(1.8ml). Entire oral cavity: 180 mg (9ml). Max: 400 mg (20 ml) per singledental procedure

977. Mepivacaine HCl3% Injection

N01BB03110P3001XX

B For dental local anaesthesiaincluding infiltration and nerveblocks on patients in whomadrenalin might becontraindicated

Adult: Single site in the jaw: 54 mg(1.8 ml). Entire oral cavity: 270 mg(9 ml). Max: 400 mg (13.3 ml) persingle dental procedure

978. Mercaptopurine50 mg Tablet

L01BB02000T1001XX

A i) Langerhan's cell histocytosisii) Acute lymphoblasticleukaemia iii) Acutepromyelocytic leukaemia APML(maintenance)

"Leukaemia adults: 2.5mg/kg or 80-00mg/m2 p.o per day, given as asingle dose. To be increased at theend of 4 weeks, If necessary, up to5mg/kg p.o per day. Maintainancedosage are 1.5mg/kg -2.5mg/kg p.oper day Children age 5 and older:Induction: 2.5mg/kg/day p.o oncedaily. Maintanance dose: 1.5mg/kg -2.5mg.kg p.o once daily or 70-100mg/m2 p.o once daily."

979. Meropenem 1 gInjection

J01DH02000P4002XX

A* i. Emperical treatment forpresume infections in patients(adult and children) with febrileneutropenia, used asmonotherapy or in combinationwith anti-virals or antifungalagent ii. Septicaemia iii. Seriousinfections in renal impairedpatients

ADULT: 0.5g - 1g 8 hourly CHILD:(aged 3 months and over): 10-40mg/kg 8 hourly, if body weightover 50kg, adult dosage should beused

980. Meropenem 500mg Injection

J01DH02000P4001XX

A* i. Emperical treatment forpresume infections in patients(adult and children) with febrileneutropenia, used asmonotherapy or in combinationwith anti-virals or antifungalagent ii. Septicaemia iii. Seriousinfections in renal impairedpatients

ADULT: 0.5g - 1g 8 hourly CHILD:(aged 3 months and over): 10-40mg/kg 8 hourly, if body weightover 50kg, adult dosage should beused

Page 169 of 296

No. Generic Name MDC Category Indications Dosage981. Mesalazine 1 g

SuppositoryA07EC02259S2002XX

A Inflammatory bowel disease ofulcerative colitis and Crohn'sdisease.

Ulcerative colitis : 1 g suppositoryinsert rectally once daily at bedtime.The dose may be increased to 500mg 3 times daily if the response isinadequate after 2 weeks oftherapy. To achieve maximumbenefit, it is recommended that thesuppository be retained in therectum for a minimum of 1 to 3hours or longer. The usual course oftherapy, depending upon response,may last from 3 to 6 weeks. CHILDnot recommended

982. Mesalazine1g/100ml enema

A07EC02-259-G20-02-XXX

A Inflammatory bowel disease ofulcerative colitis and Crohn'sdisease.

1 tube of enema at bedtime

983. Mesalazine 250mg Suppository

A07EC02259S2001XX

A Inflammatory bowel disease ofulcerative colitis and Crohn'sdisease.

Ulcerative colitis : 1 g suppositoryinsert rectally once daily at bedtime.The dose may be increased to 500mg 3 times daily if the response isinadequate after 2 weeks oftherapy. To achieve maximumbenefit, it is recommended that thesuppository be retained in therectum for a minimum of 1 to 3hours or longer. The usual course oftherapy, depending upon response,may last from 3 to 6 weeks. CHILDnot recommended

984. Mesalazine250mg MR Tablet

A07EC02259T1001XX

A Inflammatory bowel disease ofulcerative colitis and Crohn'sdisease.

ADULT: 250 - 500 mg 3 - 4 timesdaily for 3 - 6 weeks. CHILD up 2years with Crohn's disease: 20 - 30mg/daily in divided doses

985. Mesalazine500mg MR Tablet

A07EC02259T1002XX

A Inflammatory bowel disease ofulcerative colitis and Crohn'sdisease.

ADULT: 250 - 500 mg 3 - 4 timesdaily for 3 - 6 weeks. CHILD up 2years with Crohn's disease: 20 - 30mg/daily in divided doses

986. Mesalazine 6.67%w/w Enema

A07EC02259G2001XX

A Inflammatory bowel disease ofulcerative colitis and Crohn'sdisease.

60 ml (4g) at bedtime, retainedovernight, approximately 8 hours

987. Mesna 100mg/ml Injection

V03AF01520P3001XX

A For prevention of urotoxiceffects of oxazaphosphorinese.g. ifosfamide andcyclophosphamide

IV injection at a dosage of 20% ofthe correspondingoxazaphosphorine dose at the times0 hour (concurrently with theoxazaphosphorine), 4 hours and 8hours thereafter. CHILD: Dose givenat greater frequency (e.g. 6 times)and a shorter intervals (e.g. 3 hours)

Page 170 of 296

No. Generic Name MDC Category Indications Dosage988. Metformin 500

mg andGlibenclamide2.5 mg Tablet

A10BD02926T1001XX

B As second-line therapy whendiet, exercise and initialtreatment with sulphonylureaor metformin do not result inadequate glycemic control inpatients with type 2 diabetesmellitus

Initial dose:1.25 mg/250 mg ORALLYonce daily; titrate in increments of1.25 mg/250 mg per day every 2weeks,2.5 mg/500 mg to 5 mg/500mg ORALLY twice daily; titrate inincrements of 5 mg/500 mg up toMAX 20 mg/2000 mg once daily

989. Metformin HCl500 mg ExtendedRelease Tablet

A10BA02110T5001XX

A/KK Diabetes mellitus whoexperienced gastrointestinalside effects with normalmetformin

500 mg once daily. Maximum dose2000 mg once daily with eveningmeal

990. Metformin HCl500 mg Tablet

A10BA02110T1001XX

B Diabetes mellitus Initial: 500mg orally twice daily withfood. Maintenance: Titrate in500mg increments weekly, doses upto 2000 mg daily may be dividedinto 2 equal doses.

991. Metformin HCl750 mg ExtendedRelease Tablet

A10BA02110T5003XX

A/KK Diabetes mellitus whoexperienced gastrointestinalside effects with normalmetformin

500 mg once daily. Maximum dose2000 mg once daily with eveningmeal

992. Methadone5mg/ml Syrup

N07BC02110L9001XX

A/KK Detoxification treatment ofnarcotic addiction

Initial 10-20mg per day, increasingby 10-20mg per day until there areno signs of withdrawal orintoxication. Usual dose 40-60mg/day

993. Methotrexate1000mg Injection

L01BA01520P3005XX

A i) Solid tumours ii) Gestationaltrophoblastic disease iii) Acuteleukaemias, lymphomas

i) 50 mg/m2 once every 3 weeks incombination with other drugs (forthis dose, use the 50 mgpreparation) ii) 50 mg IV Day 1, 3, 5,9 every 3 weeks. For high riskgestational trophoblastic disease,use 100 mg/m2 as part of EMA-COregime iii) High dose regimes: 500 -3000 mg/m2 per dose may be used,employing the 500 mg preparations.CHILD: Central nervous systemprophylaxis for acute leukaemia 2gm/m2 over 24 hours with folinicacid rescue, 3 doses for B-celllineage. 4 doses for T-lineage allevery 3 weeks. Relapse acutelymphoblastic leukaemia (ALL): 1gm/m2 over 36 hours with folinicacid rescue every 3 weeks for 9doses, maintenance: 50 mg/m2every 2 weeks. B-cell lymphoma: 3gm/m2 over 3 hours with folinic acidrescue for three doses.Methotrexate level monitoringrecommended when using highdose regimens. THE 500 MGSTRENGTH IS NOT FORINTRATHECAL USE

Page 171 of 296

No. Generic Name MDC Category Indications Dosage994. Methotrexate 2.5

mg TabletL01BA01000T1001XX

A i) Acute lymphoblasticleukaemia and acutepromyelocytic leukemia(maintenance) ii) Extensiveplaque psoriasis, erythrodermicpsoriasis, pustular psoriasis,Reiter's syndrome, connectivetissue disease

i) ADULT: 20 mg/m2 weekly. CHILD:20 - 30 mg/m2 weekly according toprotocol ii) Relapsed acutelymphoblastic leukaemia (ALL): 100mg/m2/day for 5 days 6 weeklyaccording to protocol iii) Dose usedby dermatologist: 5 - 25 mg weekly.Liver biopsy after cumulative doseof 1.5 gram and repeat liver biopsywith additional gram received.Maximum cumulative dose is 4gram. Monitor full blood count(FBC), renal and liver function iv)Rheumatoid arthritis, psoriaticarthropathy: dose used byrheumatologist: 2.5 mg/week orallystarting dose, increasing to 7.5 - 20mg/weekly

995. Methotrexate 50mg Injection

L01BA01520P3001XX

A i) Solid tumours ii) Gestationaltrophoblastic disease iii) Acuteleukaemia/lymphomas iv)Rheumatoid arthritis, psoriaticarthropathy,severe/erythrodermic psoriasis

i) 50 mg/m2 once every 2 - 3 weeksin combination with other drugs ii)50 mg IV Day 1, 3, 5, 9 every 3weeks. For high risk gestationaltrophoblastic disease, use 100mg/m2 as part of EMA-CO regimeiii) High dose regimes: 500 - 3000mg/m2 per dose may be used,employing the 500 mg preparations.CHILD: Central nervous systemprophylaxis for acute leukaemia 2gm/m2 over 24 hours with folinicacid rescue, 3 doses for B-celllineage. 4 doses for T-lineage allevery 3 weeks. Relapse acutelymphoblastic leukaemia (ALL): 1gm/m2 over 36 hours with folinicacid rescue every 3 weeks for 9doses, maintenance: 50 mg/m2every 2 weeks. B-cell lymphoma: 3gm/m2 over 3 hours with folinic acidrescue for three doses.Methotrexate level monitoringrecommended when using highdose regimens. The 500 mg strengthis not for intrathecal (IT) use.Dosage for intrathecal treatmentand prophylaxis in leukaemia: lessthan 1 year: 5 mg, 1 - 2 years: 7.5mg, 2 - 3 years: 10 mg, more than 3years: 12.5 mg. IT preparation mustbe clearly stated/verified. ENSURETHAT PREPARATION IS SUITABLEFOR INTRATHECAL USE iv) Doseused by rheumatologist: 10 - 15 mg

Page 172 of 296

No. Generic Name MDC Category Indications DosageIM injection or oral weekly. Doseused by dermatologist: 10 - 25 mgIM injection weekly

996. Methotrexate500 mg/20 mlInjection

L01BA01520P3002XX

A i) Solid tumours ii) Gestationaltrophoblastic disease iii) Acuteleukaemias, lymphomas

i) 50 mg/m2 once every 3 weeks incombination with other drugs (forthis dose, use the 50 mgpreparation) ii) 50 mg IV Day 1, 3, 5,9 every 3 weeks. For high riskgestational trophoblastic disease,use 100 mg/m2 as part of EMA-COregime iii) High dose regimes: 500 -3000 mg/m2 per dose may be used,employing the 500 mg preparations.CHILD: Central nervous systemprophylaxis for acute leukaemia 2gm/m2 over 24 hours with folinicacid rescue, 3 doses for B-celllineage. 4 doses for T-lineage allevery 3 weeks. Relapse acutelymphoblastic leukaemia (ALL): 1gm/m2 over 36 hours with folinicacid rescue every 3 weeks for 9doses, maintenance: 50 mg/m2every 2 weeks. B-cell lymphoma: 3gm/m2 over 3 hours with folinic acidrescue for three doses.Methotrexate level monitoringrecommended when using highdose regimens. THE 500 MGSTRENGTH IS NOT FORINTRATHECAL USE

Page 173 of 296

No. Generic Name MDC Category Indications Dosage997. Methoxsalen 1%

LotionD05AD02000L6001XX

A Repigmenting agent in vitiligo inconjuction with controlleddoses of UVA or sunlight

Apply 0.1% lotion to area to beexposed to the UVA light ( need todilute the 1% lotion to 0.1% lotion,otherwise the skin will burn)

998. Methoxsalen 10mg Capsule

D05BA02000C1001XX

A Protection before exposure tosunlight, psoriasis and vitiligo

0.2 - 0.6 mg/kg/body weight. Forrepigmentation of larger lesions(greater than 6 cm sq): 20 mg/day 2hours before exposure. Take withfood or milk

999. MethoxyPolyethyleneGlycol-epoetinBeta 100 mcg/0.3ml Injection inPrefilled Syringe

B03XA03000P5001XX

A* Treatment of anaemiaassociated with chronic renalfailure in the followingcircumstances: i) Patients whorequire 2 or moresubcutaneous erythropoietininjections per week and need totravel to obtain the injections.ii) Patients who are on highdoses of subcutaneouserythropoietin injections eg.6000 units or more per timeand require more than 1injection of conventionalerythropoietin per time.iii) Patients who require 2 ormore erythropoietin injectionsper week and wherecompliance is an issue.

Non Erythropoiesis StimulatingAgent (ESA)-treated patients : 0.6mcg/kg, once every two weeks (IVor SC). When the Hb is >11g/dl,administration can be reduced toonce monthly using the dose equalto twice the previous two weeklydose. ESA-treated patients : 120-360mcg once monthly or 60-180 mcgevery two weeks.

1000. MethoxyPolyethyleneGlycol-epoetinBeta 120 mcg/0.3ml Injection inPrefilled Syringe

B03XA03000P5005XX

A* Treatment of anaemiaassociated with chronic renalfailure in the followingcircumstances: i) Patients whorequire 2 or moresubcutaneous erythropoietininjections per week and need totravel to obtain the injections.ii) Patients who are on highdoses of subcutaneouserythropoietin injections eg.6000 units or more per timeand require more than 1injection of conventionalerythropoietin per time.iii) Patients who require 2 ormore erythropoietin injectionsper week and wherecompliance is an issue.

Non Erythropoiesis StimulatingAgent (ESA)-treated patients : 0.6mcg/kg, once every two weeks (IVor SC). When the Hb is >11g/dl,administration can be reduced toonce monthly using the dose equalto twice the previous two weeklydose. ESA-treated patients : 120-360mcg once monthly or 60-180 mcgevery two weeks.

Page 174 of 296

No. Generic Name MDC Category Indications Dosage1001. Methoxy

PolyethyleneGlycol-epoetinBeta 150 mcg/0.3ml Injection inPrefilled Syringe

B03XA03000P5006XX

A* Treatment of anaemiaassociated with chronic renalfailure in the followingcircumstances: i) Patients whorequire 2 or moresubcutaneous erythropoietininjections per week and need totravel to obtain the injections.ii) Patients who are on highdoses of subcutaneouserythropoietin injections eg.6000 units or more per timeand require more than 1injection of conventionalerythropoietin per time.iii) Patients who require 2 ormore erythropoietin injectionsper week and wherecompliance is an issue

Non Erythropoiesis StimulatingAgent (ESA)-treated patients : 0.6mcg/kg, once every two weeks (IVor SC). When the Hb is >11g/dl,administration can be reduced toonce monthly using the dose equalto twice the previous two weeklydose. ESA-treated patients : 120-360mcg once monthly or 60-180 mcgevery two weeks

1002. MethoxyPolyethyleneGlycol-epoetinBeta 200 mcg/0.3ml Injection inPrefilled Syringe

B03XA03000P5007XX

A* Treatment of anaemiaassociated with chronic renalfailure in the followingcircumstances: i) Patients whorequire 2 or moresubcutaneous erythropoietininjections per week and need totravel to obtain the injections.ii) Patients who are on highdoses of subcutaneouserythropoietin injections eg.6000 units or more per timeand require more than 1injection of conventionalerythropoietin per time. iii)Patients who require 2 or moreerythropoietin injections perweek and where compliance isan issue.

Non Erythropoiesis StimulatingAgent (ESA)-treated patients: 0.6mcg/kg, once every two weeks (IVor SC). When the Hb is >11g/dl,administration can be reduced toonce monthly using the dose equalto twice the previous two weeklydose. ESA-treated patients: 120-360mcg once monthly or 60-180 mcgevery two weeks.

1003. MethoxyPolyethyleneGlycol-epoetinBeta 50 mcg/0.3ml Injection inPrefilled Syringe

B03XA03000P5002XX

A* Treatment of anaemiaassociated with chronic renalfailure in the followingcircumstances: i) Patients whorequire 2 or moresubcutaneous erythropoietininjections per week and need totravel to obtain the injections.ii) Patients who are on highdoses of subcutaneouserythropoietin injections eg.6000 units or more per timeand require more than 1injection of conventionalerythropoietin per time. iii)

Non Erythropoiesis StimulatingAgent (ESA)-treated patients : 0.6mcg/kg, once every two weeks (IVor SC). When the Hb is >11g/dl,administration can be reduced toonce monthly using the dose equalto twice the previous two weeklydose. ESA-treated patients : 120-360mcg once monthly or 60-180 mcgevery two weeks

Page 175 of 296

No. Generic Name MDC Category Indications DosagePatients who require 2 or moreerythropoietin injections perweek and where compliance isan issue.

1004. MethoxyPolyethyleneGlycol-epoetinBeta 75 mcg/0.3ml Injection inPrefilled Syringe

B03XA03000P5004XX

A* Treatment of anaemiaassociated with chronic renalfailure in the followingcircumstances: i)Patients whorequire 2 or moresubcutaneous erythropoietininjections per week and need totravel to obtain the injections.ii)Patients who are on highdoses of subcutaneouserythropoietin injections eg.6000 units or more per timeand require more than 1injection of conventionalerythropoietin per time.iii)Patients who require 2 ormore erythropoietin injectionsper week and wherecompliance is an issue

Non Erythropoiesis StimulatingAgent (ESA)-treated patients : 0.6mcg/kg, once every two weeks (IVor SC). When the Hb is >11g/dl,administration can be reduced toonce monthly using the dose equalto twice the previous two weeklydose. ESA-treated patients : 120-360mcg once monthly or 60-180 mcgevery two weeks

1005. Methyl Salicylate25% Ointment

M02AC00260G5001XX

C+ Relief of minor aches and painsof muscles and joints associatedwith simple backache, arthritisand rheumatic conditions.

To be massage well to the affectedarea, 3 - 4 times daily.

1006. Methyldopa 250mg Tablet

C02AB01110T1001XX

B Hypertension Adult: 250 mg 2 - 3 times daily,gradually increased at intervals of 2or more days, maximum; 3 g/day.Elderly: initially 125 mg twice daily,increased gradually, maximum; 2 gdaily. Child: Initially, 10 mg/kg or300 mg/m2 daily in 2-4 divideddoses; increase as necessary. Max:65 mg/kg, 2 g/m2 or 3 g daily,whichever is least.

1007. Methylene Blue1% Injection

V03AB17100P3001XX

B For treatment of idiopathic anddrug-inducedmethaemoglobinemia

Adult and children: 1 to 2 mg/kg (0.1to 0.2 mL/kg of a 1% solution) IVvery slowly over 5 minutes. Thisdosage can be repeated if necessaryafter one hour.

Page 176 of 296

No. Generic Name MDC Category Indications Dosage1008. Methylphenidate

HCl 10 mg TabletN06BA04110T1001XX

A Attention deficit hyperactivitydisorder (ADHD)

CHILD over 6 years, initially 5 mg 1 -2 times daily, increased if necessaryat weekly intervals by 5 - 10 mgdaily to maximum of 60 mg daily individed doses; discontinue if noresponse after 1 month, alsosuspend periodically to assess child'scondition (usually finallydiscontinued during or afterpuberty)

1009. MethylphenidateHCl 18 mgExtended-releaseTablet

N06BA04110T5002XX

A* Attention deficit hyperactivitydisorder (ADHD)

CHILD over 6 years: Individualizedosage, to be taken once daily in themorning. Dose may be adjusted inincrements to a maximum of 54mg/day, at weekly interval. Patientnew to methylphenidate: startingdose 18 mg once daily; adults 18mgor 36mg once daily. Patientcurrently using methylphenidate: 18- 36 mg. Maximum 54 mg/day.Discontinue if no response after 1month

1010. MethylphenidateHCl 20 mg LACapsule

N06BA04110C2003XX

A* Attention deficit hyperactivitydisorder (ADHD)

20 mg once daily to be taken in themorning. Dosage be adjusted inincrements to a maximum of 60mg/day

1011. MethylphenidateHCl 36 mgExtended-releaseTablet

N06BA04110T5003XX

A* Attention deficit hyperactivitydisorder (ADHD)

CHILD over 6 years: Individualizedosage, to be taken once daily in themorning. Dose may be adjusted inincrements to a maximum of 54mg/day, at weekly interval. Patientnew to methylphenidate: startingdose 18 mg once daily; adults 18mgor 36mg once daily. Patientcurrently using methylphenidate: 18- 36 mg. Maximum 54 mg/day.Discontinue if no response after 1month

1012. MethylphenidateHCl 40mg LACapsule

N06BA04110C2002XX

A* Attention deficit hyperactivitydisorder (ADHD)

20 mg once daily to be taken in themorning. Dosage be adjusted inincrements to a maximum of 60mg/day

Page 177 of 296

No. Generic Name MDC Category Indications Dosage1013. Methylprednisolo

ne Acetate 40mginjection

H02AB04134P3001XX

A* i) Intramuscular administration:anti-inflammatory treatment,treatment of hematological andoncological disorders,endocrine disorders ii)Intrasynovial, periarticular,intrabursal or soft tissueadministration: Indicated asadjunctive therapy for shortterm administration in :Synovitis of osteoarthritis,rheumatoid arthritis, acute andsubacute bursitis, acute goutyarthritis, epicondylitis, acutenonspecific tenosynovitis, post-traumatic osteoarthritis iii)Intralesional use in alopeciaareata, discoid lupuserythematosus; keloids,localized hypertrophic,infiltrated inflammatory lesionsof granuloma annulare, lichenplanus, psoriatic plaques, lichensimplex chronicus(neurodermatitis) *Restrictedto patients experiencing sideeffects with triamcinoloneacetonide

i. Intramuscular route a) Asthma:may be used in place of a shortburst of oral steroids in vomiting ornon-adherent patients. Therecommended dose is 80- 120mgintramuscularly as a one-dose b)Adrenogenital syndrome: 40mgevery two weeks c) Rheumatoidarthritis (maintenance): 40-120mgweekly d) Dermatologic lesions(acute severe dermatitis, chroniccontact dermatitis, seborrheicdermatitis): 40-120mg weekly for 1-4 weeks ii. Intraarticular routeRecommended dose is 4 to 80milligrams, depending upon the sizeof the joint. Injections may berepeated at intervals of 1 to 5 ormore weeks in chronic casesiii.Intralesional route 20 to 60milligrams methylprednisoloneacetate injected into the lesion

1014. Methylprednisolone SodiumSuccinate 0.5 gInjection

H02AB04520P4001XX

A Suppression of inflammatoryand allergic disorders, cerebraloedema, immunosuppressiontreatment of haematologicaland oncological disorders,treatment of shock states andendocrine disorders

15 - 30 mg/kg daily. Large dosesmay be repeated 4 - 6 hourly for upto 48 hours

1015. Methylprednisolone SodiumSuccinate 1 gInjection

H02AB04520P4002XX

A Suppression of inflammatoryand allergic disorders, cerebraloedema, immunosuppressiontreatment of haematologicaland oncological disorders,treatment of shock states andendocrine disorders

15 - 30 mg/kg daily. Large dosesmay be repeated 4 - 6 hourly for upto 48 hours

1016. MetoclopramideHCl 1 mg/mlSyrup

A03FA01110L9001XX

B i) Dyspepsia, flatulence, hiatushernia, peptic ulceration, refluxoesophagitis, gastritis,duodenitis, cholelithiasis,nausea, vomiting ii) Promotebowel transit during diagnosticprocedures

i) CHILD over 5 years: 2.5 - 5 ml 3times daily. 3 - 5 years 2 ml 2 - 3times daily. 1 - 3 years: 1 ml 2 - 3times daily. Under 1 year: 1 ml 2times daily ii) Single dose given 10minutes before examination. CHILDover 5 years: 2.5 - 5 ml. Between 3 -5 years: 2 ml. Under 1 year: 1 ml

Page 178 of 296

No. Generic Name MDC Category Indications Dosage1017. Metoclopramide

HCl 10 mg TabletA03FA01110T1001XX

B i) Dyspepsia, flatulence, hiatushernia, peptic ulceration, refluxoesophagitis, gastritis,duodenitis, cholelithiasis,nausea, vomiting ii) Promotebowel transit during diagnosticprocedures

i) ADULT over 20 years: 10 mg 3times daily. ADULT between 12 - 20years: 5 mg 3 times daily. CHILDunder 12 years: 0.12 mg/kg/dose 6 -12 hourly ii) Single dose 5 - 10minutes before examination; ADULTand CHILD over 15 years: 10 - 20 mg;CHILD less than 15 years: 0.12mg/kg/dose 6 - 12 hourly

1018. MetoclopramideHCl 5 mg/mlInjection

A03FA01110P3001XX

B i) Dyspepsia, flatulence, hiatushernia, peptic ulceration, refluxoesophagitis, gastritis,duodenitis, cholelithiasis,nausea, vomiting ii) Promotebowel transit during diagnosticprocedures

i) ADULT over 20 years: 10 mg 3times daily. ADULT between 12 - 20years: 5 mg 3 times daily. CHILDunder 12 years: 0.12 mg/kg/dose 6 -12 hourly ii) Single dose 5 - 10minutes before examination; ADULTand CHILD over 15 years: 10 - 20 mg;CHILD less than 15 years: 0.12mg/kg/dose 6 - 12 hourly

1019. Metolazone 2.5mg Tablet

C03BA08000T1002XX

A* Oedema in congestive cardiacfailure, nephrotic syndrome andimpaired renal function

Adult: 5-10 mg daily, increased ifnecessary to 20 mg daily. Max: 80mg in 24 hr. Elderly: Initially, 2.5mg/day or every other day. Shouldbe taken with food. Take afterbreakfast.

1020. MetoprololTartrate 100 mgTablet

C07AB02123T1002XX

B Hypertension, angina,myocardial infarction,arrhythmias

Hypertension: Initially 100 mg tomaximum 400 mg daily, Angina: 50mg - 100 mg in 2 - 3 times daily.Myocardial infarction: 200 mg dailyin divided doses. Arrythmias: 50 mg- 300 mg in 2 - 3 times daily

1021. MetoprololTartrate 50 mgTablet

C07AB02123T1001XX

B Hypertension, angina,myocardial infarction,arrhythmias

Hypertension: Initially 100 mg tomaximum 400 mg daily, Angina: 50mg - 100 mg in 2 - 3 times daily.Myocardial infarction: 200 mg dailyin divided doses. Arrythmias: 50 mg- 300 mg in 2 - 3 times daily

1022. Metronidazole0.5 g Suppository

P01AB01000S2001XX

B Anaerobic infection Anaerobic infections Adult: As a 1-gsuppository 8 hrly for 3 days, then12 hrly. Substitute oral therapy assoon as possible. May be unsuitablefor initiating therapy in severeinfections. Child: <1 yr: 125 mg; 1-5yr: 250 mg; 5-10 yr: 500 mg. Alldoses to be given 8 hrly for 3 days,then 12 hrly thereafter. May beunsuitable for initiating therapy insevere infections. Prophylaxis ofpostoperative anaerobic bacterialinfections Adult: 1 g 8 hrly starting 2hr before surgery.

Page 179 of 296

No. Generic Name MDC Category Indications Dosage1023. Metronidazole

200 mg TabletP01AB01000T1001XX

B Anaerobic infection Anaerobic bacterial infections Adult:Initially, 800 mg followed by 400 mg8 hly for about 7 days. Otherrecommended doses: 500 mg 8 hrlyor 7.5 mg/kg 6 hrly (max: 4 g in 24hr). Child: 7.5 mg/kg 8 hrly. Elderly:Use lower end of adult doserecommendations. Do not admin asa single dose. Prophylaxis ofpostoperative anaerobic bacterialinfections Adult: 400 mg by mouth 8hrly in the 24 hr prior to surgeryfollowed postoperatively by IV orrectal admin until oral therapy ispossible. Other sources recommendthat oral doses be initiated only 2 hrprior to surgery and that number ofdoses for all admin routes be limitedto a total of 4. Elderly: Dosereduction may be necessary. Tab:Should be taken with food.

1024. Metronidazole200 mg/5 mlSuspension

P01AB01000L8001XX

B Anaerobic infection CHILD: 7.5 mg/kg 3 times daily for 7days

1025. Metronidazole500 mg/100 mlInjection

J01XD01000P9901XX

A Anaerobic infections ADULT: 500 mg IV infusion 8 hourly.CHILD: 7.5 mg/kg body weight every8 hours. Neonates: 15mg/kg LD,followed by 7.5mg/kg every 12hourly. 1 month to 18 years:7.5mg/kg (maximum 500mg) every8 hours.

1026. MicafunginSodium 50mgPowder forSolution forInfusion

J02AX05520P4101XX

A* Treatment of invasivecandidiasis, includingcandidemia in adults whenintolerance or resistance toAmphotericin B or Fluconazole.

Dosage for adults, adolescents ≥ 16years of age and the elderly for thetreatment of invasive candidiasis: -Body weight > 40kg: 100mg/day* -Body weight ≤ 40kg: 2mg/kg/day**If the patient?s response isinadequate, e.g. persistence ofcultures or if clinical condition doesnot improve, the dose may beincreased to 200 mg/day in patientsweighing > 40kg or 4mg/kg/day inpatients weighing ≤ 40kg. Treatmentduration for invasive candidiasis:The treatment duration of candidainfection should be a minimum of 14days. The antifungal treatmentshould continue for at least oneweek after two sequential negativeblood cultures have been obtainedand after resolution of clinical signsand symptoms of infection.

Page 180 of 296

No. Generic Name MDC Category Indications Dosage1027. Miconazole 2%

CreamD01AC02221G1001XX

B i) Fungal infections: Tinea pedis,Tinea corporis, Tinea capitis andother dermatophyte infectionscaused by Trichophyton andEpidermophyton species ii)Antifungal agent that has beenin various candida infectionsincluding vaginal candidiasis

Apply sparingly and rub gently ontoaffected area 1-2 times dailycontinuing for 14 days after lesionshave healed

1028. MiconazoleNitrate 2%Powder

D01AC02221F2001XX

A Skin infections caused bydermatophytes or Candida

Dust powder over infected area 1 - 2times daily

1029. Midazolam 5mg/5 ml Injection

N05CD08110P3001XX

A Pre-operative sedation,induction of generalanaesthesia, premedication andsedation in ICU and sedation forminor procedures

Usual sedative range 2.5 - 7.5 mg(about 70 mcg/kg by IV injectionover 30 seconds). Premedication byIM injection 70 - 100 mcg/kg 30 -60minutes before surgery; ELDERLY: 1- 1.5 mg/kg. Induction: Induction byslow IV infusion 200 - 300 mcg/kg(ELDERLY 100 - 200 mcg/kg. CHILDover 7 years 150 - 200 mcg/kg);Maximum: 0.35mg/kg. Sedation inICU 0.03 - 0.2 mg/kg/hour

1030. Midazolam 5mg/ml Injection

N05CD08110P3002XX

A Pre-operative sedation,induction of generalanaesthesia, premedication andsedation in ICU and sedation forminor procedures

Usual sedative range 2.5 - 7.5 mg(about 70 mcg/kg by IV injectionover 30 seconds). Premedication byIM injection 70 - 100 mcg/kg 30 -60minutes before surgery; ELDERLY: 1- 1.5 mg/kg. Induction: Induction byslow IV infusion 200 - 300 mcg/kg(ELDERLY 100 - 200 mcg/kg. CHILDover 7 years 150 - 200 mcg/kg);Maximum: 0.35mg/kg. Sedation inICU 0.03 - 0.2 mg/kg/hour

1031. Midazolam 7.5mg Tablet

N05CD08253T1001XX

A/KK Pre and post-operative sedation ADULT: Usually 7.5 - 15 mg atbedtime; or for premedication, 30 -60 minutes before the procedure.For ELDERLY, debilitated or impairedliver/kidney function: 7.5 mg

1032. Minocycline 100mg Capsule

J01AA08110C1002XX

A* As second-line treatment forleprosy only

100 mg daily 6 - 18 months

1033. Minocycline 50mg Capsule

J01AA08110C1001XX

A* As second-line treatment forleprosy only

100 mg daily 6 - 18 months

1034. Minoxidil 5 mgTablet

C02DC01000T1001XX

A* Severe hypertension ADULTS and CHILD above 12 yearsold: Initially 5 mg daily in single ordivided doses (elderly 2.5 mg). Mayincrease by 5 - 10 mg daily atintervals of 3 or more days untiloptimum control is achieved.Maximum 50 mg daily

Page 181 of 296

No. Generic Name MDC Category Indications Dosage1035. Mirtazapine 15

mgOrodispersibleTablet

N06AX11000T4001XX

A* Major depression Initially 15 mg daily at bedtimeincreased according to response upto 45 mg daily as a single dose atbedtime or in 2 divided doses. CHILDand ADOLESCENT under 18 yearsnot recommended

1036. Mirtazapine 30mgOrodispersibleTablet

N06AX11000T4002XX

A* Major depression Initially 15 mg daily at bedtimeincreased according to response upto 45 mg daily as a single dose atbedtime or in 2 divided doses. CHILDand ADOLESCENT under 18 yearsnot recommended

1037. Mitomycin C0.002% Eye Drops

S01AX00000D2003XX

A Pterygium, conjunctivaltumour, glaucoma surgery

1 - 2 drops several times a day

1038. Mitomycin C0.02% Eye Drops

S01AX00000D2001XX

A Pterygium, conjunctivaltumour, glaucoma surgery

1 - 2 drops several times a day

1039. Mitomycin C0.04% Eye Drops

S01AX00000D2002XX

A Pterygium, conjunctivaltumour, glaucoma surgery

1 - 2 drops several times a day

1040. Mitomycin-C 10mg Injection

L01DC03000P4001XX

A* i) Gastrointestinal, lung, breast,cervical cancers ii) Bladdertumours iii) Opthalmologicalconditions: conjunctivalsquamous neoplasia, squamouscell carcinoma of conjunctiva,trabeculectomy chroniclymphocytic leukaemia, chronicmyelogenous leukaemia.Gastric, colorectal, lung cancer

i) 10 - 20 mg/m2 body surface area(BSA) given as a single dose througha running IV infusion repeated every6 - 8 weeks. The whole schedulemay be repeated depending on thebone marrow ii) 10 - 40 mg daily orevery other day (intravesical) iii) 0.4mg topically as a single applicationfor opthalmological conditions,duration: 1 to 3 minutes

1041. Mitoxantrone 20mg/10mlInjection

L01DB07110P3001XX

A* Acute leukaemia, elderlypatients with acute myeloidleukaemia (AML),relapsed/resistant acuteleukaemia, non-Hodgkin'slymphoma (NHL)

10 - 12 mg/m2 IV daily for 3 days, incombination with other cytotoxicagents. Refer to protocol. CHILD: 5 -10 mg/m2 daily for 3 - 5 daysaccording to protocol. Treatment ofacute leukaemia, ADULT: 8 - 12mg/m2/day once daily for 4 - 5 days.CHILD more than 2 years: same asadult dose. CHILD 2 years: 0.4mg/kg/day once daily for 3 - 5 days

1042. Mixed Gas-GangreneAntitoxin 25,000units/5 mlInjection

J06AA05000P3001XX

B Mixed gas-gangrene Prophylactic: 25,000 units IM or IV.Therapeutic: Not less than 75,000units IV

1043. Moclobemide150 mg Tablet

N06AG02000T1001XX

A* Treatment of depressivesyndrome

Initially 300 mg daily in divideddoses. Gradually to increase up to600 mg daily in divided dosesdepending on response. Usual range150 - 600 mg daily. Notrecommended in children

Page 182 of 296

No. Generic Name MDC Category Indications Dosage1044. Modified Fluid

Gelatin 4%Injection

B05AA06905P9901XX

B For primary volumereplacement in hypovolaemia,peri-operative stabilization ofthe circulation, haemodilution,extracorporeal circulation(haemodialysis and heart-lungmachine)

ADULT 500 - 1500 ml given as IVinfusion

1045. ModifiedPolypeptides(Polygeline) 3.5%Injection

B05AA10905P9901XX

B For primary volumereplacement in hypovolaemia,peri-operative stabilization ofthe circulation, haemodilution,extracorporeal circulation(haemodialysis and heart-lungmachine)

Administered by intravenousinfusion only. Total dosage and rateof infusion depend upon theamount of blood loss andhemodynamic parameters. Theusual dose is 500 to 1000 milliliters(mL), with total dosage not toexceed 2500 mL daily

1046. MometasoneFuroate 0.1%Cream

D07AC13139G1001XX

A* Steroid responsive dermatosisand vitiligo. Used where apotent steroid is required forshort duration not more than 6weeks

Apply thin layer to the affected skinareas once daily until the lesionheals or for a duration of 3 weekswhichever is sooner.Massage gentlyand thoroughly until the medicationdisappears.

1047. MometasoneFuroate 50 mcgAqueous NasalSpray

R01AD09139A4101XX

A* Allergic rhinitis ADULT and CHILD over 12 years: 100mcg/day (2 sprays) to each nostrilonce daily. Maximum 200 mcg (4sprays) once daily. Reduce to 50mcg (1 spray) once daily whencontrol achieved. CHILD 6 - 12 yearsold: 50 mcg (1 spray) to each nostrilonce daily

1048. MonobasicSodiumPhosphate 48%,Dibasic SodiumPhosphate 18%

A06AG01162L5001XX

A Bowel cleansing prior tocolonoscopy, radiologicalexamination or bowel surgery

45 ml diluted with half a glass (120ml) of water, followed by one fullglass (240 ml) of water to be takendepending on the time of theprocedure. For morning procedure,45 ml dilute with half glass of watershould be taken at 7 am and thesecond 45 ml at 7 pm on the daybefore the procedure. For afternoonprocedure, the first dose should betaken at 7 pm on the day before andthe second dose at 7 am on the dayof the procedure. Solid food mustnot be taken during the preparationperiod; clear fluids or water can betaken liberally. Not recommendedfor use in children

1049. MontelukastSodium 10 mgTablet

R03DC03520T1001XX

A/KK Chronic treatment of asthmaand relief of symptoms ofseasonal allergic rhinitis forchildren more than 15 yearsand adults

CHILD more than 15 years andADULT: 10 mg daily at bedtime

Page 183 of 296

No. Generic Name MDC Category Indications Dosage1050. Montelukast

Sodium 4 mg OralGranules

R03DC03520F1001XX

A* Asthmatics, not controlled onhigh dose inhaledcorticosteroids more than 1600mcg/day and with co-morbidallergic disorders. Chronictreatment of asthma

12 months - 5 years: 1 packet of4mg oral granules daily at bedtime

1051. MontelukastSodium 5 mgTablet

R03DC03520T2001XX

A* Asthmatics, not controlled onhigh dose inhaledcorticosteroids more than 1600mcg/day and with co-morbidallergic disorders. Chronictreatment of asthma

CHILD 6 - 14 years: One 5 mgchewable tablet daily at bedtime

1052. Morphine HCl 10mg/5 ml Solution

N02AA01110L9901XX

B For use in management ofmoderate to severe painespecially that associated withneoplastic disease

5-20 mg or more regularly every 4hours as needed in terminal pain

1053. MorphineSulphate 10 mgControlledRelease Tablet

N02AA01183T5001XX

A Prolonged relief of severe painassociated with neoplasticdisease; assists in procuringsleep where sleeplessness isdue to pain or shock

10 - 60 mg 12 hourly intervals,depend upon the severity of thepain. Children (more than 1 year ofage) with severe cancer pain: 0.2 -0.8mg/kg 12 hourly.

1054. MorphineSulphate 10 mgImmediateRelease Tablet

N02AA01183T6002XX

A* Relief of moderate to severepain (cancer patient)

5-10 mg every four hours. The dosemay be increased according toneeds

1055. MorphineSulphate 10 mgSuppository

N02AA01183S2001XX

A* Relief of severe chronic pain(cancer patient)

15 - 30 mg regularly every 4 hours

1056. MorphineSulphate 10mg/ml Injection

N02AA01183P3001XX

B For moderate to severe painespecially that associated withneoplastic disease

ADULT: 5-20mg SC or IM every 4hours in terminal pain CHILD: Up to1 month: 0.15 mg/kg body weight; 1- 12 months: 0.2 mg/kg bodyweight; 1 - 5 years: 2.5 - 5 mg ; 6 -12 years: 5 - 10 mg

1057. MorphineSulphate 20 mgSuppository

N02AA01183S2002XX

A* Relief of severe chronic pain(cancer patient)

15 - 30 mg regularly every 4 hours

1058. MorphineSulphate 30 mgControlledRelease Tablet

N02AA01183T5002XX

A Prolonged relief of severe painassociated with neoplasticdisease; assists in procuringsleep where sleeplessness isdue to pain or shock

10 - 60 mg 12 hourly intervals,depend upon the severity of thepain

1059. MorphineSulphate 30 mgSuppository

N02AA01183S2003XX

A* Relief of severe chronic pain(cancer patient)

15 - 30 mg regularly every 4 hours

1060. MorphineSulphate 5 mgImmediateRelease Tablet

N02AA01183T6001XX

A* Relief of moderate to severepain (cancer patient)

5-10 mg every four hours. The dosemay be increased according toneeds

1061. MorphineSulphate 60 mgControlledRelease Tablet

N02AA01183T5003XX

A Prolonged relief of severe painassociated with neoplasticdisease; assists in procuringsleep where sleeplessness is

10 - 60 mg 12 hourly intervals,depend upon the severity of thepain. Children (more than 1 year ofage) with severe cancer pain: 0.2 -

Page 184 of 296

No. Generic Name MDC Category Indications Dosagedue to pain or shock 0.8mg/kg 12 hourly.

1062. Moxifloxacin0.5% OphthalmicSolution

S01AX22110D2001XX

A* Treatment of conjunctivitiscaused by susceptible organism

CHILD more than 1 year and ADULT:1 drop to affected eye(s) 3 timesdaily for 7 days

1063. Moxifloxacin 400mg Injection

J01MA14110P3001XX

A* Second line therapy for SevereCommunity AcquiredPneumonia (CAP) patients withco-morbidity or with recentantibiotic therapy, suspectedinfections of resistantpathogens includingStreptococcus pneumoniae,Haemophilus influenzae &Mycoplasma pneumoniae.

