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DAFTAR OBAT AMAN DAN BERBAHAYA UNTUK IBU HAMIL DAN MENYUSUI Disusun kembali oleh dr.Abu Hana dari sumber URL : http://www.kellymom.com/health/meds/aap- approved-meds.html Kelompok Analgetik, NSAIDS, Obat Batuk dan Pilek, Anti Alergi dan Asma, Anestesi Obat untuk Penghilang Rasa Sakit (Pain Killer) Nama Obat AAP approved?* Kategori Risiko Kehamilan** Risiko Menyusui** Not es Acetaminophen (Tylenol) Approved B L1 Aspirin Caution C (1st, 2nd trim.) D (3rd trim.) L3 1 Azapropazone (Rheumox) Approved - L2

Daftar Obat Aman Dan Berbahaya Untuk Ibu Hamil Dan Menyusui

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Page 1: Daftar Obat Aman Dan Berbahaya Untuk Ibu Hamil Dan Menyusui

DAFTAR OBAT AMAN DAN BERBAHAYA UNTUK IBU HAMIL DAN MENYUSUI

Disusun kembali oleh dr.Abu Hana

dari sumber URL : http://www.kellymom.com/health/meds/aap-approved-meds.html

Kelompok Analgetik,  NSAIDS,  Obat Batuk dan Pilek,

Anti Alergi dan Asma, Anestesi

 

Obat untuk Penghilang Rasa Sakit (Pain Killer)

Nama ObatAAP

approved?*Kategori Risiko

Kehamilan**Risiko

Menyusui**Note

sAcetaminophen  (Tylenol) Approved B L1  

Aspirin CautionC (1st, 2nd trim.)

D (3rd trim.)L3 1

Azapropazone  (Rheumox)Approved

 - L2  

Butalbital (Fioricet, Fiorinal, Bancap, Two-dyne)

NR D L3 2

Butorphanol  (Stadol) ApprovedB (1st, 2nd trim.)

D (3rd trim.)L3  

Page 2: Daftar Obat Aman Dan Berbahaya Untuk Ibu Hamil Dan Menyusui

Celecoxib (Celebrex)) NR C L2  Codeine (in Tylenol #3, #4) Approved C L3 3Colchicine Approved D L4  Diclofenac (Cataflam, Voltaren)

NR B L2  

Fentanyl  (Sublimaze) Approved B L2  Flurbiprofen (Ansaid, Froben, Ocufen)

NRB (1st, 2nd trim.)

C (3rd trim.)L2  

Hydrocodone (Lortab, Vicodin)

NR B L3 4

Hydromorphone (Dilaudid)

NR C L3 5

Ibuprofen (Advil, Nuprin, Motrin, Pediaprofen)

ApprovedB (1st, 2nd trim.)

D (3rd trim.)L1  

Indomethacin (Indocin) ApprovedB (1st, 2nd trim.)

D (3rd trim.)L3  

Ketorolac (Toradol, Acular)

ApprovedB (1st, 2nd trim.)

D (3rd trim.)L2  

Meperidine (Demerol) Approved BL2;

L3 early postpartum

6

Methadone (Dolophine) Approved B L3 7Morphine (Duramorph, Infumorph, Epimorph, MS Contin)

Approved B L3 8

Nalbuphine (Nubain) NR B L2  Naproxen (Anaprox, Naprosyn, Naproxen, Aleve)

Approved BL3;

L4 for chronic use

9

Nefopam (Acupan) Approved - NR  Oxycodone (Tylox, Percodan,Oxycontin, Roxicet, Endocet, Roxiprin, Percocet)

NR B L3 10

Pentosan polysulfate (Elmiron)

NR B L2  

Piroxicam (Feldene) Approved B L2  Propoxyphene (Darvocet N, Propacet, Darvon)

Approved C L2 11

Rofecoxib (Vioxx) Withdrawn from the market 12Secobarbital (Seconal) Approved D L3 13Tolmetin (Tolectin) Approved C L3  Tramadol HCL (Ultram, Ultracet)

NR C L3 14

Page 3: Daftar Obat Aman Dan Berbahaya Untuk Ibu Hamil Dan Menyusui

Valdecoxib  (Bextra) Withdrawn from the market more*  Per the AAP Policy Statement The Transfer of Drugs and Other Chemicals Into Human Milk, revised September 2001.