IV or Oral: 400 mg once daily. Therecommended total treatmentduration for sequentialadministration (intravenousfollowed by oral therapy) is 7 to 14days

1064. Moxifloxacin400mg Tablet

J01MA14110T1001XX

A* Second line therapy for SevereCommunity AcquiredPneumonia (CAP) patients withco-morbidity or with recentantibiotic therapy, suspectedinfections of resistantpathogens includingStreptococcus pneumoniae,Haemophilus influenzae &Mycoplasma pneumoniae.

IV or Oral: 400 mg once daily. Therecommended total treatmentduration for sequentialadministration (intravenousfollowed by oral therapy) is 7 to 14days

1065. MultivitaminDrops

A11BA00901D5001XX

B For prevention and treatmentof vitamin deficiencies

INFANT less than 1 year: 1 ml daily

1066. MultivitaminInjection

A11BA00901P3001XX

B For prevention and treatmentof vitamin deficiencies

Initially 2 - 4 pairs IV 4 - 8 hourly,reducing to 1 pair IV daily. For lessserious cases, 1 pair IV 1 - 2 timesdaily or based on individualrequirements

1067. MultivitaminSyrup

A11BA00901L9001XX

C+ For prevention and treatmentof vitamin deficiencies

CHILD 5 ml daily or based onmanufacturer

1068. MultivitaminTablet

A11BA00901T1001XX

B For prevention and treatmentof vitamin deficiencies

1 - 2 tablets daily or based onindividual requirements

1069. Mupirocin 2%Cream

D06AX09000G1001XX

A Skin infection byStaphylococcus aureus(including MRSA),Staphylococcus epidermidis andbeta-haemolytic streptococcus

Adults and child over 1 year, applyup to 3 times daily for up to 10 days

1070. Mupirocin 2%Ointment

D06AX09000G5001XX

A For MRSA infections only ADULT and CHILD: Apply up to threetimes daily for up to 10 days

1071. MycophenolateMofetil 250 mgCapsule

L04AA06236C1001XX

A* i) Prophylaxis of acute organrejection in patients receivingallogenic renal, cardiac andhepatic transplant ii) Used withsteroids for induction andmaintenance of severe lupusnephritis resistant or intolerantto cyclophosphamide therapy

i) Renal transplant rejection: ADULT:1 g twice daily. CHILD (3 months andolder): 600 mg/m(2)/dose, twicedaily; maximum daily dose, 2 g/10mL. Cardiac transplant rejection: 1.5g twice daily. Hepatic transplantrejection: 1.5 g twice daily ii)Induction phase: 2 - 3 g/day for up

Page 185 of 296

No. Generic Name MDC Category Indications Dosageto 6 months. Maintenance phase:dose gradually tapers to 1 g/day

1072. MycophenolateMofetil 500 mgtablet

L04AA06236T1002XX

A* i) Prophylaxis of acute organrejection in patients receivingallogenic renal, cardiac andhepatic transplant ii) Used withsteroids for induction andmaintenance of severe lupusnephritis resistant or intolerantto cyclophosphamide therapy

i) Renal transplant rejection: ADULT:1 g twice daily. CHILD (3 months andolder): 600 mg/m(2)/dose, twicedaily; maximum daily dose, 2 g/10mL. Cardiac transplant rejection: 1.5g twice daily. Hepatic transplantrejection: 1.5 g twice daily ii)Induction phase: 2 - 3 g/day for upto 6 months. Maintenance phase:dose gradually tapers to 1 g/day

1073. MycophenolateSodium 180mgTablet

L04AA06520T1001XX

A* Prophylaxis of acute transplantrejection in adult patientsreceiving allogenic renaltransplant in combination withciclosporin and corticosteroids

720 mg twice daily

1074. MycophenolateSodium 360mgTablet

L04AA06520T1002XX

A* Prophylaxis of acute transplantrejection in adult patientsreceiving allogenic renaltransplant in combination withciclosporin and corticosteroids

720 mg twice daily

1075. Nalbuphine HCl10 mg/mlInjection

N02AF02110P3001XX

B Perioperative analgesia, forrelief of moderate to severepain

10 - 20 mg SC, IM or IV every 3 - 6hours

1076. Naloxone HCl0.02 mg/mlInjection

V03AB15110P3001XX

B For the complete/partialreversal of narcotic depressionincluding respiratory depressioninduced by opioids such asnatural and synthetic narcotics.Diagnosis of suspected acuteopioids overdosage

0.005 - 0.01 mg/kg body weightrepeated at intervals of 2 - 3minutes according to the patient'sneeds by IM, IV or SC

1077. Naloxone HCl 0.4mg/ml Injection

V03AB15110P3002XX

B For the complete/partialreversal of narcotic depressionincluding respiratory depressioninduced by opioids such asnatural and synthetic narcotics.Diagnosis of suspected acuteopioids overdosage

Initially 0.4 - 2 mg IV repeated atintervals of 2 - 3 minutes accordingto patient's needs

1078. Naltrexone HCl50 mg Tablet

N07BB04110T1001XX

A Adjunct in relapse preventiontreatment in detoxifiedformerly opioid-dependantpatients

Initial 25 mg may be increased to 50mg. Maintenance: 350 mg weekly;administered as 50 mg daily. Dosinginterval may be lengthened toimprove compliance; 100 mg onalternate days or 150 mg every thirdday

Page 186 of 296

No. Generic Name MDC Category Indications Dosage1079. Nandrolone

Decanoate 25mg/ml Injection

A14AB01135P3001XX

A Anabolic therapy ADULT: 25 - 50 mg every 3 weeks byIM. CHILD over 2 years: 25 - 50 mgevery 3 to 4 weeks

1080. Naproxen 250 mgTablet

M01AE02000T1001XX

A/KK i) Rheumatic arthritis,osteoarthritis and ankylosingspondylitis ii) Acute gout iii)Muscular skeletal disorder,dysmenorrhoea

i) 0.5 - 1 g daily in 2 divided doses ii)750 mg initially then 250 mg 8hourly iii) 500 mg initially then 250mg every 6 - 8 hour as required

1081. Naproxen Sodium275 mg Tablet

M01AE02520T1001XX

A i) Rheumatic arthritis,osteoarthritis and alkylosingspondylitis ii) Acute gout iii)Muscular skeletal disorder anddysmenorrhoea

550 mg- 1100 mg in two divideddoses

1082. Neomycin 0.5%Cream

D06AX04256G1001XX

B Infections of the skin due tosusceptible organisms

Apply sparingly to affected area upto 3 times daily (For short term use,1 - 2 weeks)

1083. Neomycin 0.5% inBetamethasone17-Valerate0.01% Cream

D07CC01947G1001XX

B Treatment of the followingconditions where bacterialinfection is present or likely tooccur: eczemas, prurigonodularis, psoriasis (excludingwidespread plaque psoriasis),neurodermatoses, anal andgenital intertrigo

Apply sparingly to affected area 2 - 3times daily. (May cause sensitisationto neomycin. Use with caution)

1084. Neomycin 0.5% inBetamethasone17-Valerate0.01% Ointment

D07CC01947G5001XX

B Treatment of the followingconditions where bacterialinfection is present or likely tooccur: eczemas, prurigonodularis, psoriasis (excludingwidespread plaque psoriasis),neurodermatoses, anal andgenital intertrigo

Apply sparingly to affected area 2 to3 times daily. (May causesensitisation to Neomycin. Use withcaution)

1085. Neomycin 0.5% inBetamethasone17-Valerate 0.1%Cream

D07CC01947G1002XX

A Treatment of the followingconditions where bacterialinfection is present or likely tooccur: eczemas, prurigonodularis, psoriasis (excludingwidespread plaque psoriasis),neurodermatoses, anal andgenital intertrigo

Apply sparingly to affected area 2 - 3times daily (May cause sensitisationto neomycin. Use with caution)

1086. Neomycin 0.5% inBetamethasone17-Valerate 0.1%Ointment

D07CC01947G5002XX

A Treatment of the followingconditions where bacterialinfection is present or likely tooccur: eczemas, prurigonodularis, psoriasis (excludingwidespread plaque psoriasis),neurodermatoses, anal andgenital intertrigo

Apply sparingly to affected area 2 to3 times daily. (May causesensitisation to neomycin. Use withcaution)

1087. Neomycin 0.5%Ointment

D06AX04256G5001XX

B Infections of the skin due tosusceptible organisms

Apply sparingly to affected area upto 3 times daily (For short term use,1- 2 weeks)

Page 187 of 296

No. Generic Name MDC Category Indications Dosage1088. Neomycin with

Polymyxin BSulphate andGramicidin EyeDrops

S01AA30990D2001XX

A Eye infections that require abroad spectrum antibiotic

1 - 2 drops in the affected eye 2 - 4times daily. In severe infections : 1 -2 drops every 15 - 30 minutes

1089. NeostigmineMethylsulphate2.5 mg/mlInjection

N07AA01183P3002XX

B i) Myasthenia gravis ii) Reversalof non-depolarisingneuromuscular blockade

i) ADULT: 1 - 2.5 mg at suitableintervals by SC, IM or IV. Usual totaldaily dose 5 - 20 mg. CHILD: 200 -500 mcg at suitable intervalsthroughout the day. NEONATE: 50 -250 mcg every 4 hours ii) By IVinjection over 1 minute, 50 - 70mcg/kg (maximum 5 mg) after orwith atropine sulphate 0.6 - 1.2 mg

1090. Nepafenac 0.1%ophthalmicsolution

S01BC10-000-D20-01-XXX

A* Reduction in the risk ofpostoperative macular oedemaassociated with cataractsurgery in diabetic patients.

One drop 3 times/day beginning 1day prior to cataract surgery,continued on the day of surgery andup to 60 days of the postoperativeperiod as directed by the clinician.An additional drop should beadministered 30 to 120 minutesprior to surgery.

1091. NetilmicinSulphate 100mg/2 ml Injection

J01GB07183P3002XX

A Systemic infections ADULT: 4 - 6.5 mg/kg/day IM or IV in2 - 3 equally divided doses for 7 - 14days. Maximum: 7.5 mg/kg/day.CHILD: 5 - 7.5 mg/kg/day 8 - 12hourly depending on gestation andage. Maximum: 7.5 mg/kg/day

1092. NetilmicinSulphate 150mg/2 ml Injection

J01GB07183P3003XX

A Systemic infections ADULT: 4 - 6.5 mg/kg/day IM or IV in2 - 3 equally divided doses for 7 - 14days. Maximum: 7.5 mg/kg/day.CHILD: 5 - 7.5 mg/kg/day 8 - 12hourly depending on gestation andage. Maximum: 7.5 mg/kg/day

1093. NetilmicinSulphate 50 mg/2ml Injection

J01GB07183P3001XX

A Systemic infections ADULT: 4 - 6.5 mg/kg/day IM or IV in2 - 3 equally divided doses for 7 - 14days. Maximum: 7.5 mg/kg/day.CHILD: 5 - 7.5 mg/kg/day 8 - 12hourly depending on gestation andage. Maximum: 7.5 mg/kg/day

1094. Nevirapine 200mg Tablet

J05AG01000T1001XX

A/KK Treatment of HIV-1 infection incombination with otherantiretroviral agents

Combined with other antiretrovirals:200 mg once daily for the 1st 14days; up to 200 mg twice daily ifrash does not develop. Re-introduceat a lower dose for the 1st 14 days iftreatment is interrupted for >7days,necessitate reintroduction at alower dose for the first 14 days.

Page 188 of 296

No. Generic Name MDC Category Indications Dosage1095. Nevirapine

50mg/5ml OralSuspension

J05AG01000L8001XX

A/KK Treatment of HIV-1 infection incombination with otherantiretroviral agents

The total daily dose should notexceed 400mg. Nevirapine may bedosed in paediatric patients eitherby body surface area (BSA) or bybody weight. i)By BSA using theMosteller formula: therecommended oral dose forpaediatric patients of all ages is 150mg/m2 once daily for 2 weeksfollowed by 150 mg/m2 twice dailythereafter. ii)By body weight: -<8years of age: 4 mg/kg once daily for2 weeks followed by 7 mg/kg twicedaily thereafter. -≥8 years: 4 mg/kgonce daily for 2 weeks followed by 4mg/kg twice daily thereafter.

1096. Nicotine 10 mg/16 hourTransdermalPatch

N07BA01000M7005XX

A/KK For the treatment of tobaccodependence by relievingnicotine withdrawal symptoms,thereby facilitating smokingcessation in smokers motivatedto quit.

Adult over 18 years old: 15 mg patchon waking (usually in the morning)and remove 16 hours later (usuallyat bedtime) for 8 weeks, then 10 mgpatch daily for 2 weeks followed byone 5 mg patch daily for another 2weeks. Apply to dry non-hairy skinsite. Application limited to 16 hoursin a 24-hr period in each case.Review at 3 months.

1097. Nicotine14mg/24 hourTransdermalPatch

N07BA01000M7002XX

A/KK For the treatment of tobaccodependence by relievingnicotine withdrawal symptoms,thereby facilitating smokingcessation in smokers motivatedto quit.

Apply 1 patch daily for 24 hours asin the product leaflet

1098. Nicotine 15 mg/16 hourTransdermalPatch

N07BA01000M7006XX

A/KK For the treatment of tobaccodependence by relievingnicotine withdrawal symptoms,thereby facilitating smokingcessation in smokers motivatedto quit.

Adult over 18 years old: 15 mg patchon waking (usually in the morning)and remove 16 hours later (usuallyat bedtime) for 8 weeks, then 10 mgpatch daily for 2 weeks followed byone 5 mg patch daily for another 2weeks. Apply to dry non-hairy skinsite. Application limited to 16 hoursin a 24-hr period in each case.Review at 3 months.

1099. Nicotine 2 mgGum

N07BA01000M9901XX

A/KK For the treatment of tobaccodependence by relievingnicotine withdrawal symptoms,thereby facilitating smokingcessation in smokers motivatedto quit.

Smokes ≤ 20 sticks/day, chew 2mggum. Smokes ≥ 20 sticks/day,chew 4mg gum. (MAX 24 pieces /day for upto 12 week.)

1100. Nicotine21mg/24 hourTransdermalPatch

N07BA01000M7003XX

A/KK For the treatment of tobaccodependence by relievingnicotine withdrawal symptoms,thereby facilitating smokingcessation in smokers motivated

Apply 1 patch daily for 24 hours asin the product leaflet.

Page 189 of 296

No. Generic Name MDC Category Indications Dosageto quit.

1101. Nicotine 4 mgGum

N07BA01000M9902XX

A/KK For the treatment of tobaccodependence by relievingnicotine withdrawal symptoms,thereby facilitating smokingcessation in smokers motivatedto quit.

Smokes ≤ 20 sticks/day, chew 2mggum. Smokes ≥ 20 sticks/day,chew 4mg gum. (MAX 24 pieces /day for upto 12 week.)

1102. Nicotine 7mg/24hour TransdermalPatch

N07BA01000M7001XX

A/KK For the treatment of tobaccodependence by relievingnicotine withdrawal symptoms,thereby facilitating smokingcessation in smokers motivatedto quit.

Apply 1 patch daily for 24 hours asin the product leaflet.

1103. NicotineTransdermalPatch 25mg/16hours.

NO7BA01000M7007XX

A/KK For the treatment of tobaccodependence by relievingnicotine craving and withdrawalsymptoms thereby facilitatingsmoking cessation in smokersmotivated to quit. Advice andsupport normally improve thesuccess rate.

The patch should be apply to anintact area of the skin upon wakingup in the morning and removed atbedtime. Heavy smoker(thosesmoking 15 or more cigarettes in a24-hour period) are recommendedto start at Step 1 with 25mg/16hours patch and use one patch dailyfor 8 weeks. Gradual weaning fromthe patch should then be initiated.One 15mg/16hours patch should bedaily for 2 weeks followed by one10mg/16 hours patch daily for 2weeks. Light smokers (thosesmoking less than 15 cigarettes in a24-hour period) are recommendedto start at Step 2 (15mg/16hourspatch) for 8 weeks and decrease thedose to Step 3 (10mg/16hours) forthe final 4 weeks. Heavy smokerLight smoker Dose RegimenDuration Dose Regimen DurationStep 1 25mg/16hr patch First 8weeks Step 2 15mg/16hr patch Next2 weeks Step 2 15mg/16hr patchFirst 8 weeks Step 3 10mg/16hrpatch Last 2 weeks Step 310mg/16hr patch Last 4 weeksCombination therapy Highlydependent smokers, smokers whoexperience ?breakthrough? cravingsor those who have failed with singleNRT treatment, can use a flexiblesmoking cessation format, incombination with the patch for fastrelief of cravings.

Page 190 of 296

No. Generic Name MDC Category Indications Dosage1104. Nicotinic Acid 50

mg TabletA11HA01000T1001XX

B For prophylaxis and treatmentof Vitamin B3 deficiency

Prophylactic: 15 - 30 mg daily.Therapeutic: 50 - 250 mg daily.Maximum single dose: 200 mg.Maximum dose in 24 hours: 800 mg

1105. Nicotinic Acid500 mg Tablet

C10AD02000T1001XX

B Hyperlipidaemia 100 - 200 mg 3 times daily, graduallyincreased over 2 - 4 weeks to 1 - 2 g3 times daily with or after meals.CHILD: 100 - 250 mg/day in 3divided doses with meals, increase100 mg/day weekly or 250 mg/dayevery 2 - 3 weeks as tolerated.Maximum: 10 mg/kg/day

1106. Nifedipine 10 mgCapsule

C08CA05000C1001XX

B Hypertension 10 - 30 mg 3 times daily. Maximum:120 - 180 mg per day

1107. Nifedipine 10 mgTablet

C08CA05000T1001XX

B Hypertension Initial dose of 10 mg twice daily.Usual range 10 - 30 mg 3 times daily.Maximum: 120 - 180 mg per day.Elderly: Dose reduction may benecessary.

1108. Nilotinib 150mgcapsule

L01XE08110T1001XX

A* For the treatment of adultpatients with newly diagnosedPhiladelphia chromosomepositive chronic myelogenousleukemia in the chronic phase(CP).

300mg twice daily. Doseadjustments or modifications:Forneutropenia & thrombocytopenia

1109. Nilotinib 200 mgCapsule

L01XE08110C1001XX

A* Treatment of chronic phase andaccelerated phase Philadelphiachromosome positive chronicmyelogenous leukaemia (CML)in adults who: i) Failed imatinibie no cytogenic response and nohaematological response by 12months ii) Have molecularresistance to Imatinib as shownby molecular mutation studiesiii) Are intolerant to Imatinib

400 mg twice daily, 12 hours apart.No food should be taken two hoursbefore and 1 hour after taking thedose

1110. Nimodipine 10mg/50 mlInfusion Solution

C08CA06000P9901XX

A* Prophylaxis & treatment ofischaemic neurological deficitscaused by cerebral vasospasmfollowing subarachnoidhaemorrhage of aneurysmalorigin

IV infusion of 1 mg/hour for a periodof 2 hours (about 15 mcg/kg/hour).IV therapy should be started nolater than 4 days after haemorrhage& continue for up to 10 - 14 days

1111. Nimodipine 30mg Tablet

C08CA06000T1001XX

A* Prophylaxis & treatment ofischaemic neurological deficitscaused by cerebral vasospasmfollowing subarachnoidhaemorrhage of aneurysmalorigin

360 mg daily in divided doses for 7days

1112. Nitrazepam 5 mgTablet

N05CD02000T1001XX

B Epilepsy (infantile spasms) 5 - 10 mg at bedtime. ELDERLY ordebilitated 2.5 - 5 mg. CHILD notrecommended. Increasing slowlyaccording to response

Page 191 of 296

No. Generic Name MDC Category Indications Dosage1113. Nitrofurantoin

100 mg TabletJ01XE01000T1002XX

B Uncomplicated lower urinarytract infections

Acute uncomplicated urinary tractinfections Adult: 50-100 mg 4 timesdaily for 7 days. Dual-releasepreparation: 100 mg bid. Child: >3mth and older children: 3 mg/kgdaily in 4 divided doses. Prophylaxisof uncomplicated urinary tractinfections Adult: 50-100 mg atbedtime. Child: >3 mth and olderchildren: 1 mg/kg once daily.

1114. Nonacog alfa1000 IU injection

B02BD09000P4003XX

A* Treatment and prophylaxis ofbleeding in patients withhaemophilia B (congenitalfactor IX deficiency)

Number of factor IX units required =body weight (kg) x desired factor IXincrease (% or units/dL) x reciprocalof observed recovery (units/kg perunits/dL). Average dose forsecondary prophylaxis for previouslytreated adult patients (PTP) was 40units/kg (range 13 to 78 units/kg) atintervals of 3 to 4 days

1115. Nonacog alfa2000 IU injection

B02BD09000P4004XX

A* Treatment and prophylaxis ofbleeding in patients withhaemophilia B (congenitalfactor IX deficiency)

Number of factor IX units required =body weight (kg) x desired factor IXincrease (% or units/dL) x reciprocalof observed recovery (units/kg perunits/dL). Average dose forsecondary prophylaxis for previouslytreated adult patients (PTP) was 40units/kg (range 13 to 78 units/kg) atintervals of 3 to 4 days

1116. Nonacog alfa 250IU injection

B02BD09000P4001XX

A* Treatment and prophylaxis ofbleeding in patients withhaemophilia B (congenitalfactor IX deficiency)

Number of factor IX units required =body weight (kg) x desired factor IXincrease (% or units/dL) x reciprocalof observed recovery (units/kg perunits/dL). Average dose forsecondary prophylaxis for previouslytreated adult patients (PTP) was 40units/kg (range 13 to 78 units/kg) atintervals of 3 to 4 days

1117. Nonacog alfa 500IU injection

B02BD09000P4002XX

A* Treatment and prophylaxis ofbleeding in patients withhaemophilia B (congenitalfactor IX deficiency)

Number of factor IX units required =body weight (kg) x desired factor IXincrease (% or units/dL) x reciprocalof observed recovery (units/kg perunits/dL). Average dose forsecondary prophylaxis for previouslytreated adult patients (PTP) was 40units/kg (range 13 to 78 units/kg) atintervals of 3 to 4 days

1118. NoradrenalineAcid Tartrate(NorepinephrineBitartrate) 1mg/ml Injection

C01CA03123P3001XX

A Septic shock and shock whereperipheral vascular resistance islow

Infuse and titrate to desiredpressure response. Range: 0.05 - 0.5mcg/kg/minute

1119. Norethisterone0.35 mg Tablet

G03AC01000T1001XX

C+ Contraception 1 tablet daily starting on the firstday of the menstrual bleeding

Page 192 of 296

No. Generic Name MDC Category Indications Dosage1120. Norethisterone

Enanthate 200mg/ml Injection

G03AC01257P3001XX

B Contraception By deep IM injection only. Firstinjection is within first 5 days of thecycle. The next 3 injections are givenat 8 weeks interval after which theinjection interval should beextended to 12 weeks

1121. Norfloxacin 0.3%Eye Drops

S01AX12000D2001XX

A* Superficial infections of the eye(Pseudomonas aeruginosa andMRSA) and its adnexae

ADULT and CHILD more than 1 year :1-2 drops 4 times daily. First day : 1 -2 drops two hourly during wakinghours (depending on severity)

1122. Nystatin 100,000units/g Cream

D01AA01000G1001XX

C Prevention and treatment ofcutaneous infections caused byCandida albicans

Apply liberally to affected area twicedaily or as required. After lesion hasdisappeared continue treatment for10 days to prevent relapses. Nailinfection: Cut nails as short aspossible. Apply cream once dailyuntil growth of new nail has set in

1123. Nystatin 100,000units/g Ointment

D01AA01000G5001XX

C Prevention and treatment ofcutaneous or mucocutaneousinfections caused by Candidaalbicans

Apply liberally to affected area twicedaily or as required. After lesion hasdisappeared continue treatment for10 days to prevent relapses. Nailinfection: Cut nails as short aspossible. Apply cream once dailyuntil growth of new nail has set in

1124. Nystatin 100,000units/mlSuspension

A07AA02000L8001XX

B Prevention and treatment ofcandidiasis of the skin andmucous membranes, protectionagainst candidas overgrowthduring antimicrobial/corticosteroid therapy and asselective decontaminationregimens

NEWBORN: 50,000-100,000 unitsdaily. CHILD up to 5 years: 100,000 -500,000 units 6 hourly. CHILD up to6-12 years and ADULT: 500,000-1,000,000 units 3 to 4 times daily

1125. Nystatin 500,000units Tablet

A07AA02000T1001XX

B Prevention and treatment ofcandidiasis of the skin andmucous membranes, protectionagainst candidas overgrowthduring antimicrobial/corticosteroid therapy and asselective decontaminationregimens

ADULT: 500,000 -1,000,000 units 6hourly, according to severity ofinfections. CHILD: 100,000-500,000units 6 hourly

1126. Octreotide 0.05mg/ml Injection

H01CB02122P3002XX

A i) Acromegaly ii) Treatment ofpatients with symptomsassociated with gastro-entero-pancreatic endocrine tumoursiii) Carcinoid tumours withfeatures of the carcinoidsyndrome, VIPomas,glucagonomas,gastrinomas/Zollinger-Ellisonsyndrome, GRFomas,insulinomas iv) Prevention ofcomplications followingpancreatic surgery v)

i, ii and iii) Initially 0.005 - 0.1 mg SC1 - 2 times daily, increase graduallyup to 0.1 - 0.2 mg 3 times daily iv)0.1 mg 3 times daily for 7consecutive days, starting on theday of operation, at least 1 hourbefore laparotomy v) 25 mcg/hourfor 5 days by continous IV infusion

Page 193 of 296

No. Generic Name MDC Category Indications DosageEmergency management ofbleeding gastro-eosophagealvarices in patients with cirrhosis

1127. Octreotide 0.1mg/ml Injection

H01CB02122P3001XX

A i) Acromegaly ii) Treatment ofpatients with symptomsassociated with gastro-entero-pancreatic endocrine tumoursiii) Carcinoid tumours withfeatures of the carcinoidsyndrome, VIPomas,glucagonomas,gastrinomas/Zollinger-Ellisonsyndrome, GRFomas,insulinomas iv) Prevention ofcomplications followingpancreatic surgery v)Emergency management ofbleeding gastro-eosophagealvarices in patients with cirrhosis

i, ii and iii) Initially 0.005 - 0.1 mg SC1 - 2 times daily, increase graduallyup to 0.1 - 0.2 mg 3 times daily iv)0.1 mg 3 times daily for 7consecutive days, starting on theday of operation, at least 1 hourbefore laparotomy v) 25 mcg/hourfor 5 days by continous IV infusion

1128. OctreotideAcetate 20 mgInjection

H01CB02122P2001XX

A* i) Adjunctive treatment foractive acromegaly(second/third line therapy inwhom surgery or radiotherapyis inappropriate or ineffective-based on level of growthhormone and high IGF-1 andresidual pituitary tumor). ii)Treatment of symptomsassociated with functionalgastro-entero-pancreaticendocrine tumours. iii)Carcinoid tumours withfeatures of the carcinoidsyndrome, VIPomas,Glucagonomas,Gastrinomas/Zollinger-Ellisonsyndrome, Insulinomas, for pre-operative control ofhypoglycemia and formaintenance therapy,GRFomas.

10 - 30 mg every 4 weeks as deepintragluteal injection

Page 194 of 296

No. Generic Name MDC Category Indications Dosage1129. Octreotide

Acetate 30 mgInjection

H01CB02122P2002XX

A* i) Adjunctive treatment foractive acromegaly(second/third line therapy inwhom surgery or radiotherapyis inappropriate or ineffective-based on level of growthhormone and high IGF-1 andresidual pituitary tumor). ii)Treatment of symptomsassociated with functionalgastro-entero-pancreaticendocrine tumours. iii)Carcinoid tumours withfeatures of the carcinoidsyndrome, VIPomas,Glucagonomas,Gastrinomas/Zollinger-Ellisonsyndrome, Insulinomas, for pre-operative control ofhypoglycemia and formaintenance therapy,GRFomas.

10 - 30 mg every 4 weeks as deepintragluteal injection

1130. Ofloxacin 0.3%Otic Solution

S02AA00000D1001XX

A/KK i. Acute otitis media withtympanostomy tubes ii. Chronicsuppurative otitis media withperforated tympanicmembranes and iii. Otitisexterna

CHILD: 1 - 12 years: 5 drops twicedaily for 10 days. ADULT and CHILDover 12 years: 6 - 10 drops twicedaily and remain in the ear about 10minutes

1131. Ofloxacin 100 mgTablet

J01MA01000T1001XX

A i) As second-line treatment ofleprosy ii) As second-linetreatment for tuberculosis andmultidrug resistant tuberculosis(MDR-TB) iii) Sequential therapyfor UTI and pyelonephritis

i) 400 mg/day ii) 400 mg twice dailyiii) 200 mg twice daily

1132. Ofloxacin 200 mgInjection

J01MA01000P4001XX

A Sequential therapy for UTI andpyelonephritis

200 mg IV twice daily for 3 - 5 daysfollowed with 200 mg tablet twicedaily for 3 - 5 days as maintenancedose (if necessary)

1133. Olanzapine 10 mgDisintegratingTablet

N05AH03000T4002XX

A* i) Acute and maintenancetreatment of schizophrenia andother psychoses where positiveand or negative symptoms areprominent ii) Short-term use foracute mania episodesassociated with Bipolar 1disorder

i) 5 - 10 mg once daily, increase to10 mg once daily within 5 - 7 days,adjust by 5 - 10 mg/day at 1 weekintervals, maximum 20 mg/day ii) 10- 15 mg once daily, increase by 5mg/day at intervals of not less than24 hours. Maintenance 5 - 20mg/day; maximum 20 mg/day

1134. Olanzapine 10 mgTablet

N05AH03000T1002XX

A* i) Acute and maintenancetreatment of schizophrenia andother psychoses where positiveand or negative symptoms areprominent ii) Short-term use foracute mania episodesassociated with Bipolar 1

i) 5 - 10 mg once daily, increase to10 mg once daily within 5 - 7 days,adjust by 5 - 10 mg/day at 1 weekintervals, maximum 20 mg/day ii) 10- 15 mg once daily, increase by 5mg/day at intervals of not less than24 hours. Maintenance 5 - 20

Page 195 of 296

No. Generic Name MDC Category Indications Dosagedisorder mg/day; maximum 20 mg/day

1135. Olanzapine 5 mgTablet

N05AH03000T1001XX

A* i) Acute and maintenancetreatment of schizophrenia andother psychoses where positiveand or negative symptoms areprominent ii) Short-term use foracute mania episodesassociated with Bipolar 1disorder

i) 5 - 10 mg once daily, increase to10 mg once daily within 5 - 7 days,adjust by 5 - 10 mg/day at 1 weekintervals, maximum 20 mg/day ii) 10- 15 mg once daily, increase by 5mg/day at intervals of not less than24 hours. Maintenance 5 - 20mg/day; maximum 20 mg/day

1136. Olanzapine 5mgDisintegratingTablet

N05AH03000T4001XX

A* i) Acute and maintenancetreatment of schizophrenia andother psychoses where positiveand or negative symptoms areprominent ii) Short-term use foracute mania episodesassociated with Bipolar 1disorder

i) 5 - 10 mg once daily, increase to10 mg once daily within 5 - 7 days,adjust by 5 - 10 mg/day at 1 weekintervals, maximum 20 mg/day ii) 10- 15 mg once daily, increase by 5mg/day at intervals of not less than24 hours. Maintenance 5 - 20mg/day; maximum 20 mg/day

1137. Olive Oil EarDrops

S02DC00000D1001XX

C Impacted wax softener 3 - 4 drops 3 - 4 or as directed

1138. Olodaterol HCL2.5mcg/puff,solution forinhalation

R03AC19110A3001XX

A* Indicated as a maintenancebronchodilator treatment inpatients with chronicobstructive pulmonary disease(COPD).

5 mcg (2 puffs) once daily.

1139. Olopatadinehydrochlorideophthalmicsolution 0.2%

S01GX09110D2002XX

A* Temporary prevention of ocularitching due to allergicconjunctivitis

One drop in each affected eye oncea day

1140. Omalizumab 150mg (powder andsolvent forsolution)

R03DX05000P3001XX

A* i) For adults and adolescents(≥12 years), for severepersistent allergic asthmawhose symptoms areinadequately controlled withinhaled corticosetroids ii) ForChildren (6 to <12 years of age):As add-on therapy to improveasthma control with severepersistent allergic asthma whohave positive skin test or invitro reactivity to a perennialaero allergen and frequentdaytime symptoms or night-time awakenings and who havehad multiple documentedsevere asthma exacerbationsdespite daily high-dose inhaledcorticosteroids, plus a long-acting inhaled beta 2 agonist

i) Adult & adolescent ≥12 yr, 150-375 mg SC every 2-4 wk, accordingto body wt & baseline serum totalIgE level.. For subcutaneousadministration only. Do notadminister by the intravenous orintramuscular route. ii) Appropriatedose and dosing frequency ofomalizumab is determined bybaseline IgE (IU/ml), measuredbefore the start of treatment, andbody weight (kg). Prior to initialdosing, patients should have theirIgE level determined for their doseassignment. Based on thesemeasurements 150-375mg in 1 -3injections may be needed for eachadministration. Patients whosebaseline IgE levels or body weight inkilograms are outside the limits of

Page 196 of 296

No. Generic Name MDC Category Indications Dosagethe dosing table should not be givenomalizumab. For subcutaneousadministration only.

1141. Omeprazole 10mg Capsule

A02BC01000C1001XX

A/KK Only for : i)Reflux oesophagitisii)For eradication ofHelicobacter pylori infectioniii)Benign peptic ulcer notresponding to conventionaltherapy iv)Zollinger-EllisonSyndrome

i)20 - 80 mg 1 - 2 times daily up to 8- 12 weeks ii)20 mg twice daily incombination with any of the 2antibiotics (clarithromycin 500 mgtwice daily, amoxicillin 1 g twicedaily or metronidazole 400 mg twicedaily)for 1 - 2 weeks iii) 20 mg oncedaily for 4 - 6 weeks iv) ADULT: 20 -120 mg once daily adjustedaccording to the patient's response.CHILD 0.4 - 0.8 mg/kg/day

1142. Omeprazole 20mg Capsule

A02BC01000C1002XX

A/KK Only for : i)Reflux oesophagitisii)For eradication ofHelicobacter pylori infectioniii)Benign peptic ulcer notresponding to conventionaltherapy iv)Zollinger-EllisonSyndrome

i)20 - 80 mg 1 - 2 times daily up to 8- 12 weeks ii)20 mg twice daily incombination with any of the 2antibiotics (clarithromycin 500 mgtwice daily, amoxicillin 1 g twicedaily or metronidazole 400 mg twicedaily)for 1 - 2 weeks iii) 20 mg oncedaily for 4 - 6 weeks iv) ADULT: 20 -120 mg once daily adjustedaccording to the patient's response.CHILD 0.4 - 0.8 mg/kg/day

1143. Omeprazole 40mg Injection

A02BC01000P4001XX

A* i) Reflux oesophagitis,eradication of H. Pyloriinfection, benign peptic ulcernot responding to conventionaltherapy, Zollinger-EllisonSyndrome ii) Endoscopicallyconfirmed peptic ulcer

i) 40 mg IV once daily when oraltherapy is inappropriate ii) 40- 160mg by IV in single or divided doses

Page 197 of 296

No. Generic Name MDC Category Indications Dosage1144. Ondansetron 2

mg/ml InjectionA04AA01110P3001XX

A i)Prevention of nausea andvomiting induced bychemotherapy andradiotherapy ii)Postoperativenausea and vomiting

i)8 mg given by IV infusion over 15minutes or by IM immediatelybefore treatment followed by 8 mgorally every 12 hours for up to 5days. CHILD 5 mg/m2 body surfaceIV over 15 minutes immediatelybefore chemotherapy followed by 4mg orally every 12 hours for up to 5days ii)Prevention : 4 mg given by IVat induction of anaesthesia. CHILDover 2 years, 100 mcg/kg (max 4mg)by slow IV before, during or afterinduction of anaesthesia. Treatmentof postoperative: 4 mg by IM orslow. CHILD over 2 years 100mcg/kg (maximum 4mg) by slow IV

1145. Ondansetron 4mg Tablet

A04AA01110T1001XX

A i)Prevention of nausea andvomiting induced bychemotherapy andradiotherapy ii) Postoperativenausea and vomiting

i)8 mg 1 - 2 hours before treatmentthen 8 mg every 12 hours for up to 5days. CHILD, treatment by infusionfollowed by 4 mg by mouth every 12hours for up to 5 days ii)Preventionof postoperative nausea andvomiting, 16 mg 1 hour beforeanaesthesia or 8 mg 1 hour beforeanaesthesia followed by 8 mg atintervals of 8 hours for a further 2doses

1146. Ondansetron 8mg Tablet

A04AA01110T1002XX

A i)Prevention of nausea andvomiting induced bychemotherapy andradiotherapy ii) Postoperativenausea and vomiting

i)8 mg 1 - 2 hours before treatmentthen 8 mg every 12 hours for up to 5days. CHILD, treatment by infusionfollowed by 4 mg by mouth every 12hours for up to 5 days ii)Preventionof postoperative nausea andvomiting, 16 mg 1 hour beforeanaesthesia or 8 mg 1 hour beforeanaesthesia followed by 8 mg atintervals of 8 hours for a further 2doses

1147. Ondansetron 8mg/4ml Injection

A04AA01110P3002XX

A i)Prevention of nausea andvomiting induced bychemotherapy andradiotherapy ii)Postoperativenausea and vomiting

i)8 mg given by IV infusion over 15minutes or by IM immediatelybefore treatment followed by 8 mgorally every 12 hours for up to 5days. CHILD 5 mg/m2 body surfaceIV over 15 minutes immediatelybefore chemotherapy followed by 4mg orally every 12 hours for up to 5days ii)Prevention : 4 mg given by IVat induction of anaesthesia. CHILDover 2 years, 100 mcg/kg (max 4mg)by slow IV before, during or afterinduction of anaesthesia. Treatmentof postoperative: 4 mg by IM orslow. CHILD over 2 years 100

Page 198 of 296

No. Generic Name MDC Category Indications Dosagemcg/kg (maximum 4mg) by slow IV

1148. Oral RehydrationSalt

A07CA00905F2101XX

C Replacement of fluid andelectrolytes loss in diarrhoea

ADULT: 200 - 400 ml ( 1 - 2 sachets )for every loose motion. CHILD: 200ml (1 sachet) for every loosemotion. In severe dehydration 100ml/kg for 3 - 4 hours. INFANT: 1 - 1.5times their usual feed volume (50 mlper stool for small infant)

1149. Orphenadrine100 mg Tablet

M03BC01110T1001XX

A Painful muscle spasm Initially 150 mg daily in divideddoses. Maximum: 400 mg daily

1150. Ortho-phthalaldehyde0.55% Solution

V07AV00000L9909XX

A High level disinfectant forsensitive endoscopes or semi-critical reusable medical devices

Manual reprocessing, at least 12minute immersion time at roomtemperature (20 degree celcius) isrequired. Automatic endoscopereprocessor, at least 5 minuteimmersion time at a minimum of 25degree celcius is required

1151. Oseltamivir60mg/5ml oralsuspension.

J05AH02000L8001XX

A/KK i) For treatment of patientswith suspected or confirmedinfluenza and severe disease(requiring hospitalization orevidence of lower respiratorytract infection). ii) Fortreatment of patients withsuspected or confirmedinfluenza and with co-morbidityand associated with increasedrisk of influenza complications.Not to be used as prophylaxis.

Children with body weight morethan 40kg is recommended to bedosed as adults. The followingweight adjusted dosing regimensare recommended for children agedone year and older for duration offive days: a) ≤15 kg: 30mg twicedaily b) >15kg to 23kg:45mg twicedaily c) >23kg to 40kg: 60mg twicedaily

Page 199 of 296

No. Generic Name MDC Category Indications Dosage1152. Oseltamivir 75mg

capsule.J05AH02000C1001XX

A/KK i) For treatment of patientswith suspected or confirmedinfluenza and severe disease(requiring hospitalization orevidence of lower respiratorytract infection). ii) Fortreatment of patients withsuspected or confirmedinfluenza and with co-morbidityand associated with increasedrisk of influenza complications.Not to be used as prophylaxis.

Recommended dose in adults andadolescents ≥ 13 years of age andbody weight >40kg is 75mg twicedaily for 5 days. No dose adjustmentis necessary for patients withcreatinine clearance above 60ml/min. Dose recommendations forrenal impairment patients asfollows: a) Creatinine clearance of>30-60 mL/min: 30 mg twice dailyfor 5 days b) Creatinine clearance of10-30 ml/min: 30 mg of once dailyfor 5 days c) In patients undergoingroutine hemodialysis an initial doseof 30 mg can be administered priorto the start of dialysis if influenzasymptoms develop during the 48hours between dialysis sessions. Tomaintain plasma concentrations at atherapeutic level, a dose of 30 mgshould be administered after everyhemodialysis session. d) Forperitoneal dialysis a dose of 30 mgadministered prior to the start ofdialysis followed by further 30 mgdoses administered every 5 days isrecommended for treatment.Dosing recommendation cannot beprovided for patients with end-stagerenal disease (creatinine clearanceof <10 ml/min) not undergoingdialysis. No dose adjustment neededin patients with hepatic impairmentand the elderly.