Approved: (Table 6) Maternal Medication Usually Compatible With Breastfeeding Caution: (Table 5) Drugs That Have Been Associated With Significant Effects on

Some Nursing Infants and Should Be Given to Nursing Mothers With Caution NR: Not Reviewed. This drug has not yet been reviewed by the AAP.

** Per Medications’ and Mothers’ Milk by Thomas Hale, PhD (2004 edition).

 Lactation Risk Categories  Pregnancy Risk Categories 

L1 (safest) L2 (safer) L3 (moderately safe) L4 (possibly hazardous) L5 (contraindicated)

A (controlled studies show no risk) B (no evidence of risk in humans) C (risk cannot be ruled out) D (positive evidence of risk) X (contraindicated in pregnancy)

NR: Not Reviewed. This drug has not yet been reviewed by Hale.

1. Aspirin use is discouraged in children and nursing mothers due to the risk of Reye’s syndrome and internal bleeding.

2. Fioricet (Fiorinal, Bancap, Two-dyne) contains acetaminaphen or asprin, caffeine, and butalbital. Per Hale, baby should be observed for sedation.

3. Hale suggests weakened or premature infants be observed for sedation and apnea.4. Hale suggests newborns be observed for sedation, apnea, constipation.5. Per Hale, use of frequent, higher dose may result in infant sedation.6. Per Hale, Meperidine use during labor or early postpartum has been associated with

sedation, poor sucking reflex, and neurobehavioral delay in infants.7. Per Hale, observe infant for sedation, respiratory depression, addiction, withdrawal

syndrome.8. Per Hale, higher doses may result in infant sedation.9. Per Hale, should be used with caution due to its long half-life and its effect on baby’s

cardiovascular system, kidneys and GI tract; short-term, infrequent or occasional use is not necessarily incompatible with breastfeeding.

10. Roxicet, Endocet, Roxiprin, Percocet also contain acetaminophen. Per Hale, observe infant for sedation.

11. Per Hale, observe infant for sedation.12. Per Hale, observe infant for GI cramping, distress, diarrhea.13. Per Hale, observe infant for sedation.14. Per Hale, observe infant for sedation.

     Non-steroidal anti-inflammatory analgesics (NSAIDs) [more]Nama Generik Nama Dagang AAP Kategori Risiko

Page 4: Daftar Obat Aman Dan Berbahaya Untuk Ibu Hamil Dan Menyusui

approved?*

Risiko Kehamilan** Menyusui**

Azapropazone (apazone) Rheumox Approved - L2Dipyrone (banned in the US & UK)

- Approved - NR

         Flufenamic acid - Approved - NR

IbuprofenAdvil, Nuprin, Motrin, Pediaprofin

ApprovedB (1st, 2nd

trim.)D (3rd trim.)

L1

Indomethacin Indocin ApprovedB (1st, 2nd

trim.)D (3rd trim.)

L3

Ketorolac Toradol, Acular ApprovedB (1st, 2nd

trim.)D (3rd trim.)

L2

Mefenamic acid Ponstan, Ponstel Approved - NR

NaproxenAnaprox, Naprosyn, Naproxen, Aleve

Approved BL3

L4 (for chronic use)

Phenylbutazone Butazolidine Approved - NRPiroxicam Feldene Approved B L2Suprofen Profenal Approved - NRTolmetin Tolectin Approved C L3    Steroid [contents]Methylprednisolone[ high dosage methylprednisolone]

Solu-Medrol, Depo-Medrol, Medrol

Approved C L2

Prednisolone - Approved C L2

PrednisoneDeltasone, Meticorten, Orasone

Approved C L2

         Obat Asma [contents]

DyphyllineDilor, Lufyllin, Dyphylline

Approved C L3

Terbutaline Bricanyl, Brethine Approved B L2

TheophyllineAminophylline, Quibron, Theo-Dur

Approved C L3

              Analgetik Narkotik  [more]

Butorphanol Stadol ApprovedB (1st, 2nd

trim.)D (3rd trim.)

L3

Page 5: Daftar Obat Aman Dan Berbahaya Untuk Ibu Hamil Dan Menyusui

Codeine Tylenol #3, #4 Approved C L3Fentanyl Sublimaze Approved B L2

Meperidine Demerol Approved BL2

L3 (if used early postpartum)

Methadone Dolophine Approved B L3Morphine Morphine Approved B L3

PropoxypheneDarvocet N, Propacet, Darvon

Approved C L2

 

Obat Batuk

Nama ObatAAP

approved?*Risiko Menyusui**

Codeine yes L3 (moderately safe)Dextromethorphan not reviewed L1 (safest)Guaifenesin not reviewed L2 (safer)Dekongestan (Obat Pilek)

Nama ObatAAP

approved?*Risiko Menyusui**

Phenylephrine not reviewed L3 (moderately safe)

Pseudoephedrine (Sudafed, Actifed)

yesL3 (moderately safe) for acute use

L4 (possibly hazardous) for chronic use due to potential for decreasing milk supply

*  Per the AAP Policy Statement The Transfer of Drugs and Other Chemicals Into Human Milk, revised September 2001.** Per Medications’ and Mothers’ Milk by Thomas Hale, PhD (2006 edition)Nasal Sprays (Spray Hidung)

Nama ObatAAP

approved?*Risiko Menyusui**

Beclomethasone (Vanceril, Beclovent, Beconase, Vancenase)

not reviewed L2 (safer)

Cromlyn sodium (Nasalcrom)

not reviewed L1 (safest)

Fluticasone (Flonase) not reviewed L3 (moderately safe)Mometasone (Nasonex)

not reviewed L3 (moderately safe)

Phenylephrine (in some forms of Sinex and Neo-Synephrine)

not reviewed L3 (moderately safe)

Triamcinolone Acetonide (Nasacort)

not reviewed L3 (moderately safe)

Page 6: Daftar Obat Aman Dan Berbahaya Untuk Ibu Hamil Dan Menyusui

Antihistamin (Anti Alergi)

 Nama ObatAAP

approved?*Risiko Menyusui**

 Brompheniramine not reviewed L3 (moderately safe)

 Chlorpheniramine (Chlor-Trimeton) CTM

not reviewed L3 (moderately safe)

 Cetirizine (Zyrtec) not reviewed L2 (safer)

 Dexbrompheniramine maleatewith d-isoephedrine

yes not reviewed

 Diphenhydramine (Benadryl)

not reviewed L2 (safer)

 Doxylamine not reviewed L4 (possibly hazardous)

 Fexofenadine (Allegra)

yes L3 (moderately safe)

 Loratadine (Claritin) yes L2 (safer)

 Terfenadine (Seldane)

yes not reviewed

 Triprolidine (Actidil, Actifed)

yes L1 (safest)

 *  Per the AAP Policy Statement The Transfer of Drugs and Other Chemicals Into Human Milk, revised September 2001.** Per Medications’ and Mothers’ Milk by Thomas Hale, PhD (2002 edition)

       

 

Obat Anestesi

Nama ObatAAP

approved?*

Kategori Risiko Kehamilan**

Risiko Menyusui*

*

Notes

     Local anesthetics Articaine (Septocaine) NR - NR moreBupivacaine (Marcaine) NR C L2  Lidocaine (Xylocaine) Approved C L2  Mepivacaine (Carbocaine, Polocaine)