1153. Oxaliplatin 50 mgInjection

L01XA03000P4001XX

A* Only for patients withcolorectal cancer who: i) haverelapsed within 6 months afterthe end of adjuvantchemotherapy with 5-fluorouracil-based regime ii)have progressive diseasedespite 5-fluorouracilchemotherapy for advanceddisease iii) good performancestatus (WHO of 2 or less). Thetreatment must be given in atertiary oncology centre or haveclearance in writing by anoncologist

85 mg/m2 IV repeated every 2weeks

Page 200 of 296

No. Generic Name MDC Category Indications Dosage1154. Oxybutynin

Chloride 5 mgTablet

G04BD04110T1001XX

A* For the relief of symptoms ofbladder instability associatedwith voiding in patients withuninhibited neurogenic orreflex neurogenic bladder (ieurgency, frequency, urinaryleakage, urge incontinence,dysuria)

ADULT: Initially 5 mg 2 - 3 timesdaily increased if necessary tomaximum 5 mg 4 times daily.ELDERLY: Initially 2.5 - 3 mg twicedaily, increased to 5 mg twice dailyaccording to response andtolerance. CHILD over 5 years,neurogenic bladder instability: 2.5 -3 mg twice daily increased to 5 mgtwice daily to maximum 3 timesdaily

1155. Oxycodone HCl10 mg ImmediateRelease Capsules

N02AA05110C1002XX

A* i)As a second line drug in themanagement of opioidresponsive, moderate to severechronic cancer pain ii)As a step-down analgesic drug in post-operative procedures (Initiatedby palliative medicinephysicians, oncologists,anaesthesiologists,haematologists and painspecialists only)

Initially 5 mg every 4 to 6 hours,increased if necessary according toseverity of pain, usual max. 400 mgdaily, but some patients may requirehigher doses

1156. Oxycodone HCl10 mg ProlongedRelease Tablet

N02AA05110T5001XX

A* Management of moderate tosevere chronic cancer pain non-responsive to morphine (inaccordance with WHO step-wise ladder of chronic painmanagement) [Initiated byChronic Pain Specialist only]

ADULT, ELDERLY and CHILDRENmore than 18 years, opioid-naivepatients: 10 mg 12 hourly. Renal orhepatic impairment: 5 mg 12 hourly.Titrate dose carefully, as frequentlyas once a day if necessary, toachieve pain relief

1157. Oxycodone HCl20 mg ImmediateRelease Capsules

N02AA05110C1003XX

A* i)As a second line drug in themanagement of opioidresponsive, moderate to severechronic cancer pain ii)As a step-down analgesic drug in post-operative procedures (Initiatedby palliative medicinephysicians, oncologists,anaesthesiologists,haematologists and painspecialists only)

Initially 5 mg every 4 to 6 hours,increased if necessary according toseverity of pain, usual max. 400 mgdaily, but some patients may requirehigher doses

1158. Oxycodone HCl20 mg ProlongedRelease Tablet

N02AA05110T5002XX

A* Management of moderate tosevere chronic cancer pain non-responsive to morphine (inaccordance with WHO step-wise ladder of chronic painmanagement) [Initiated byChronic Pain Specialist only]

ADULT, ELDERLY and CHILDRENmore than 18 years, opioid-naÔvepatients: 10 mg 12 hourly. Renal orhepatic impairment: 5 mg 12 hourly.Titrate dose carefully, as frequentlyas once a day if necessary, toachieve pain relief

1159. Oxycodone HCl40 mg ProlongedRelease Tablet

N02AA05110T5003XX

A* Management of moderate tosevere chronic cancer pain non-responsive to morphine(Initiated by palliative medicinephysicians, oncologists,anaesthesiologists,

Initially, 10 mg every 12 hours,increased if necessary according toseverity of pain, usual max. 200 mgevery 12 hours, but some patientsmay require higher doses

Page 201 of 296

No. Generic Name MDC Category Indications Dosagehaematologists and painspecialists only)

1160. Oxycodone HCl 5mg ImmediateRelease Capsules

N02AA05110C1001XX

A* i)As a second line drug in themanagement of opioidresponsive, moderate to severechronic cancer pain ii)As a step-down analgesic drug in post-operative procedures (Initiatedby palliative medicinephysicians, oncologists,anaesthesiologists,haematologists and painspecialists only)

Initially 5 mg every 4 to 6 hours,increased if necessary according toseverity of pain, usual max. 400 mgdaily, but some patients may requirehigher doses

1161. OxycodoneHydrochloride 10mg/ml Injection

N02AA05110P3001XX

A* For the treatment of moderateto severe pain in patients withcancer and post-operative pain.For the treatment of severepain requiring the use of astrong opioid.

Adults over 18 years: The followingstarting doses are recommended. Agradual increase in dose may berequired if analgesia is inadequateor if pain severity increases. IVBolus: Dilute to 1 mg/ml in 0.9%saline, 5% dextrose or water forinjections. Administer a bolus doseof 1 to 10 mg slowly over 1-2minutes. Doses should not beadministered more frequently thanevery 4 hours. IV Infusion: Dilute to1 mg/ml in 0.9% saline, 5% dextroseor water for injections. A startingdose of 2 mg/hour is recommended.IV PCA: Dilute to 1 mg/ml in 0.9%saline, 5% dextrose or water forinjections. Bolus doses of 0.03mg/kg should be administered witha minimum lock-out time of 5minutes. SC Bolus: Use as 10 mg/mlconcentration. A starting dose of 5mg is recommended, repeated at 4-hourly intervals as required. SCInfusion: Dilute in 0.9% saline, 5%dextrose or water for injections ifrequired. A starting dose of 7.5mg/day is recommended in opioidnaÔve patients, titrating graduallyaccording to symptom control.Cancer patients transferring fromoral oxycodone may require muchhigher doses (see below).Transferring patients between oraland parenteral oxycodone: The doseshould be based on the followingratio: 2 mg of oral oxycodone isequivalent to 1 mg of parenteraloxycodone. It must be emphasisedthat this is a guide to the dose

Page 202 of 296

No. Generic Name MDC Category Indications Dosagerequired.Inter-patient variabilityrequires that each patient iscarefully titrated to the appropriatedose.

1162. OxycodoneHydrochloride10mg andNaloxoneHydrochlorideDihydrate 5mgTablet

N02AA55900T1002XX

A* The management of moderateto severe chronic painunresponsive to non-narcoticanalgesics. The opioidantagonist naloxone in the fixedcombination is added tocounteract and/or preventopioid-induced constipatio. Forpain specialist only

Adults and paediatric patients from18 years of age: The usual startingdose for opioid-naÔve patients orpatients presenting with moderateto severe chronic pain uncontrolledby weaker opioids is one tablet10mg/5mg at 12 hourly intervals, orone tablet 5mg/2.5mg 12-hourly forpatients with mild hepaticimpairment and patients with renalimpairment. The dose should thenbe cautiously titrated, as frequentlyas every 1-2 days if necessary, toachieve pain relief.

1163. OxycodoneHydrochloride10mg ControlledRelease Tablet

N02AA05110T5301XX

A* Management of moderate tosevere chronic cancer pain non-responsive to morphine inaccordance with WHO step-wise ladder of chronic painmanagement. (Initiated bypalliative medicine physicians,oncologists, anaesthesiologists,haematologists and painspecialists only)

Adults, elderly and children over 12years: Usual starting dose foropioid-naive patients or patientspresenting with moderate to severepain uncontrolled by weaker opioids(especially if they are receivingconcurrent sedatives, musclerelaxants or other CNS medicines) is10mg 12 hourly. The dose shouldthen be carefully titrated withlongitudinal patient monitoring,assessing whether the pain is opioidresponsive and providing thepatient significant pain relief.Patients with renal or hepaticimpairment: The recommendedadult starting dose should bereduced by 1/3 to 1/2, and eachpatient should be titrated toadequate pain control according totheir clinical situation.

1164. OxycodoneHydrochloride20mg andNaloxoneHydrochlorideDihydrate 10mgTablet

N02AA55900T1003XX

A* The management of moderateto severe chronic painunresponsive to non-narcoticanalgesics. The opioidantagonist naloxone in the fixedcombination is added tocounteract and/or preventopioid-induced constipatio. Forpain specialist only

Adults and paediatric patients from18 years of age: The usual startingdose for opioid-naÔve patients orpatients presenting with moderateto severe chronic pain uncontrolledby weaker opioids is one tablet10mg/5mg at 12 hourly intervals, orone tablet 5mg/2.5mg 12-hourly forpatients with mild hepaticimpairment and patients with renalimpairment. The dose should thenbe cautiously titrated, as frequentlyas every 1-2 days if necessary, toachieve pain relief.

Page 203 of 296

No. Generic Name MDC Category Indications Dosage1165. Oxycodone

Hydrochloride20mg ControlledRelease Tablet

N02AA05110T5302XX

A* Management of moderate tosevere chronic cancer pain non-responsive to morphine inaccordance with WHO step-wise ladder of chronic painmanagement. (Initiated bypalliative medicine physicians,oncologists, anaesthesiologists,haematologists and painspecialists only)

Adults, elderly and children over 12years: Usual starting dose foropioid-naive patients or patientspresenting with moderate to severepain uncontrolled by weaker opioids(especially if they are receivingconcurrent sedatives, musclerelaxants or other CNS medicines) is10mg 12 hourly. The dose shouldthen be carefully titrated withlongitudinal patient monitoring,assessing whether the pain is opioidresponsive and providing thepatient significant pain relief.Patients with renal or hepaticimpairment: The recommendedadult starting dose should bereduced by 1/3 to 1/2, and eachpatient should be titrated toadequate pain control according totheir clinical situation.

1166. OxycodoneHydrochloride40mg andNaloxoneHydrochlorideDihydrate 20mgTablet

N02AA55900T1004XX

A* The management of moderateto severe chronic painunresponsive to non-narcoticanalgesics. The opioidantagonist naloxone in the fixedcombination is added tocounteract and/or preventopioid-induced constipation.For pain specialist only

Adults and paediatric patients from18 years of age: The usual startingdose for opioid-naÔve patients orpatients presenting with moderateto severe chronic pain uncontrolledby weaker opioids is one tablet10mg/5mg at 12 hourly intervals, orone tablet 5mg/2.5mg 12-hourly forpatients with mild hepaticimpairment and patients with renalimpairment. The dose should thenbe cautiously titrated, as frequentlyas every 1-2 days if necessary, toachieve pain relief.

1167. OxycodoneHydrochloride40mg ControlledRelease Tablet

N02AA05110T5303XX

A* Management of moderate tosevere chronic cancer pain non-responsive to morphine inaccordance with WHO step-wise ladder of chronic painmanagement (Initiated bypalliative medicine physicians,oncologists, anaesthesiologists,haematologists and painspecialists only)

Adults, elderly and children over 12years: Usual starting dose foropioid-naive patients or patientspresenting with moderate to severepain uncontrolled by weaker opioids(especially if they are receivingconcurrent sedatives, musclerelaxants or other CNS medicines) is10mg 12 hourly. The dose shouldthen be carefully titrated withlongitudinal patient monitoring,assessing whether the pain is opioidresponsive and providing thepatient significant pain relief.Patients with renal or hepaticimpairment: The recommendedadult starting dose should bereduced by 1/3 to 1/2, and each

Page 204 of 296

No. Generic Name MDC Category Indications Dosagepatient should be titrated toadequate pain control according totheir clinical situation.

1168. OxycodoneHydrochloride 5mg and NaloxoneHydrochlorideDihydrate 2.5mgTablet

N02AA55900T1001XX

A* The management of moderateto severe chronic painunresponsive to non-narcoticanalgesics. The opioidantagonist naloxone in the fixedcombination is added tocounteract and/or preventopioid-induced constipation.For pain specialist only

Adults and paediatric patients from18 years of age: The usual startingdose for opioid-naÔve patients orpatients presenting with moderateto severe chronic pain uncontrolledby weaker opioids is one tablet10mg/5mg at 12 hourly intervals, orone tablet 5mg/2.5mg 12-hourly forpatients with mild hepaticimpairment and patients with renalimpairment. The dose should thenbe cautiously titrated, as frequentlyas every 1-2 days if necessary, toachieve pain relief.

1169. OxymetazolineHCI 0.01% NasalDrops

R01AA05110D6003XX

A* Acute cold, paranasal sinusitis,syringitis, otitis media.

Newborn (up to 4 weeks): 1 drop.Infant (1 - 12 month): 1 - 2 drop.Doses to be given twice or threetimes daily

1170. OxymetazolineHCl 0.025%(Paediatric) NasalDrops

R01AA05110D6001XX

A/KK Acute colds, paranasal sinusitisand otitis media

1 - 2 drops twice daily in each nostrilfor child more than 1 year

1171. OxymetazolineHCl 0.025%(Paediatric) NasalSpray

R01AA05110A4101XX

A Acute colds, paranasal sinusitisand otitis media

2 - 3 sprays into each nostril twicedaily for child more than 1 year

1172. OxymetazolineHCl 0.05% (Adult)Nasal Drops

R01AA05110D6002XX

A/KK Acute colds, paranasal sinusitisand otitis media

1 - 2 drops twice daily in each nostril

1173. OxymetazolineHCl 0.05% (Adult)Nasal Spray

R01AA05110A4102XX

A Acute colds, paranasal sinusitisand otitis media

2 - 3 sprays into each nostril twicedaily, maximum 6 sprays pernostril/day

1174. Oxymetholone 50mg Tablet

A14AA05000T1001XX

A Anaemias caused by theadministration of myelotoxicdrugs, treatment of AIDS-wasting syndrome

ADULT and CHILD: 1 - 5 mg/kg dailyin one daily dose. Usual effectivedose 1 - 2 mg/kg/day, given for aminimum trial of 3 - 6 monthsbecause response may be delayed

Page 205 of 296

No. Generic Name MDC Category Indications Dosage1175. Oxytetracycline

with Polymyxin BSulphate EyeOintment

S01AA30947G5101XX

B Conjunctivitis, dacryocystitis,blepharoconjunctivitis, keratitis,trachoma, blepharitis, pre-opprophylaxis against infection

Apply into the conjunctival sac 4times daily

1176. Oxytocin 10units/ml Injection

H01BB02000P3001XX

B Induction of labour IV: 0.5 - 1 milliunits/minute;gradually increase dose inincrements of 1 - 2 milliunits/minuteuntil desired contraction pattern isestablished; dose may be decreasedafter desired frequency ofcontractions is reached and laborhas progressed to 5 - 6 cm dilation

1177. Oxytocin 5 units& ErgometrineMaleate 0.5mg/ml Injection

G02AC01900P3001XX

C+ i) Prevention and treatment ofpost partum haemorrhage ii)Management of third stage oflabour

i) 1 ml IM, may be repeated after 2hours. Should not exceed 3 mlwithin 24 hours ii) For routinemanagement of third stage oflabour, 1 ml IM following delivery ofthe anterior shoulder orimmediately after delivery of thechild

1178. Paclitaxel 100mg/16.6 mlInjection

L01CD01000P3002XX

A* i) Treatment of recurrent breastcancer, after failure ofanthracycline-basedchemotherapy ii) Primaryadjuvant therapy in advancedovarian cancer in combinationwith cisplatin iii) Treatment oflocally advanced or metastaticnon-small cell lung cancer(NSCLC) in chemonaive patientsin combination with platinumcompounds

i) 175 mg/m2 IV over 3 hours every3 weeks ii) 175 mg/m2 IV over 3hour followed by cisplatin 75 mg/m2in every 3 weeks or 135 mg/m2 IVover 24 hours followed by cisplatin75 mg/m2 every 3 weeks iii) 135mg/m2 IV over 24 hours followed bycisplatin 75 mg/m2 every 3 weeks

1179. Paclitaxel 30mg/5 ml Injection

L01CD01000P3001XX

A* i) Treatment of recurrent breastcancer, after failure ofanthracycline-basedchemotherapy ii) Primaryadjuvant therapy in advancedovarian cancer in combinationwith cisplatin iii) Treatment oflocally advanced or metastaticnon-small cell lung cancer(NSCLC) in chemonaive patientsin combination with platinumcompounds

i) 175 mg/m2 IV over 3 hours every3 weeks ii) 175 mg/m2 IV over 3hour followed by cisplatin 75 mg/m2in every 3 weeks or 135 mg/m2 IVover 24 hours followed by cisplatin75 mg/m2 every 3 weeks iii) 135mg/m2 IV over 24 hours followed bycisplatin 75 mg/m2 every 3 weeks

1180. Paliperidone 100mg ProlongedRelease Injection

N05AX13000P2004XX

A* Second or third line treatmentof acute and maintenancetreatment of schizophrenia inadults

Initiation: Deltoid IM 150 mg eq onDay1, followed by deltoid IM 100mg eq on one week later.Maintenance: Monthly dose of 75mg eq (this can be increased ordecreased based on individualpatient?s tolerability and/orefficacy). These monthly maintenacedose can be administered in either

Page 206 of 296

No. Generic Name MDC Category Indications Dosagethe deltoid or gluteal muscle

1181. Paliperidone 150mg ProlongedRelease Injection

N05AX13000P2005XX

A* Second or third line treatmentof acute and maintenancetreatment of schizophrenia inadults

Initiation: Deltoid IM 150 mg eq onDay1, followed by deltoid IM 100mg eq on one week later.Maintenance: Monthly dose of 75mg eq ( this can be increased ordecreased based on individualpatient?s tolerability and/orefficacy). These monthly maintenacedose can be administered in eitherthe deltoid or gluteal muscle

1182. Paliperidone 3mg ExtendedReleased Tablet

N05AX13000T5001XX

A* Second or third line treatmentof schizophrenia

ADULT 6 mg once daily in themorning, adjusted if necessary;usual range 3 -12 mg daily. Renalimpairment (creatinine clearancebetween 10-50 mL/min) 3 mg oncedaily. Avoid if creatinine clearanceless than 10mL/min

1183. Paliperidone 50mg ProlongedRelease Injection

N05AX13000P2002XX

A* Second or third line treatmentof acute and maintenancetreatment of schizophrenia inadults

Initiation: Deltoid IM 150 mg eq onDay1, followed by deltoid IM 100mg eq on one week later.Maintenance: Monthly dose of 75mg eq ( this can be increased ordecreased based on individualpatient?s tolerability and/orefficacy). These monthly maintenacedose can be administered in eitherthe deltoid or gluteal muscle

1184. Paliperidone 6mg ExtendedReleased Tablet

N05AX13000T5002XX

A* Second or third line treatmentof schizophrenia

ADULT 6 mg once daily in themorning, adjusted if necessary;usual range 3 -12 mg daily. Renalimpairment (creatinine clearancebetween 10-50 mL/min) 3 mg oncedaily. Avoid if creatinine clearanceless than 10mL/min

1185. Paliperidone 75mg ProlongedRelease Injection

N05AX13000P2003XX

A* Second or third line treatmentof acute and maintenancetreatment of schizophrenia inadults

Initiation: Deltoid IM 150 mg eq onDay1, followed by deltoid IM 100mg eq on one week later.Maintenance: Monthly dose of 75mg eq ( this can be increased ordecreased based on individualpatient?s tolerability and/orefficacy). These monthly maintenacedose can be administered in eitherthe deltoid or gluteal muscle

Page 207 of 296

No. Generic Name MDC Category Indications Dosage1186. Paliperidone 9

mg ExtendedReleased Tablet

N05AX13000T5004XX

A* Second or third line treatmentof schizophrenia

ADULT 6 mg once daily in themorning, adjusted if necessary;usual range 3 -12 mg daily. Renalimpairment (creatinine clearancebetween 10-50 mL/min) 3 mg oncedaily. Avoid if creatinine clearanceless than 10mL/min

1187. Palivizumab100mg Injection

J06BB16000P3001XX

A* For the prevention of seriouslower respiratory tract diseasecaused by respiratory syncytialvirus (RSV) in paediatricpatients at high risk of RSVdisease

15 mg/kg IM once a month duringseason of RSV risk

1188. PamidronateDisodium 30 mgInjection

M05BA03520P3001XX

A* Hypercalcaemia of malignancy(tumour -inducedhypercalcaemia)

Dose depends on the initial serumcalcium levels. Doses range from asingle infusion of 30 - 90 mg

1189. PamidronateDisodium 90 mgInjection

M05BA03520P3002XX

A* Hypercalcaemia of malignancy(tumour -inducedhypercalcaemia)

Dose depends on the initial serumcalcium levels. Doses range from asingle infusion of 30 - 90 mg

1190. Pancreatin 150mg Capsule

A09AA02000C1001XX

A/KK Treatment of pancreaticexocrine insufficiency due toconditions such as cysticfibrosis, chronic pancreatitisand non-pancreatic diseases

Initially 1 - 2 capsules with eachmeal. May increase to 5 - 15capsules daily

1191. PancuroniumBromide 2 mg /ml lnjection

M03AC01320P3001XX

B Muscle relaxant as an adjunctto general anaesthesia

ADULT: Initially 50 - 100 mcg/kg IV,then 10 - 20 mcg/kg as required.CHILD > 2 YEARS: Initially 60 - 100mcg/kg then 10 - 20 mcg/kg.Intensive care, by IV, 60 mcg/kgevery 60 - 90 minutes

1192. Pantoprazole 40mg Injection

A02BC02000P3001XX

A* Bleeding peptic ulcer and acutestress ulceration

40 mg twice daily until oraladministration can be resumed.CHILD not recommended

1193. Pantoprazole 40mg Tablet

A02BC02000T1001XX

A/KK i) Helicobacter pylorieradication ii) Peptic ulcerdisease iii) Erosive and non-erosive reflux oesophagitis(GERD and NERD) iv) Zollinger-Ellison Syndrome v) Preventionof NSAID induced gastropathy

i) 40 mg twice daily in combinationwith any of the 2 antibiotics(Clarithromycin 500 mg twice daily,Amoxicillin 1 g twice daily orMetronidazole 400 mg twice daily)for 1-2 weeks ii) 40 mg daily for 2 - 4weeks iii) 20 - 40 mg daily onmorning for 4 weeks iv) Initially 80mg daily, dose can be titrated up ordown as needed. v) 20 mg daily.CHILD not recommended

1194. Papaverine HCl120 mg/10mlInjection

A03AD01110P3002XX

A Relief of cerebral andperipheral ischaemia associatedwith arterial spasm andmyocardial ischaemiacomplicated by arrhythmias

ADULT: 30 - 120 mg may berepeated every 3 hours asnecessary. CHILD: 6 mg/kg daily in 4divided doses

Page 208 of 296

No. Generic Name MDC Category Indications Dosage1195. Paracetamol

10mg/ml in100ml Solutionfor IV Infusion

N02BE01000P3101XX

A Mild to moderate pain andpyrexia

Body Weight (BW) ≤ 10kg:7.5mg/kg, max: 30mg/kg BW >10kgto ≤ 33kg: 15mg/kg, max 60mg/kgnot exceeding 2g BW >33kg to ≤50kg: 15mg/kg, max 60mg/kg notexceeding 3g BW >50kg (with risk ofhepatotoxicity): 1g, max 3g BW>50kg (without risk ofhepatotoxicity): 1g, max 4g OR as inthe product leaflet

1196. Paracetamol 120mg/5 ml Syrup

N02BE01000L9001XX

C+ Mild to moderate pain andpyrexia

CHILD: up to 1 year: 60 - 120 mg. 1 -5 years: 120 - 240 mg. 6 - 12 years:240 - 480 mg per dose. Repeat every4 - 6 hours when necessary.Maximum of 4 doses in 24 hours

1197. Paracetamol 125mg Suppository

N02BE01000S2002XX

C+ Symptomatic relief of fever andpost operative pain whomcannot tolerate oralpreparations.

ADULT & CHILDREN more than 12years old: 500mg - 1g every 4-6hours CHILD 6 - 12 years : 250 - 500mg; 1 - 5 years : 125 - 250 mg; 3 - 11months : 80 mg inserted every 4 - 6hours if necessary, maximum 4doses in 24 hours. INFANTS under 3months should not be givenParacetamol unless advised bydoctor; a dose of 10 mg/kg (5 mg/kgif jaundiced) is suitable.

1198. Paracetamol 250mg Suppository

N02BE01000S2001XX

B Symptomatic relief of fever andpost operative pain whomcannot tolerate oralpreparations.

ADULT & CHILDREN more than 12years old: 500mg - 1g every 4-6hours CHILD 6 - 12 years : 250 - 500mg; 1 - 5 years : 125 - 250 mg; 3 - 11months : 80 mg inserted every 4 - 6hours if necessary, maximum 4doses in 24 hours. INFANTS under 3months should not be givenParacetamol unless advised bydoctor; a dose of 10 mg/kg (5 mg/kgif jaundiced) is suitable.

1199. Paracetamol 250mg/5 ml Syrup

N02BE01000L8002XX

C+ Mild to moderate pain andpyrexia

CHILD: 6 - 12 years: 250 - 500 mgper dose. Repeat every 4 - 6 hourswhen necessary. Maximum of 4doses in 24 hours

1200. Paracetamol 500mg Tablet

N02BE01000T1001XX

C+ Mild to moderate pain andpyrexia

ADULT: 500 - 1000 mg every 4 - 6hours, maximum of 4 g daily

1201. Paraffin MoleAlba (White SoftParaffin)

D02AC00000G5001XX

C Xerosis and ichthyosis Apply to the affected area

1202. Paraffin MoleFlava

D02AC00000G5002XX

C Xerosis and ichthyosis Apply to the affected area

Page 209 of 296

No. Generic Name MDC Category Indications Dosage1203. Paraldehyde

InjectionN05CC05000P3001XX

C Status epilepticus The usual intramuscular dose ofparaldehyde for status epilepticus is0.15 to 0.3 milliliter/kilogram, amoderate additional dose (0.05milliliter/kilogram) may benecessary. The dose may berepeated in 2 to 6 hours and nomore than 5 milliliters should beadministered in one site

1204. Parecoxib Sodium40mg Injection

M01AH04520P3001XX

A* Management of post operativepain in the immediate postoperative setting only

40 mg followed by 20 or 40 mgevery 6 to 12 hours, as required. Uselimited to two days only with amaximum dose of 80 mg/day.Reduce the initial dose by 50% inelderly less than 50 kg

1205. PazopanibHydrochloride200 mg Tablet

L01XE11110T1001XX

A* For treatment of advancedand/or metastatic renal cellcarcinoma (RCC) Restriction: i)KPS ≥ 70% ii) Clear cell histologyiii) No brain metastasis iv)Haemoglobin ≥ 9g/dl v)Creatinine ≤2x the ULN vi)Corrected calcium < 12mg/dlvii) Platelet count of>100x103/uL viii) Neutrophilcount >1,500/mm3

Recommended dose is 800 mgORALLY once daily. Should be takenwithout food (at least one hourbefore or two hours after meal). Thedose should not exceed 800 mg.

1206. PazopanibHydrochloride400 mg Tablet

L01XE11110T1002XX

A* For treatment of advancedand/or metastatic renal cellcarcinoma (RCC) Restriction: i)KPS ≥ 70% ii) Clear cell histologyiii) No brain metastasis iv)Haemoglobin ≥ 9g/dl v)Creatinine ≤2x the ULN vi)Corrected calcium < 12mg/dlvii) Platelet count of>100x103/uL viii) Neutrophilcount >1,500/mm3

Recommended dose is 800 mgORALLY once daily. Should be takenwithout food (at least one hourbefore or two hours after meal). Thedose should not exceed 800 mg.

1207. Pefloxacin 400mg Injection

J01MA03196P3001XX

A Infections due to gram-positiveand gram-negative pathogens

Administered as a slow (one hour)intravenous perfusion, after dilutingthe contents of the 400 mg in 250ml 5% glucose (two perfusions daily,morning and evening)

1208. Pefloxacin 400mg Tablet

J01MA03000T1001XX

A i) Infections due to gram-positive and gram-negativepathogens ii) UncomplicatedUTI, chancroid gonococcalurethritis

ADULT i) 800 mg/day in 2 divideddoses ii) 800 mg stat

Page 210 of 296

No. Generic Name MDC Category Indications Dosage1209. Pegfilgrastim Pre-

filled Syringe 6mg/0.6 ml (10mg/ml)

L03AA13000P5001XX

A* Reduction in the duration ofneutropenia, the incidence offebrile neutropenia and theincidence of infection asmanifested by febrileneutropenia in patients treatedwith cytotoxic chemotherapyfor malignancy (with theexception of chronic myeloidleukaemia and myelodysplasticsyndromes)

Adults (≥18 years): One 6 mg dose (asingle pre-filled syringe) ofpegfilgrastim for eachchemotherapy cycle, administeredas a subcutaneous injectionapproximately 24 hours followingcytotoxic chemotherapy. Renalimpairment: Pharmacokinetics ofpegfilgrastim is not expected to beaffected by renal impairment.Hepatic impairment:Pharmacokinetics of pegfilgrastim isnot expected to be affected byhepatic impairment. Paediatricpopulation: Insufficient data torecommend the use of pegfilgrastimin children and adolescents under18 years of age.

1210. PeginterferonAlfa-2b 80 mcgInjection

L03AB10000P5002XX

A* Treatment of: i) ChronicHepatitis C ii) Chronic HepatitisB

i) Combination therapy withRibavirin: ADULT: SC 1.5mcg/kg/week CHILD andADOLESCENT (3-17 yr): SC 60mcg/m2/week for 24-48 weeksMonotherapy: ADULT: SC 1mcg/kg/week for 24 weeks to 1 yearii) SC 1.0 - 1.5 mcg/kg once weeklyfor 52 weeks

1211. PeginterferonAlpha-2a 135 mcgPrefilled Syringe

L03AB11000P5002XX

A* i) Chronic hepatitis C usually incombination with ribavirin(Important to establishhepatitis C virus (HCV) genotypeand viral load wherecombination treatment isadvocated) ii) For the treatmentof both HbeAg-positive andHbeAg-negative chronichepatitis B with compensatedliver disease and evidence ofviral replication who are notresponding or tolerating oralantiviral therapy (Initiated byHepatologist andGasteroenterologist only)

i) 180 mcg weekly SC with ribavirin800 mg daily for 24 weeks inpatients in genotype 2 and 3 and180 mcg weekly SC with ribavirin(1000 - 1200 mg) for 48 weeks forthose with genotype 1 and 4. 135mg dose may be used for patientswho cannot tolerate the 180 mcgdose ii) 180 mcg weekly SC for 48weeks

1212. PeginterferonAlpha-2a 180 mcgPrefilled Syringe

L03AB11000P5001XX

A* i) Chronic hepatitis C usually incombination with ribavirin(Important to establishhepatitis C virus (HCV) genotypeand viral load wherecombination treatment isadvocated) ii) For the treatmentof both HbeAg-positive andHbeAg-negative chronichepatitis B with compensated

i) 180 mcg weekly with ribavirin 800mg daily for 24 weeks in patients ingenotype 2 and 3 and 180 mcgweekly with ribavirin (1000 - 1200mg) for 48 weeks for those withgenotype 1 and 4. 135 mg dose maybe used for patients who cannottolerate the 180 mcg dose ii) 180mcg subcutaneously once a weekfor 48 weeks

Page 211 of 296

No. Generic Name MDC Category Indications Dosageliver disease and evidence ofviral replication who are notresponding or tolerating oralantiviral therapy (Initiated byHepatologist andGasteroenterologist only)

1213. PegylatedInterferon Alpha-2b 100 mcgInjection

L03AB10000P5003XX

A* Treatment of: i) ChronicHepatitis C ii) Chronic HepatitisB

i) Monotherapy: SC at a dose of 0.5or 1 mcg/kg once weekly for at least6 months. Combination therapy: 1.5mcg/kg/week SC in combinationwith ribavirin capsules. ii) 1-1.5mcg/kg once weekly for at least 24weeks and up to 52 weeks.

1214. PegylatedInterferon Alpha-2b 120 mcgInjection

L03AB10000P5004XX

A* Treatment of: i) ChronicHepatitis C ii) Chronic HepatitisB

i) Monotherapy: SC at a dose of 0.5or 1 mcg/kg once weekly for at least6 months. Combination therapy: 1.5mcg/kg/week SC in combinationwith ribavirin capsules. ii) 1-1.5mcg/kg once weekly for at least 24weeks and up to 52 weeks.

1215. PegylatedInterferon Alpha-2b 150 mcgInjection

L03AB10000P5005XX

A* Treatment of: i) ChronicHepatitis C ii) Chronic HepatitisB

i) Monotherapy: SC at a dose of 0.5or 1 mcg/kg once weekly for at least6 months. Combination therapy: 1.5mcg/kg/week SC in combinationwith ribavirin capsules. ii) 1-1.5mcg/kg once weekly for at least 24weeks and up to 52 weeks.

1216. PegylatedInterferon Alpha-2b 50 mcgInjection

L03AB10000P5001XX

A* Treatment of: i) ChronicHepatitis C ii) Chronic HepatitisB

i) Monotherapy: SC at a dose of 0.5or 1 mcg/kg once weekly for at least6 months. Combination therapy: 1.5mcg/kg/week SC in combinationwith ribavirin capsules. ii) 1-1.5mcg/kg once weekly for at least 24weeks and up to 52 weeks.

Page 212 of 296

No. Generic Name MDC Category Indications Dosage1217. Pegylated

LiposomalDoxorubicin HCl20 mg/vial

L01DB01110P3003XX

A* i) For patients with platinum-resistant ovarian cancer wherethe disease relapses within 6months after completion of theinitial platinum-basedchemotherapy ii) For patientswith platinum-sensitive ovariancancer where the diseaseresponds to first-line platinum-based therapy but relapses 12months or more aftercompletion of the initialplatinum based chemotherapy.As third line therapy for veryselected patients. (GyneOncology Specialist only)

50 mg/m2 IV every 4 weeks for aslong as the disease does notprogress & patient continues totolerate treatment.For doses <90mg: dilute in 250 ml Dextrose 5 % inWater. For doses >90 mg: dilute in500 ml Dextrose 5 % in Water. Tominimize the risk of infusionreactions, the initial dose isadministered at a rate no greaterthan 1 mg/minute. Renalimpairment: No dose adjustmentrequired in patients with creatinineclearance 30-156 ml/min, nopharmacokinetic data are availablein patients with creatinine clearanceof less than 30 ml/min. Hepaticimpairment: At initiation of therapy:Bilirubin 1.2 - 3.0 mg/dl, the firstdose is reduced by 25 %, Bilirubin >3.0 mg/dl, the first dose is reducedby 50 %.

1218. PemetrexedDisodium 100 mgInjection

L01BA04016P3002XX

A* In combination with Cisplatinfor the 2nd line treatment ofpatients with locally advancedor metastatic non small celllung cancer (NSCLC) other thanpredominantly squamous cellhistology

Initial therapy 500 mg/m(2) IV over10 minutes on day 1, followed 30minutes later by cisplatin 75mg/m(2) infused IV over 2 hours;repeat cycle every 21-days. Priorchemotherapy : 500 mg/m(2) IV, asa single-agent, over 10 minutes onday 1 of each 21-day cycle

1219. PemetrexedDisodium 500 mgInjection

L01BA04016P3001XX

A* In combination with Cisplatinfor the 2nd line treatment ofpatients with locally advancedor metastatic non small celllung cancer (NSCLC) other thanpredominantly squamous cellhistology

Initial therapy 500 mg/m(2) IV over10 minutes on day 1, followed 30minutes later by cisplatin 75mg/m(2) infused IV over 2 hours;repeat cycle every 21-days. Priorchemotherapy : 500 mg/m(2) IV, asa single-agent, over 10 minutes onday 1 of each 21-day cycle

1220. PentamidineIsethionate 300mg Injection

P01CX01198P3001XX

A* Only for the treatment ofpneumonia due toPneumocytosis carinii

4 mg/kg once daily by slow IVinfusion for at least 14 days

1221. Pentoxifylline 400mg Tablet

C04AD03000T1001XX

A/KK Peripheral vascular disease 400 mg 2 - 3 times daily

1222. Peracetic Acidand HydrogenPeroxide

V07AV00000L9906XX

A High level disinfectant orsterilant for heat labileendoscopes

Immersion time based onmanufacturer recommendation

1223. Perindopril 4 mgand Indapamide1.25 mg Tablet

C09BA04900T1001XX

A/KK Essential hypertension, forpatients whose blood pressureis insufficiently controlled byperindopril alone.

One tablet daily, preferably taken inthe morning and before a meal.

Page 213 of 296

No. Generic Name MDC Category Indications Dosage1224. Perindopril 4 mg

TabletC09AA04000T1001XX

B i) Hypertension ii) Congestiveheart failure iii) Stable coronaryartery disease

i) 4 mg as single dose, may beincreased to a single 8 mg dose.ELDERLY: Start treatment with 2 mgdose. In renal insufficiency, doseshould be adapted according tocreatinine clearance ii) Singlestarting oral dose of 2 mg should beincreased to a single 4 mg once BPacceptability has beendemonstrated iii) 4 mg once dailyfor 2 weeks, may be increased to 8mg once daily. ELDERLY: 2 mg oncedaily for 1 week, then 4 mg oncedaily for the following week, may beincreased up to 8 mg once daily

1225. Perindopril 8 mgTablet

C09AA04000T1002XX

B i) Hypertension ii) Congestiveheart failure iii) Stable coronaryartery disease

i) 4 mg as single dose, may beincreased to a single 8 mg dose.ELDERLY: Start treatment with 2 mgdose. In renal insufficiency, doseshould be adapted according tocreatinine clearance ii) Singlestarting oral dose of 2 mg should beincreased to a single 4 mg once BPacceptability has beendemonstrated iii) 4 mg once dailyfor 2 weeks, may be increased to 8mg once daily. ELDERLY: 2 mg oncedaily for 1 week, then 4 mg oncedaily for the following week, may beincreased up to 8 mg once daily

1226. PeritonealDialysis Solution(1.5% Dextrose)

B05DB00908H2001XX

B For chronic renal diseaserequiring dialysis and for acuterenal failure

Dose depending on clinical cases

1227. PeritonealDialysis Solution(4.25% Dextrose)

B05DB00908H2002XX

B For chronic renal diseaserequiring dialysis and for acuterenal failure

Dose depending on clinical cases

1228. PeritonealDialysis with 7.5%IcodextrinSolution

B05DB00908H2003XX

A* As a once replacement for asingle glucose exchange as partof a continuous ambulatoryperitoneal dialysis (CAPD) orautomated peritoneal dialysis(APD) regimen for thetreatment of chronic renalfailure, particularly for patientswho have lost ultra filtration onglucose solutions

Administered as a single dailyexchange for the long dwell incontinuous ambulatory peritonealdialysis or automated peritonealdialysis. The recommended dwelltime is 8 to 16 hours

1229. Permethrin 1%w/v Lotion.

P03AC04000L6002XX

B For topical treatment of headlice.

Apply lotion onto clean towel driedhair ensuring every strand comes incontact with lotion for at least 10minutes. Rinse completely. Re-applyafter 10 days to ensure totalrecovery.

Page 214 of 296

No. Generic Name MDC Category Indications Dosage1230. Permethrin 5%

w/v LotionP03AC04000L6001XX

A/KK Treatment of scabies Two applications needed one weekapart. Apply thoroughly to all bodyparts from neck down. Leaveovernight for 8 - 14 hours. Washedoff. Reapply after one week. Notrecommended for children less than2 months of age.

1231. Perphenazine 4mg Tablet

N05AB03000T1001XX

B Schizophrenia and otherpsychoses

ADULT: Initially 4 mg 3 times dailyadjusted according to response,maximum 24 mg daily. ELDERLY: 1/4to 1/2 adult dose. CHILD notrecommended

1232. Pethidine HCl 100mg/2 ml Injection

N02AB02110P3002XX

B For relief of moderate to severepain (medical and surgical), pre-anaesthetic medication andobstetrical analgesia

ADULT: 0.5 - 2 mg/kg SC or IM every3 - 4 hours if necessary. CHILD: byIM 0.5 - 2 mg/kg. Up to 1 year : 1- 2mg/kg weight IM, 1 - 5 years : 12.5 -25 mg IM, 6 - 12 years: 25 - 50 mgIM

1233. Pethidine HCl 50mg/ml Injection

N02AB02110P3001XX

B For relief of moderate to severepain (medical and surgical), pre-anaesthetic medication andobstetrical analgesia

ADULT: 0.5 - 2 mg/kg SC or IM every3 - 4 hours if necessary. CHILD: byIM 0.5 - 2 mg/kg. Up to 1 year : 1- 2mg/kg weight IM, 1 - 5 years : 12.5 -25 mg IM, 6 - 12 years: 25 - 50 mgIM

1234. Phenobarbitone30 mg Tablet

N03AA02000T1002XX

B Epilepsy ADULT: 60 - 180 mg daily on. CHILD:Up to 8 mg/kg daily

1235. PhenobarbitoneSodium 200mg/ml Injection

N03AA02520P3001XX

B Status Epilepticus ADULT: 10 mg/kg IV at a rate of notfaster than 100 mg/minute. Initialmaximum dose does not exceeding1 gm. Daily maintenance of 1 - 4mg/kg/day. CHILD: 10 - 20mg/kg/dose loading dose, followedby repeated doses at 10 mg/kg/dose(strictly in ICU setting). Maintenance5 - 8 mg/kg/day

1236. Phenol 80% w/wLiquid

D08AE03000L5001XX

C As disinfectant Use in various dilutions

1237. Phenoxybenzamine HCl 100 mg/2ml Injection

C04AX02110P3001XX

A* Hypertensive episodesassociated withphaeochromocytoma

1 mg/kg daily over at least 2 hoursinto large vein. Do not repeat within24 hours.

1238. PhenoxymethylPenicillin 125 mgTablet

J01CE02500T1001XX

C i) Treatment or prophylaxis ofinfections caused by susceptibleorganisms ii) Prophylactic,rheumatic fever

i) ADULT: 500 - 750 mg 6hourly.CHILD; up to 1 year: 62.5 mg,1 - 5 years: 125 mg, 6 - 12 years: 250mg 6 hourly ii) ADULT: 125 - 250 mgtwice daily. CHILD: 25 - 50 mg/kg individed doses every 6 - 8 hours.Maximum: 3 g/day

1239. PhenoxymethylPenicillin 125mg/5 ml Syrup

J01CE02500F2101XX

C Treatment or prophylaxis ofinfections caused by susceptibleorganisms

CHILD: Up to 1 year: 62.5 mg 6hourly; 1 - 5 years: 125 mg 6 hourly;6 - 12 years: 250 mg 6 hourly

Page 215 of 296

No. Generic Name MDC Category Indications Dosage1240. Phenoxymethyl

Penicillin 250 mgTablet

J01CE02500T1002XX

C i) Treatment or prophylaxis ofinfections caused by susceptibleorganisms ii) Prophylactic,rheumatic fever

i) ADULT: 500 - 750 mg 6hourly.CHILD; up to 1 year: 62.5 mg,1 - 5 years: 125 mg, 6 - 12 years: 250mg 6 hourly ii) ADULT: 125 - 250 mgtwice daily. CHILD: 25 - 50 mg/kg individed doses every 6 - 8 hours.Maximum: 3 g/day

1241. PhenylephrineHCI 2.5% EyeDrops

S01FB01110D2001XX

B For pupillary dilation in uveitis,for refraction withoutcyclopegic. For fundoscopy andother diagnostic procedures

Mydriasis and vasoconstriction: 1drop of 2.5% or 10% solution,repeated in one hour if necessary.Chronic mydriasis: 1 drop of a 2.5%or 10% solution 2 - 3 times a day.Uveitis with posterior synechiae(treatment) or synechiae, posterior(prophylaxis): 1 drop of a 2.5% or10% solution, repeated in one hourif necessary, not to exceed threetimes a day. Treatment may becontinued the following day, ifnecessary

1242. PhenylephrineHCl 10% EyeDrops

S01FB01110D2002XX

B For pupillary dilation in uveitis,for refraction withoutcyclopegic. For fundoscopy andother diagnostic procedures

Mydriasis and vasoconstriction: 1drop of 2.5% or 10% solution,repeated in one hour if necessary.Chronic mydriasis: 1 drop of a 2.5%or 10% solution 2 - 3 times a day.Uveitis with posterior synechiae(treatment) or synechiae, posterior(prophylaxis): 1 drop of a 2.5% or10% solution, repeated in one hourif necessary, not to exceed threetimes a day. Treatment may becontinued the following day, ifnecessary

1243. PhenytoinSodium 100 mgCapsule

N03AB02520C1002XX

B Epilepsy ADULT and CHILD more than 6years: 300-400 mg/day in 3 - 4divided doses before meals.Maximum: 600 mg/day. CHILD:Initially 5 mg/kg/day in 2 - 3 divideddoses. Maintenance: 4 - 8mg/kg/day. Maximum: 300 mg/day

1244. PhenytoinSodium 125mg/5mlSuspension

N03AB02520L8001XX

B Epilepsy ADULT: Patients with no previoustreatment may be started on 1teaspoonful or 5 mL (125 milligrams)3 times daily. It is thenindividualized to the patient. Anincrease to 5 teaspoonfuls (625milligrams) may be made ifnecessary. CHILD: Initially 5mg/kg/day in 2 - 3 divided doses.Maintenance: 4 - 8 mg/kg/day.Maximum: 300 mg/day. Childrenover 6 years and adolescents mayrequire the minimum adult dose

Page 216 of 296

No. Generic Name MDC Category Indications Dosage(300mg/day).

1245. PhenytoinSodium 30 mgCapsule

N03AB02520C1001XX

B Epilepsy ADULT and CHILD more than 6years: 300-400 mg/day in 3 - 4divided doses before meals.Maximum: 600 mg/day. CHILD:Initially 5 mg/kg/day in 2 - 3 divideddoses. Maintenance: 4 - 8mg/kg/day. Maximum: 300 mg/day

1246. PhenytoinSodium 50mg/mllnjection

N03AB02520P3001XX

B Status epilepticus i) Status epilepticus: ADULT 10 - 15mg/kg by slow IV. Maximum 50mg/minute. Maintenance: 100 mgorally/IV every 6 - 8 hours. CHILD 15- 20 mg/kg by slow IV. Maximum: 1 -3 mg/kg/minute ii) Neurosurgery100 - 200 mg IM approximately at 4hourly interval

1247. PhosphateSolutioncontainingSodium AcidPhosphate 1.936g /15 ml

B05XA09902L5001XX

A For supplemental ionicphosphorus for correction ofhypophosphataemia

According to the needs of thepatient

1248. Phyllanthus NiruriExtract 250 mgCapsule

HA05BA5999C1001XX

A/KK Liver tonic 2 capsules to be taken orally, 3times a day, before or after meals

1249. Pilocarpine 1%Eye Drops

S01EB01110D2001XX

B Miotics in chronic open-angleglaucoma

1 drop 1 - 4 times a day

1250. Pilocarpine 2%Eye Drops

S01EB01110D2002XX

B Miotics in chronic open-angleglaucoma

1 drop 1 - 4 times a day

1251. Piperacillin 4 g &Tazobactam 500mg Injection

J01CR05961P3001XX

A* Febrile neutropenia, lowerrespiratory tract infection andsevere sepsis

Adult and children more than 12years: 4.5g 6 hourly, for neutropeniaadult and children more than 50kg:4.5g 6 hourly. Children less than50kg: 90mg/kg 6 hourly

1252. PiperacillinSodium 4 gInjection

J01CA12520P4002XX

A Infections due to Pseudomonasaeruginosa

ADULT: 100 - 150 mg/kg IM/IV individed doses. Increase to 200 - 300mg/kg in severe infections & at least16 g in life-threatening infections.Single dose over 2 g: IV route only.Maximum: 24 g/day. CHILD: 50-75mg/kg/dose every 6 - 8 hourly

1253. Piracetam 1 gInjection

N06BX03000P3001XX

A* Treatment of cerebralfunctional impairment

30 - 160 mg/kg/day orally orparenterally 2 times daily or 3 to 4times daily. Maximum: 24 g/day

1254. Piracetam 1.2 gTablet

N06BX03000T1001XX

A* Mild cognitive impairment, postconcussional head syndrome,head injury disorder, chronicvertigo and myoclonus

Initially 7.2 g daily in 2 - 3 divideddoses, increased according toresponse by 4.8 g daily every 3 - 4days to maximum of 20 g daily.CHILD under 16 years notrecommended

1255. Piracetam 20%Solution

N06BX03000L5001XX

A* Children with learning disability,progressive myoclonic epilepsyand hypoxia

30 - 160 mg/kg/day orally. To begiven 2 times daily or 3 - 4 timesdaily. Maximum 24 g/day

Page 217 of 296

No. Generic Name MDC Category Indications Dosage1256. Piribedil 50 mg

TabletN04BC08000T5001XX

A* Parkinson disease As monotherapy: 150 - 250 mg as 3 -5 divided doses daily. Ascombination with L-dopa therapy:50 - 150 mg daily (50 mg per 250 mgof L-dopa)

1257. Piroxicam 10 mgCapsule

M01AC01000C1001XX

A/KK i) Rheumatoid arthritis,osteoarthritis, ankylosingspondylitis ii) Acutemusculoskeletal disorders iii)Acute gout

i) 20 mg daily, maintenance 10 - 30mg daily, in single or divided dosesii) 40 mg daily in single or divideddoses for 2 days, then 20 mg dailyfor 7 - 14 days iii) 40 mg initially,then 40 mg daily in single or divideddoses for 4 - 6 days

1258. Pizotifen 0.5 mgTablet

N02CX01253T1001XX

B Prophylactic treatment ofvascular headache

Starting with 0.5mg daily, thedosage should be progressivelyincreased. The average maintenancedosage is 1.5mg daily in divideddoses or as a single dose at night.Max dose: 4.5 mg/day and 3mg/dose. Child: >2 yr: Up to 1.5 mgdaily in divided doses. Max dose: 1mg/dose.

1259. Pneumococcalpolysaccharideconjugate vaccine(adsorbed) 13-valent injection

J07AL01-000-P30-01-XXX

A* Active immunization for theprevention of pneumococcaldisease caused byStreptococcus pneumoniaeserotypes 1,3,4,5,6A, 6B, 7F, 9V,14, 18C, 19A, 19F and 23F in thepopulation with associated riskin IPD with the followingconditions: • Functional oranatomical asplenia; • Cochlearimplant; • Congenital immune-deficiency; • Haematopoieticand solid organ transplant; •Adults aged 60 years and abovewith one of the followingconditions: i) Chronic lungdiseases, including chronicobstructive pulmonary disease(COPD), emphysema & asthma(requiring frequent hospitalvisit & use of multiplemedications). ii) Chronic liverdisease including cirrhosis,biliary atresia, chronic hepatitisiii) Chronic cardiac disease,including congestive heartfailure, congenital heartdisease, and cardiomyopathies

Pneumococcal polysaccharideconjugate vaccine (adsorbed), 13-valent [PCV13] is to be administeredas a single dose to adults 18 yearsand older including those previouslyvaccinated with a pneumococcalpolysaccharide vaccine. The needfor re-vaccination with a subsequentdose of PCV13 has not beenestablished

Page 218 of 296

No. Generic Name MDC Category Indications Dosage1260. Pneumococcal

Vaccine(Polyvalent)

J07AL01000P3001XX

A Prevention of pneumococcalinfections in high risk subjectsfrom the age of 2 yearsincluding patient with a historyof splenectomy or scheduledsplenectomy

Primary injection: 1 single injection(0.5 ml) only. Booster: Must not begiven within 5 years except in veryhigh risk patient who received thevaccine while underimmunosuppressive treatment

1261. Podophyllum 10 -20% Paint

D06BB04000L7001XX

B External anogenital warts Apply 2 - 3 drops carefully to lesionafter protecting surrounding areawith vaseline. Wash off after 6 hoursor if feel burning sensation andrepeat 2 - 3 times weekly or onceweekly

1262. Policresulen 360mg/gConcentrate

G01AX03900L9901XX

A Local treatment of cervical andvaginal inflammation and tissuedamage eg. discharge due tobacterial, trichomonal andfungal infections, protrusions ofendocervical mucosa (erosion),haemostasis following biopsy orexcision of uterine polyps

For cauterization, undiluted once ortwice weekly whilst for vaginaldouches, to be diluted 1 partconcentrate to 5 parts of water

1263. Poliomyelitis OralLive Vaccine (10Doses)

J07BF02000D5001XX

C+ Immunisation againstpoliomyelitis

Two drops (0.1 ml). Primaryimmunization: 1 oral dose at 3,4 & 5month of age. Booster doses at 1-4years & 7 years.

1264. Polycitra Syrup A12BA02955L9001XX

C For treatment of calcium anduric acid stones

The usual dose of potassium citrateis 30 - 60 mEq/day orally in 3 or 4doses with meals or within 30minutes after meals. ADULT: 15 ml 3times daily well diluted with water.CHILD 5-15 ml 3 times daily, aftermeals and at bedtime.

1265. PolyethyleneGlycol /Macrogol4000 Powder

A06AD15000F2101XX

A Bowel cleansing prior tocolonoscopy, radiologicalexamination or colonic surgery.Suitable for patients with heartfailure or renal failure

1 sachet dissolved in 1 L of water. 2-3 L of oral solution are required.When morning surgery is planned,the oral solution is given in the lateafternoon the day prior. If surgery isscheduled in afternoon, the oralsolution should be given on thesame day for ingestion to becompleted three hours beforesurgery

1266. Polymyxin BSulphate 10,000U, NeomycinSulphate 5 mgandHydrocortisone10 mg Ear Drops

S02CA03991D1001XX

B Treatment of bacterial infectionand inflammation of theexternal auditory meatus

3 drops 3 - 4 times daily. Externalauditory meatus and canal to bethoroughly cleansed and driedbefore each application but soapshould not be used as the antibioticsmay be inactivated by it

Page 219 of 296

No. Generic Name MDC Category Indications Dosage1267. Posaconazole

40mg/ml OralSuspension

J02AC04000L8001XX

A* Prophylaxis of invasive fungalinfections in the following adultpatients: i. Patient receivingremission-inductionchemotherapy for acutemyelogenous leukemia (AML)or myelodysplastic syndrome(MDS) expected to result inprolonged neutropenia andwho are at high risk ofdeveloping invasive fungalinfections. ii. Haematopoieticstem cell transplant (HSCT)recipients who are undergoinghigh-dose immunosuppressivetherapy for graft versus hostdisease and who are at high riskof developing invasive fungalinfections.

Prophylaxis of invasive fungalinfections: 200mg (5ml) three timesa day. The duration of therapy isbased on recovery from neutropeniaor immunosuppression. For patientswith acute myelogenous leukemiaor myelodysplastic syndromes,prophylaxis with posaconazoleshould start several days before theanticipated onset of neutropeniaand continue 7 days after theneutrophil count rises above500cell/mm3. Increasing the totaldaily dose above 800mg does notfurther enhance the exposure toposaconazole.

1268. PotassiumChloride 0.15%w/v & SodiumChloride 0.9%w/v Injection

A06AD10921L9902XX

B Prevention and treatment ofpotassium, sodium and chloridedepletion

Dosage depends on the age, weight,clinical and biological (acid-basebalance) conditions of the patientand concomitant therapy. Maximumrecommended dose of potassium is2 to 3 mmol/kg/24hr

1269. PotassiumChloride 1 g/10ml Injection

B05XA01100P3001XX

B For the correction of severehypokalaemia and whensufficient potassium cannot betaken by mouth

By slow IV infusion depending onthe deficit or the daily maintenancerequirements. 1 g diluted in 500 mlnormal saline or glucose and givenslowly over 2 - 3 hours

1270. PotassiumChloride 1 g/15ml Mixture

A12BA01100L2101XX

C Potassium depletion 1 g once or twice daily until serumpotassium is restored

1271. PotassiumChloride 600 mgSR Tablet

A12BA01100T5001XX

B For the treatment and specificprevention of hypokalaemia

ADULT: 2 - 3 tablets daily. Severedeficiency: 9 - 12 tablets daily oraccording to the needs of thepatient

1272. Potassium Citrate3 g/10 ml andCitric AcidMixture

A12BA02955L2101XX

C For systemic or urinealkalinization

ADULT: 15-30 ml well diluted withwater. CHILD up to 1 year: 2.5 ml 3times daily; 1 - 5 years: 5 ml 3 timesdaily; 6 - 12 years: 10 ml 3 timesdaily. To be taken well diluted withwater, after meals and at bedtime.

1273. PotassiumDihydrogenPhosphateInjection

B05XA06170P3001XX

A For treatment ofhypophosphataemia

Up to 10mmol phosphateadministered over 12 hours

1274. Potassium IodideMixture

H03CA00200L2101XX

B Pre-operative management ofhyperthyroidism andthyrotoxicosis

ADULT and CHILD: 50 - 250 mg 3times daily

1275. PotassiumPermanganate1:10,000 Solution

D08AX06362L9901XX

C+ Cleansing and deodorisingsuppurative eczematousreactions and wounds

As soaks or wet dressing 1 - 3 timesdaily or as required

Page 220 of 296

No. Generic Name MDC Category Indications Dosage1276. Potassium

Permanganate1:20,000 Solution

D08AX06362L9902XX

C Cleansing and deodorisingsuppurative eczematousreactions and wounds

As a bath once to twice daily or asrequired

1277. Povidone Iodine10% (equivalentto 1% iodine)Solution

D08AG02000L9902XX

B Skin operation prior to surgery,in cleansing open wounds, as anantiseptic for operative woundsinfections

To be applied undiluted in pre-operative skin disinfection andgeneral antisepsis.

1278. Povidone Iodine7.5% (equivalentto 0.75% iodine)Scrub

D08AG02000L9901XX

B As preoperative scrub for handsand skin

Spread 5 ml over both hands andrub thoroughly for about 5 minutes.Rinse thoroughly. Repeat if desired.Pre-operative use on patient: Applyscrub and rub thoroughly for about5 minutes. Rinse off using a sterilegauze saturated with water

1279. Pralidoxime 25mg/ml Injection

V03AB04000P3002XX

B Antidote in the treatment oforganophosphorus insecticidepoisoning and in the control ofoverdosage by anticholinergicdrugs used in the treatment ofmyasthenia gravis

Adult: Used in combination withatropine. Admin atropine via IM/IVinj and repeat as needed untilpatient shows signs of atropinetoxicity. Maintain atropinisation forat least 48 hr. As soon as the effectsof atropine are observed, 1-2 g ofpralidoxime (chloride, iodide ormesilate) may be given via IM/IV inj.Repeat dose after 1 hr, then every8-12 hr, if necessary. In severepoisoning, continuous infusion of200-500 mg/hr may be given,titrated according to response.Alternatively, pralidoxime chloridemay be given at an initial dose of 30mg/kg via IV infusion over 20minutes or IV inj over 5 minutes,followed by IV infusion at 8mg/kg/hr. Max: 12 g/24 hr. Child: Asmesilate: 20-60 mg/kg. Renalimpairment: Dose adjustment maybe required.

1280. PramipexoleDihydrochloride0.125 mg Tablet

N04BC05110T1001XX

A* Treatment for signs andsymptoms of advancedidiopathic Parkinson's disease.It may be used as monotherapyor in combination withlevodopa

Dose escalation: 0.125 mg 3 timesdaily on week 1 then 0.25 mg 3times daily week 2 then 0.5 mg 3times daily on week 3. Increase by0.75 mg at weekly intervals ifneeded up to maximum of 4.5mg/day. Patient on levodopa:Reduce dose. Renal impairment: Inpatient with creatinine clearance <20ml/min, the daily dose ofpramipexole should be started at0.125 mg daily instead of 0.25mgand the maximum dose should not >1.5 mg daily

Page 221 of 296

No. Generic Name MDC Category Indications Dosage1281. Pramipexole

Dihydrochloride 1mg Tablet

N04BC05110T1002XX

A* Treatment for signs andsymptoms of advancedidiopathic Parkinson's disease.It may be used as monotherapyor in combination withlevodopa

Dose escalation: 0.125 mg 3 timesdaily on week 1 then 0.25 mg 3times daily week 2 then 0.5 mg 3times daily on week 3. Increase by0.75 mg at weekly intervals ifneeded up to maximum of 4.5mg/day. Patient on levodopa:Reduced dose. Renal impairment: Inpatient with creatinine clearance <20ml/min, the daily dose ofpramipexole should be started at0.125 mg daily instead of 0.25mgand the maximum dose should not >1.5 mg daily

1282. PramipexoleDihydrochlorideExtended Release0.375mg Tablet

N04BC05110T5001XX

A Treatment for signs andsymptoms of advancedidiopathic Parkinson's disease.It may be used as monotherapyor in combination withlevodopa

Dose escalation: 0.375 mg/day onweek 1, 0.75 mg/day on week 2, 1.5mg/day on week 3. Increase by 0.75mg at weekly intervals if needed upto a max of 4.5 mg/day. Patient on l-dopa: reduce dose. RenalImpairment: CrCl 30-50 mL/minInitially 0.375 mg every other day.May be increased by 0.375 mg atweekly intervals to max 2.25 mg/day

1283. PramipexoleDihydrochlorideExtended Release1.5mg Tablet

N04BC05110T5003XX

A Treatment for signs andsymptoms of advancedidiopathic Parkinson's disease.It may be used as monotherapyor in combination withlevodopa

Dose escalation: 0.375 mg/day onweek 1, 0.75 mg/day on week 2, 1.5mg/day on week 3. Increase by 0.75mg at weekly intervals if needed upto a max of 4.5 mg/day. Patient on l-dopa: reduce dose. RenalImpairment: CrCl 30-50 mL/minInitially 0.375 mg every other day.May be increased by 0.375 mg atweekly intervals to max 2.25 mg/day

1284. Prasugrel HCl 10mg Tablet

B01AC22110T1002XX

A* Co-administered with aspirin, isindicated to reduce the rate ofthrombotic cardiovascular (CV)events (including stentthrombosis) in patients withacute coronary syndromes whoare to be managed withpercutaneous coronaryintervention (PCI) as follows:STEMI with or without diabetes,UA and NSTEMI with diabetes,age <75yrs old, weight >60kg,without history of TIA strokeand clinically suspectedclopidogrel resistance subset.(Only to be used in CardiologyCentre as third line treatment/adjunctive therapy).

Initiate treatment with a single60mg oral loading dose. Continue at10mg/5mg once daily with orwithout food. Patients should alsotake aspirin (75 mg - 325 mg) daily.

Page 222 of 296

No. Generic Name MDC Category Indications Dosage1285. Pravastatin

Sodium 20 mgTablet

C10AA03520T1001XX

A/KK Hypercholesterolaemia andcoronary heart diseaseintolerant or not responsive toother forms of therapy. Inhealth clinics, Pravastatin isrestricted to HIV patients onHAART.

10 - 20 mg once daily. Maximum: 40mg daily. In patients concomitantlytaking cyclosporine, with or withoutother immunosuppressive drugs:Initial dose is 10mg/day andtitration to higher doses should beperformed with caution. Maximumdose 20mg/day.

1286. Prazosin HCl 1 mgTablet

C02CA01110T1001XX

B Hypertension Initially 0.5 mg 2 - 3 times daily, theinitial dose on retiring to bed atnight; increased to 1 mg 2 - 3 timesdaily after 3 - 7 days: furtherincreased if necessary to maximum20 mg daily

1287. Prazosin HCl 2 mgTablet

C02CA01110T1002XX

B Hypertension Initially 0.5 mg 2 - 3 times daily, theinitial dose on retiring to bed atnight; increased to 1 mg 2 - 3 timesdaily after 3 - 7 days: furtherincreased if necessary to maximum20 mg daily

1288. Prazosin HCl 5 mgTablet

C02CA01110T1003XX

B Hypertension Initially 0.5 mg 2 - 3 times daily, theinitial dose on retiring to bed atnight; increased to 1 mg 2 - 3 timesdaily after 3 - 7 days: furtherincreased if necessary to maximum20 mg daily

1289. Pre/Post NatalVitamin &Mineral Capsule

A11AA03903C1001XX

C+ Vitamin and mineralsupplement for use duringpregnancy and lactation

1 capsule daily or based onindividual requirements

1290. Pre/Post NatalVitamin &Mineral Tablet

A11AA03903T1001XX

C+ Vitamin and mineralsupplement for use duringpregnancy and lactation

1 tablet daily or based on individualrequirements

1291. Prednisolone 2.5mg/5 ml Syrup

H02AB06000L9002XX

B i) Replacement therapy forprimary and secondaryadrenocortical insufficiency ii)Adrenogenital syndrome iii)Other therapy

i) 5 - 25 mg daily in divided doses ii)10 - 20 mg/m2 body surface daily individed doses iii) ADULT: 5 - 60 mgdaily. CHILD: 0.5 - 2 mg/kg/day individed doses every 6 - 8 hours or asa single daily

1292. Prednisolone 5mg Tablet

H02AB06000T1001XX

B i) Replacement therapy forprimary and secondaryadrenocortical insufficiency ii)Adrenogenital syndrome iii)Other therapy

i) 5 - 25 mg daily in divided doses ii)10 - 20 mg/m2 body surface daily individed doses iii) ADULT: 5 - 60 mgdaily. CHILD: 0.5 - 2 mg/kg/day individed doses every 6 - 8 hours or asa single daily

1293. Prednisoloneacetate 1%ophthalmicsuspension

S01BA04122D2001XX

A For steroid responsiveinflammation of the palpebraland bulbar conjunctiva, corneaand anterior segment of theglobe.

1 to 2 drops to be instilled into theconjunctival sac 2 to 4 times daily.During the initial 24 to 48 hours thedosage may be safely increased to 2drops every hour. Care should betaken not to discontinue therapyprematurely.

Page 223 of 296

No. Generic Name MDC Category Indications Dosage1294. Pregabalin 150

mg CapsulesN03AX16000C1002XX

A* i) Second line treatment ofneuropathic pain in patientswho do not response to firstline drugs ii) Fibromyalgia

i) Initially, 75 mg twice daily. May beincreased to 150 mg twice dailyafter 3-7 days. Max: 600 mg/dayafter an additional 7-day interval ii)Initially, 75 mg twice daily. May beincreased to 150 mg twice dailywithin 1 week or 225 mg twice daily.Max: 450 mg/day

1295. Pregabalin 75 mgCapsule

N03AX16000C1001XX

A* i) Second line treatment ofneuropathic pain in patientswho do not response to firstline drugs ii) Fibromyalgia

i) Initially, 75 mg twice daily. May beincreased to 150 mg twice dailyafter 3-7 days. Max: 600 mg/dayafter an additional 7-day interval ii)Initially, 75 mg twice daily. May beincreased to 150 mg twice dailywithin 1 week or 225 mg twice daily.Max: 450 mg/day

1296. Primaquine 7.5mg base Tablet

P01BA03162T1001XX

B i) Treatment of malaria ii)Prophylaxis together with aschizonticide such aschloroquine

i) 15 mg daily for 14 days, increasedto higher doses or longer course ifresistance in P.vivax occurs. ii)ADULT: 30 mg once weekly. CHILD:0.5 mg once weekly Child: 250mcg/kg daily for 14 days. Should betaken with food. Take with meals toavoid GI discomfort.

1297. Primidone 250mg Tablet

N03AA03000T1001XX

B Epilepsy ADULT: Initially 1 tablet daily in theevening, increasing by 1 tablet every4 - 7 days to 3 - 4 tablets daily.Maximum dosage: 1.5 g daily individed doses. CHILD: 6 - 8 years: Upto 1/2 adult dose

1298. Probenecid 500mg Tablet

M04AB01000T1001XX

A Hyperuricemia associated withgout and gouty arthritis (forcases allergic to allopurinol orserum uric acid not controlledby allopurinol alone)

500 mg to 1000 mg twice daily

1299. ProcaineBenzylpenicillinAqueous 3 megaunits (3 g)Injection

J01CE09702P4001XX

B Treatment of infections due toPenicillin G-sensitive organisms

ADULT: 300,000 - 900,000 units (300- 900 mg) IM daily. CHILD: Up to 1year: 150 mg IM daily. 1 - 5 years:300 mg IM daily. 6 - 12 years: 600mg IM daily

1300. ProcainePenicillinFortified 4 MUInjection

J01CE09702P4002XX

B Treatment of infections due toPenicillin G-sensitive organisms

ADULT: 300,000 - 900,000 units (300- 900 mg) IM daily. CHILD: Up to 1year: 150 mg IM daily. 1 - 5 years:300 mg IM daily. 6 - 12 years: 600mg IM daily

Page 224 of 296

No. Generic Name MDC Category Indications Dosage1301. Procarbazine HCl

50 mg CapsuleL01XB01110C1001XX

A Lymphomas Adult: Monotherapy: Initially, 50mg/day, increased by 50 mg daily to250-300 mg daily in divided doses.Continue doses until max responseis achieved or appearance of signs oftoxicity. Maintenance: 50-150mg/day or 1-2 mg/kg daily until acumulative dose of at least 6 g.Combination Therapy: 100 mg/m2on days 1-14 of each 4- or 6-wkcycle. Child: Initially, 50 mg/m2daily, up to 100 mg/m2 adjustaccording to response.

1302. ProchlorperazineMaleate 5mgTablet

N05AB04253T1002XX

B i) Severe nausea and vomitingii) Vertigo/labyrinthinedisorders

Nausea and vomiting Adult: Asmaleate or mesilate: 20 mg, furtherdoses are given if needed.Recommended buccal dose: Asmaleate: 3-6 mg bid. Vertigo Adult:As maleate or mesilate: 15-30 mgdaily, given in divided doses. Mayreduce gradually to 5-10 mg daily.Recommended buccal dose: 3-6 mgbid. May be taken with or withoutfood.

1303. ProchlorperazineMesylate 12.5mg/ml Injection

N05AB04253P3001XX

B i) Severe nausea and vomitingii) Vertigo/labyrinthinedisorders

Deep IM injection, 12.5 mg repeatedif necessary after 6 hours and thenfollowed by an oral dose. Notrecommended in children

1304. Procyclidine HCl 5mg/ ml Injection

N04AA04110P3001XX

B i) All forms of Parkinson'sdisease (idiopathic paralysisagitants), post-encephalitis andarteriosclerosis ii) To controltroublesome extrapyramidalsymptoms induced byneuroleptic drugs includingpseudo-parkinsonism, acutedystonic reactions and akathisia

i) Initial dose 2.5mg TDS, increasingby 2.5-5mg/day at intervals of 2 or 3days until the optimum clinicalresponse is achieved. Usualmaintenance dose: 15-30mg/day.Max: 60mg/day ii) Initial dose 2.5mgTDS, increasing by 2.5mg daily untilsymptoms are relieved. Usualmaintenance dose: 10-30mg/day. IVEmergency: 5-10 mg. IM Emergency:5-10 mg as a single dose, mayrepeat after 20 mins if needed. Max:20 mg/day.

1305. Progesterone 100mg capsule

G03DA04000C1001XX

A* Supplementation of the lutealphase.

Oral route: On average forprogesterone insufficiency, the dailydose of progesterone is 200-300mgper day; one capsule after breakfastand one to two capsules at bedtime.Vaginal route: 4 to 6 capsules (in 2to 3 divided doses) per day startingfrom the day of the HCG injectionuntil the 12th week of pregnancy.

1306. Progesterone 8%Vaginal Gel

G03DA04000G3001XX

A* Treatment of infertility due toinadequate luteal phase

90 mg intravaginally daily from dayof egg retrieval till pregnancyestablished

Page 225 of 296

No. Generic Name MDC Category Indications Dosage1307. Prolase Tablet M09AB0000

0T1001XXB Oedema and inflammation in

conjunction with other physicalor chemotherapeutic measures

2 tablet 4 times daily

1308. Promethazine HCl25 mg/mlInjection

R06AD02110P3001XX

B Allergic conditions By deep IM: ADULT: 25 - 50 mg,maximum 100 mg. CHILD 5 - 10years : 6.25 - 12.5 mg. By slow IV: 25- 50 mg in a solution of 2.5 mg/ml inwater for injection. Maximum 100mg

1309. Promethazine HCl5 mg/5 ml Syrup

R06AD02110L9001XX

B Allergic conditions CHILD 2 - 5 years: 5 - 15 mg daily 5 -10 years : 10 - 25 mg daily

1310. Proparacaine HCI0.5% OphthalmicDrops

S01HA04110D2001XX

B Topical anaesthesia inophthalmic procedures

Deep anaesthesia:1 or 2 drops in the(eyes) every 5 to 10 minutes for 3 to5 doses. For minor surgicalprocedures: instill 1 to 2 drops every5 to 10 minutes for 1 to 3 doses.Tonometry and/or tonographyprocedure: 1 to 2 drops in each eyebefore procedure.

1311. Propiverine HCl15 mg Tablet

G04BD06110T1001XX

A* Treatment of urinaryincontinence, urgency andfrequency in neurogenicdetrusor overactivity (detrusorhyperreflexia) and in idiopathicdetrusor overactivity(overactive bladder)

ADULT: 15 mg twice daily to 3 timesdaily, increase to 4 times daily ifrequired. Max dose: 60 mg daily.CHILD more than 5 years: 0.2 to 0.4mg/kg per day in 2 divided doses

1312. Propofol10mg/ml (1%)Injection

N01AX10000P9901XX

A* Induction & maintenance ofgeneral anaesthesia. Sedationof ventilated ICU patients

Adult: Induction: 20- 40 mg byinjection or infusion every 10 sec.Usual dose: 1.5-2.5 mg/kg.Maintenance: 4-12 mg/kg/hr orintermittent bolus inj of 20-50 mg.Child: >8 yr: Induction dose of 2.5mg/kg. Maintenance dose: 9-15mg/kg/hr by IV infusion orintermittent bolus inj. Elderly:Including neurosurgical anddebilitated patients: Infuse at a rateof 20 mg every 10 sec.Maintenance: 3-6 mg/kg/hr. Usualdose needed: 1-1.5 mg/kg. Durationof use : Can be administered for amaximum period of 7 days.Sedation: 0.3 - 4 mg/kg/hour up to 3days

1313. Propofol20mg/ml (2%)emulsion forinjection ofinfusion

N01AX10000P9902XX

A* Induction & maintenance ofgeneral anaesthesia. Sedationof ventilated ICU patients

Adult: IV Induction and maintenanceof general anesth Induction: 40 mgevery 10 sec. Maintenance: 4-12mg/kg/hr or intermittent boluses of20-50 mg. Sedation In diagnosticand surgical procedures: Initial: 6-9mg/kg/hr by infusion. Maintenance:1.5-4.5 mg/kg/hr. For ventilatedpatients: 0.3-4 mg/kg/hr. Monitor

Page 226 of 296

No. Generic Name MDC Category Indications Dosagelipid concentrations if duration ofsedation >3 days.

1314. Propranolol HCl 1mg/ml Injection

C07AA05110P3001XX

A Arrhythmias and thyrotoxicosiscrisis

Slow IV injection in a dose of 1 mgover 1 minute, repeated if necessaryevery 2 minutes until a maximum of10 mg has been given in consciouspatients and 5 mg in patients underanaesthesia. CHILD: 25 - 50 mcg/kgslow IV with appropriate monitoring

1315. Propranolol HCl10 mg Tablet

C07AA05110T1001XX

B Dysrythmias, tachycardia,hypertrophic obstructivecardiomyopathy (Forcardiologist only)

10 - 40 mg 3 - 4 times daily

1316. Propranolol HCl40 mg Tablet

C07AA05110T1002XX

B i) Hypertension ii) Angina iii)Myocardial infarct iv) Cardiacarrhythmia v) Portalhypertension vi) Migraine vii)Thyrotoxicosis

i) Initially 80 mg twice dailyincreased as required to a usualrange of 160 - 320 mg daily. CHILD:Initial doses of 1 mg/kg in divideddoses, can be increased to 2 - 4mg/kg/day in divided doses ii) Initialdose of 40 mg 2 - 3 times daily.Maintenance 120 - 240 mg daily iii)40mg 4 times daily for 2 - 3 daysthen 80 mg twice daily, beginning 5 -21 days after infarction iv) 10 - 40mg 3 - 4 times daily v) Initially 40 mgtwice daily. The dose may beincreased as required up to 160 mgtwice daily vi) Initial prophylaxisdose: 40 mg 2 - 3 times daily. Thedose may be increased at weeklyintervals up to 160 mg daily vii)Adjunct: 10 - 40 mg 3 - 4 times daily.CHILD: Arrythmias, thyrotoxicosis:0.25 - 0.5 mg/kg 3 - 4 times daily asrequired

1317. Propylthiouracil50 mg Tablet

H03BA02000T1001XX

B Hyperthyroidism ADULT Initially 300-450mg in 8hourly intervals (can be given up to600-900mg/daily) until symptomsare controlled in 1-2 months.Maintenance 50-150mg daily for atleast 12-18 months. CHILDREN 6-10years: 50-150mg. CHILDREN > 10years: 150-300mg daily. All dosesare to be given in 3 divided dosesdaily. Taken with food.

Page 227 of 296

No. Generic Name MDC Category Indications Dosage1318. Protamine

Sulphate 10mg/ml Injection

V03AB14183P3001XX

B Heparin overdose and followingcardiac or arterial surgery ordialysis procedures whenrequired to neutralize theeffects of heparin administeredduring extracorporealcirculation

5 ml slow IV injected over 10minutes. If administered within 15minutes of heparin dose, 1 mg willneutralise approximately 100 unitsof heparin. If longer time haselapsed, less protamine is required.Not more than 50 mg should beinjected at any one time. The dose isdependent on the amount and typeof heparin to be neutralised, itsroute of administration and the timeelapsed since it was last given andblood coagulation studies.

1319. Protein FreeHaemodialysate10% Jelly

D03AX00000G4001XX

A Trophic lesions in patients witharterial occlusive disease andwith chronic venousinsufficiency, burn injuries,impaired wound healing,decubitus ulcers and skin ulcercaused by irradiation

Apply 3 - 5 times daily

1320. Protein FreeHaemodialysate20% Eye Gel

S01XA20000G3001XX

A Eyes disorders e.g. burns,scalds, ulcers, prevention andtreatment of radiationdermatitis, traumatic andischaemic wound

Instill 1 drop 3 - 4 times daily

1321. Protein FreeHaemodialysate5% Ointment

D03AX00000G5001XX

A Trophic lesions in patients witharterial occlusive disease andwith chronic venousinsufficiency, burn injuries,impaired wound healing,decubitus ulcers and skin ulcercaused by irradiation

Apply 3 - 5 times daily

1322. Protein FreeHaemodialysateDental AdhesivePaste

D03AX00000G6001XX

A Painful and inflammatoryaffliction on the oral mucosa,gums and lips, teething pain,denture pressure sores, oraland maxillofacial surgery anddressing after scaling

Apply to lesions 3 - 5 times daily

1323. Pyrantel Pamoate125 mg Tablet

P02CC01127T1001XX

C Intestinal nematodes ADULT and CHILD : 2 years and older- single dose 10mg/kg body weightonce. Maximum 1 g

1324. Pyrantel Pamoate250 mg Tablet

P02CC01127T1002XX

C Intestinal nematodes ADULT and CHILD : 2 years and older- single dose 10mg/kg body weightonce. Maximum 1 g

1325. Pyrazinamide 500mg Tablet

J04AK01000T1001XX

B Tuberculosis Adult: 20-40mg/kg daily (max1500mg) or 50mg/kg biweekly (max2000mg). Children: 20-30mg/kgdaily or 30-40mg/kg thrice weekly.

1326. PyridostigmineBromide 60 mgTablet

N07AA02320T1001XX

B Myasthenia gravis ADULT: 30 - 120 mg at suitableintervals throughout the day, totaldaily dose 0.3 - 1.2 g. CHILD up to 6years initially 30 mg, 6 - 12 yearsinitially 60 mg, usual total daily dose

Page 228 of 296

No. Generic Name MDC Category Indications Dosage30 - 360 mg

1327. Pyridoxine HCl 10mg Tablet

A11HA02110T1001XX

C+ i)Pyridoxine-dependentconvulsions in infantii)Sideroblastic anaemia iii)B6-deficient anaemia in adult iv)Prophylaxis to peripheralneuritis in isoniazid therapy v)Nausea and vomiting ofpregnancy and irradiationsickness

i) INFANT 4 mg/kg daily for shortperiods ii) 100 - 400 mg daily individed doses iii) ADULT 20 - 50 mgup to 3 times daily iv) Prophylaxis 10mg daily, therapeutic 50 mg 3 timesdaily v) 20 - 100 mg daily

1328. Pyridoxine HCl 50mg/2 ml Injection

A11HA02110P3001XX

B i) Pyridoxine-dependentconvulsions in infancy ii)Sideroblastic anaemia iii) B6-deficient anaemia in adult iv)Prophylaxis to peripheralneuritis in isoniazid therapy v)Nausea and vomiting ofpregnancy and irradiationsickness

i) INFANT 4 mg/kg daily for shortperiods ii) 100 - 400 mg daily individed doses iii) ADULT 20 - 50 mgup to 3 times daily iv) Prophylaxis 10mg daily, therapeutic 50 mg 3 timesdaily v) 20 - 100 mg daily

1329. QuetiapineFumarate 100 mgImmediateRelease Tablet

N05AH04138T1002XX

A* i) Schizophrenia ii) Short termtreatment of acute manicepisodes associated withbipolar I disorder, eithermonotherapy or adjunct tolithium or divalproex iii)Treatment of depressiveepisodes associated withbipolar disorder

i) Initial titration schedule over 4days: 25 mg twice daily on Day 1,increase in steps of 25 - 50 mg 2 to 3times daily on Days 2 and 3 to reachtarget dose of 300 - 400 mg daily byDay 4, given in 2 - 3 divided doses.Institute further dose adjustments,if indicated, at intervals of 2 days ormore, in steps of 25 - 50 mg twicedaily ii) 100 mg (Day 1), 200 mg (Day2), 300 mg (Day 3) & 400 mg (Day 4).Further dosage adjustments up to800 mg/day by Day 6 should be inincrements of not more than 200mg/day. Adjust dose within therange of 200 - 800 mg/daydepending on clinical response andtolerability of the patient. Usualeffective dose range: 400 - 800mg/day iii) 50 mg ORALLY once aday on Day 1, then 100 mg oncedaily on Day 2, then 200 mg oncedaily on Day 3, then 300 mg oncedaily on Day 4 (all doses given atbedtime); patients requiring higherdoses should receive 400 mg on Day5, increased to 600 mg on Day 8(week 1)

Page 229 of 296

No. Generic Name MDC Category Indications Dosage1330. Quetiapine

Fumarate 200 mgExtended ReleaseTablet

N05AH04138T5002XX

A* i)Schizophrenia ii) Moderate tosevere manic episodes inbipolar disorder iii) Majordepressive episodes in bipolardisorder

i) & ii) 300 mg once daily on Day 1then 600 mg on Day 2. Maintenancedose: 400 to 800 mg once daily.Maximum dose: 800 mg daily iii) 50mg on Day 1, 100 mg on Day 2, 200mg on Day 3 and 300 mg on Day 4.Recommended daily dose is 300 mg.May be titrated up to 600 mg daily.In elderly or hepaticimpairment:Start with 50mg/ day,may be increased in increments of50mg /day to an effective dose.

1331. QuetiapineFumarate 200 mgImmediateRelease Tablet

N05AH04138T1004XX

A* i) Schizophrenia ii) Short termtreatment of acute manicepisodes associated withbipolar I disorder, eithermonotherapy or adjunct tolithium or divalproex iii)Treatment of depressiveepisodes associated withbipolar disorder

i) Initial titration schedule over 4days: 25 mg twice daily on Day 1,increase in steps of 25 - 50 mg 2 to 3times daily on Days 2 and 3 to reachtarget dose of 300 - 400 mg daily byDay 4, given in 2 - 3 divided doses.Institute further dose adjustments,if indicated, at intervals of 2 days ormore, in steps of 25 - 50 mg twicedaily ii) 100 mg (Day 1), 200 mg (Day2), 300 mg (Day 3) & 400 mg (Day 4).Further dosage adjustments up to800 mg/day by Day 6 should be inincrements of not more than 200mg/day. Adjust dose within therange of 200 - 800 mg/daydepending on clinical response andtolerability of the patient. Usualeffective dose range: 400 - 800mg/day iii) 50 mg ORALLY once aday on Day 1, then 100 mg oncedaily on Day 2, then 200 mg oncedaily on Day 3, then 300 mg oncedaily on Day 4 (all doses given atbedtime); patients requiring higherdoses should receive 400 mg on Day5, increased to 600 mg on Day 8(week 1)

1332. QuetiapineFumarate 300 mgExtended ReleaseTablet

N05AH04138T5003XX

A* i) Schizophrenia ii) Moderate tosevere manic episodes inbipolar disorder iii) Majordepressive episodes in bipolardisorder

i) & ii) 300 mg once daily on Day 1and 600 mg on Day 2. Maintenancedose: 400 ? 800 mg once daily.Maximum dose: 800 mg daily iii) 50mg on Day 1, 100 mg on Day 2, 200mg on Day 3 and 300 mg on Day 4.Recommended daily dose is 300 mg.May be titrated up to 600 mg daily

Page 230 of 296

No. Generic Name MDC Category Indications Dosage1333. Quetiapine

Fumarate 400 mgExtended ReleaseTablet

N05AH04138T5004XX

A* i) Schizophrenia ii) Moderate tosevere manic episodes inbipolar disorder iii) Majordepressive episodes in bipolardisorder

i) & ii) 300 mg once daily on Day 1and 600 mg on Day 2. Maintenancedose: 400 ? 800 mg once daily.Maximum dose: 800 mg daily iii) 50mg on Day 1, 100 mg on Day 2, 200mg on Day 3 and 300 mg on Day 4.Recommended daily dose is 300 mg.May be titrated up to 600 mg daily

1334. QuetiapineFumarate 50 mgExtended ReleaseTablet

N05AH04138T5001XX

A* i)Schizophrenia ii)Moderate tosevere manic episodes inbipolar disorder iii)Majordepressive episodes in bipolardisorder

i) & ii) 300 mg once daily on Day 1then 600 mg on Day 2. Maintenancedose: 400 to 800 mg once daily.Maximum dose: 800 mg daily. iii)50mg on Day 1, 100 mg on Day 2, 200mg on Day 3 and 300 mg on Day 4.Recommended daily dose is 300 mg.May be titrated up to 600 mg daily.In elderly or hepatic impairment:Start with 50mg/ day, may beincreased in increments of 50mg/day to an effective dose.

1335. QuinineDihydrochloride600 mg/2 mlInjection

P01BC01110P3001XX

B Severe and complicated malaria By slow intravenous infusion (over 4hours). ADULT : 20 mg/kg followedby 10 mg/kg every 8 hours. CHILD :20 mg/kg followed by 10 mg/kgevery 12 hours, initial dose shouldbe half in patients who havereceived quinine, quinidine ormefloquine during the previous 12or 24 hours

1336. Quinine Sulphate300 mg Tablet

P01BC01183T1001XX

B Severe and complicated malaria 300 - 600 mg daily. Treatment : 1.2 -2 g daily in divided doses. CHILDSless than 1 year : 100 - 200 mg daily,1 - 3 years : 200 - 300 mg daily, 4 - 6years: up to 500 mg daily, more than7 years : up to 1 g daily. All abovedoses are given for 7 days in 2 - 3divided doses

1337. RabeprazoleSodium 20 mgTablet

A02BC04520T1001XX

A* i) Treatment and maintenanceof erosive or ulcerativegastroesophageal reflux disease(GERD) ii) Duodenal ulcers

i) 10-20 mg daily for 4-8 weeks,maintenance 10-20 mg daily ii) 20mg daily at morning for up to 4-8weeks

1338. Rabies HumanDiploid CellVaccine(Lyophilised)Injection

J07BG01000P4001XX

B Pre-exposure and post-exposure vaccination againstrabies

Prophylaxis: 3 dose (1 ml each)schedule on D0, D7 and D28.Booster dose after every 2 - 3 years.Post exposure prophylaxis: use afterattack of a potential rabid animal: 1dose on D0, D3, D7, D14 and D28. Inpreviously vaccinated individuals 2doses on D0 and D3

1339. Raloxifene HCl 60mg Tablet

G03XC01110T1001XX

A* Prevention and treatment ofpostmenopausal osteoporosis

1 tablet daily

Page 231 of 296

No. Generic Name MDC Category Indications Dosage1340. Raltegravir 400

mg tabletJ05AX08500T1001XX

A* Raltgeravir combination withother antiretroviral agents isindicated for the treatment ofHIV-1 infection in patients whoare contraindicated to boostedProtease Inhibitor or who areintolerant to boosted ProteaseInhibitor.

400mg administered orally, twicedaily with or without food, to begiven combination with otherantiretroviral agent.

1341. Ramipril 2.5 mgTablet

C09AA05000T1001XX

A i) Hypertension and congestiveheart failure ii) Post-myocardialinfarction iii) Reducing risk ofmyocardial infarction, stroke orcardiovascular death indiabetics or patients withincreased cardiovascular risks

i) Hypertension: Initially 2.5 mg oncedaily, increased at intervals of 1 - 2weeks to maximum 10 mg oncedaily; Congestive heartfailure:Initially 1.25 mg once daily.Max: 10 mg/day ii) Initially 2.5 mgtwice daily for 2 days then increasedto maximum 5 mg twice daily iii)Initially 1.25 - 2.5 mg once daily,increased to 5 mg once daily after 1week, maximum dose: 10 mg oncedaily after 3 weeks

1342. Ramipril 5 mgTablet

C09AA05000T1002XX

A i) Hypertension and congestiveheart failure ii) Post-myocardialinfarction iii) Reducing risk ofmyocardial infarction, stroke orcardiovascular death indiabetics or patients withincreased cardiovascular risks

i) Hypertension: Initially 2.5 mg oncedaily, increased at intervals of 1 - 2weeks to maximum 10 mg oncedaily; Congestive heartfailure:Initially 1.25 mg once daily.Max: 10 mg/day ii) Initially 2.5 mgtwice daily for 2 days then increasedto maximum 5 mg twice daily iii)Initially 1.25 - 2.5 mg once daily,increased to 5 mg once daily after 1week, maximum dose: 10 mg oncedaily after 3 weeks

1343. Ranibizumab 10mg/mlIntravitrealInjection

S01LA04000P3001XX

A* i) Treatment of Neovascular(wet) Age-Related MacularDegeneration (ARMD). ii)Treatment of visual impairmentdue to diabetic macular edema(DME). iii) Treatment of visualimpairment due to macularedema secondary to retinal veinocclusion (RVO). iv) Treatmentof visual impairment due tochoroidal neovascularization(CNV) secondary to pathologicmyopia (PM). Note: Indicationii) and iii) approved to be usedby retinal specialist only(PFUKKM 1/2015)

0.5 mg (0.05ml) as a singleintravitreal Injection.Intervalbetween 2 doses should not beshorter than 1 month, then monitorfor visual acuity monthly. Treatmentis given monthly & continued untilmax visual acuity is achieved,confirmed by stable visual acuity for3 consecutive monthly assessments.

Page 232 of 296

No. Generic Name MDC Category Indications Dosage1344. Ranitidine 150

mg TabletA02BA02110T1001XX

B i) Benign gastric and duodenalulcer ii) Reflux oesophagitis iii)Non-ulcer dyspepsia iv)Zollinger-Ellison Syndrome

i) 150 mg twice daily (at morningand night) or 300 mg on night for 4-8 weeks. Maintenance: 150-300 mgon night ii) 150 mg twice daily or300 mg on night for 8-12 weeks iii)150 mg daily or twice daily iv) 150mg and may be increased asnecessary to 6 g/day

1345. Ranitidine 150mg/10 ml Syrup

A02BA02110L9001XX

B Peptic ulcer disease CHILD 2-4 mg/kg 2 times daily.Maximum 300 mg daily

1346. Ranitidine 25mg/ml Injection

A02BA02110P3001XX

B i) Benign gastric/ duodenalulceration, reflux oesophagitis,Zollinger Ellison Syndrome ii)Stress ulcer prophylaxis in post-operative and high risk patients

i) ADULT: Slow IV injection of 50 mgdiluted to 20 ml and given over atleast 2 minutes. May be repeatedevery 6-8 hours or IV infusion at rateof 25 mg/hour for 2 hours, may berepeated at 6-8 hours intervals orIM. CHILD: 1 mg/kg/dose 6-8 hourly.ii) Initial slow IV injection of 50 mg,then continuous infusion of 125-250mcg/kg/hour

1347. Ranitidine 300mg Tablet

A02BA02110T1002XX

B i) Benign gastric and duodenalulcer ii) Reflux oesophagitis iii)Non-ulcer dyspepsia iv)Zollinger-Ellison Syndrome

i) 150 mg twice daily (at morningand night) or 300 mg on night for 4-8 weeks. Maintenance: 150-300 mgon night ii) 150 mg twice daily or300 mg on night for 8-12 weeks iii)150 mg daily or twice daily iv) 150mg and may be increased asnecessary to 6 g/day

1348. Recombinantfactor VIII 250 IUInjection

B02BD02000P4001XX

A* i)Control and prevention ofbleeding episodes in adults andchildren (0-16 years) withhemophilia A. ii)Surgicalprophylaxis in adults andchildren with hemophilia A.iii)Routine prophylactictreatment to reduce thefrequency of bleeding episodesand the risk of joint damage inchildren with no pre-existingjoint damage. Not indicated fotthe treatment of vonwillebrand's disease.

The dosage and duration oftreatment should be individualisedand taking into account the severityof factor VIII deficiency, location andextent of bleeding and patient'sclinical condition. Dose can becalculated by using: i. Required dose(IU) = body weight (kg) x desiredfactor VIII rise (IU/dl or % of normal)x 0.5 (IU/kg) or ii. Expected factorVIII rise (% of normal) = 2 x (doseadministered)/ bodyweight (kg)Dose administered should betitrated to patient's clinical response

1349. RecombinantFactor VIII 500 IUInjection

B02BD02000P4002XX

A* i)Control and prevention ofbleeding episodes in adults andchildren (0-16 years) withhemophilia A. ii)Surgicalprophylaxis in adults andchildren with hemophilia A.iii)Routine prophylactictreatment to reduce thefrequency of bleeding episodesand the risk of joint damage inchildren with no pre-existing

The dosage and duration oftreatment should be individualisedand taking into account the severityof factor VIII deficiency, location andextent of bleeding and patient'sclinical condition. Dose can becalculated by using: i. Required dose(IU) = body weight (kg) x desiredfactor VIII rise (IU/dl or % of normal)x 0.5 (IU/kg) or ii. Expected factorVIII rise (% of normal) = 2 x (dose

Page 233 of 296

No. Generic Name MDC Category Indications Dosagejoint damage. Not indicated forthe treatment of vonwillebrand's disease.

administered)/ bodyweight (kg)Dose administered should betitrated to patient's clinicalresponse.

1350. Remifentanil 5mg Injection

N01AH06110P4001XX

A* i) As an analgesic agent for useduring induction and/ormaintenance of generalanaesthesia during surgicalprocedures including cardiacsurgery. ii)Continuation ofanalgesia into the immediatepost-operative period underclose supervision, duringtransition to longer actinganalgesia. iii)Provision ofanalgesia and sedation inmechanically ventilatedintensive care patients.

For IV use only. ADULT:Induction:Bolus infusion: 1µg/kgover 30-60 seconds; Continuousinfusion: 0.5-1µg/kg/min;Maintenance: Continuous infusion:0.025 to 2 µg/kg/min. CHILD (1-12years of age): Induction: Insufficientdata; Neonates: IV infusion 0.4-1.0mcg/kg/minute depending on theanaesthetic method and adjustaccording to patient response,supplemental IV inj of 1 mcg/kgdose may be given. 1-12 yr: initially0.1-1 mcg/kg by IV inj over at least30 seconds (excluded if not needed),followed by IV infusion 0.05-1.3mcg/kg/minute depending on theanaesthetic method and adjustaccording to patient response,supplemental IV bolus inj may beadmin during infusion. 12-18 yr: 0.1-1 mcg/kg IV inj over at least 30seconds (excluded if not needed),followed by IV infusion of 0.05-2mcg/kg/minute depending onanaesthetic method and adjustaccording to patient response,supplemental IV bolus inj may beadmin during infusion.

1351. Ribavirin 200 mgCapsule

J05AB04000C1001XX

A* For the treatment of chronichepatitis C (in combination withinterferon alfa-2a/2b)

ADULT (more than 18 years old):50mg/kg/day Recommended: Bodyweight: ≤ 75kg should receive1000mg daily as two 200mgcapsules in the morning and three200mg capsules in the evening Bodyweight: >75kg should receive1200mg as three 200mg capsules inthe morning and three 200mgcapsules in the evening Genotype1,4: 48 weeks Genotype: 24 weeksduration should be individualized inaccordance with the baseline

Page 234 of 296

No. Generic Name MDC Category Indications Dosagecharacteristics of the disease.

1352. Riboflavine 3 mgTablet

A11HA04000T1001XX

C For prevention and treatmentof riboflavine deficiency

CHILD: 2.5-10 mg/day in divideddoses. ADULT: 5-30 mg/day individed doses

1353. Rifampicin 100mg/5 ml Syrup

J04AB02000L9001XX

A Tuberculosis and leprosy CHILD: 20 mg/kg body weight dailyin 1 - 2 doses. Up to 1 year: 10mg/kg body weight in a single dailydose

1354. Rifampicin 150mg Capsule

J04AB02000C1001XX

B i) Tuberculosis ii) Leprosy iii)Prophylaxis for meningococcalmeningitis

i) ADULT: 450 - 600 mg as a singlemorning dose. CHILD: 10 - 20 mg/kgbody weight daily in 1 - 2 doses.Directly observed therapy (DOT): 10mg/kg twice weekly or 3times/week. Maximum: 600 mg ii)600 mg/day iii) 600 mg twice dailyfor 2 days

1355. Rifampicin 150mg, Isoniazid 75mg &Pyrazinamide 400mg Tablet

J04AM05000T1001XX

B Initial phase (2 months) oftuberculosis treatment

Patient more than or 71 kg: 5tab/day, 55 -70 kg: 4 tab/day, 38-54kg: 3 tab/day, 30-37 kg: 2 tab/day.To be taken as a single dose

1356. Rifampicin 150mg, Isoniazid 75mg, Pyrazinamide400 mg &Ethambutol HCl275 mg Tablet

J04AM06000T1001XX

B Treatment of both pulmonaryand extrapulmonarytuberculosis, in the intensivetreatment phase

ADULT: 30 - 37 kg: 2 tablets daily, 38- 54 kg: 3 tablets daily, 55 - 70 kg: 4tablets daily, more than 70 kg: 5tablets daily

1357. Rifampicin150mg + Isoniazid75mg tablet

J04AM02000T1001XX

B For pulmonary tuberculosis inwhich organisms aresusceptible in continuationphase treatment for 4 months

30-37kg: 2 tablets once daily, 38-54kg: 3 tablets once daily, 55-70kg:4 tablets once daily, Above 70kg: 5tabs once daily

1358. Rifampicin 300mg Capsule

J04AB02000C1002XX

B i) Tuberculosis ii) Leprosy iii)Prophylaxis for meningococcalmeningitis

i) Tuberculosis ADULT: Daily doses:10mg/kg/day Body weight doses:10-15/kg/day CHILD: 10 - 20 mg/kgbody weight daily in 1 - 2 doses.Maximum daily dose : 600mgDirectly observed therapy (DOT): 10mg/kg twice weekly or 3times/week. Maximum: 600 mg ii)Leprosy: ADULT: 600 mg/dayCHILDREN: 10mg/kg iii) Prophylaxisfor meningococcal meningitis:ADULT: 600 mg twice daily for 2days CHILDREN: 10mg/kg twice daily

Page 235 of 296

No. Generic Name MDC Category Indications Dosagefor 2 days INFANT: 5mg/kg twicedaily for 2 days"

1359. Rifampicin,Dapsone &Clofazimine

J04AM02961T9901XX

B For the treatment of leprosyand tuberculosis

Rifampicin: 600 mg once monthly,Dapsone: 100 mg daily, Clofazimine:300 mg once monthly and 50 mgdaily (or 100 mg on alternate days)

1360. Ringers Solution(containedsodium chloride,potassiumchloride andcalcium chloride)

B05XA30905P6001XX

B As a source of electrolytes andwater forhydration/replenishing ofchloride

According to the needs of thepatient

1361. Risperidone 1 mgTablet

N05AX08000T1001XX

B Psychoses and schizophrenia ADULT : 2 mg in 1 - 2 divided doseson first day then 4 mg in 1 - 2divided doses on 2nd day then 6 mgin 1 - 2 divided doses on 3rd day(slower titration appropriate insome patients); usual range 4 - 8 mgdaily; dose above 10 mg daily only ifbenefit outweigh risk (maximum 16mg daily). Elderly (or in hepatic orrenal impairment): initially 0.5 mgtwice daily increased in steps of 0.5mg twice daily to 1 - 2 mg twicedaily. Not recommended in childrenunder 15 years

1362. Risperidone 1mg/ml OralSolution

N05AX08000L5001XX

A Psychoses and schizophrenia ADULT: 2 mg in 1 - 2 divided doseson 1st day then 4 mg in 1 - 2 divideddoses on 2nd day then 6 mg in 1 - 2divided doses on 3rd day (slowertitration appropriate in somepatients); usual range 4 - 8 mg daily;dose above 10 mg daily only ifbenefit outweighs risk (maximum 16mg daily). Elderly (or in hepatic orrenal impairment): initially 0.5 mgtwice daily increased in steps of 0.5mg twice daily to 1-2 mg twice daily.Not recommended in children under15 years

Page 236 of 296

No. Generic Name MDC Category Indications Dosage1363. Risperidone 2 mg

TabletN05AX08000T1002XX

B Psychoses and schizophrenia ADULT : 2 mg in 1 - 2 divided doseson first day then 4 mg in 1 - 2divided doses on 2nd day then 6 mgin 1 - 2 divided doses on 3rd day(slower titration appropriate insome patients); usual range 4 - 8 mgdaily; dose above 10 mg daily only ifbenefit outweigh risk (maximum 16mg daily). Elderly (or in hepatic orrenal impairment): initially 0.5 mgtwice daily increased in steps of 0.5mg twice daily to 1 - 2 mg twicedaily. Not recommended in childrenunder 15 years

1364. Risperidone 25mg Injection(Long Acting)

N05AX08000P3001XX

A* Treatment of acute and chronicschizophrenic psychosis andother psychotic conditions, inwhich positive and negativesymptoms are prominent. Italso alleviates affectivesymptoms associated withschizophrenia

25 mg IM every 2 weeks. Doseincrements (if required) to 37.5 mgor 50 mg can be considered after aminimum of 4 weeks on eachdosage

1365. Risperidone 37.5mg Injection(Long Acting)

N05AX08000P3002XX

A* Treatment of acute and chronicschizophrenic psychosis andother psychotic conditions, inwhich positive and negativesymptoms are prominent. Italso alleviates affectivesymptoms associated withschizophrenia

25 mg IM every 2 weeks. Doseincrements (if required) to 37.5 mgor 50 mg can be considered after aminimum of 4 weeks on eachdosage

1366. Risperidone 50mg Injection(Long Acting)

N05AX08000P3003XX

A* Treatment of acute and chronicschizophrenic psychosis andother psychotic conditions, inwhich positive and negativesymptoms are prominent. Italso alleviates affectivesymptoms associated withschizophrenia

25 mg IM every 2 weeks. Doseincrements (if required) to 37.5 mgor 50 mg can be considered after aminimum of 4 weeks on eachdosage

1367. Ritodrine HCl 50mg/5 ml Injection

G02CA01110P3001XX

A Prevention of preterm labour IV 0.05 mg/min to be graduallyincreased by 0.05 mg/min every 10-15 minutes. IM injection: 10 mg 4-6hourly. Continue treatment for 12-48 hours after ceased contraction

1368. Ritonavir 100 mgCapsule

J05AE03000C1001XX

A* Progressive or advanced HIVinfection in combination withother antiretroviral agents.Criteria for use: a) Clinical AIDSb) CD4 less than 350 cells or c)Viral load more than 10,000copies/ml

ADULT: (Single PI) initially 300 mgtwice daily, increase by 100 mgtwice daily increments to 600 mgtwice daily. (Dual PI) Initially 200mgBD, then increase by 100mg BD &reaching 400mg BD within 2 wk.

Page 237 of 296

No. Generic Name MDC Category Indications Dosage1369. Ritonavir 80

mg/ml SolutionJ05AE03000L9901XX

A* Progressive or advanced HIVinfection in combination withother antiretroviral agents.Criteria for use: a) Clinical AIDSb) CD4 less than 350 cells or c)Viral load more than 10,000copies/ml

ADULT: 400 - 600 mg twice daily.CHILD: >1 month, initiate at dise of25mg/m2 twice daily, titrate doseupward every 2-3 days by 50mg/m2twice daily (maximum dose 600mgtwice daily)

1370. Rituximab 10mg/ml Injection

L01XC02000P3001XX

A* i) Treatment of patients withrelapsed or chemo-resistantlow grade or follicular B-cellNon-Hodgkin's lymphoma ii)Adjunctive therapy withcombination chemoagents foraggressive Non-HodgkinLymphoma iii) Severe activerheumatoid arthritis withinadequate response orintolerance to other disease-modifying anti-rheumatic drugs(DMARDs) including one ormore tumour necrosis factor(TNF) inhibitor therapies iv)Maintenance in relapsed/refractory follicular lymphomaafter response to inductiontherapy

i) 375 mg/m2 BSA administered asan IV infusion through a dedicatedline once weekly for 4 weeks ii)Combination with CHOP(cyclophosphamide, doxorubicin,prednisone and vincristine) as 375mg/m2 BSA on day 1 of eachchemotherapy cycle for 8 cyclesafter IV administration of theglucocorticoid component of CHOP.iii) 1000 mg IV infusion followed bya second 1000 mg IV infusion twoweeks later iv) 375mg/m2 BSA onceevery 3 months until diseaseprogression or for a maximumperiod of two years.

1371. Rivaroxaban 10mg Tablet

B01AX06000T1001XX

A* Prevention of venousthromboembolism in patientsundergoing elective hip or kneereplacement surgery

10 mg once daily. Initial dose shouldbe taken 6 to 10 hour post-surgeryprovided that haemostasis has beenestablished. Duration of treatment:Major hip surgery 5 weeks. Majorknee surgery 2 weeks

1372. Rivaroxaban 15mg Tablet

B01AX06000T1002XX

A* i)Prevention of stroke andsystemic embolism in adultpatients with non-valvular atrialfibrillation with one or morerisk factors, such as Congestiveheart failure (CHF),hypertension, age ≥ 75 yrs,diabetes mellitus, prior strokeor transient ischaemic attack.ii)Treatment of deep veinthrombosis (DVT), andprevention of recurrent DVTand pulmonary embolism (PE)following an acute DVT inadults. iii) Treatment ofPulmonary Embolism (PE), andprevention of recurrent DVTand pulmonary embolism (PE)following an acute PE in adults.

i)20mg once daily or 15mg oncedaily (for patients with moderaterenal impairment (creatinineclearance 30-49 ml/min) Dosage: ii)& (iii) 15mg BD for 21 days, followedby 20mg OD.

1373. Rivaroxaban 20mg Tablet

B01AX06000T1003XX

A* i)Prevention of stroke andsystemic embolism in adult

i)20mg once daily or 15mg oncedaily (for patients with moderate

Page 238 of 296

No. Generic Name MDC Category Indications Dosagepatients with non-valvular atrialfibrillation with one or morerisk factors, such as Congestiveheart failure (CHF),hypertension, age ≥ 75 yrs,diabetes mellitus, prior strokeor transient ischaemic attack.ii)Treatment of deep veinthrombosis (DVT), andprevention of recurrent DVTand pulmonary embolism (PE)following an acute DVT inadults. iii) Treatment ofPulmonary Embolism (PE), andprevention of recurrent DVTand pulmonary embolism (PE)following an acute PE in adults.

renal impairment (creatinineclearance 30-49 ml/min) Dosage (ii)& (iii)15mg BD for 21 days, followedby 20mg OD.

1374. Rivastigmine 1.5mg Capsule

N06DA03123C1001XX

A* For psychiatrists andneurologists only. Mild tomoderately severe dementiaassociated with Alzheimer's orParkinson's disease

Initial dose 1.5 mg 2 times daily,may increase by 1.5 mg 2 times dailyevery 2 weeks to maximum of 6 mg2 times daily. If treatment isinterrupted for several days, shouldbe reinitiated at the lowest dailydose

1375. Rivastigmine 2mg/ml OralSolution

N06DA03123L9901XX

A* For psychiatrists andneurologists only. Mild tomoderately severe dementiaassociated with Alzheimer's orParkinson's disease

Initial dose 1.5 mg 2 times daily.May be increased after a minimumof 2 weeks of treatment to 3 mg 2times daily. Subsequently to 4.5 mg2 times daily, up to maximum of 6mg 2 times daily. If treatment isinterrupted for several days, shouldbe reinitiated at the lowest dailydose

1376. Rivastigmine 3mg Capsule

N06DA03123C1002XX

A* For psychiatrists andneurologists only. Mild tomoderately severe dementiaassociated with Alzheimer's orParkinson's disease

Initial dose 1.5 mg 2 times daily,may increase by 1.5 mg 2 times dailyevery 2 weeks to maximum of 6 mg2 times daily. If treatment isinterrupted for several days, shouldbe reinitiated at the lowest dailydose

1377. Rivastigmine 4.5mg Capsule

N06DA03123C1003XX

A* For psychiatrists andneurologists only. Mild tomoderately severe dementiaassociated with Alzheimer's orParkinson's disease

Initial dose 1.5 mg 2 times daily,may increase by 1.5 mg 2 times dailyevery 2 weeks to maximum of 6 mg2 times daily. If treatment isinterrupted for several days, shouldbe reinitiated at the lowest dailydose

1378. Rivastigmine4.6mg/24hrTransdermalPatch

N06DA03123M7001XX

A* Mild to moderately severedementia associated withAlzheimer's or Parkinson'sdisease

Initial, 4.6 mg/24 hr patchTOPICALLY once daily; after aminimum of 4 weeks and goodtolerability, increase the dose to 9.5mg/24 hr patch once daily

1379. Rivastigmine 6 N06DA0312 A* For psychiatrists and Initial dose 1.5 mg 2 times daily,

Page 239 of 296

No. Generic Name MDC Category Indications Dosagemg Capsule 3C1004XX neurologists only. Mild to

moderately severe dementiaassociated with Alzheimer's orParkinson's disease

may increase by 1.5 mg 2 times dailyevery 2 weeks to maximum of 6 mg2 times daily. If treatment isinterrupted for several days, shouldbe reinitiated at the lowest dailydose

1380. Rivastigmine 9.5mg/24hrTransdermalPatch

N06DA03123M7002XX

A* Mild to moderately severedementia associated withAlzheimer's or Parkinson'sdisease

Initial, 4.6 mg/24 hr patchTOPICALLY once daily; after aminimum of 4 weeks and goodtolerability, increase the dose to 9.5mg/24 hour patch once daily

1381. RivastigmineTransdermalPatch 13.3mg/24hours

N03DA03123M7003XX

A* i) Mild to moderately severedementia associated withAlzheimer's or Parkinson'sdisease. ii) Severe dementia ofthe Alzheimer's type: - Patientwith mild to moderately severedementia (currently on lowerstrength of rivastigmine patch)and developed to severedementia. - Use as secondline/alternative option if thefirst line medication with oraltablet failed or patients are notable to tolerate the oralmedication.

Initial, 4.6mg/24 hours patchTOPICALLY once daily, after aminimum of 4 weeks of treatmentand if well tolerated, this increasedto 9.5mg/24 hours or 13.3mg/24hours (individual responses torivastigmine may vary and somepatients may derive additionalbenefit from higher doses)

1382. RocuroniumBromide 10mg/ml Injection

M03AC09320P3001XX

A* As an adjunct to generalanaesthesia to facilitateendotracheal intubation, toprovide skeletal musclerelaxation during surgery and tofacilitate mechanical ventilationin adults, children and infantsfrom 3 months of age

Adult: Initially, 600 mcg/kg by inj.Higher doses of 1 mg/kg may beused for intubation during rapidsequence induction of anaesthesia.Maintenance: 150 mcg/kg by inj(may reduce to 75-100 mcg/kg ifinhalational anaesthesia is used) orby infusion at a rate of 300-600mcg/kg/hr. Doses should be basedon lean body weight for obesepatients weighing >30% above theideal body weight. Child: Infants andchildren >1 mth: Initially, 600mcg/kg by inj. Maintenance: 150mcg/kg by inj or by infusion at a rateof 300-600 mcg/kg/hr, maintenancedoses may be required morefrequently than in adult patients.Elderly: Reduced maintenancedoses: 75-100 mcg/kg. Renalimpairment: Initially, 600 mcg/kg byinj. Maintenance: 75-100 mcg/kg.Hepatic impairment: or biliary tractdisease: Initially, 600 mcg/kg by inj.Maintenance: 75-100 mcg/kg.

Page 240 of 296

No. Generic Name MDC Category Indications Dosage1383. Ropinirole HCI 2

mg ExtendedRelease Tablet

N04BC04110T5003XX

A* Treatment of idiopathicParkinson?s disease. It may beused as monotherapy or incombination with levodopa

ADULT: Initially 2 mg once daily forthe 1st week. May be increased by 2mg at ≥1 week intervals. Max: 24mg/day. Switching from ropiniroleimmediate-realease to prolonged-release tablet; dose of ropiniroleprolonged release tablet should bebased on the total daily dose ofropinirole immediate-release tabthe patient was taking. Tabletsshould be taken at a similar timeeach day with or without food, mustbe swallowed whole and must notbe chewed, crushed or divided.

1384. Ropinirole HCI 4mg ExtendedRelease Tablet

N04BC04110T5004XX

A* Treatment of idiopathicParkinson?s disease. It may beused as monotherapy or incombination with levodopa

ADULT: Initially 2 mg once daily forthe 1st week. May be increased by 2mg at ≥1 week intervals. Max: 24mg/day. Switching from ropiniroleimmediate-realease to prolonged-release tablet; dose of ropiniroleprolonged release tablet should bebased on the total daily dose ofropinirole immediate-release tabthe patient was taking. Tabletsshould be taken at a similar timeeach day with or without food, mustbe swallowed whole and must notbe chewed, crushed or divided.

1385. Ropinirole HCl0.25 mg Tablet

N04BCO4110T1001XX

A* Parkinson disease in youngerpatients and patients withdyskinesias, especially peakdose dyskinesias

0.25 mg 3 times daily graduallyincreasing till adequate responseobtained up to a maximum of 24mg/day. Most patients need 3-9mg/day

1386. Ropinirole HCl 1mg Tablet

N04BCO4110T1002XX

A* Parkinson disease in youngerpatients and patients withdyskinesias, especially peakdose dyskinesias

0.25 mg 3 times daily graduallyincreasing till adequate responseobtained up to a maximum of 24mg/day. Most patients need 3-9mg/day

1387. Ropivacaine HCl 2mg/ml Injection

N01BB09110P3001XX

A* i) Surgical anaesthaesiaincluding obstetrics ii) Acutepain management

Dose adjusted according to patientphysical status and nature ofprocedure. i) Lumbar epidural: 15-25 ml of 7.5 mg/ml solution;Caesarean section, 15-20 ml of 7.5mg/ml solution in incremental doses( max . total dose 150 mg). ii)lumbar epidural: 10-20 ml of2mg/ml solution followed by 10-15ml of 2 mg/ml solution at interval atof least 30 minutes. Labour pain 6-10 ml/hour of 2mg/ml solution

Page 241 of 296

No. Generic Name MDC Category Indications Dosage1388. Ropivacaine HCl

7.5 mg/mlInjection

N01BB09110P3002XX

A* i) Surgical anaesthaesiaincluding obstetrics ii) Acutepain management

Dose adjusted according to patientphysical status and nature ofprocedure. i) Lumbar epidural: 15-25 ml of 7.5 mg/ml solution;Caesarean section, 15-20 ml of 7.5mg/ml solution in incremental doses( max . total dose 150 mg). ii)lumbar epidural: 10-20 ml of2mg/ml solution followed by 10-15ml of 2 mg/ml solution at interval atof least 30 minutes. Labour pain 6-10 ml/hour of 2mg/ml solution

1389. Rosuvastatin 10mg Tablet

C10AA07390T1002XX

A* Dyslipidaemia not responsive toatorvastatin 40 mg orequivalent doses of otherstatins

Initially 5-10 mg once daily (5mg inpatients with pre-disposing factorsto myopathy), increased if necessaryat intervals of at least 4 weeks to 20mg once daily, increased afterfurther 4 weeks to 40 mg daily ONLYin severe hypercholesterolemia withhigh cardiovascular risk. Patient ofAsian origin, patients onconcomitant ciclosporin/fibrate andpatients with risk factors formyopathy/rhabdomyolysis(including personal/family history ofmuscular disorders/toxicity), themaximum dose should be 20 mgdaily

1390. Rosuvastatin 20mg Tablet

C10AA07390T1003XX

A* Dyslipidaemia not responsive toatorvastatin 40 mg orequivalent doses of otherstatins

Initially 5-10 mg once daily (5mg inpatients with pre-disposing factorsto myopathy), increased if necessaryat intervals of at least 4 weeks to 20mg once daily, increased afterfurther 4 weeks to 40 mg daily ONLYin severe hypercholesterolemia withhigh cardiovascular risk. Patient ofAsian origin, patients onconcomitant ciclosporin/fibrate andpatients with risk factors formyopathy/rhabdomyolysis(including personal/family history ofmuscular disorders/toxicity), themaximum dose should be 20 mgdaily

1391. Rotigotine 2 mgper 24 hourTransdermalPatch

N04BC09000M7001XX

A* For stage IV Parkinson Diseasewith peak dyskinesia

A single daily dose should beinitiated at 4mg/24 h and thenincreased in weekly increments of2mg/24 h to an effective dose up toa maximal dose of 16mg/24 hr.

1392. Rotigotine 4 mgper 24 hourTransdermalPatch

N04BC09000M7002XX

A* For stage IV Parkinson Diseasewith peak dyskinesia

A single daily dose should beinitiated at 4mg/24 h and thenincreased in weekly increments of2mg/24 h to an effective dose up to

Page 242 of 296

No. Generic Name MDC Category Indications Dosagea maximal dose of 16mg/24 hr.

1393. Rotigotine 6 mgper 24 hourTransdermalPatch

N04BC09000M7003XX

A* For stage IV Parkinson Diseasewith peak dyskinesia

A single daily dose should beinitiated at 4mg/24 h and thenincreased in weekly increments of2mg/24 h to an effective dose up toa maximal dose of 16mg/24 hr.

1394. Rotigotine 8 mgper 24 hourTransdermalPatch

N04BC09000M7004XX

A* For stage IV Parkinson Diseasewith peak dyskinesia

A single daily dose should beinitiated at 4mg/24 h and thenincreased in weekly increments of2mg/24 h to an effective dose up toa maximal dose of 16mg/24 hr.

1395. Rubella VirusVaccine Injection(Single injection)

J07BJ01000P3001XX

C Immunization against rubella(German measles)

0.5 ml SC as a a single dose

1396. Ruxolitinib 15mgtablet

L01XE18162T1002XX

A* For the treatment of disease-related splenomegaly orsymptoms in adult patientswith primary myelofibrosis (alsoknown as chronic idiopathicmyelofibrosis), post-polycythemia veramyelofibrosis or post-essentialthrombocythemiamyelofibrosis. Place in therapy:To be used as 3rd line afterhydroxyurea and other bestavailable treatment such asdanazol and S.C. Interferon

The recommended starting dose is15 mg twice daily for patients with aplatelet count between100,000/mm3 and 200,000/mm3and 20 mg twice daily for patientswith a platelet count of>200,000/mm3. There is limitedinformation to recommend astarting dose for patients withplatelet counts between50,000/mm3 and <100,000/mm3.The maximum recommendedstarting dose in these patients is 5mg twice daily and the patientsshould be titrated cautiously.

1397. Ruxolitinib 20mgtablet

L01XE18162T1003XX

A* For the treatment of disease-related splenomegaly orsymptoms in adult patientswith primary myelofibrosis (alsoknown as chronic idiopathicmyelofibrosis), post-polycythemia veramyelofibrosis or post-essentialthrombocythemiamyelofibrosis. Place in therapy:To be used as 3rd line afterhydroxyurea and other bestavailable treatment such asdanazol and S.C. Interferon

The recommended starting dose is15 mg twice daily for patients with aplatelet count between100,000/mm3 and 200,000/mm3and 20 mg twice daily for patientswith a platelet count of>200,000/mm3. There is limitedinformation to recommend astarting dose for patients withplatelet counts between50,000/mm3 and <100,000/mm3.The maximum recommendedstarting dose in these patients is 5mg twice daily and the patientsshould be titrated cautiously.

Page 243 of 296

No. Generic Name MDC Category Indications Dosage1398. Ruxolitinib 5mg

tabletL01XE18162T1001XX

A* For the treatment of disease-related splenomegaly orsymptoms in adult patientswith primary myelofibrosis (alsoknown as chronic idiopathicmyelofibrosis), post-polycythemia veramyelofibrosis or post-essentialthrombocythemiamyelofibrosis. Place in therapy:To be used as 3rd line afterhydroxyurea and other bestavailable treatment such asdanazol and S.C. Interferon

The recommended starting dose is15 mg twice daily for patients with aplatelet count between100,000/mm3 and 200,000/mm3and 20 mg twice daily for patientswith a platelet count of>200,000/mm3. There is limitedinformation to recommend astarting dose for patients withplatelet counts between50,000/mm3 and <100,000/mm3.The maximum recommendedstarting dose in these patients is 5mg twice daily and the patientsshould be titrated cautiously.

1399. Salbutamol 0.5 %InhalationSolution

R03AC02183A3001XX

B Asthma and other conditionsassociated with reversibleairways obstruction

2 ml may be inhaled up to 4 timesdaily over a period of 3 minutes perinhalation (0.5 ml diluted in 2.5 mlof normal saline by inhalation over 5to 15 minutes)

1400. Salbutamol 0.5mg/ml Injection

R03CC02183P3001XX

A Asthma and other conditionsassociated with reversibleairways obstruction

500 mcg by SC/IM injection 4 hourlyor 250 mcg by slow IV. If required,by IV infusion, initially 5 mcg/minadjusted according to response andheart rate, usually in the range 3 -20 mcg/min

1401. Salbutamol 100mcg/doseInhalation

R03AC02183A1001XX

B Asthma and other conditionsassociated with reversibleairways obstruction

ADULT : 100 - 200 mcg up to 3 - 4times daily. CHILD : 100 mcgincreased to 200 mcg if necessary

1402. Salbutamol 2 mgTablet

R03CC02183T1001XX

B Asthma and other conditionsassociated with reversibleairways obstruction

CHILD 2 - 6 years : 1 - 2 mg 3 - 4times daily, 6 - 12 years : 2 mg 3 - 4times daily. CHILD over 12 years andADULT : 2 - 4 mg 3 - 4 times daily

1403. Salbutamol 2mg/5 ml Syrup

R03CC02183L9001XX

B Asthma and other conditionsassociated with reversibleairways obstruction

CHILD 2 - 6 years : 1 - 2 mg 3 - 4times daily, 6 - 12 years : 2 mg 3 -4times daily

1404. Salbutamol200mcg/doseInhaler

R03AC02183A2001XX

B Asthma and other conditionsassociated with reversibleairways obstruction

CHILD : 100 - 200 mcg. Maintenance: 100 - 200 mcg 2 - 4 times daily.ADULT : 100 - 400 mcg. Maitenance: 100 - 400 mcg 2 - 4 times daily

1405. Salbutamol 5mg/5 ml Injection

R03CC02183P3002XX

A* Prevention of uncomplicatedpremature labour only

Infusions containing 5 mg in 500ml(10 mcg/ml) at the rate of 10 - 45mcg/min increased at intervals of 10minutes until evidence of patientresponse as shown by reduction ofstrength, frequency or duration ofcontractions; maintain rate for 1hour after contractions havestopped, then gradually reduce by50% every 6 hours

Page 244 of 296

No. Generic Name MDC Category Indications Dosage1406. Salicylazosulphap

yridine(Sulfasalazine)500 mg Tablet

A07EC01000T1001XX

A/KK i) Treatment of inflammatorybowel disease of ulcerativecolitis and Crohn's disease ii)Rheumatoid arthritis

i) ADULT, acute attack 1-2 g 4 timesdaily until remission occurs (ifnecessary corticosteroids may alsobe given), reducing to amaintenance dose of 500 mg 4times daily, CHILD over 2 years,acute attack 40-60 mg/kg daily,maintenance dose 20-30 mg/kgdaily ii) ADULT, initially; 0.5-1 g/day,increase weekly to maintenancedose of 2 g/day in 2 divided doses,maximun 3 g/day. CHILD over 6years, juvenile rheumatoid arthritis:30-50 mg/kg/day in 2 divided dosesup to a maximum of 2 g/day

1407. Salicylic Acid 1 -2% inHydrocortisone1% Ointment

D07XA01952G5001XX

B Seborrhoeic capitis Apply sparingly to affected areas 1-2times daily

1408. Salicylic Acid 2 -10% Cream

D01AE12000G1001XX

C Seborrhoeic dermatitis, scalppsoriasis and hyperkeratoticskin conditions

Apply sparingly to the affected area2-3 times daily

1409. Salicylic Acid 2 -10% Ointment

D01AE12000G5001XX

C Seborrhoeic dermatitis, scalp,psoriasis and hyperkeratoticskin disorders

Apply sparingly to the affected area2-3 times daily

1410. Salicylic Acid 2 %Lotion

D01AE12000L6001XX

B Seborrhoeic dermatitis, scalp,psoriasis and hyperkeratoticskin conditions

Apply sparingly to the affected area2-3 times daily. Wash with cleanser2 - 3 times per day

1411. Salicylic Acid 20%Ointment

D01AE12000G5002XX

C Plantar warts Apply daily and protect surroundingskin (eg with soft paraffin orspecially designed plaster) ,mayneed to continue up to 3 months

1412. Salicylic Acid,Starch, Zinc OxidePaste

D01AE12952G6001XX

C Use as a protective or base Apply the paste liberally andcarefully to the lesions twice daily

1413. Salmeterol 25mcg andFluticasonePropionate 125mcg Inhalation

R03AK06989A2102XX

A* Regular treatment of reversibleobstructive airway diseasesincluding asthma.

ADULT and CHILD more than 12years : 1 - 2 puff twice daily. CHILDover 4 years : 1 puff twice daily

1414. Salmeterol25mcg andFluticasonePropionate50mcg Inhalation

R03AK06989A2104XX

A* Regular treatment of reversibleobstructive airway diseasesincluding asthma in children,where use of lower dose of acombination (bronchodilatorand inhaled corticosteroids) isappropriate.

ADULT and CHILD more than 12years : 2 puff twice daily. CHILD over4 years : 2 puff twice daily No dataon use for children aged under 4years.

1415. Salmeterol 50mcg andFluticasonePropionate 250mcg Inhalation

R03AK06989A2101XX

A/KK i) Regular treatment ofreversible obstructive airwaysdiseases including asthma ii)For the regular treatment ofchronic obstructive pulmonarydisease (COPD) including

i) ADULT and CHILD more than 12years : 1 puff twice daily. ii) ForCOPD: Dose is one inhalation50/250mcg to 50/500mcg twicedaily.

Page 245 of 296

No. Generic Name MDC Category Indications Dosagechronic bronchitis andemphysema

1416. Salmeterol 50mcg andFluticasonePropionate 500mcg Inhalation

R03AK06989A2106XX

A/KK Category of prescriber A/KK isonly approved for indication (i):i) Regular treatment ofreversible obstructive airwaysdiseases including asthma. Thefollowing indication is stillunder category of prescriberA*: ii) Chronic obstructivepulmonary disease includingchronic bronchitis andemphysema

i) ADULT and CHILD more than 12years : 1 puff twice daily ii) ADULT 1puff twice daily

1417. Saxagliptin 2.5mg Tablet

A10BH03000T1001XX

A/KK FUKKM restriction: As add-ontherapy for patient who failedtherapy and/orcontraindicated/unable totolerate metformin and/orsulphonylurea. i) As add ontherapy in type 2 diabetespatients inadequatelycontrolled on metforminmonotherapy and high risk ofhypoglycaemia, especiallyelderly patients with co-morbidities. ii) As add ontherapy in type 2 diabetespatients inadequatelycontrolled with a sulphonylureand intolerant/contraindicatedfor metformin therapy iii) Asadd on therapy in type 2diabetes patients inadequatelycontrolled on metformin andsulphonylurea combinationtherapy iv) In patients withrenal failure where metformincontraindicated Not to be usedin patients with HbA1c > 8% onsingle/combination OAD, asinsulin initiation is preferred.

Recommended starting dose andmaintenance dose in patients withnormal renal function and mild renalinsufficiency (CrCl more than 50ml/min) is 5 mg once daily. Forpatients with moderate to severerenal insufficiency (CrCl less than orequal to 50 ml/min) dose is 2.5 mgonce daily

Page 246 of 296

No. Generic Name MDC Category Indications Dosage1418. Saxagliptin 2.5mg

and MetforminHCl 1000mgExtended-ReleaseTablet

A10BD10926T1001XX

A FUKKM restriction: As add-ontherapy for patient who failedtherapy and/orcontraindicated/unable totolerate metformin and/orsulphonylurea. Indicated as anadjunct to diet and exercise toimprove glycemic control inadults with type 2 diabetesmellitus when treatment withboth saxagliptin and metforminis appropriate.

The recommended starting dose ofin patients who need 5mg ofsaxagliptin and who are notcurrently treated with metformin is5mg saxagliptin/500 mg metforminextended-release once daily withgradual dose escalation to reducethe gastrointestinal side effects dueto metformin. In patients treatedwith metformin, the dose of shouldprovide metformin at the dosealready being taken, or the nearesttherapeutically appropriate dose.Patients who need 2.5mg saxagliptinin combination with metforminextended-release may be treatedwith 2.5mg/1000mg. Patients whoneed 2.5mg saxagliptin who areeither metformin naive or whorequire a dose of metformin higherthan 1000mg should use theindividual components. Max dailyrecommended dose is 5mg/2000mg.

1419. Saxagliptin 5 mgTablet

A10BH03000T1002XX

A/KK FUKKM restriction: As add-ontherapy for patient who failedtherapy and/orcontraindicated/unable totolerate metformin and/orsulphonylurea. i) As add ontherapy in type 2 diabetespatients inadequatelycontrolled on metforminmonotherapy and high risk ofhypoglycaemia, especiallyelderly patients with co-morbidities. ii) As add ontherapy in type 2 diabetespatients inadequatelycontrolled with a sulphonylureand intolerant/contraindicatedfor metformin therapy iii) Asadd on therapy in type 2diabetes patients inadequatelycontrolled on metformin andsulphonylurea combinationtherapy iv) In patients withrenal failure where metformincontraindicated Not to be usedin patients with HbA1c > 8% onsingle/combination OAD, asinsulin initiation is preferred.

2.5-5mg once daily. Patients withCrCl < 50ml/min, and whencoadministered with strong CYP4503A4/5 inhibitors: 2.5mg OD

Page 247 of 296

No. Generic Name MDC Category Indications Dosage1420. Saxagliptin 5mg

and MetforminHCl 1000mgExtended-ReleaseTablet

A10BD10926T1002XX

A FUKKM restriction: As add-ontherapy for patient who failedtherapy and/orcontraindicated/unable totolerate metformin and/orsulphonylurea. - Indicated as anadjunct to diet and exercise toimprove glycemic control inadults with type 2 diabetesmellitus when treatment withboth saxagliptin and metforminis appropriate.

The recommended starting dose ofin patients who need 5mg ofsaxagliptin and who are notcurrently treated with metformin is5mg saxagliptin/500 mg metforminextended-release once daily withgradual dose escalation to reducethe gastrointestinal side effects dueto metformin. In patients treatedwith metformin, the dose of shouldprovide metformin at the dosealready being taken, or the nearesttherapeutically appropriate dose.Patients who need 2.5mg saxagliptinin combination with metforminextended-release may be treatedwith 2.5mg/1000mg. Patients whoneed 2.5mg saxagliptin who areeither metformin naive or whorequire a dose of metformin higherthan 1000mg should use theindividual components. Max dailyrecommended dose is 5mg/2000mg.

1421. Saxagliptin 5mgand MetforminHCl 500 mgExtended-ReleaseTablet

A10BD10926T1003XX

A FUKKM restriction: As add-ontherapy for patient who failedtherapy and/orcontraindicated/unable totolerate metformin and/orsulphonylurea. - Indicated as anadjunct to diet and exercise toimprove glycemic control inadults with type 2 diabetesmellitus when treatment withboth saxagliptin and metforminis appropriate.

The recommended starting dose ofin patients who need 5mg ofsaxagliptin and who are notcurrently treated with metformin is5mg saxagliptin/500 mg metforminextended-release once daily withgradual dose escalation to reducethe gastrointestinal side effects dueto metformin. In patients treatedwith metformin, the dose of shouldprovide metformin at the dosealready being taken, or the nearesttherapeutically appropriate dose.Patients who need 2.5mg saxagliptinin combination with metforminextended-release may be treatedwith 2.5mg/1000mg. Patients whoneed 2.5mg saxagliptin who areeither metformin naive or whorequire a dose of metformin higherthan 1000mg should use theindividual components. Max dailyrecommended dose is 5mg/2000mg.

1422. Selected PlasmaProtein 5 g/100ml Injection

B05AA02000P3001XX

B For treatment of shock due toburns, crushing injuries,abdominal emergencies andwhere there is a predominantloss of plasma fluids and redblood cells, emergencytreatment of shock due to

ADULT 12.5-25 g (250-500 ml) by IV.CHILD usual dose 33 ml/kg bodyweight at rate of 5-10 ml/min

Page 248 of 296

No. Generic Name MDC Category Indications Dosagehaemorrhage and in infants andsmall children in the initialtherapy of shock due todehydration and infection

1423. Selegiline HCl 5mg Tablet

N04BD01110T1001XX

A* Only for treatment of late stageParkinsonism with on and offphenomenon

5 mg twice daily at breakfast andlunch. Maximum 10 mg/day

1424. SeleniumSulphide 2.5%Shampoo

D11AC03180L5201XX

A/KK Dandruff, seborrheic dermatitisof scalp

Dandruff: apply 5-10 mL topicallytwice weekly for 2 weeks, then 1-4times per month, as needed, leaveon for 2-3 min, then rinsethoroughly. Seborrheic dermatitis ofscalp: apply 5-10 mL topically twiceweekly for 2 weeks, then 1-4 timesper month, as needed, leave on for2-3 min, then rinse thoroughly

1425. Sertraline HCI 50mg Tablet

N06AB06110T1001XX

B Major depression, obsessive-compulsive disorder (OCD),panic disorder

Depression, obsessive-compulsivedisorder: 50 mg/day, may increasein steps of 50mg at weekly interval,max:200mg/day. Panic disorder:Initially 25 mg/day. After 1 week,increase dose to 50 mg/day. All dosechanges should be made at intervalsof more than 1 week, max: 200mg/day

1426. Sevelamer 800mgTablet

V03AE02121T1001XX

A* Control of hyperphosphatemiain adult patients receivinghaemodialysis and peritonealdialysis. Restriction: Sevelamercarbonate 800mg tablet shouldbe used in context of multipletherapeutic approach whichinclude calcium supplement, 1,25-hydroxy Vitamin D3 or oneof its analogues to control thedevelopment of renal bonedisease.

Starting dose is one or two 800mgtablets three times per day withmeals. Adjust by one tablet per mealin two weeks interval as needed toobtain serum phosphorus target(1.13 to 1.78mmol/L).

1427. SevofluraneLiquid

N01AB08000L5001XX

A* To be used only for i) inductionand ii) maintenance ofanaesthesia

i) Adult: Given via a calibratedvaporiser: Up to 5% v/v with oxygenor a mixture of oxygen and nitrousoxide. Child: Given via a calibratedvaporiser: Up to 7% v/v. ii) Adult:0.5-3% v/v with or without nitrousoxide. Child: 0.5-3% v/v with orwithout nitrous oxide.

Page 249 of 296

No. Generic Name MDC Category Indications Dosage1428. Sildenafil Citrate

20 mg Film-coated Tablet

G04BE03136T1004XX

A* Treatment of adult patientswith pulmonary arterialhypertension classified as WHOfunctional class II and III, toimprove exercise capacity.Efficacy has been shown inprimary pulmonaryhypertension and pulmonaryhypertension associated withconnective tissue disease.

ADULTS ≥ 18 years: Therecommended dose is 20mg threetimes a day. Tablets should be takenapproximately 6 to 8 hours apartwith or without food. ELDERLY (≥65years): Dosage adjustments are notrequired in elderly patients. Clinicalefficacy as measured by 6-minutewalk distance could be less inelderly patients. IMPAIRED RENALFUNCTION: Initial dose adjustmentsare not required in patients withrenal impairment, including severerenal impairment (creatinineclearance <30ml/min). A downwarddose adjustment to 20 mg twicedaily should be considered after acareful benefit-risk assessment onlyif therapy is not well-tolerated.IMPAIRED HEPATIC FUNCTION:Initial dose adjustments are notrequired in patients with hepaticimpairment (Child-Pugh class A andB). A downward dose adjustment to20mg twice daily should beconsidered after a careful benefit-risk assessment only if therapy is notwell-tolerated.

1429. Silver Nitrate0.5% Lotion

D08AL01221L6001XX

B Use as antiseptic Apply undiluted to affected area fora limited period

1430. SilverSulfadiazine 1%Cream

D06BA01199G1001XX

B Prevention and treatment ofinfections in severe burns, legulcers where infections mayprevent healing and for theprophylaxis of infections in skingrafting

Burns: Apply 3 mm thick layer twicedaily with sterile applicator. Legulcer: apply at least 3 times a week

1431. Simvastatin 10mg Tablet

C10AA01000T1001XX

B Hypercholesterolaemia andcoronary heart diseaseintolerant or not responsive toother forms of therapy

10 - 20 mg once daily. Maximum: 80mg daily

1432. Simvastatin 20mg Tablet

C10AA01000T1002XX

B Hypercholesterolaemia andcoronary heart diseaseintolerant or not responsive toother forms of therapy

10 - 20 mg once daily. Maximum: 80mg daily

1433. Simvastatin 40mg Tablet

C10AA01000T1003XX

B Hypercholesterolaemia andcoronary heart diseaseintolerant or not responsive toother forms of therapy

10 - 20 mg once daily. Maximum: 80mg daily

Page 250 of 296

No. Generic Name MDC Category Indications Dosage1434. Sitagliptin 100 mg

TabletA10BH01000T1003XX

A* FUKKM Restriction: As add-ontherapy for patient who failedtherapy and/orcontraindicated/unable totolerate metformin and/orsulphonylurea. - Managementof diabetes in patients withrenal failure wheremetformin/sulphonylurea iscontraindicated/untoleratedand elderly with multiple co-morbidities that alwaysexperience hypoglycemia withother antidiabetic. Not to beused in diabetic patient whoseHbA1c is more than 9%.

ADULT over 18 years, 100 mg oncedaily: 100mg once daily CrCl ≥ 30 to< 50ml/min: 50mg once daily CrCl <30 ml/min: 25mg once daily

1435. Sitagliptin 25 mgTablet

A10BH01000T1001XX

A* FUKKM restriction: As add-ontherapy for patient who failedtherapy and/orcontraindicated/unable totolerate metformin and/orsulphonylurea. - Managementof diabetes in patients withrenal failure wheremetformin/sulphonylurea iscontraindicated/untoleratedand elderly with multiple comorbidities that alwaysexperience hypoglycemia withother antidiabetic. Not to beused in diabetic patient whoseHbA1c is more than 9%.

ADULT over 18 years, 100 mg oncedaily: 100mg once daily CrCl ≥ 30 to< 50ml/min: 50mg once daily CrCl <30 ml/min: 25mg once daily

1436. Sitagliptin 50 mgand MetforminHCl 1000 mgTablet

A10BD07926T1003XX

A* FUKKM restriction: As add-ontherapy for patient who failedtherapy and/orcontraindicated/unable totolerate metformin and/orsulphonylurea. i) Type 2diabetes patients, especially theelderly, with multiple co-morbidities that alwaysexperience hypoglycaemia withother antidiabetics who areinadequately controlled onmetformin or sitagliptin aloneor already being treated withthe combination of sitagliptinand metformin. ii) Newlydiagnosed type 2 diabetespatients with high baselineHbA1c and multiple co-morbidities who mayexperience hypoglycaemia with

50 mg/500 mg twice daily. Therecommended maximum daily doseis 100 mg sitagliptin plus 2000 mgmetformin

Page 251 of 296

No. Generic Name MDC Category Indications Dosageother antidiabetics.

1437. Sitagliptin 50 mgand MetforminHCl 500 mgTablet

A10BD07926T1001XX

A* FUKKM restriction: As add-ontherapy for patient who failedtherapy and/orcontraindicated/unable totolerate metformin and/orsulphonylurea. i)Type 2diabetes patients, especially theelderly, with multiple co-morbidities that alwaysexperience hypoglycaemia withother antidiabetics who areinadequately controlled onmetformin or sitagliptin aloneor already being treated withthe combination of sitagliptinand metformin. ii)Newlydiagnosed type 2 diabetespatients with high baselineHbA1c and multiple co-morbidities who mayexperience hypoglycaemia withother antidiabetics.

50 mg/500 mg twice daily. Therecommended maximum daily doseis 100 mg sitagliptin plus 2000 mgmetformin

1438. Sitagliptin 50 mgand MetforminHCl 850 mgTablet

A10BD07926T1002XX

A* FUKKM restriction: As add-ontherapy for patient who failedtherapy and/orcontraindicated/unable totolerate metformin and/orsulphonylurea. i) Type 2diabetes patients, especially theelderly, with multiple co-morbidities that alwaysexperience hypoglycaemia withother antidiabetics who areinadequately controlled onmetformin or sitagliptin aloneor already being treated withthe combination of sitagliptinand metformin. ii) Newlydiagnosed type 2 diabetespatients with high baselineHbA1c and multiple co-morbidities who mayexperience hypoglycaemia withother antidiabetics.

50 mg/500 mg twice daily. Therecommended maximum daily doseis 100 mg sitagliptin plus 2000 mgmetformin

Page 252 of 296

No. Generic Name MDC Category Indications Dosage1439. Sitagliptin 50 mg

TabletA10BH01000T1002XX

A* FUKKM restriction: As add-ontherapy for patient who failedtherapy and/orcontraindicated/unable totolerate metformin and/orsulphonylurea. - Managementof diabetes in patients withrenal failure wheremetformin/sulphonylurea iscontraindicated/untoleratedand elderly with multiple comorbidities that alwaysexperience hypoglycemia withother antidiabetic. Not to beused in diabetic patient whoseHbA1c is more than 9%.

ADULT over 18 years, 100 mg oncedaily: 100mg once daily CrCl ≥ 30 to< 50ml/min: 50mg once daily CrCl <30 ml/min: 25mg once daily

1440. Sodium Alginate1000 mg/10 ml &PotassiumBicarbonate 200mg/10 mlSuspension

A02BX13915L8001XX

A* Treatment of symptoms ofgastro-oesophageal reflux eg.acid regurgitation, heartburn,indigestion due to the reflux ofstomach contents notresponding to conventionalantacids or as an addition to PPIwhen PPI alone fails to controlthe symptoms

Adult, elderly & children ≥12 year:5-10 mL.

1441. Sodium andMeglumineDiatrizoate 58-60% Injection

V08AA01993P3002XX

B For IV pyelography Depend on the type of procedureand the degree and extent ofcontrast required

1442. SodiumBicarbonate 1g/15 ml Mixture

A02AH00131L2102XX

B i) Relief of discomfort in mildurinary tract ii) Alkalinisation ofurine

i) 3 g in every 2 hours until urinarypH exceeds 7 ii) Maintenance ofalkaline urine 5-10 g daily

1443. SodiumBicarbonate 4.2%(0.5 mmol/ml)Injection

B05XA02131P3001XX

B For acceleration of excretion indrug intoxication (whereexcretion of the drug into theurine is accelerated by elevatedurine pH) and for acidosis

IV infusion of 2 - 5 mmol/kg bodyweight over a period of 4 - 8 hoursor according to the needs of thepatients

1444. SodiumBicarbonate 5%w/v Ear Drops

S02DC00131D1001XX

C To soften the impacted ear wax 2-3 drops 3-4 times daily

1445. SodiumBicarbonate 8.4%(1 mmol/ml)Injection

B05XA02131P3002XX

B For acceleration of excretion indrug intoxication (whereexcretion of the drug into theurine is accelerated by elevatedurine pH) and for acidosis

According to the needs of thepatient. In severe shock due tocardiac arrest: 50 ml by IV

1446. SodiumBicarbonate andMagnesiumCarbonateCompoundMixture

A02AH00912L2101XX

C Heartburn, for rapid relief ofdyspepsia

ADULT 10-20 ml 3 times daily

1447. SodiumBicarbonate

A02AH00131L2101XX

C Heartburn for rapid relief ofdyspepsia

CHILD up to 1 year 5 ml; up to 1-5years 10 ml in 4 to 6 divided doses

Page 253 of 296

No. Generic Name MDC Category Indications DosageMixture(Paediatric)

1448. SodiumBicarbonate,Citric Acid,Sodium Citrateand Tartaric Acid- 4 g per sachet

B05CB10955M4001XX

B For relieving of discomfort inmild urinary tract infection,symptomatic relief of dysuria toenchance the action to certainantibiotics especially somesulphonamides. In gout asurinary alkalinizers to preventcystallisation of urates

4 - 8 g (1- 2 sachets) dissolved in aglass of cold water 4 times daily asprescribed

1449. SodiumBiphosphate16%, SodiumPhosphate 6%Rectal Solution

A06AG01162G2001XX

A Bowel cleansing before colonicsurgery, colonoscopy orradiological examination toensure the bowel is free of solidcontents. It is not to be used fortreatment of constipation

ADULT 133 ml (1 bottle)administered rectally. CHILD morethan 2 years half the adult dose(66.6ml)

1450. SodiumBiphosphate16%, SodiumPhosphate 6%Solution

A06AG01162L9901XX

A Bowel cleansing before colonicsurgery, colonoscopy orradiological examination toensure the bowel is free of solidcontents. It is not to be used fortreatment of constipation

45 ml diluted with half a glass (120mL) of water, followed by one fullglass (240 mL) of water. Timing ofdoses is dependent on the time ofthe procedure. For morningprocedure, first dose should betaken at 7 a.m. and second at 7 p.m.on day before the procedure. Forafternoon procedure, first doseshould be taken at 7 p.m. on daybefore and second dose at 7 a.m. onday of the procedure. Solid foodshould not be taken during thebowel preparation period. Howeverclear fluids or water can be takenliberally. CHILD under 12 years notrecommended

1451. Sodium Chloride0.18% withDextrose 10%Injection

B05XA03904P6001XX

B For replenishing fluid andenergy and for restoring ormaintaining the concentrationof sodium and chloride ions

According to the needs of thepatient

1452. Sodium Chloride0.18% withDextrose 4.23%Injection

B05XA03904P6004XX

B For replenishing fluid andenergy and for restoring ormaintaining the concentrationof sodium and chloride ions

According to the needs of thepatient

1453. Sodium Chloride0.45% Injection

B05XA03100P6001XX

B For replenishing fluid and forrestoring / maintaining theconcentration of sodium andchloride ions

100 - 1000 ml by IV or according tothe needs of the patient

1454. Sodium Chloride0.45% withDextrose 10%Injection

B05XA03904P6002XX

B For replenishing fluid andenergy and for restoring ormaintaining the concentrationof sodium and chloride ions

According to the needs of thepatient

1455. Sodium Chloride0.45% withDextrose 5%Injection

B05XA03904P6005XX

B For replenishing fluid andenergy and for restoring ormaintaining the concentrationof sodium and chloride ions

According to the needs of thepatient

Page 254 of 296

No. Generic Name MDC Category Indications Dosage1456. Sodium Chloride

0.9% Eye DropsS01XA03000D2001XX

C Irrigation of conjunctival sac 1 - 2 drops every 3 - 4 hours

1457. Sodium Chloride0.9% Injection

B05XA03100P6002XX

C+ For replenishing fluid and forrestoring/maintaining theconcentration of sodium andchloride ions

100 - 1000 ml by IV or according tothe needs of the patient

1458. Sodium Chloride0.9% withDextrose 5%Injection

B05XA03904P6003XX

C+ For replenishing fluid andenergy and for restoring ormaintaining the concentrationof sodium and chloride ions

According to the needs of thepatient

1459. Sodium Chloride20% Injection

B05XA03100P9902XX

B Addition of sodium electrolytein parenteral nutrition bagsespecially in paediatrics orneonates with restricted fluidallowance

According to the needs of thepatient

1460. Sodium Chloride3% Injection

B05XA03100P9901XX

B Acute dilutional hyponatraemia According to the needs of thepatient

1461. SodiumChromate(Chromium-51)Solution

V09GX00143L9901XX

A* Labelling of erythrocytes for theinvestigation of haemotologicaldisorders

Usual dose range : 10 - 200microcuries IV by IV injection

1462. Sodium Citrate0.3 M Solution

B05CB02136L9901XX

B Prophylaxis for aspirationpneumonitis (use as an oralsolution)

Dose depending on clinical cases.Usually, 30 ml given 10- 60 minutesbefore anaesthesia prior to electivecesarean surgery is an effectiveantacid

1463. Sodium Citrate3.8% Solution

B05CB02136H3001XX

B Sterile solution for irrigation orwashout of infected bladder

Dose depending on clinical cases

1464. Sodium Citrate,Citric AcidMixture 3 g/10ml

B05CB02136L2101XX

B Citrates and citric acid solutionsare used to correct the acidosisof certain renal tubulardisorders to treat metabolicacidosis for long-term urinealkalinization for preventionand treatment of uric acid andcalcium kidney stones and asnonparticulate neutralizingbuffers

ADULT 10 - 20 ml. CHILD up to 1year 2.5 ml tds; 1-5 year 5 ml tds; 6-12 years 10 ml tds. To be taken welldiluted with water

1465. SodiumCromoglycate 2%Eye Drops

S01GX01520D2001XX

A/KK Prevention and treatment ofallergic conjunctivitis includingseasonal and perennial allergicconjunctivitis and vernalkeratoconjunctivitis

1 or 2 drops 4 times daily

1466. SodiumDichloroisocyanurate 2.5 g Tablet

V07AV00000T1001XX

C Low and medium leveldisinfectant

50 - 10,000 ppm av chlorine

1467. SodiumDichloroisocyanurate 5 g Tablet

V07AV00000T1002XX

C Low and medium leveldisinfectant

50 - 10,000 ppm av chlorine

1468. Sodium Fusidate2% Ointment

D06AX01520G5001XX

A Skin infections caused bystaphylococci, streptococci,corynebacterium minutissumunand other sodium fusidate-

Apply to affected area 2 - 3 timesdaily

Page 255 of 296

No. Generic Name MDC Category Indications Dosagesensitive organisms

1469. Sodiumglycerophosphatefor addition intoinfusion solution,20ml vial

B05XA14171P3001XX

A Indicated in adult patients andinfants as a supplement inintravenous nutrition to meetthe requirement of phosphate.

Adults: The recommended dosage isindividual. The recommended dailydosage of phosphate duringintravenous nutrition wouldnormally be 10-20mmol. This can bemet by using 10-20ml of sodiumglycerophosphate to the infusionsolution or to the admixture forwhich compatibility has beenproved. Infants: The recommendeddosage is individual. Therecommended dose for infants andneonates is 1.0-1.5 mmol/kgbodyweight/day.

1470. SodiumHypochloriteSolution

V07AV00000L9903XX

C Low-level disinfectant andantiseptic

Antiseptic: less than 0.5%.Disinfectant: 5%

1471. Sodium Iodide(Iodide-131)Injection

V09FX03200P3001XX

A* Used in the determination ofvarious thyroid functions

5 - 50 millicuries

1472. Sodium Iodide(Iodine-131)Capsule

V09FX03200C1001XX

A* Determination of variousthyroid functions

5 - 10 milicuries (5 mCi for wholebody scan)

1473. Sodium Iodide(Iodine-131)Capsule(Therapeutic)

V10XA01200C1001XX

A* i) Thyrotoxicosis ii) Thyroidcarcinoma

i) 2 - 30 millicuries ii) 80 - 300millicuries

1474. Sodium Iodide(Iodine-131)Solution

V10XA01200L9901XX

A* i) Thyrotoxicosis ii) Thyroidcarcinoma

i) 5-25 millicuries ii) 30-150millicuries

1475. Sodium Nitrite 30mg/ml Injection

V03AB08220P3001XX

B For cyanide poisoning Adult: 300 mg sodium nitrite IV over3 minutes followed after 5 minuteswith 12.5g sodium thiosulphate IVadministered over 10 minutes.CHILD: 4 - 10 mg/kg of sodiumnitrite (max: 300 mg) followed by400 mg/kg of sodium thiosulfate, asa 25 or 50% solution (max: 12.5 g).Methaemoglobin concentrationshould not exceed 30-40%. Ifsymptoms of cyanide toxicity recur,the doses of nitrite and thiosulfatemay be repeated after 30 min at halfthe initial doses.

Page 256 of 296

No. Generic Name MDC Category Indications Dosage1476. Sodium

Nitroprusside 10mg/ml Injection

C02DD01520P3001XX

A i) Hypertensive crisis ii)Controlled hypotension duringanaesthesia in order to reducebleeding in surgical procedures

i) By IV infusion, initially 0.5-1.5mcg/kg/min, then adjusted beforeincreasement of 0.5 mcg/kg/minevery 5 mins within range 0.5-8mcg/kg/min (lower doses in patientsalready receiving otherantihypertensives); stop if markedresponse not obtained with maxdose in 10 minutes. Use only ininfusion with 5 % Dextrose IV. ii) ByIV infusion, max: 1.5 mcg/kg/min

1477. SodiumPhosphate(Phosphorus-32)Injection

V10XX01162P3001XX

A* Polycythemia vera, chronicmyeloid and chroniclymphocytic leukaemia andpalliative treatment of bonemetastases

Initially 5 millicuries, follow ifnecessary by a dose of not morethan 3 or 4 millicurie at intervals ofnot less than 2 months

1478. SodiumPolystyreneSulphonatePowder

V03AE01520F2101XX

A Treatment and prevention ofhyperkalaemia associated withanuria or severe oliguria, indialysis patients or those onprolonged peritoneal dialysis

ADULT : Oral : 15 g 1 - 4 times/day.Rectal : 30 g in 100 ml 2%methylcellulose and 100 ml water asa daily retention enema. Retain for 9hours followed by non-sodiumcleansing enema. CHILD : 1 g/kg in 1- 4 doses in acute hyperkalemia.Maintenance : 0.5 g/kg/daily

1479. SodiumTetradecylSulphate 1 %Injection

C05BB04183P3001XX

A* Sclerotherapy of oesophagealvarices, haemorrhoids andvaricose veins

0.5-2 mL into the submucosal layerat the base of the oesophageal varixor the haemorrhoid; severalinjections may be given at differentsites, max. total injected 10-15 mLof 1% per treatment

1480. SodiumTetradecylSulphate 3 %Injection

C05BB04183P3002XX

A* Sclerotherapy of oesophagealvarices, haemorrhoids andvaricose veins

0.5-2 mL into the submucosal layerat the base of the oesophageal varixor the haemorrhoid, severalinjections may be given at differentsites, max. total injected 10-15 mLof 1% per treatment

1481. SodiumThiosulphate 10-20% Solution

D01AE00181L9901XX

C Fungicides. For the treatmentof pityriasis versicolor

Apply to all affected parts of thebody and face with a brush after abath once daily or twice daily or 3times daily

Page 257 of 296

No. Generic Name MDC Category Indications Dosage1482. Sodium

Thiosulphate 500mg/ml Injection

V03AB06181P3001XX

B For cyanide poisoning Adult: To be given after 300 mg ofsodium nitrite has been admin over5-20 min: 12.5 g of sodiumthiosulfate (50 ml of a 25% solutionor 25 ml of a 50% solution) givenover 10 min. Methaemoglobinconcentration should not exceed 30-40%. If symptoms of cyanide toxicityrecur, the doses of nitrite andthiosulfate may be repeated after30 min at half the initial doses.Child: To be given after 4-10 mg/kgof sodium nitrite (max: 300 mg) hasbeen admin: 400 mg/kg of sodiumthiosulfate, as a 25 or 50% solution(max: 12.5 g). Methaemoglobinconcentration should not exceed 30-40%. If symptoms of cyanide toxicityrecur, the doses of nitrite andthiosulfate may be repeated after30 min at half the initial doses.

1483. Sodium Valproate200 mg Tablet

N03AG01520T1001XX

B i. Epilepsy ii. Treatment andprevention of mania associatedwith bipolar disorders

i. Epilepsy: ADULT: Initially 600mg/day in 2 - 3 divided doses, dosemay be increased by 200 mg at 3-day intervals to max 2.5 g/day.Usual maintenance dose: 1-2 g/day(20-30 mg/kg/day). CHILD: Morethan 20 kg. Initially 400 mg/day withspaced increases until control isachieved (usually 20-30 mg/kg/day),dose may be increased to 35mg/kg/day. Less than 20 kg 20mg/kg/day, in severe cases the dosemay be increased provided plasmaconcentration can be monitored. ii.Treatment and prevention of maniaassociated with bipolar disorders:Adults: The recommended initialdose is 1000mg/day. The doseshould be increased as rapidly aspossible to achieve the lowesttherapeutic dose, which producesthe desired clinical effects. Therecommended maintenance dosagefor the treatment of bipolar disorderis between 1000mg and 2000mgdaily. In exceptional cases, the dosemay be increased to not more than3000mg daily.

Page 258 of 296

No. Generic Name MDC Category Indications Dosage1484. Sodium Valproate

200 mg/5 mlSyrup

N03AG01520L9001XX

B Epilepsy ADULT: Initially 600 mg/day; dosemay be increased by 200 mg at 3-day intervals to max 2500 mg/day.Usual maintenance dose: 1000-2000mg/day (20-30 mg/kg/day). CHILD:More than 20 kg. Initially 400mg/day with spaced increases untilcontrol is achieved (usually 20-30mg/kg/day), dose may be increasedto 35 mg/kg/day. Less than 20 kg, 20mg/kg/day. Severe cases: 50 mg/kgdaily

1485. Sodium Valproate400 mg Injection

N03AG01520P4001XX

B Status epilepticus ADULT and CHILD above 10 years:10 to 15 mg/kg/day IV, may increase5 to 10 mg/kg/week to achieveoptimal clinical response (Maximum60 mg/kg/day or less with atherapeutic range of 50 to 100mcg/mL)

1486. SolifenacinSuccinate 5 mgTablet

G04BD08000T1001XX

A* Symptomatic treatment of urgeincontinence and/or increasedurinary frequency and urgencyas may occur in patients withoveractive bladder syndrome.

5mg od. Dose can be increased to10mg if necessary.

1487. Somatropin 10mg (30IU)Injection

H01AC01000P5002XX

A* To be used in children for: i)Growth failure due toinadequate endogenous growthhormone. ii) Growth failure ingirls due to gonadal dysgenesis(Turner syndrome). iii) Growthfailure in short children bornsmall gestational age (SGA) Tobe used in adult for: i)Pronounced growth hormonedeficiency (GHD) in knownhypothalamic-pituitary disease.ii) Childhood onset growthhormone insufficiency.

i) 0.7-1 mg/m2/day or 0.025-0.035mg/kg/day SC/IM. ii) 1.4 mg/m2/dayor 0.045-0.05 mg/kg/day SC. iii)0.035 mg/kg/day or 1 mg/m2/daySC For adult: a) Replacementtherapy: The dosage must beadjusted to the need of theindividual patient. b) Childhood-onset GHD: The recommended doseto restart is 0.2?0.5 mg/day withsubsequent dose adjustment on thebasis of IGF-I concentrationdetermination. c) Adult-onset GHD:It is recommended to starttreatment with a low dose 0.1?0.3mg/day and to increase the dosagegradually at monthly intervals inorder to meet the need of theindividual patient. Serum IGF-I canbe used as guidance for the dosetitration. Women may requirehigher doses than men, with menshowing an increasing IGF-Isensitivity over time. This meansthat there is a risk that women,especially those on oral oestrogenreplacement, are under-treatedwhile men are over-treated. Doserequirements decline with age.

Page 259 of 296

No. Generic Name MDC Category Indications DosageMaintenance dosages vary fromperson to person, but seldomexceed 1.0 mg/day (equal to 3IU/day).

1488. Somatropin 12mg (36IU)Injection

H01AC01000P3002XX

A* i) Growth failure due toinadequate endogenous growthhormone ii) Growth failure ingirls due to gonadal dysgenesis(Turner syndrome) iii) Growthfailure in short children bornsmall gestational age (SGA)

i) 0.7-1 mg/m2/day or 0.025-0.035mg/kg/day SC/IM ii) 1.4 mg/m2/dayor 0.045-0.05 mg/kg/day SC iii)0.035 mg/kg/day or 1 mg/m2/daySC

1489. Somatropin 5mg(15IU) Injection

H01AC01000P3004XX

A* To be used in children for: i)Growth failure due toinadequate endogenous growthhormone. ii) Growth failure ingirls due to gonadal dysgenesis(Turner syndrome). iii) Growthfailure in short children bornsmall gestational age (SGA) Tobe used in adult for: i)Pronounced growth hormonedeficiency (GHD) in knownhypothalamic-pituitary disease.ii) Childhood onset growthhormone insufficiency.

i) 0.7-1 mg/m2/day or 0.025-0.035mg/kg/day SC/IM ii) 1.4 mg/m2/dayor 0.045-0.05 mg/kg/day SC iii)0.035 mg/kg/day or 1 mg/m2/daySC For adult: Indication ii): a)Replacement therapy: The dosagemust be adjusted to the need of theindividual patient. b) Childhood-onset GHD: The recommended doseto restart is 0.2?0.5 mg/day withsubsequent dose adjustment on thebasis of IGF-I concentrationdetermination. c) Adult-onset GHD:It is recommended to starttreatment with a low dose 0.1?0.3mg/day and to increase the dosagegradually at monthly intervals inorder to meet the need of theindividual patient. Serum IGF-I canbe used as guidance for the dosetitration. Women may requirehigher doses than men, with menshowing an increasing IGF-Isensitivity over time. This meansthat there is a risk that women,especially those on oral oestrogenreplacement, are under-treatedwhile men are over-treated. Doserequirements decline with age.Maintenance dosages vary fromperson to person, but seldomexceed 1.0 mg/day (equal to 3IU/day).

1490. Somatropin 8 mg(24IU) Injection

H01AC01000P3003XX

A* i) Growth failure due to growthhormone insufficiencyii)Growth failure in girls due togonadal dysgenesis (Turnersyndrome) iii)Growth failure inshort children born smallgestational age(SGA)

i) 0.7-1 mg/m2/day or 0.025-0.035mg/kg/day SC/IM ii) 1.4 mg/m2/dayor 0.045-0.05 mg/kg/day SC iii)0.035 mg/kg/day or 1 mg/m2/daySC

Page 260 of 296

No. Generic Name MDC Category Indications Dosage1491. Sotalol HCl 160

mg TabletC07AA07110T1002XX

A* Ventricular tachyarrythmias Supraventricular and ventriculararrhythmias Adult: Initially, 80mg/day as single or in 2 divideddoses, increased gradually every 2-3days. Usual dose: 160-320 mg/day in2 divided doses. Life-threateningventricular arrhythmias Adult:Initially, 80 mg bid, increasedgradually every 3 days to 240-320mg/day in divided doses if needed.Maintenance: 160-320 mg/day individed doses. Max: 480-640 mg individed doses.

1492. Sotalol HCl 80 mgTablet

C07AA07110T1001XX

A* Ventricular tachyarrythmias Supraventricular and ventriculararrhythmias Adult: Initially, 80mg/day as single or in 2 divideddoses, increased gradually every 2-3days. Usual dose: 160-320 mg/day in2 divided doses. Life-threateningventricular arrhythmias Adult:Initially, 80 mg bid, increasedgradually every 3 days to 240-320mg/day in divided doses if needed.Maintenance: 160-320 mg/day individed doses. Max: 480-640 mg individed doses.

1493. Spironolactone25 mg Tablet

C03DA01000T1001XX

B Oedema and ascites in cirrhosisof the liver, congestive heartfailure

ADULT: 100 - 200 mg daily in divideddoses. Increase to 400 mg ifrequired. CHILD: initially 3 mg/kgdaily in divided doses

1494. Stavudine 30 mg,Lamivudine 150mg & Nevirapine200 mg Tablet

J05AR07964T1001XX

A/KK Fixed dose triple therapy fortreatment of HIV infection inadults once patients have beenstabilized on the maintenanceregimen of nevirapine 200 mgtwice daily and havedemonstrated adequatetolerability to nevirapine

SLN 30: 30-60 kg 1 tablet twice daily.SLN 40 ≥60 kg 1 tablet twice daily

1495. Stavudine 40 mg,Lamivudine 150mg & Nevirapine200 mg Tablet

J05AR07964T1002XX

A* Fixed dose triple therapy fortreatment of HIV infection inadults once patients have beenstabilized on the maintenanceregimen of nevirapine 200 mgtwice daily and havedemonstrated adequatetolerability to nevirapine

SLN 30: 30-60 kg 1 tablet twice daily.SLN 40 ≥60 kg 1 tablet twice daily

1496. Streptokinase1,500,000 IUInjection

B01AD01000P4001XX

A* Acute myocardial infarction,acute pulmonary embolism

Myocardial infarction: 1,500,000units over 30 - 60 minutes.Pulmonary embolism: 250,000 unitsby IV infusion over 30 minutes, then100,000 units every hour for up to12-72 hours with monitoring ofclotting factors

Page 261 of 296

No. Generic Name MDC Category Indications Dosage1497. Streptomycin

Sulphate 1 gInjection

J01GA01183P4001XX

B Tuberculosis ADULT: 15 mg/kg daily; max: 1 gdaily. Reduce max daily dose to 500-750 mg in patients >40 yr. As part ofan intermittent therapy: 25-30mg/kg/day 2-3 times/wk; max: 1.5g/dose. Not >120 g over the courseof treatment should be given unlessthere are no other treatmentoptions. Child: 20-40 mg/kg (max: 1g) daily or 25-30 mg/kg (max: 1.5 g)2-3 times wkly.

1498. StrontiumRanelate 2 gGranules

M05BX03000F1001XX

A* Treatment of postmenopausalosteoporosis to reduce risk ofvertebral and hip fractureswhen biphosphonates arecontraindicated or nottolerated

2 g sachet once daily

1499. Succindialdehyde11% &Dimethoxytetrahydrofuran 3%

V07AV00000L9907XX

A High level disinfection forendoscopes, ultrasonicprobes,anaesthesia equipment etc

Immersion time is based onmanufacturers recommendation

1500. Sucralfate 1 gTablet

A02BX02000T1001XX

A i) Benign gastric and duodenalulceration ii) Stress ulcerprophylaxis

i) 2 g twice daily or 1 g 4 times dailyfor 4-6 weeks or in resistant casesup to 12 weeks (maximum 8 g daily)ii) 1 g 6 times daily (maximum 8 gdaily). CHILD not recommended

1501. Sugammadex 100mg/ml Injection

V03AB35000P3001XX

A* Indicated for reversal ofneuromuscular blockadeinduced by rocuronium andvecuronium in selective patientgroup: obese, elderly,underlying cardiovasculardisease. For pediatricpopulation, sugammadex isrecommended for routinereversal

2 mg/kg sugammadex isrecommended, if spontaneousrecovery has occurred up to at leastthe reappearance of second twitchtension of the train-of-four (T2). 4mg/kg sugammadex isrecommended if recovery hasreached at least 1- 2 post-tetaniccounts (PTC). For immediatereversal following administration ofrocuronium a dose of 16 mg/kgsugammadex is recommended

1502. Sulfadoxine 500mg andPyrimethamine25 mg Tablet

P01BD51981T1001XX

B Treatment of Plasmodiumfalciparum malaria in patientsin whom chloroquine resistanceis suspected and malariaprophylaxis for travellers toareas where chloroquine-resistant malaria is endemic

Chloroquine resistant falciparummalaria acute attack Adult: Per tabcontains pyrimethamine 25 mg andsulfadoxine 500 mg: 2-3 tabs as asingle dose. Do not repeat for atleast 7 days. Child: Pyrimethamine25mg + Sulfadoxine 500mg (Tablet):<2 yr (5-10 kg): 1/2 (half) tab as asingle dose; 2-5 yr (>10-20 kg): 1 tabas a single dose; 5-10 yr (< 20-30kg): 1 1/2 (one and half) tab as asingle dose; 10-14 yr (> 30-45 kg): 2tab as a single dose. Do not repeatfor at least 7 days. Renalimpairment: Dose reduction may be

Page 262 of 296

No. Generic Name MDC Category Indications Dosageneeded. Severe: contra-indicated.Hepatic impairment: Dose reductionmay be needed. Severe: contra-indicated.

1503. Sulphamethoxazole 200 mg &Trimethoprim 40mg/5mlSuspension

J01EE01961L8001XX

B Infections caused by susceptiblepathogens

Mild to moderate infections: morethan 2months: 8 - 12mgTrimethoprim/kg/day divided every12hours. Serious Infections: 15-20mg Trimethoprim/kg/day dividedevery 6hours.

1504. Sulphamethoxazole 400 mg &Trimethoprim 80mg Injection

J01EE01961P3001XX

A i) Severe or complicatedinfections when oral therapy isnot feasible ii) Treatment andprophylaxis of pneumocystiscarinii pneumonia (PCP) inimmunocompromised patients

i) ADULT: 960 mg twice dailyincreased to 1.44 g twice daily insevere infections. CHILD: 36 mg/kgdaily in 2 divided doses increased to54 mg/kg/day in severe infections ii)Treatment: ADULT & CHILD over 4weeks: 120 mg/kg/day PO/IVinfusion in 2 - 4 divided doses for 14days. Prophylaxis: ADULT: 960 mgonce daily or 960 mg on alternatedays (3 times a week) or 960 mgtwice daily on alternate days (3times a week). CHILD 6 weeks - 5months: 120 mg twice daily on 3consecutive days or 7 days perweek; 6 months - 5 years: 240 mg; 6- 12 years: 480 mg

1505. Sulphamethoxazole 400 mg &Trimethoprim 80mg Tablet

J01EE01961T1001XX

B i) Severe or complicatedinfections due to susceptibleinfection ii) Treatment andprophylaxis of pneumocystiscarinii pneumonia (PCP) inimmunocompromised patients

i) ADULT: 1 - 3 tablets twice daily ii)Treatment: ADULT & CHILD over 4weeks: 120 mg/kg/day in 2 - 4divided doses for 14 days.Prophylaxis: ADULT: 960 mg oncedaily or 960 mg on alternate days (3times a week) or 960 mg twice dailyon alternate days (3 times a week).CHILD; 6 weeks - 5 months: 120 mgtwice daily on 3 consecutive days or7 days per week; 6 months - 5 years:240 mg; 6 - 12 years: 480 mg

Page 263 of 296

No. Generic Name MDC Category Indications Dosage1506. Sulphur 2% &

Salicylic Acid 2%Cream

D10AB02951G1001XX

C Acne vulgaris and seborrhoeicdermatitis

When used in scalp disorders, asmall amount of cream should berubbed gently into the roots of thehair. When used in skin disorders,the cream should be appliedsparingly to the affected area. Applyonce daily or until noticeableimprovement, then once or twice aweek

1507. Sulpiride 200 mgTablet

N05AL01000T1001XX

B Acute and chronicschizophrenia, chronicdelusional psychoses

200-400 mg twice daily; 800 mgdaily in predominantly negativesymptoms and 2.4 g daily in mainlypositive symptoms. Elderly, lowerinitial dose; increased graduallyaccording to response. Child under14 years not recommended

1508. Sumatriptan 100mg Tablet

N02CC01000T1002XX

A/KK Treatment of acute migraineattacks

50 mg per attack and not more than300 mg daily

1509. Sumatriptan 50mg FastDisintegratingTablet

N02CC01000T5001XX

A Treatment of acute migraineattacks

50 mg per attack and not more than300 mg daily

1510. Sumatriptan 50mg Tablet

N02CC01000T1001XX

A/KK Treatment of acute migraineattacks

50 mg per attack and not more than300 mg daily

1511. Sumatriptan 6mg/0.5 mlInjection

N02CC01000P5001XX

A Treament of acute migraineattacks and cluster headache

6 mg given by SC as soon as possibleafter onset. Dose may be repeatedonce after not less than 1 hour ifneeded. Max. 12 mg in 24 hours.Child not recommended

1512. Sunitinib malate12.5mg capsule

L01XE04253C1003XX

A* Treatment of advanced renalcell carcinoma (RCC) Restrictioncriteria: i) KPS ≥70% ii) Clear cellhistology iii) No brainmetastases iv) Haemoglobin≥9g/dl v) Creatinine ≤2x theULN vi) Corrected calcium<12mg/dl vii) Platelet count of>100 x 103/uL viii) Neutrophilcount>1500/mm3

50 mg orally once daily for 4consecutive weeks, followed by a 2-week off period to comprise acomplete cycle of 6 weeks.

1513. Sunscreen 5 -20% w/w Cream

D02BA02000G1001XX

B Photodermatitis Apply to exposed areas at least 30minutes prior to solar exposure;reapply after swimming, prolongedperspiration and after 2 hours ofcontinuos sun exposure

Page 264 of 296

No. Generic Name MDC Category Indications Dosage1514. Suxamethonium

Chloride 50mg/ml lnj

M03AB01100P3001XX

B Muscle relaxant as an adjunctto anaesthesia

Intravenous: Muscle relaxant ingeneral anaesthesia Adult: Aschloride: single dose of 0.3-1.1mg/kg injected; supplementarydoses of 50-100% of the initial dosemay be given at 5-10 min intervals.Max dose (repeated IV injection orcontinuous infusion): 500 mg/hrChild: As chloride: <1 yr: 2 mg/kg; 1-12 yr: 1 mg/kg. Intramuscular:Muscle relaxant in generalanaesthesia Adult: As chloride: 3-4mg/kg. Max total dose: 150 mgChild: As chloride: <1 yr: Up to 4-5mg/kg; ≥1 yr: Up to 4 mg/kg. Maxdose: 150 mg.

1515. Synthetic ACTH(TetracosactrinAcetate) 250mcg/ml Injection

H01AA02000P3001XX

A Diagnostic test to differentiateprimary adrenal fromsecondary (pituitary)adrenocortical insufficiency

Diagnostic test for investigation ofadrenocortical insufficiency Adult:As plain preparation: Measureplasma cortisol concentrationimmediately before and exactly 30min after IM/IV inj of 250 mcg. Post-inj rise in plasma cortisolconcentration ≥200 nmol/l (70mcg/l) if normal adrenocorticalfunction. As depot preparation (ifinconclusive results with plainpreparation): Measure plasmacortisol concentration before andexactly 30 min, 1, 2, 3, 4 and 5 hrafter an IM inj of 1 mgtetracosactide acetate depot.Adrenocortical function normal ifthe post-inj rise in plasma cortisolconcentration increases 2-fold in 1sthr, and continues to rise steadily.Expected levels in 1st hr: 600-1,250nmol/l, increasing slowly up to1000-1800 nmol/l by 5th hr. Child:IV 250 mcg/1.73 m2 BSA.Intramuscular

1516. Tacrolimus 0.03%Ointment

D11AH01000G5002XX

A* For short-term and intermittentlong-term therapy in thetreatment of patients withmoderate to severe atopicdermatitis in whom the use ofalternative, conventionaltherapies are deemedinadvisable because ofpotential risks, or in thetreatment of patients who arenot adequately responsive to orare intolerant of alternative,

Adult ≥16 years: Apply 0.03% or0.1% to the affected skin twice dailyand rub in gently and completely.Children ≥ 2 years: Apply 0.03%ointment thinly to the affected skinbd and rub in gently and completely.Treatment should be continued for1 week after clearing of signs &symptoms of atopic dermatitis.

Page 265 of 296

No. Generic Name MDC Category Indications Dosageconventional therapies

1517. Tacrolimus 0.1%Ointment

D11AH01000G5001XX

A* For short-term and intermittentlong-term therapy in thetreatment of patients withmoderate to severe atopicdermatitis in whom the use ofalternative, conventionaltherapies are deemedinadvisable because ofpotential risks, or in thetreatment of patients who arenot adequately responsive to orare intolerant of alternative,conventional therapies

Adult ≥16 years: Apply 0.03% or0.1% to the affected skin twice dailyand rub in gently and completely.Children ≥ 2 years: Apply 0.03%ointment thinly to the affected skinbd and rub in gently and completely.Treatment should be continued for1 week after clearing of signs &symptoms of atopic dermatitis.

1518. Tacrolimus 0.5mg Capsule

L04AD02000C1003XX

A* i) Primary immunosuppressionin liver and kidney allograftrecipients. ii) Liver and kidneyallograft rejection resistant toconventionalimmunosuppressive agents. It isrecommended to be usedconcomitantly with adrenalcorticosteroids. Because of therisk of anaphylaxis. Injectionshould be reserved for patientsunable to take capsules only.

0.1-0.2 mg/kg/day for livertransplantation and at 0.15-0.3mg/kg/day for kidneytransplantation administered as 2divided doses.

1519. Tacrolimus 0.5mgProlonged-Release HardCapsule

L04AD02000C2203XX

A* i) Prophylaxis of transplantrejection in adult kidney or liverallograft recipients. ii)Treatment of kidney or liverallograft rejection resistant totreatment with otherimmunosuppressive medicinalproducts in adult.

i) Prophylaxis of kidney transplantrejection: Tacrolimus PR therapyshould commence at dose of 0.20-0.30 mg/kg/day administered oncedaily in the morning. Administrationshould commence within 24 hoursafter completion of surgery. ii)Prophylaxis of liver transplantrejection: Tacrolimus PR therapyshould commence at a dose of 0.10-0.20 mg/kg/day administered oncedaily in the morning. Administrationshould commence within 12-18hours after completion of surgery.iii) Treatment of allograft rejection:Increased doses of tacrolimus,supplemental corticosteroidtherapy, and introduction of shortcourses of mono-/polyclonalantibodies have all been used to

Page 266 of 296

No. Generic Name MDC Category Indications Dosagemanage rejection episodes. If signsof toxicity such as severe adversereactions are noted, the dose ofTacrolimus PR might need to bereduced. iv) Treatment of allograftrejection after kidney or livertransplantation: For conversionfrom other immunosuppressants toonce daily Tacrolimus PR, treatmentshould begin with the initial oraldose recommended in kidney andliver transplantation respectively forprophylaxis of transplant rejection.v) Conversion of Tacrolimus toTacrolimus PR: Allograft transplantpatients maintained on twice dailyPR capsules dosing requiringconversion to once daily PR shouldbe converted on a 1:1 (mg:mg) totaldaily dose basis. Tacrolimus PRshould be administered in themorning. (Please refer to theproduct leaflet for furtherinformation on dosage)

1520. Tacrolimus 1 mgCapsule

L04AD02000C1001XX

A* i) Primary immunosuppressionin liver and kidney allograftrecipients. ii) Liver and kidneyallograft rejection resistant toconventionalimmunosuppressive agents. It isrecommended to be usedconcomitantly with adrenalcorticosteroids. Because of therisk of anaphylaxis. Injectionshould be reserved for patientsunable to take capsules only.

0.1-0.2 mg/kg/day for livertransplantation and at 0.15-0.3mg/kg/day for kidneytransplantation administered as 2divided doses.

Page 267 of 296

No. Generic Name MDC Category Indications Dosage1521. Tacrolimus 1mg

Prolonged-Release HardCapsule

L04AD02000C2201XX

A* i) Prophylaxis of transplantrejection in adult kidney or liverallograft recipients. ii)Treatment of kidney or liverallograft rejection resistant totreatment with otherimmunosuppressive medicinalproducts in adult.

i) Prophylaxis of kidney transplantrejection: Tacrolimus PR therapyshould commence at dose of 0.20-0.30 mg/kg/day administered oncedaily in the morning. Administrationshould commence within 24 hoursafter completion of surgery. ii)Prophylaxis of liver transplantrejection: Tacrolimus PR therapyshould commence at a dose of 0.10-0.20 mg/kg/day administered oncedaily in the morning. Administrationshould commence within 12-18hours after completion of surgery.iii) Treatment of allograft rejection:Increased doses of tacrolimus,supplemental corticosteroidtherapy, and introduction of shortcourses of mono-/polyclonalantibodies have all been used tomanage rejection episodes. If signsof toxicity such as severe adversereactions are noted, the dose ofTacrolimus PR might need to bereduced. iv) Treatment of allograftrejection after kidney or livertransplantation: For conversionfrom other immunosuppressants toonce daily Tacrolimus PR, treatmentshould begin with the initial oraldose recommended in kidney andliver transplantation respectively forprophylaxis of transplant rejection.v) Conversion of Tacrolimus toTacrolimus PR: Allograft transplantpatients maintained on twice dailyPR capsules dosing requiringconversion to once daily PR shouldbe converted on a 1:1 (mg:mg) totaldaily dose basis. Tacrolimus PRshould be administered in themorning. (Please refer to theproduct leaflet for furtherinformation on dosage)

1522. Tacrolimus 5 mgCapsule

L04AD02000C1002XX

A* i) Primary immunosuppressionin liver and kidney allograftrecipients. ii) Liver and kidneyallograft rejection resistant toconventionalimmunosuppressive agents. It isrecommended to be usedconcomitantly with adrenalcorticosteroids. Because of the

0.1-0.2 mg/kg/day for livertransplantation and at 0.15-0.3mg/kg/day for kidneytransplantation administered as 2divided doses.

Page 268 of 296

No. Generic Name MDC Category Indications Dosagerisk of anaphylaxis. Injectionshould be reserved for patientsunable to take capsules only.

1523. Tacrolimus 5mgProlonged-Release HardCapsule

L04AD02000C2202XX

A* i) Prophylaxis of transplantrejection in adult kidney or liverallograft recipients. ii)Treatment of kidney or liverallograft rejection resistant totreatment with otherimmunosuppressive medicinalproducts in adult.

i) Prophylaxis of kidney transplantrejection: Tacrolimus PR therapyshould commence at dose of 0.20-0.30 mg/kg/day administered oncedaily in the morning. Administrationshould commence within 24 hoursafter completion of surgery. ii)Prophylaxis of liver transplantrejection: Tacrolimus PR therapyshould commence at a dose of 0.10-0.20 mg/kg/day administered oncedaily in the morning. Administrationshould commence within 12-18hours after completion of surgery.iii) Treatment of allograft rejection:Increased doses of tacrolimus,supplemental corticosteroidtherapy, and introduction of shortcourses of mono-/polyclonalantibodies have all been used tomanage rejection episodes. If signsof toxicity such as severe adversereactions are noted, the dose ofTacrolimus PR might need to bereduced. iv) Treatment of allograftrejection after kidney or livertransplantation: For conversionfrom other immunosuppressants toonce daily Tacrolimus PR, treatmentshould begin with the initial oraldose recommended in kidney andliver transplantation respectively forprophylaxis of transplant rejection.v) Conversion of Tacrolimus toTacrolimus PR: Allograft transplantpatients maintained on twice dailyPR capsules dosing requiringconversion to once daily PR shouldbe converted on a 1:1 (mg:mg) totaldaily dose basis. Tacrolimus PRshould be administered in themorning. (Please refer to theproduct leaflet for furtherinformation on dosage)

Page 269 of 296

No. Generic Name MDC Category Indications Dosage1524. Tacrolimus

5mg/ml InjectionL04AD02000P3001XX

A* i) Primary immunosuppressionin liver and kidney allograftrecipients. ii) Liver and kidneyallograft rejection resistant toconventionalimmunosuppressive agents. It isrecommended to be usedconcomitantly with adrenalcorticosteroids. Because of therisk of anaphylaxis. Injectionshould be reserved for patientsunable to take capsules only.

0.01-0.05 mg/kg for liver transplantand 0.05-0.1 mg/kg for kidneytransplant as 24-hours continuousinfusion.

1525. Tamoxifen Citrate20 mg Tablet

L02BA01136T1001XX

A Breast cancer 20 mg in 1-2 divided doses. Max: 40mg/day

1526. Tamsulosin HCl400 mcgExtended ReleaseTablet

G04CA02110T5001XX

A* Second line treatment offunctional symptoms of benignprostatic hyperplasia (BPH) inpatients who do not toleratefirst line drugs or when first linedrugs are inappropriate orcontraindicated

400 mcg once daily

1527. Tar, Coal Tar andOleyl AlcoholLiquid

D05AA00952L5001XX

A/KK Dandruff, seborrhoeicdermatitis and atopic dermatitis

Massage into wet hair, rinse andrepeat. Use once or twice weekly

1528. Technetium-99mSterile Generator

V09CA01000P3001XX

A* Sodium pertechnetate is usedfor scintigraphy or nuclear scanparticularly of the brain andthyroid to prepare varioustechnetium-99m labelledinjections for selective organimaging

Technetium-99m as pertechnetateis obtained by elution with a sterilesolution of Sodium Chloride 0.9%.The dosage depend on type of scani) Thyroid scintigraphy: 18.5-80 MBq(0.5-2.2 mCi) Scintigraphyperformed 20 minutes afterintravenous injection ii) Salivarygland scintigraphy: 40 MBq (1.1mCi) Scintigraphy performedimmediately after intravenousinjection and at regular intervals upto 15 minutes iii) Meckel?sdiverticulum scintigraphy: 400 MBq(10.8 mCi) Scintigraphy performedimmediately after intravenousinjection and at regular interval upto 30 minutes iv) Brain scintigraphy:370-800 MBq (10-22 mCi) Rapidsequential images are takenimmediately within the first minuteafter intravenous administration,static images 1 to 4 hours later.Thyroid and coriod plexus should beblocked to avoid non-specific 99mTcuptake v) Cardiac and vascularscintigraphy: 740-925 MBq (20-25mCi) Red cells are labeled in vivo orin vitro by pretreating with a

Page 270 of 296

No. Generic Name MDC Category Indications Dosagereducing agent. Dynamic images aretaken in the first minute afterintravenous administration,followed by regular images over 30minutes vi) Gastrointestinalbleeding: 740-925 MBq (20-25 mCi)Red cells are labeled in vivo or invitro by pretreating with a reducingagent. Dynamic images are taken inthe first minutes after intravenousadministration, followed by regularimages at appropriate intervals forup to 24 hours vii) Lacrimal ductscintigraphy: 2-4 MBq each eye (50-100 mCi) Drops are instilled into eyeand dynamic images are taken over2 minutes, followed by static imagesat appropriate intervals over 20minutes

1529. Tegafur 100 mg &uracil 224 mgCapsule

L01BC53980C1001XX

A* Non small cell lung cancer 300-600 mg daily in 2-3 divideddoses

1530. Telbivudine 600mg Tablet

J05AF11000T1001XX

A* Treatment of chronic hepatitisB in patients with evidence ofviral replication and active liverinflammation

ADULT and CHILD over 16 years: 600mg once daily. Renal DoseAdjustment: 600mg every 48hours(30-49ml/min), 600 mg every72hours. (<30ml/min; not requiringdialysis); 600mg every 96 days(ESRD)

1531. Telmisartan 40mg Tablet

C09CA07000T1001XX

A/KK Hypertension in patients whocannot tolerate ACE inhibitorsbecause of cough

40mg - 80mg once daily

1532. Telmisartan 80mg &Hydrochlorothiazide 12.5 mgTablet

C09DA07000T1001XX

A/KK Hypertension in patients whocannot tolerate ACE inhibitorsbecause of cough

1 tablet daily

1533. Telmisartan 80mg Tablet

C09CA07000T1002XX

A/KK i)Hypertension in patients whocannot tolerate ACE inhibitorsbecause of cough ii)Reductionof the risk of myocardialinfarction, stroke, or deathfrom cardiovascular causes inpatients 55 years or older athigh risk of developing majorcardiovascular events who areunable to take ACE inhibitors

i) 40mg - 80mg once daily ii) 80mgonce daily

Page 271 of 296

No. Generic Name MDC Category Indications Dosage1534. Temozolomide

100 mg CapsuleL01AX03000C1003XX

A* In patients with glioblastomamultiforme who fulfill all thefollowing criteria: i. Total /neartotal resection ii. ECOG/WHOperformance status 0-2 iii. Ageless than 60 years

Concomitant phase : 75mg/m2 dailywith radiotherapy for 42 days,followed by 6 cycle of adjuvanttreatment. Adjuvant phase:Additional 6 cycles of adjuvantphase. Cycle 1- 150mg/m2 oncedaily for 5 days followed by 23 dayswithout treatment. Cycle 2-6 :200mg/m2 once daily for 5 days per28-day cycle

1535. Temozolomide 20mg Capsule

L01AX03000C1001XX

A* In patients with glioblastomamultiforme who fulfill all thefollowing criteria : i. total /neartotal resection ii. ECOG/WHOperformance status 0-2 iii. Ageless than 60 years

Concomitant phase : 75mg/m2 dailywith radiotherapy for 42 days,followed by 6 cycle of adjuvanttreatment. Adjuvant phase:Additional 6 cycles of adjuvantphase. Cycle 1- 150mg/m2 oncedaily for 5 days followed by 23 dayswithout treatment. Cycle 2-6 :200mg/m2 once daily for 5 days per28-day cycle

1536. Tenecteplase10,000 unit (50mg) Injection

B01AD11000P4001XX

A* Acute myocardial reinfarctionwhere streptokinase iscontraindicated due to previousstreptokinase inducedantibodies. [Indicated whenantibodies was given more than5 days and less than 12 months]

Less than 60 kg: 30 mg, 60 - 69 kg:35 mg, 70 - 79 kg: 40 mg; 80 -90 kg:45 mg, 90 kg or above: 50 mg.Administer single IV bolus over 5-10seconds

1537. TenofovirDisoproxilFumarate 300 mg& Emtricitabine200 mg Tablet

J05AR03964T1001XX

A/KK Treatment of HIV-1 infection inadults in combination withother antiretroviral agents(such as non-nucleoside reversetranscriptase inhibitors orprotease inhibitors).

1 tablet once daily.

1538. TenofovirDisoproxilFumarate 300 mgTablet

J05AF07138T1001XX

A* i)Treatment of HIV-1 infectedadults in combination withother antiretroviral agents.ii)Use as first line monotherapyfor chronic hepatitis B or as arescue therapy for patients withdrug resistance hepatitis B virus(according to resistant profile ortreatment guidelines).

300mg once daily. Renal DoseAdjustment: 300mg every 48hours(30-49ml/min); 300mg every72hours (10-29ml/min); 300mgevery 7 days after dialysis(Hemodialysis)

1539. Terazosin HCl 1mg Tablet

G04CA03110T1001XX

A/KK Only for treatment of BenignProstatic Hyperplasia. Not to beused for treatment ofhypertension

Initially 1 mg at night, increased in astepwise fashion to 2 mg, 5 mg or 10mg once daily

1540. Terazosin HCl 2mg Tablet

G04CA03110T1002XX

A/KK i) Treatment of Benign ProstaticHyperplasia. ii)Hypertension

i)Initially 1 mg at night, increased ina stepwise fashion to 2 mg, 5 mg or10 mg once daily. ii)Initial: 1mg oncedaily at bedtime, Maintenance: 1-5mg once (morning or evening) ortwice daily. Max: 20-40mg/day

Page 272 of 296

No. Generic Name MDC Category Indications Dosage1541. Terazosin HCl 5

mg TabletG04CA03110T1003XX

A/KK i) Treatment of Benign ProstaticHyperplasia. ii)Hypertension

i) Initially 1 mg at night, increased ina stepwise fashion to 2 mg, 5 mg or10 mg once daily. ii) Initial: 1mgonce daily at bedtime, Maintenance:1-5mg once (morning or evening) ortwice daily. Max: 20-40mg/day

1542. Terbinafine HCl250 mg Tablet

D01BA02110T1001XX

A/KK Fungal infections especiallyonchomycosis caused bydermatophytes

250 mg once daily for 6 weeks forfingernails: 12 weeks for toenails

1543. TerbutalineSulphate 0.5mg/ml Injection

R03CC03183P3001XX

B Bronchial asthma, chronicbronchitis, emphysema andother lung diseases wherebroncoconstriction is acomplicating factor

SC, IM or slow IV : 250-500 mcg upto 4 times daily. CHILD 2 - 15 years10mcg/kg to a maximum of 300mcg. Continuous IV infusion, as asolution containing 3 - 5 mcg/ml, 1.5- 5 mcg/minute for 8 - 10 hours;reduce dose for children

1544. TerbutalineSulphate 10mg/ml NebulizerSolution

R03AC03183A3001XX

B Asthma and other conditionsassociated with reversibleairways obstruction

ADULT : 5 - 10 mg 2 -4 times daily,additional doses may be necessaryin severe acute asthma. CHILD up to3 years : 2 mg, 3 - 6 years : 3 mg, 6 -8 years : 4 mg, over 8 years : 5 mg 2- 4 times daily

1545. Terlipressin1mg/5mgInjection

H01BA04000P4001XX

A* Acute oesophageal varicealbleeding

2 mg IV bolus over 1 minute.Maintenance: 1 - 2 mg IV bolus 4 - 6hourly until bleeding is controlled,up to 24 - 36 hours. The maximumdaily dosage is 120-150 mcg/kgbody weight.

1546. Testosterone 250mg/ml Injection

G03BA03000P3001XX

A* Only for treatment of maleinfertility, protein deficiencyduring convalescence aftersurgery and wasting disorder. Inwomen, supplementary therapyof progressive mammarycarcinoma

By IM only. Hypogonadism 250 mgevery 2-3 weeks. To maintain anadequate androgenic effect 250 mgevery 3-6 weeks. Potency disorders250 mg every 4 weeks. Maleclimateric disorders: 250 mg every3-4 weeks. Repeated 6-8 weekscourses at 2-3 months interval

1547. Tetanus ToxoidInjection

J07AM01000P3001XX

C+ Immunization against tetanusinfection

2 doses of 0.5 mL IM at an intervalof 4-8 wk, followed by the 3rd dose6-12 mth later. Booster: 0.5 mL IMevery 10 yr.

1548. Tetracycline HCl250 mg Capsule

J01AA07110C1001XX

B Infections caused by susceptiblepathogens

"Adult: 250-500 mg 6 hrly. Max: 4g/day. Child: ≥12 yr Max: 2 g daily"

1549. Tetracycline HCl250 mg Tablet

J01AA07110T1001XX

B Infections caused by susceptiblepathogens

"Adult: 250-500 mg 6 hrly. Max: 4g/day. Child: ≥12 yr Max: 2 g daily"

1550. Thalidomide 50mg Capsule

L04AX02000C1001XX

A* First line induction therapy innewly diagnosed multiplemyeloma, salvage therapy inrelapsed multiple myeloma andmaintenance therapy inmultiple myeloma(contraindicated for pregnantwomen; pregnancy test forfemales in reproductive age

50 mg to 200 mg daily

Page 273 of 296

No. Generic Name MDC Category Indications Dosagegroup before starting treatmentshould be done).

1551. Thallous Chloride(Thallium-201)Injection

V09GX01100P3001XX

A* Used in myocardial perfusionscintigraphy, acute myocardialinfarction and post-surgicalassessment of coronary arterybypass graft patency, muscleperfusion scintigraphy,visualisation of brain andthyroid tumours andmetastases

As IV infusion

1552. Theophylline 125mg Tablet

R03DA04000T1001XX

B Reversible airways obstruction,acute severe asthma

ADULT: 125 mg 3 - 4 times dailyafter food, increased to 250 mg ifrequired. CHILD: 1 - 15 years : 5mg/kg/dose (up to 600 mg/ day)every 3 - 4 times daily

1553. Theophylline 250mg Long ActingTablet

R03DA04000T5001XX

B Reversible airways obstructionand acute severe asthma

ADULT: 250 mg 2 times daily. CHILDunder 12 years : Up to 10 mg/kgbody weight 2 times daily

1554. Theophylline 80mg/15 ml Syrup

R03DA04000L9001XX

B Reversible airways obstructionand acute severe asthma

ADULT : 125 mg 3 - 4 times dailyafter food, increased to 250 mg ifrequired. CHILD 1 - 15 years : 5mg/kg/dose (up to 600 mg/day)every 3 - 4 times per day

1555. Thiamine HCl 100mg/ml Injection

A11DA01110P3001XX

B i) For the prevention ortreatment of Vitamin B1deficiency syndromes includingberi-beri and peripheral neuritisassociated with pellagra ii)Wernicke-Korsakoff Syndrome

i) Mild to chronic deficiency: 10-25mg daily. Severe deficiency: 200-300 mg daily ii) 500 mg every 8hours for 2 days, followed by 100mg 2 times daily until patient cantake oral dose

1556. ThiamineMononitrate 10mg Tablet

A11DA01221T1002XX

C For the prevention or treatmentof Vitamin B1 deficiencysyndromes including beri-beriand peripheral neuritisassociated with pellagra

i) Mild to chronic deficiency: 10-25mg daily ii) Severe deficiency: 200-300 mg daily

1557. ThiamineMononitrate 3mg Tablet

A11DA01221T1001XX

C For the prevention or treatmentof Vitamin B1 deficiencysyndromes including beri-beriand peripheral neuritisassociated with pellagra

i) Mild to chronic deficiency: 10-25mg daily ii) Severe deficiency: 200 -300 mg daily

1558. Thioguanine 40mg Tablet

L01BB03000T1001XX

A For acute leukaemia andchronic granulocytic leukaemia

Refer to specific protocols. Usually100 mg/m2 for 5 - 7 days (acutemyeloid leukaemia) or up to 2weeks (chronic myeloid leukaemiafor accelerated/ advanced disease).CHILD: 40 - 60 g/m2 daily accordingto protocol

Page 274 of 296

No. Generic Name MDC Category Indications Dosage1559. Thiopental

Sodium 500 mgInjection

N05CA19520P3001XX

B i) General anaesthesia,induction ii) Anticonvulsant forcases resistant to conventionalanticonvulsants in the ICU

i) ADULT : For induction 200 - 400mg. For repeat injection 3 - 5 mg/kgover 10 - 15 seconds until desireddepth of anaesthesia is obtained.Not FDA approved for use inpediatric patients ii) 75 - 125 mg IVsingle dose; for local-anaestheticinduced convulsion: 125 - 250 mg IVover 10 minutes

1560. ThymolCompoundGargle

A01AD11985M2001XX

C For sore throat and minormouth inflammation

To be gargled 3-4 times daily

1561. Thyrotropin alfa0.9mg/mlInjection

H01AB01000P3002XX

A* Thyrogen (thyrotropin alfa) isindicated for use as anadjunctive treatment forradioiodine ablation of thyroidtissue remnants in patients whohave undergone a near-total ortotal thyroidectomy for well-differentiated thyroid cancerand who do not have evidenceof distant metastatic thyroidcancer.

A two-injection regimen isrecommended for thyrotropinadministration.The two-injectionregimen is thyrotropin 0.9 mgintramuscularly (IM), followed by asecond 0.9 mg IM injection 24 hourslater. After reconstitution with 1.2mL Sterile Water for Injection, 1.0mL solution (0.9 mg thyrotropinalfa) is administered byintramuscular injection to thebuttock. For radioiodine imaging ortreatment, radioiodineadministration should be given 24hours following the final Thyrogeninjection. Diagnostic scanningshould be performed 48 hours afterradioiodine administration, whereaspost-therapy scanning may bedelayed additional days to allowbackground activity to decline.

1562. Tibolone 2.5 mgTablet

G03CX01000T1001XX

A* Treatment of complaintsresulting from the natural orsurgical menopause & in casesat high risk for breastcarcinomas where generalhormone replacement therapyis contraindicated

2.5mg daily

1563. Ticagrelor 90 mgTablet

B01AC24000T1001XX

A* a)Patient who failed clopidogrelreadmitted to hospital withrecurrent atherothromboticevent while patients are onclopidogrel. b) ACS patientswith:i) STEMI - going forinvasive (PCI), ii) NSTEMI/UA -intermediate to high risk (basedon TIMI score). iii) Othercomplicated ACS cases treatedeither medically or invasivelyvia PCI or CABG (risk of Stentthrombosis, 3VD etc.)

Initially, 180mg as single dosefollowed by 90mg bd withmaintenance dose of ASA 75-150mg daily.

Page 275 of 296

No. Generic Name MDC Category Indications Dosage1564. Ticlopidine HCl

250 mg TabletB01AC05110T1001XX

A/KK i) Prevention of thromboticstroke for patients who aresensitive /intolerant toAcetysalicylic Acid ii)Maintenance of coronarybypass surgery or angioplastyiii) Maintenance of patency ofaccess in patients on chronichaemodialysis

250 mg twice daily taken with food

1565. Timolol Maleate0.5% Eye Drops

S01ED01253D2002XX

A Elevated intraocular pressure,chronic open angle glaucoma

1 drop for once daily or 2 times dailydepending on manufacturer'srecommendation.

1566. Tinidazole 500mg Tablet

P01AB02000T1001XX

B i) Amoebiasis ii) Urogenitaltrichomoniasis and giardiasis

i) ADULT : 2 g as a single dose for 2 -3 days. CHILD 3 years and older : 50mg/kg daily for 3 days ii) ADULT : 2 gas a single dose (repeated once ifnecessary). Sexual partners shouldbe treated concomitantly with thesame dose. CHILD 6 years and older: single dose of 1 gram

1567. Tinzaparinsodium 10,000anti-Factor XaIU/ml Injection inPrefilledsyringe/cartridge

B01AB10520P5001XX

A* i)Treatment of deep veinthrombosis (DVT) andpulmonary embolism (PE), notamounting to hemodynamicinstability. ii)Prevention of post-operative DVT in patientsundergoing general andorthopaedic surgery.

i)Treatment of DVT and PE, inconjunction with warfarin: 175 anti-Factor Xa IU/kg SC once daily for atleast 6 days. ii)Thromboprophylaxisin patients with:Moderate risk ofthrombosis (general surgery):3,500anti-Factor Xa IU SC 2 hrs beforesurgery and postoperatively, 3,500anti-Factor Xa IU once daily for 7-10days. High risk of thrombosis (eg.total hip replacement):4,500 anti-Factor Xa IU SC or 50 anti-Factor XaIU/kg body weight SC 2 hrs beforesurgery and then once daily until thepatients has been mobilized.

1568. Tinzaparinsodium 20,000anti-Factor XaIU/ml Injection inPrefilledsyringe/cartridge

B01AB10520P5002XX

A* i)Treatment of deep veinthrombosis (DVT) andpulmonary embolism (PE), notamounting to hemodynamicinstability. ii)Prevention of post-operative DVT in patientsundergoing general andorthopaedic surgery.

i)Treatment of DVT and PE, inconjunction with warfarin: 175 anti-Factor Xa IU/kg SC once daily for atleast 6 days. ii)Thromboprophylaxisin patients with:Moderate risk ofthrombosis (general surgery):3,500anti-Factor Xa IU SC 2 hrs beforesurgery and postoperatively, 3,500anti-Factor Xa IU once daily for 7-10days. High risk of thrombosis (eg.total hip replacement):4,500 anti-Factor Xa IU SC or 50 anti-Factor XaIU/kg body weight SC 2 hrs beforesurgery and then once daily until thepatients has been mobilized.

1569. Tioconazole 1%Cream

D01AC07000G1001XX

A Skin fungal infections resistantto antifungal drugs such asmiconazole and clotrimazole

Gently massage into the affectedand surrounding area 1-2 times daily

Page 276 of 296

No. Generic Name MDC Category Indications Dosage1570. Tioconazole 100

mg Vaginal TabletG01AF08000S1001XX

A Vulvovaginal candidiasis Adult & Child > 12yr: Insert nightlyon retiring for 3-6 or 14 days

1571. Tioconazole 6.5%Vaginal Ointment

G01AF08000G5001XX

A Vulvaginal candidiasis Apply 4.6 g intravaginally prior tobedtime as a single dose therapy,therapy may extend to 7 days

1572. Tiotropium2.5mcg/puffsolution forinhalation

R03BB04320A3001XX

A/KK i) Maintenance bronchodilatortreatment to relieve symptomsof patients with chronicobstructive pulmonary disease(COPD) in which the diagnosisof COPD is confirmed byspirometry. ii) As add-onmaintenance bronchodilatortreatment in adult patients withasthma who are currentlytreated with the maintenancecombination of inhaledcorticosteroids (≥800µgbudesonide/day or equivalent)and long-acting β2-agonist andwho experienced one or moresevere exacerbations in theprevious year.

5 mcg (2 puff) once daily, at thesame time of the day

1573. TiotropiumBromide 18 mcgInhalationCapsules

R03BB04320C9901XX

A/KK Long term maintenancetreatment of bronchospasmand dypsnoea associated withCOPD. Tiotropium has usuallybeen added to standardtherapy (e.g. inhaled steroids,theophylline, albuterol rescue)

Contents of one capsule is inhaledonce daily with the Handihalerinhalation device at the same timeof the day.

1574. Tirofiban HCl 0.25mg/ml Injection

B01AC17110P9901XX

A* Unstable angina or non-STsegment elevation myocardialinfarction with the following:elevated cardiac markers,refractory chest pain, ST-segment changes andthrombolysis in myocardialinfarction (TIMI) risk score 4

By IV infusion, 0.4 mcg/kg/min for30 minutes, then 0.1 mcg/kg/minfor at least 48 hours, maximum 108hours

1575. Tocilizumab162mg/0.9mlsolution forinjection inprefilled syringe(forsubcutaneousinjection)

L04AC07000P3003XX

A* Indicated for the treatment ofmoderate to severe activerheumatoid arthritis (RA) inadult patients: i) withinadequate respond orintolerance to conventionaldisease- modifyingantirheumatic drugs (DMARDS)ii) who has failed antitumournecrosis factors (antiTNFs) iii)where TNF is contraindicated(patients with history ofpulmonary tuberculosis [PTB]) Italso can be used asmonotherapy or with

Adult patients: 162mg given onceevery week as a subcutaneousinjection.

Page 277 of 296

No. Generic Name MDC Category Indications Dosagecombination with methotrexate(MTX) and/ or other DMARDS.

1576. Tocilizumab 20mg/ml Injection

L04AC07000P3001XX

A* Indicated for the treatment ofmoderate to severe activerheumatoid arthritis (RA) inadult patients: i) withinadequate respond orintolerance to conventionaldisease- modifyingantirheumatic drugs (DMARDS)ii) who has failed antitumournecrosis factors (antiTNFs) iii)where TNF is contraindicated(patients with history ofpulmonary tuberculosis [PTB]) Italso can be used asmonotherapy or withcombination with methotrexate(MTX) and/ or other DMARDS.

Recommended dose for rheumatoidarthritis of tocilizumab for adultpatients is 8mg/kg given once every4 weeks as a single-drip IV infusionover 1 hour. It should be diluted to100 ml by a healthcare professionalwith sterile 0.9% w/v sodiumchloride solution over 1 hour. Forpatients whose body weight is morethan 100kg, doses exceeding 800mgper infusion are not recommended

1577. Tofacitinib citrate5mg film coatedtablet

L04AA29136T3201XX

A* Indicated for the treatment ofadult patients with moderatelyto severely active rheumatoidarthritis who have had aninadequate response orintolerance to methotrexate. Itmay be used as monotherapyor in combination withmethotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

One tablet twice daily

1578. TolterodineTartrate ER 4 mgCapsule

G04BD07123C2002XX

A* Treatment of overactivebladder with symptoms ofurinary, frequency or urgeincontinence

4 mg once daily. May decrease to 2mg once daily depending onresponse and tolerability

1579. Topiramate 100mg Tablet

N03AX11000T1003XX

A* Add-on therapy for intractablepartial epilepsy

ADULT: Initially 25-50mg nightly for1 week. Subsequently at wkly or bi-wkly intervals, increase dose by 25-50 to 100mg/day in 2 divided doses.CHILD aged 2 and above: Approx 5-9mg/kg/day in 2 divided doses.Titrate at 25mg (or less, based on arange of 1-3mg/kg/day) nightly forthe 1st week. Subsequently at 1 or 2wkly intervals, with increments of 1-3 mg/kg/day in 2 divided dose.

Page 278 of 296

No. Generic Name MDC Category Indications Dosage1580. Topiramate 15

mg CapsuleSprinkle

N03AX11000C1001XX

A* Add-on therapy for intractablepartial epilepsy

ADULT: Initially 25-50mg nightly for1 week. Subsequently at wkly or bi-wkly intervals, increase dose by 25-50 to 100mg/day in 2 divided doses.CHILD aged 2 and above: Approx 5-9mg/kg/day in 2 divided doses.Titrate at 25mg (or less, based on arange of 1-3mg/kg/day) nightly forthe 1st week. Subsequently at 1 or 2wkly intervals, with increments of 1-3 mg/kg/day in 2 divided dose.

1581. Topiramate 25mg CapsuleSprinkle

N03AX11000C1002XX

A* Add-on therapy for intractablepartial epilepsy

ADULT: Initially 25-50mg nightly for1 week. Subsequently at wkly or bi-wkly intervals, increase dose by 25-50 to 100mg/day in 2 divided doses.CHILD aged 2 and above: Approx 5-9mg/kg/day in 2 divided doses.Titrate at 25mg (or less, based on arange of 1-3mg/kg/day) nightly forthe 1st week. Subsequently at 1 or 2wkly intervals, with increments of 1-3 mg/kg/day in 2 divided dose.

1582. Topiramate 25mg Tablet

N03AX11000T1001XX

A* Add-on therapy for intractablepartial epilepsy

ADULT: Initially 25-50mg nightly for1 week. Subsequently at wkly or bi-wkly intervals, increase dose by 25-50 to 100mg/day in 2 divided doses.CHILD aged 2 and above: Approx 5-9mg/kg/day in 2 divided doses.Titrate at 25mg (or less, based on arange of 1-3mg/kg/day) nightly forthe 1st week. Subsequently at 1 or 2wkly intervals, with increments of 1-3 mg/kg/day in 2 divided dose.

1583. Topiramate 50mg Tablet

N03AX11000T1002XX

A* Add-on therapy for intractablepartial epilepsy

ADULT: Initially 25-50mg nightly for1 week. Subsequently at wkly or bi-wkly intervals, increase dose by 25-50 to 100mg/day in 2 divided doses.CHILD aged 2 and above: Approx 5-9mg/kg/day in 2 divided doses.Titrate at 25mg (or less, based on arange of 1-3mg/kg/day) nightly forthe 1st week. Subsequently at 1 or 2wkly intervals, with increments of 1-3 mg/kg/day in 2 divided dose.

1584. Trace Elementsand Electrolytes(Adult) Solution

B05XA30905P3001XX

A* Only to be used to cover dailyloss of electrolyte and traceelements for patient onparenteral nutrition

10 ml added to 500-1000 mlsolution, given by IV infusion

Page 279 of 296

No. Generic Name MDC Category Indications Dosage1585. Trace Elements

and Electrolytes(Paediatric)Solution

B05XA30905P3002XX

A* Only to be used to cover dailyloss of electrolyte and traceelements for patient onparenteral nutrition

According to the needs of thepatient. INFANT and CHILD weighing15 kg or less: Basal requirements ofthe included trace elements arecovered by 1 ml/kg/day to amaximum dose of 15 ml. CHILDweighing 15 kg or more, a daily doseof 15 ml, should meet basic traceelement requirements. However, forpatients weighing more than 40 kgthe adult preparation trace elementshould be used

1586. Tramadol HCl 100mg Suppository

N02AX02110S2001XX

A Post-operative pain, chroniccancer pain, analgesia/painrelief for patients with impairedrenal function

100mg rectally up to qds

1587. Tramadol HCl 100mg/ml Drops

N02AX02110D5001XX

A Post-operative pain, chroniccancer pain, analgesia/painrelief for patients with impairedrenal function.

50 - 100 mg every 4 hours. Max :400 mg daily. Not recommended inchildren

1588. Tramadol HCl 50mg Capsule

N02AX02110C1001XX

A/KK Moderate to severe acute orchronic pain (eg. Post-operativepain, chronic cancer pain andanalgesia/pain relief forpatients with impaired renalfunction)

ADULT: 50mg initially, can takeanother 50mg after 30 - 60 min ifpain not relieved. Max 400 mg daily.CHILD: 1mg/kg/dose repeated every6 hours (Max: 2mg/kg/dose and100mg/dose)

1589. Tramadol HCl 50mg/ml Injection

N02AX02110P3001XX

A Moderate to severe acute orchronic pain (eg. Post-operativepain, chronic cancer pain andanalgesia/pain relief forpatients with impaired renalfunction)

ADULT: IV/IM/SC 50 - 100mg. (IV injover 2-3 min or IV infusion). Initially100 mg then 50 - 100 mg every 4 - 6hours. . Max: 400 mg daily. CHILD (1year and above): 1 - 2mg/kg/dose

1590. Tranexamic Acid100 mg/mlInjection

B02AA02000P3001XX

B Haemorrhage associated withexcessive fibrinolysis

ADULT: Slow IV 0.5-1 g (10 - 15mg/kg) 3 times daily. Continuousinfusion at a rate of 25 - 50 mg/kgdaily. CHILD: slow IV 10 mg/kg/day2-3 times daily

1591. Tranexamic Acid250 mg Capsule

B02AA02000C1001XX

B Haemorrhage associated withexcessive fibrinolysis

ADULT: 1-1.5 g (15-25 mg/kg) 2-4times daily. CHILD: 25 mg/kg/day 2-3 times daily. Menorrhagia (initiatedwhen menstruation has started), 1 g3 times daily for up to 4 days;maximum 4 g daily

1592. Trastuzumab 440mg Injection

L01XC03000P4001XX

A* Used only in adjuvant settingfor patients with HER2 over-expressed breast cancer, that isHER2 3+ byimmunohistochemistry andover-expressed by FISH(Fluorescence in situhybridization) and high riskgroup

Initial loading dose is 4 mg/kgadministered as a 90 minutes IVinfusion. Subsequent doses is 2mg/kg administered as 30 minutesIV infusion weekly for 51 weeks

Page 280 of 296

No. Generic Name MDC Category Indications Dosage1593. Trastuzumab

600mg/5mlSolution forInjection (forsubcutaneous)

L01XC03000P3001XX

A* Used only in adjuvant settingfor patients with HER2 over-expressed breast cancer, that isHER2 3+ byimmunohistochemistry andover-expressed by FISH(Fluorescence in situhybridization) and high riskgroup.

The recommended fixed dose oftrastuzumab 600mg is 600mgirrespective of the patient?s bodyweight. No loading dose is required.This dose should be administeredover 2-5 minutes every three weeks.

1594. Travoprost0.004% & Timolol0.5% Eye Drops

S01ED51990D2003XX

A* To decrease intraocularpressure (IOP) in patients withopen-angle glaucoma or ocularhypertension who areinsufficiently responsive toother topical anti glaucomas

1 drop in the affected eye(s) oncedaily

1595. Tretinoin 0.01%Gel

D10AD01000G3001XX

A/KK Acne vulgaris, recalcitrant casesof acne (comedonal type)

Apply thinly to the affected areaonce daily or twice daily. Avoidexposure to sunlight. Duration oftreatment: 8-12 weeks is requiredbefore any noticeable response

1596. Tretinoin 0.05%Cream

D10AD01000G1001XX

A/KK Acne vulgaris and recalcitrantcases of acne (comedonal type)

Apply thinly to the affected areaonce daily or twice daily. Avoidexposure to sunlight. Duration oftreatment: 8 - 12 weeks is requiredbefore any noticeable response

1597. Tretinoin 0.1%Cream

D10AD01000G1002XX

A Acne vulgaris and recalcitrantcases of acne (comedonal type)

Apply thinly to the affected areaonce daily or twice daily. Avoidexposure to sunlight. Duration oftreatment: 8 - 12 weeks is requiredbefore any noticeable response

1598. TriamcinoloneAcetonide 0.1%Oral Paste

A01AC01351G3101XX

B Oral and perioral lesions Apply a thin layer to affected area 2-4 times daily

1599. TriamcinoloneAcetonide 10mg/ml Injection

H02AB08351P3001XX

A Inflammation of joints, bursaeand tendon sheaths

Smaller joints: 2.5 - 5 mg and largerjoints: 5 - 15 mg. Treatment shouldbe limited to 1 mg/injection site toprevent cutaneous atrophy

1600. TriamcinoloneAcetonide 40mg/ml Injection

H02AB08351P3002XX

A/KK Allergies, dermatoses,rheumatoid arthritis andinflammatory opthalmicdiseases

40-80 mg deep into the glutealmuscle

1601. TrifluoperazineHCI 5 mg Tablet

N05AB06110T1001XX

B Psychotic disorder ADULT: Initially 5 mg twice daily,increase by 5 mg after 1 week, thenat 3-day intervals. Maximum 40mg/day. CHILD up to 12 years:Initially up to 5 mg daily in divideddoses adjusted to response, age andbody weight

1602. Trimetazidine 20mg Tablet

C01EB15110T1001XX

B Prophylactic treatment ofepisodes of angina pectoris

20 mg 3 times daily

1603. Trimetazidine 35mg MR Tablet

C01EB15110T5001XX

B Prophylactic treatment ofepisodes of angina pectoris

35 mg twice daily in the morningand evening with meals

Page 281 of 296

No. Generic Name MDC Category Indications Dosage1604. Trimethoprim

100 mg TabletJ01EA01000T1001XX

B Treatment of urinary tractinfections due to susceptiblepathogens

ADULT: 200 mg daily in 1 or 2divided doses or 300 mg daily as asingle dose. Acute infection: 200 mgtwice daily. CHILD: 6-8 mg/kg/day in2 divided doses. 6 - 12 years: 100mg twice daily; 6 months - 5 years:50 mg twice daily. 6 weeks - 5months: 25mg twice daily

1605. Trimethoprim300 mg Tablet

J01EA01000T1002XX

B Treatment of urinary tractinfections due to susceptiblepathogens

ADULT: 200 mg daily in 1 or 2divided doses or 300 mg daily as asingle dose. Acute infection: 200 mgtwice daily. CHILD: 6 - 12 years: 100mg twice daily; 6 months - 5 years:50 mg twice daily. 6 weeks - 5months: 25mg twice daily

1606. Trioxsalen 5 mgTablet

D05BA01000T1001XX

A Vitiligo 5 - 10 mg daily, 2 - 4 hours beforeexposure to sunlight. To increasepigmentation: 10 mg daily, 2 hoursprior to UV irradiation

1607. Triprolidine HCl1.25 mg andPseudoephedrineHCl 30 mg per 5ml Syrup

R01BA52110L9001XX

B Decongestion of the upperrespiratory tract in commoncold, hay fever, allergic andvasomotor rhinitis and sinusitis.Doses to be taken twice daily orthree times daily

ADULT and CHILD more than 12 year: 10 ml. CHILD 6 - 12 years : 5 ml 2 -5 years : 2.5 ml

1608. Triprolidine HCl2.5 mg andPseudoephedrineHCl 60 mg Tablet

R01BA52988T1002XX

B Decongestion of the upperrespiratory tract in commoncold, hay fever, allergic andvasomotor rhinitis and aerotitis

ADULT 2.5 mg every 4 - 6 hours;maximum dose 10 mg/day. CHILD(syrup) 6 - 12 years : 1.25 mg every4 - 6 hours; maximum dose 5mg/day 4 - 6 years : 0.938 mg every4 - 6 hours; maximum dose 3.744mg/day 2 - 4 years : 0.625 mg every4 - 6 hours; maximum dose 2.5mg/day

1609. Triptorelin 3.75mg Injection

L02AE04000P2001XX

A i) Treatment of confirmedcentral precocious puberty(preterm sexual development)in girls under 9 years, boysunder 10 years of age ii) Genitaland extragenital endometriosis(stage I to stage IV). Treatmentshould not be administered formore than 6 months. It is notrecommended to start a secondtreatment course withtriptorelin or another GnRHanalogue.

1 intramuscular injection every 4weeks. The treatment must bestarted in the first 5 days of themenstrual cycle. The duration oftreatment depends on the initialseverity of the endometriosis andthe changes observed in the clinicalfeatures. In principle, the treatmentshould be administered for at least 4months and for at most 6 months. Itis not recommended to start asecond treatment course withtriptorelin or another GnRHanalogue.

1610. Tropicamide 1%Eye Drops

S01FA06000D2002XX

A/KK Topical use to producecycloplegic refraction fordiagnostic purposes

1 - 2 drops several times a day

Page 282 of 296

No. Generic Name MDC Category Indications Dosage1611. Trospium

Chloride 20mgcoated tablet

G04BD09100C1001XX

A* Symptomatic treatment forurge incontinence and/orincreased urinary frequencyand urgency as may occur inpatients with overactivebladder (eg. Idiopathic orneurologic detrusoroveractivity) Place in therapy:As first line treatment foroveractive bladder in patientswith Parkinsonism, Alzheimer?sor other cognitive disease

1 tablet twice daily. Tablet should beswallowed whole with a glass ofwater before meals on emptystomach. Severe renal impairment(CrCl between 10 & 30 mL/min/1.73m2): 1 tab daily or every other day

1612. Tuberculine PPDInjection

V04CF01000P3001XX

B For routine Mantoux(tuberculin sensitivity) test

10 units is injected intradermally

1613. Typhoid VaccineCapsule

J07AP01000C1001XX

B Active immunization againsttyphoid fever in adult and child6 years of age or older

ADULT and CHILD 6 years of age orolder, 1 capsule on days 1, 3 and 5

1614. Typhoid VaccineInjection (20doses)

J07AP02000P3001XX

B Active immunization againsttyphoid fever in adult and childmore than 2 years

0.5 ml single IM injection into thedeltoid or vastus lateralis, mayreimmunize with 0.5 ml IM every 3years if needed.

1615. Ulipristal Acetate30mg Tablet

G03AD02122T1001XX

A Emergency contraceptionwithin 4-5 days of unprotectedsexual intercourse for sexualassault victim.

Dosage is one tablet to be takenorally as soon as possible, but nolater than 120 hours (5 days) afterunprotected sexual intercourse orcontraceptive failure.

1616. Urofollitropin(FSH) 150 IUInjection

G03GA04000P3002XX

A* Stimulation of follicular growthin infertile women

To be individualized. 75 IU-150 IUdaily and maybe increased ordecreased by up to 75 IU/day at 7 or14 day intervals if necessary

1617. Urofollitropin(FSH) 75 IUInjection

G03GA04000P3001XX

A* Stimulation of follicular growthin infertile women

To be individualized. 75 IU-150 IUdaily and maybe increased ordecreased by up to 75 IU/day at 7 or14 day intervals if necessary

1618. Urokinase250,000 IUInjection

B01AD04-000-P40-04-XXX

A Treatment of thromboembolicdisease such as mycocardialinfarction, peripheral arteryocclusion, pulmonaryembolism, retinal arterythrombosis and otherophthalmologic use

ADULT: Acute pulmonary embolism:IV loading dose 4400 iu/kg over 10mins, maintenance 4400 iu/kg/hourfor 12 hours. Peripheral vascularocclusion: infuse 2500 iu/ml intoclot at a rate of 4000 iu/min for 2hours. This may be repeated up to 4times. Hyphaema: 5000 IU in 2 mlsaline solution is injected andwithdrawn repeatedly over the iris.If residual clot remains, leave 0.3mlin the anterior chambers for 24-48hours to facilitate futher dissolution

1619. UrsodeoxycholicAcid 250 mgCapsule

A05AA02000C1001XX

A Cholestatic liver diseases (eg.primary biliary cirrhosis,primary cholangitis etc)

10-15 mg/kg daily in 2 to 4 divideddoses usually for 3 months to 2years. If there is no decrease instone size after 18 months, furthertreatment seems not to be useful

Page 283 of 296

No. Generic Name MDC Category Indications Dosage1620. Ustekinumab 90

mg/ml InjectionL04AC05000P3002XX

A* Treatment of moderate tosevere plaque psoriasis inadults who failed to, or whohave contraindication to, or areintolerant to conventionalsystemic therapies includingciclosporin, methotrexate andphotochemotherapy (PUVA).

Body weight less than 100kg: Initialdose of 45 mg SC, followed by 45 mg4 weeks later, then every 12 weeksthereafter. Body weight more than100 kg: initial dose 90 mg SC,followed by 90 mg 4 weeks later, &then every 12 weeks thereafter.

1621. Valganciclovir450 mg Tablet

J05AB14110T1001XX

A* For the prevention ofcytomegalovirus (CMV) diseasein CMV-negative patients whohave received a solid organtransplant from a CMV-positivedonor

For adult patients who havereceived other than kidneytransplant, the recommended doseis 900 mg (two 450 mg tablets) oncea day starting within 10 days oftransplantation until 100 days post-transplantation. For adult patientswho have received a kidneytransplant, the recommended doseis 900 mg (two 450 mg tablets) oncea day starting within 10 days oftransplantation until 200 days post-transplantation.

1622. Valproic Acid andSodium Valproate(ER) 500mgTablet

N03AG01520T5001XX

B i) In the treatment ofgeneralized or partial epilepsy,particularly with the followingpatterns of seizures:absence,myoclonic, tonic-clonic, atonic-mixed as well as, for partialepilepsy:simple or complexseizures, secondary generalizedseizures, specific syndrome(West, Lennox-Gastatut). ii)Treatment and prevention ofmania associated with bipolardisorders.

i) Adults: Dosage should start at500mg daily increasing by 200mg atthree-day intervals until control isachieved. This is generally within thedosage range 1000mg to 2000mgper day. Children: >20KG:500mg/day (irrespective of weight)with spaced increases until controlis achieved. ii) Initial dose of1000mg/day, to be increase rapidlyas possible to achieve lowesttherapeutic dose, which producedesired clinical effects. Recommendinitial dose is 1000mg & 2000mgdaily. Max dose 3000mg daily.

1623. Valsartan 160 mgandHydrochlorothiazide 12.5 mgTablet

C09DA03935T1005XX

A/KK Treatment of essentialhypertension

1 tablet once daily

1624. Valsartan 160 mgTablet

C09CA03000T1002XX

A/KK Patients who cannot tolerateACE inhibitors because ofcough, in i) Heart failure ii) Postmyocardial infarction

i) 40 mg twice daily. Uptitration to80 mg and 160mg twice daily. Max:320 mg in divided doses. ii) 20 mgtwice daily increased over severalweeks to 160mg twice daily iftolerated.

1625. Valsartan 80 mgandHydrochlorothiazide 12.5 mgTablet

C09DA03935T1001XX

A/KK Hypertension in patients whocannot tolerate ACE inhibitorsbecause of cough

1 tablet once daily

Page 284 of 296

No. Generic Name MDC Category Indications Dosage1626. Valsartan 80 mg

TabletC09CA03000T1001XX

A/KK Patients who cannot tolerateACE inhibitors because ofcough, in i) Heart failure; ii) Postmyocardial infarction

i) 40 mg twice daily. Uptitration to80 mg and 160mg twice daily. Max:320 mg in divided doses. ii) 20 mgtwice daily increased over severalweeks to 160mg twice daily iftolerated.

1627. Vancomycin HCl500 mg Injection

J01XA01110P4001XX

A* Only for the treatment of MRSAand CAPD peritonitis

Slow IV infusion, ADULT: 500 mgover at least 60 minutes every 6hours or 1 g over at least 100minutes every 12 hours. NEONATEup to 1 week, 15 mg/kg initially,then 10 mg/kg every 12 hours.INFANT 1 - 4 weeks, 15 mg/kginitially then 10 mg/kg every 8hours. CHILD over 1 month, 10mg/kg every 6 hours

1628. VareniclineTartrate 0.5 mgand 1 mg Tablet

N07BA03123T1001XX

A/KK Smoking cessation treatment 0.5 mg once daily for Day 1-3, then0.5 mg twice daily for Day 4-7, then1 mg twice daily; duration oftreatment is 12 weeks

1629. VareniclineTartrate 1 mgTablet

N07BA03123T1002XX

A/KK Smoking cessation treatment 0.5 mg once daily for Day 1-3, then0.5 mg twice daily for Day 4-7, then1 mg twice daily; duration oftreatment is 12 weeks

1630. Varicella VirusVaccine LiveAttenuatedInjection

J07BK01000P4001XX

A* i) Health staff working withchildren, pregnant women,transplant, cancer andimmunocompromised patientswho are at high risk ofcontacting varicella andtransmitting it to at riskpatients ii) Transplant patientsor candidates who are: a)Immunocompetent and notreceiving immunosuppressantdrugs, do not have graft versushost disease 2 years or moreafter transplant b) Susceptibleto Varicella-Zoster virus at least3 weeks before grafting iii)Children: a) with impairedhumoral immunity b) HIV-infected children more than 12months of age, in CDC class N1(asymptomatic) or A1 (mildlysymptomatic) with age specificCD4 more than 25% c) withconditions that require systemicsteroid therapy less than 2mg/kg body weight or a total of20 mg/day of prednisolone orits equivalent. [Those receivinghigh doses of systemic steroids

ADULT and CHILD 13 years or more:2 doses of 0.5 ml SC injectionseparated by 4 - 8 weeks apart.CHILD 12 months - 12 years: 0.5mlSC as a single dose

Page 285 of 296

No. Generic Name MDC Category Indications Dosageat 2 mg/kg body weight ormore of prednisolone for morethan 2 weeks may bevaccinated after steroid therapyhas been discontinued for atleast three months] iv) Acutelymphoblastic leukemia (ALL)patients with negative historyof varicella who:- a) are 12months to 17 years of age b)have leukemia in remission forat least 12 months c) have aperipheral blood lymphocytecount 700 cells/ mm3 or more.[If platelet count of greater100,000/mm3 within 24 hoursof vaccination are not beingsubmitted to radiotherapy.Chemotherapy should bewithheld for seven days beforeand after immunisation] v)Susceptible subjects in clinicaltrials who will be submitted forchemotherapy vi) Children andsusceptible patients on chronicdialysis

1631. Vasopressin 20units/ml Injection

H01BA01000P3001XX

A i) Pituitary diabetes insipidus ii)Oesophageal variceal bleeding

i) 5 - 20 units SC or IM every 4 hoursii) 20 units in 100 - 200 ml 5%dextrose saline over 15 minutes asinfusion which may be repeatedafter at intervals of 1 - 2 hours.Maximum: 4 doses

1632. VecuroniumBromide 10mg/10 mlInjection

M03AC03320P3001XX

A* As an adjunct in anaesthesia toproduce skeletal musclerelaxation

ADULT & NEONATES > 5 MONTHSInitial: 80-100 mcg/kg as inj.Maintenance: 20-30 mcg/kg, adjustaccording to response. Alternatively,as continuous infusion at 0.8-1.4mcg/kg/min after initial IV dose of40-100 mcg/kg. NEONATE andINFANT up to 4 months: Initially 10 -20 mcg/kg, then incremental doseto achieve response

1633. VecuroniumBromide 4 mg/mlInjection

M03AC03320P3002XX

A* As an adjunct in anaesthesia toproduce skeletal musclerelaxation

ADULT & NEONATES > 5 MONTHSInitial: 80-100 mcg/kg as inj.Maintenance: 20-30 mcg/kg, adjustaccording to response. Alternatively,as continuous infusion at 0.8-1.4mcg/kg/min after initial IV dose of40-100 mcg/kg. NEONATE andINFANT up to 4 months: Initially 10 -20 mcg/kg, then incremental doseto achieve response.

Page 286 of 296

No. Generic Name MDC Category Indications Dosage1634. Venlafaxine HCl

150 mg ExtendedRelease Capsule

N06AX16110C2002XX

A* i) Depression ii) Generalizedanxiety disorder iii) Socialanxiety disorder (social phobia)iv) Panic disorder

i), ii) & iii) ADULT: 75 mg once daily.May increase dose by 75 mg/dayevery 4 days to a maximum dose of225 mg/day, (severe depression:max: 375mg/day) iv) 37.5 mg/dayfor the first 4-7 days after which thedose should be increased to 75 mgonce daily. CHILD and ADOLESCENTunder 18 years not recommended.

1635. Venlafaxine HCl75 mg ExtendedRelease Capsule

N06AX16110C2001XX

A* i) Depression ii) Generalizedanxiety disorder iii) Socialanxiety disorder (social phobia)iv) Panic disorder

i), ii) & iii) ADULT: 75 mg once daily.May increase dose by 75 mg/dayevery 4 days to a maximum dose of225 mg/day, (severe depression:max: 375mg/day) iv) 37.5 mg/dayfor the first 4-7 days after which thedose should be increased to 75 mgonce daily. CHILD and ADOLESCENTunder 18 years not recommended

1636. Verapamil HCl 2.5mg/ml Injection

C08DA01110P3001XX

A/KK Supraventricular tachycardia Initially 5-10mg given by slow IVover at least 2 minutes. The dosecan be repeated 10mg 30 minutesafter the first dose if the initialresponse is not adequate.

1637. Verapamil HCl 40mg Tablet

C08DA01110T1001XX

B i) Supraventriculartachyarrhythmias (SVT)prophylaxisii) angina

ADULT: 40 - 80 mg 3-4 times daily.In oral long term therapy, max: 480mg daily

1638. Vildagliptin 50mg andMetformin HCl1000 mg Tablet

A10BD08926T1002XX

A* FUKKM restriction: As add-ontherapy for patient who failedtherapy and/orcontraindicated/unable totolerate metformin and/orsulphonylurea. - Treatment oftype 2 diabetes mellituspatients who are unable toachieve sufficient glycaemiccontrol at their maximallytolerated dose of oralmetformin alone or who arealready treated with thecombination of vildagliptin andmetformin as separate tablets.

50 mg/850 mg or 50 mg/1000 mgtwice daily. Maximum daily dose is100 mg vildagliptin plus 2000 mgmetformin hydrochloride.

1639. Vildagliptin 50mg andMetformin HCl500 mg Tablet

A10BD08926T1003XX

A* FUKKM restriction: As add-ontherapy for patient who failedtherapy and/orcontraindicated/unable totolerate metformin and/orsulphonylurea. - Treatment oftype 2 diabetes mellituspatients who are unable toachieve sufficient glycaemiccontrol at their maximallytolerated dose of oral

50/500mg or 50/850mg or50/1000mg twice daily. Maximumdaily dose is 100mg vildagliptin and2000mg metformin.

Page 287 of 296

No. Generic Name MDC Category Indications Dosagemetformin alone or who arealready treated with thecombination of vildagliptin andmetformin as separate tablets.

1640. Vildagliptin 50mg andMetformin HCl850 mg Tablet

A10BD08926T1001XX

A* FUKKM restriction: As add-ontherapy for patient who failedtherapy and/orcontraindicated/unable totolerate metformin and/orsulphonylurea. - Treatment oftype 2 diabetes mellituspatients who are unable toachieve sufficient glycaemiccontrol at their maximallytolerated dose of oralmetformin alone or who arealready treated with thecombination of vildagliptin andmetformin as separate tablets.

50 mg/850 mg or 50 mg/1000 mgtwice daily. Maximum daily dose is100 mg vildagliptin plus 2000 mgmetformin hydrochloride.

1641. Vildagliptin 50mg Tablet

A10BH02000T1001XX

A* FUKKM restriction: As add-ontherapy for patient who failedtherapy and/orcontraindicated/unable totolerate metformin and/orsulphonylurea. i) As second linetherapy in type 2 diabetespatients inadequatelycontrolled on maximaltolerated dose of metforminmonotherapy and high risk ofhypoglycaemia. ii) As secondline therapy in type 2 diabetespatients inadequatelycontrolled on maximaltolerated dose of sulphonylureaand intolerant/contraindicatedfor metformin therapy. iii) Asthird line therapy in type 2diabetes patients inadequatelycontrolled with dual OADcombination therapy withsulphonylurea and metforminiv) As a monotherapy in type 2diabetes mellitus patientsinadequately controlled by dietand exercise alone and forwhom metformin isinappropriate due tocontraindications orintolerance. v) An adjunct todiet and exercise to improveglycaemic control in patientswith type 2 diabetes mellitus:

ADULT over 18 years: 50mg bdwhen combine with metformin, 50mg od when combine withsulphonylurea

Page 288 of 296

No. Generic Name MDC Category Indications DosageAs a dual therapy incombination with insulin inpatients with insufficientglycaemic control. Insulin doseand regimen should beoptimized before addition ofvildagliptin.

1642. VinblastineSulphate 10 mgInjection

L01CA01183P3002XX

A Hodgkin's disease,choriocarcinoma resistant toother chemotherapeuticagents, non-small cell lungcancer, Langerhans cellhistiocytosis

Adult: Initially, 3.7 mg/m2, increasedose weekly based on WBC countsin increments of about 1.8 mg/m2until leukocyte count decreases toabout 3000/mm3, or maximumweekly dose of 18.5 mg/m2reached. Usual dose: 5.5-7.4 mg/m2per week. Do not administer nextdose, even though 7 days havelapsed unless the leukocyte counthas returned to at least 4000/mm3.Child: Initial 2.5 mg/m2 of BSA,increased dose at weekly intervals inincrements of about 1.25 mg/m2until leukocyte count decreases toabout 3000/ mm3, or maximumweekly dose of 12.5 mg/m2reached. Do not increase dose onceleukocyte count reachesapproximately 3000 cells/mm3,instead, a dose of 1 incrementsmaller to be admin at wkly intervalsfor maintenance. Do not administernext dose, even though 7 days havelapsed unless the leukocyte counthas returned to at least 4000/mm3.

1643. VincristineSulphate 1 mgInjection

L01CA02183P3001XX

A i) Solid tumours ii) Gestationaltrophoblastic disease iii) Non-Hodgkin's lymphoma iv)Multiple myeloma v) Acutelymphoblastic leukemia

i) ADULT: 1.4 mg/m2 weekly(maximum 2 mg weekly) ii) Refer toprotocol iii) 1.4 mg/m2 weekly(maximum 2 mg weekly) iv) 0.4mg/m2 IV continuous infusion ondays 1 - 4 v) Refer to protocol.CHILD: 1 mg/m2 to 2 mg/m2 weeklyaccording to protocol (0.05 mg/kgfor infants less than 10kg)

Page 289 of 296

No. Generic Name MDC Category Indications Dosage1644. Vinorelbine 10

mg InjectionL01CA04000P4001XX

A* i) First line treatment in non-small cell lung cancer incombination withcisplatin/ifosfomide ii)Metastatic breast cancer

i) Single agent: Adult 30mg/m2 IVadministered over 6-10 minutesonce weekly Combination withcisplatin : 30mg/m2 IV administeredover 6-10mintes once weeklycombination with cisplatin IV ondays and 29 and then every 6 weeksor Vinolrebine administered at adose of 25mg/m2 IV weekly incombination with cisplatin givenevery 4 weeks at a dose of100mg/m2 ii) 25 - 30 mg/m2 dilutedin saline solution, infused over 6 - 10minutes, administered weekly orvinolrebine maybe given as an8mg/m2 IV BOLUS followed by8mg/m2 as a 96-hour intravenousinfusion

1645. Vinorelbine 50mg Injection

L01CA04000P4002XX

A* i) First line treatment in non-small cell lung cancer incombination withcisplatin/ifosfomide ii)Metastatic breast cancer

i) Single agent: Adult 30mg/m2 IVadministered over 6-10 minutesonce weekly Combination withcisplatin : 30mg/m2 IV administeredover 6-10mintes once weeklycombination with cisplatin IV ondays and 29 and then every 6 weeksor Vinolrebine administered at adose of 25mg/m2 IV weekly incombination with cisplatin givenevery 4 weeks at a dose of100mg/m2 ii) 25 - 30 mg/m2 dilutedin saline solution, infused over 6 - 10minutes, administered weekly orvinolrebine maybe given as an8mg/m2 IV BOLUS followed by8mg/m2 as a 96-hour intravenousinfusion.

1646. Vitamin A & D(Cod Liver Oil)

A11CB00901L5001XX

C Prevention of ricketts Not more than 10 ml daily,allowance being made for Vitamin Dobtained from other sources

1647. Vitamin A & DConcentrate25,000units/0.6mlLiquid

A11CB00901L5002XX

B Prevention of ricketts 0.06 - 0.6ml (2,500-25,000 IU ofVitamin A and 250-2,500 IU of D)daily, allowance being made for Aand D obtained from other sources

1648. Vitamin A 50,000IU Capsule

A11CA01000C1001XX

C Children with measlesmalnutrition and seriousinfections. Category C can usethis drug for Orang Asli and inSabah

i) 0-5 months, 50,000 IU ii) 6-11months, 100,000 IU iii) 1-5 years,200,000 IU. Frequency twice daily

1649. Vitamin BComplex 10 mlInjection

A11EX00901P3001XX

B Prophylaxis and treatment ofvitamin B deficiency

1-2 ml daily by IM

Page 290 of 296

No. Generic Name MDC Category Indications Dosage1650. Vitamin B

Complex TabletA11EA00901T1001XX

C+ Prophylaxis and treatment ofvitamin B deficiency

1-2 tablets daily

1651. Vitamin B1, B6,B12 Injection

A11DB00901P3001XX

B For deficiency or raisedrequirement of Vitamin B1, B6,B12

Mild cases: 1 ampoule given by IM2-3 times weekly. Severe cases: 1ampoule daily

1652. Vitamin B1, B6,B12 Tablet

A11DB00901T1001XX

B For deficiency or raisedrequirement of Vitamin B1, B6,B12

1 - 3 tablets 3 times daily swallowedunchewed.

1653. Vitamin E, B12,B6, NicotinamideTablet

A11E000901T1001XX

A To improve appetite andgrowth. Neurasthenia, nauseaand vomiting in pregnancy,radiation sickness and neuritisdue to isoniazid therapy andalcoholism

1 - 2 tablet daily

1654. Vitamin K1 1mg/ml Injection

B02BA01000P3001XX

C+ Vitamin K deficiency inneonates

Prophylaxis of vitamin K deficiencybleeding in neonates Child:Neonate: 0.5-1 mg, given as a singledose via IM inj. Alternatively, 2 mgmay be given orally, followed by a2nd dose of 2 mg after 4-7 days.Intravenous Vitamin K deficiencybleeding in neonates Child: Infant: 1mg by IV/IM/SC inj, further dosesmay be given if necessary

1655. Vitamin K1 10mg/ml Injection

B02BA01000P3002XX

B Haemorrhage associated withhypoprothrombinaemia causedby overdose of anticoagulants

0.5 - 20 mg by very slow IV at a ratenot exceeding 1 mg per minute

1656. Vitamin K1 MixedMicelle 2 mg/0.2ml Injection

B02BA01000P3004XX

B Prevention of bleeding inneonates

Healthy neonate 2 mg orally at birthor soon after followed by 2 mg at 4 -7 days. Exclusively breastfed baby,in addition, 2 mg orally at monthlyintervals until end of breastfeedingperiod. Neonate at special risk, 1 mgIM/IV at birth or soon after if oralroute is not suitable. Treatment: 1mg IV initially. Further doses dependon clinical picture and coagulationstatus

1657. Voriconazole 200mg Injection

J02AC03000P3001XX

A* i) Treatment ofimmunocompromised patientswith progressive, possibly life-threatening infections such asinvasive aspergillosis,fluconazole-resistant seriousinvasive candidiasis, seriousfungal infections caused byScedosporium species andFusarium species ii)Preventionof breakthrough fungalinfections in febrile high-riskneutropenic patients

Adult and Children 12 years andgreater: Loading dose: 6 mg/kg 12hourly for first 24 hours.Maintenance: i) 4 mg/kg 12 hourlyii) 3 mg/kg 12 hourly. Dose may beincreased to 4 mg/kg 12 hourly ifresponse is inadequate. Childrenaged 2years to <12years withnormal hepatic and renal function:No loading dose needed; 7mg/kg12hourly

Page 291 of 296

No. Generic Name MDC Category Indications Dosage1658. Voriconazole 200

mg TabletJ02AC03000T1002XX

A* i) Treatment ofimmunocompromised patientswith progressive, possibly life-threatening infections such asinvasive aspergillosis,fluconazole-resistant seriousinvasive candidiasis, candidiasisof the oesophagus, seriousfungal infections caused byScedosporium species andFusarium species ii) Preventionof breakthrough fungalinfections in febrile high-riskneutropenic patients

Adult and Children 12 years andgreater and over 40 kg: Loadingdose: 400 mg 12 hourly for first 24hours. Maintenance: 200 - 300 mg12 hourly. Less than 40 kg: Loadingdose: 200 mg 12 hourly for first 24hours. Maintenance: 100 - 150 mg12 hourly. Children aged 2years to<12years with normal hepatic andrenal function: No loading doseneeded; 200mg 12hourly

1659. Voriconazole 50mg Tablet

J02AC03000T1001XX

A* i) Treatment ofimmunocompromised patientswith progressive, possibly life-threatening infections such asinvasive aspergillosis,fluconazole-resistant seriousinvasive candidiasis, candidiasisof the oesophagus, seriousfungal infections caused byScedosporium species andFusarium species ii) Preventionof breakthrough fungalinfections in febrile high-riskneutropenic patients

ADULT and CHILDREN 12 years andgreater and over 40 kg: Loadingdose: 400 mg 12 hourly for first 24hours. Maintenance: 200 - 300 mg12 hourly. Less than 40 kg: Loadingdose: 200 mg 12 hourly for first 24hours. Maintenance: 100 - 150 mg12 hourly

1660. Warfarin Sodium1 mg Tablet

B01AA03520T1001XX

B Treatment and prophylaxis ofthromboembolic disorders

Initially 10 mg daily for 2 days.Maintenance dose, 3-9 mg dailyaccording to the INR (taken at thesame time each day)

1661. Warfarin Sodium2 mg Tablet

B01AA03520T1002XX

B Treatment and prophylaxis ofthromboembolic disorders

Initially 10 mg daily for 2 days.Maintenance dose, 3-9 mg dailyaccording to the INR (taken at thesame time each day)

1662. Warfarin Sodium3 mg Tablet

B01AA03520T1003XX

B Treatment and prophylaxis ofthromboembolic disorders

Initially 10 mg daily for 2 days.Maintenance dose, 3-10 mg dailyaccording to the INR (taken at thesame time each day)

1663. Warfarin Sodium5 mg Tablet

B01AA03520T1004XX

B Treatment and prophylaxis ofthromboembolic disorders

Initially 10 mg daily for 2 days.Maintenance dose, 3-10 mg dailyaccording to the INR (taken at thesame time each day)

1664. Water forInjection

V07AB00000P3001XX

C+ As a diluent and vehicle for theadministration of medications

According to the needs of thepatient

Page 292 of 296

No. Generic Name MDC Category Indications Dosage1665. Zidovudine 1%

InjectionJ05AF01000P3001XX

A To reduce the rate of maternal-foetal transmission of HIV in: i)HIV-positive pregnant womenover 14 weeks of gestation ii)Their newborn infants

i) Prophylaxis of maternal-foetal HIVtransmission during labour anddelivery Adult: Loading dose: 2mg/kg, followed by continuousinfusion of 1 mg/kg/hr untilumbilical cord is clamped. Ifcaesarean section is planned, startthe IV infusion 4 hr before theoperation. Renal and Hepaticimpairment: Dose reduction may beneeded. HIV infection (to be discuss:not in indication) Adult: 1-2 mg/kgevery 4 hr, given as 2-4 mg/mlinfusion over 1 hr. Child: Ascontinuous infusion: 20 mg/m2/hr.Alternatively, as intermittentinfusion: 120 mg/m2 every 6 hr.Renal impairment: Haemodialysis orperitoneal dialysis: 1 mg/kg every 6-8 hr. ii) Prophylaxis of HIV infectionin neonates Child: Neonates: 1.5mg/kg every 6 hr. Start treatmentwithin 12 hr after birth and continuefor 1st 6 wk of life. Dose to be givenvia IV infusion over 30 minutes.Renal impairment: Dose adjustmentmay be needed.

1666. Zidovudine 10mg/ml Syrup

J05AF01000L9001XX

A* i) Management of patients withasymptomatic and symptomatic(early or advanced) HIVinfections with CD4 cell countsless than 500 cu. mm. ii)Neonatal prophylaxis

i) HIV infection Adult: 600 mg dailyin divided doses, in combinationwith other antiretroviral agents.Child: 6 wk - 12 yr: 160 mg/m2 every8 hr. Max: 200 mg every 8 hr. Maybe used in combination with otheranti-retrovirals. Renal and Hepaticimpairment: Dose reduction may beneeded. ii) Prophylaxis of HIVinfection in neonates Child:Neonates: 2 mg/kg every 6 hr for 1st6 wk of life, starting within 12 hrafter birth. Renal and hepaticimpairment: Dose adjustment maybe needed.

1667. Zidovudine 100mg Capsule

J05AF01000C1001XX

A/KK i) Management of patients withasymptomatic and symptomatic(early or advanced) HIVinfections with CD4 cell countsless than 500 cu. mm ii)Neonatal prophylaxis

i) HIV infection Adult: 600 mg dailyin divided doses, in combinationwith other antiretroviral agents.Child: 6 wk - 12 yr: 160 mg/m2 every8 hr. Max: 200 mg every 8 hr. Maybe used in combination with otheranti-retrovirals. Renal and Hepaticimpairment: Dose reduction may beneeded. ii) Prophylaxis of HIVinfection in neonates Child:Neonates: 2 mg/kg every 6 hr for 1st

Page 293 of 296

No. Generic Name MDC Category Indications Dosage6 wk of life, starting within 12 hrafter birth. Renal and hepaticimpairment: Dose adjustment maybe needed.

1668. Zidovudine 300mg & Lamivudine150 mg Tablet

J05AR01964T1001XX

A/KK HIV infection in combinationwith at least one otherantiretroviral drug

ADULT and CHILD over 12 years: 1tablet twice daily

1669. Zidovudine 300mg Tablet

J05AF01000T1001XX

A* i) Management of patients withasymptomatic and symptomatic(early or advanced) HIVinfections with CD4 cell counts< 500 cu. mm ii) HIV positivepregnant mothers

HIV infection Adult: 600 mg daily individed doses, in combination withother antiretroviral agents. Child: 6wk - 12 yr: 160 mg/m2 every 8 hr.Max: 200 mg every 8 hr. May beused in combination with other anti-retrovirals. ii)Prophylaxis ofmaternal-foetal HIV transmissionAdult: 100 mg 5 times daily or 200mg tid or 300 mg bid. Starttreatment after 14th wk of gestationuntil the start of labour.Haemodialysis or peritoneal dialysis(CrCl <10 ml/min: 100 mg every 6-8hr.

1670. Zinc Oxide Cream D02AB00000G1001XX

C+ Skin protective in various skinconditions such as nappy rash,eczema and problem skin

Apply 3 times daily or as required

1671. Zinc OxideOintment

D02AB00240G5001XX

C Skin protective in various skinconditions such as nappy rashand eczema

Apply 3 times daily or as required

1672. zinc oxide, benzylbenzoate andbalsam perusuppository

C05AX04931S1001XX

C For relief of pruritus, burningand soreness in patients withhaemorrhoids and perianalconditions

Insert 1 suppository night andmorning after bowel movements; donot uses for longer than 7 days ORplease refer to the product insert.

1673. Ziprasidone 20mg/ml Injection

N05AE04110P3001XX

A* Acute agitation in schizophrenia ADULT: Initially 10 mg (every 2 hour)or 20 mg (every 4 hour). Maximum:40 mg/day. IM administration morethan 3 days has not been studied

1674. Zoledronic Acid 4mg Injection

M05BA08000P3001XX

A* i) Treatment of hypercalcaemiaof malignancy ii) Prevention ofskeletal related events inpatients with multiple myelomainvolving multiple bone lesions

4 mg reconstituted and should begiven as a 15 minutes IV infusionevery 3-4 weeks

1675. ZolpidemTartrate 10 mgTablet

N05CF02123T1001XX

A For treatment of insomnia 10-mg tablet daily. Stilnox shouldalways be taken just before going tobed. In elderly patients or patientswith hepatic insufficiency: Dosageshould be halved ie, 5 mg. Dosage

Page 294 of 296

No. Generic Name MDC Category Indications Dosagemust never exceed 10 mg/day.

1676. Zonisamide100mg tablet

N03AX15000T1001XX

A* As adjunctive therapy in thetreatment of partial seizures inadults with epilepsy.Restrictions: As adjunctivetherapy in the treatment ofpartial seizures in adults withepilepsy when 1st line and 2ndline therapy failed.

For adults, usually 100 to 200mg ofzonisomide is to be administeredorally 1 to 3 times a day initially. Thedose is gradually increased at everyone to two weeks up to 200-400mgdaily, in 1 to 3 divided dose. Themaximum daily dose should notexceed 600mg per day.

1677. Zuclopenthixol 20mg/ml Drops

N05AF05000D5001XX

A* Only for psychoses with insightor compliance

Acute Schizophrenia and OtherAcute Psychoses; Severe AcuteStates of Agitation; Mania: Oraltreatment: Usually 10-50 mg/day. Inmoderate to severe cases initially 20mg/day increased, if necessary, by10-20 mg/day every 2-3 days to ≥75mg daily.

1678. ZuclopenthixolAcetate 100 mg/2ml Injection

N05AF05122P3002XX

A* Only for treatment of agitatedand violent patients sufferingfrom schizophrenia who are notresponding to the availablestandard drugs

Clopixol-Acuphase: Clopixol-Acuphase is administered by IMinjection. The dosage range shouldnormally be 50-150 mg (1-3 mL) IMrepeated if necessary, preferablywith a time interval of 2-3 days. In afew patients, an additional injectionmay be needed 24-48 hrs followingthe 1st injection. In themaintenance therapy, treatmentshould be continued with oralClopixol or Clopixol Depot IM afterthe following guidelines: Change toOral Clopixol: 2-3 days after the lastinjection of Clopixol-Acuphase, apatient who has been treated with100 mg Clopixol-Acuphase, oraltreatment should be started at adosage of about 40 mg daily,possibly in divided dosages. Ifnecessary, the dose can be furtherincreased by 10-20 mg every 2-3days up to 75 mg or more.

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No. Generic Name MDC Category Indications Dosage1679. Zuclopenthixol

Acetate 50mg/ml Injection

N05AF05122P3001XX

A* Only for treatment of agitatedand violent patients sufferingfrom schizophrenia who are notresponding to the availablestandard drugs

Clopixol-Acuphase: Clopixol-Acuphase is administered by IMinjection. The dosage range shouldnormally be 50-150 mg (1-3 mL) IMrepeated if necessary, preferablywith a time interval of 2-3 days. In afew patients, an additional injectionmay be needed 24-48 hrs followingthe 1st injection. In themaintenance therapy, treatmentshould be continued with oralClopixol or Clopixol Depot IM afterthe following guidelines: Change toOral Clopixol: 2-3 days after the lastinjection of Clopixol-Acuphase, apatient who has been treated with100 mg Clopixol-Acuphase, oraltreatment should be started at adosage of about 40 mg daily,possibly in divided dosages. Ifnecessary, the dose can be furtherincreased by 10-20 mg every 2-3days up to 75 mg or more.

1680. ZuclopenthixolDecanoate 200mg/ml Injection

N05AF05135P2001XX

B Only for treatment of agitatedand violent patients sufferingfrom schizophrenia who are notresponding to the availablestandard drugs

By deep IM injection test dose 100mg followed after 7 - 28 days by 100- 200 mg or more followed by 200 -400 mg at intervals of 2 - 4 weeksadjusted according to response.Maximum 600 mg weekly. Child notrecommended

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