NR C L3 more

Procaine HCL (Novocaine) NR C L3       General anestheticsHalothane (Fluothane) Approved C L2 moreIsoflurane (Forane) NR - NR 1Ketamine NR - NR more

Page 7: Daftar Obat Aman Dan Berbahaya Untuk Ibu Hamil Dan Menyusui

Methohexital (Brevital) Approved B L3  Nitrous oxide NR - L3  Sevoflurane (Ultane) NR B L3  Thiopental (Pentothal) Approved C L3       Other medications often used during anesthesiaSedativesDiazepam (Valium) Concern D L3; L4 for

chronic use 

Midazolam (Versed) Concern D L3  Propofol (Diprivan) NR B L2 moreTriazolam (Halcion) NR X L3  Narcotic AnalgesicsAlfentanil (Alfenta) NR C L2  Fentanyl (Sublimaze) Approved B L2  Hydromorphone (Dilaudid) NR C L3  Morphine Approved B L3  Reversal MedicationFlumazenil (Romazicon) NR C NR 2Naloxone (Narcan) NR C NR 3SteroidsDecadron (Dexamethasone) NR C NR moreStimulantsEpinephrine (Adrenaline) NR C L1  Anti-nauseaPromethazine (Phenergan) NR C L2  *  Per the AAP Policy Statement The Transfer of Drugs and Other Chemicals Into Human Milk, revised September 2001.

Approved: (Table 6) Maternal Medication Usually Compatible With Breastfeeding Concern: (Table 4) Drugs for Which the Effect on Nursing Infants Is Unknown but

May Be of Concern Caution: (Table 5) Drugs That Have Been Associated With Significant Effects on

Some Nursing Infants and Should Be Given to Nursing Mothers With Caution NR: Not Reviewed. This drug has not yet been reviewed by the AAP.

** Per Medications’ and Mothers’ Milk by Thomas Hale, PhD (2004 edition).

 Lactation Risk Categories  Pregnancy Risk Categories 

L1 (safest) L2 (safer) L3 (moderately safe) L4 (possibly hazardous)

A (controlled studies show no risk) B (no evidence of risk in humans) C (risk cannot be ruled out) D (positive evidence of risk)

Page 8: Daftar Obat Aman Dan Berbahaya Untuk Ibu Hamil Dan Menyusui

L5 (contraindicated) X (contraindicated in pregnancy)

NR: Not Reviewed. This drug has not yet been reviewed by Hale.

1. Isoflurane (Forane) is used for c-sections and directly in newborns. Induction of and recovery from isoflurane anesthesia are rapid, so the majority of the medication is out of the body (and milk) very quickly. More here.

2. Flumazenil (Romazicon) is used directly in children aged 12 months and up.3. Naloxone (Narcan) is used directly in newborns and children.4. Many forms of Robitussin, Delsym and Benylin are considered compatible with

breastfeeding. Always check the active ingredients, as there are many versions.

 

Kelompok Antasida, Antibiotik, Antivirus, Antijamur, Kontrasepsi, Obat jantung & Hipertensi, Vitamin, dll

 

Nama Generik Nama DagangAAP

approved?*

Kategori Risiko

Kehamilan**

Risiko Menyusui*

*Antasida [contents]Cimetidine (Antacid) Tagamet Approved B L2Cisapride (GI tract stimulant) Propulsid Approved C L2Domperidone (used for nausea & vomiting, stimulates lactation) [more]

Motilum Approved - L1

Antibiotika [contents]Amoxicillin Larotid, Amoxil Approved B L1Aztreonam Azactam Approved B L2

CefadroxilUltracef, Duricef

Approved B L1

Cefazolin Ancef, Kefzol Approved B L1Cefotaxime Claforan Approved B L2Cefoxitin Mefoxin Approved B L1Cefprozil Cefzil Approved C L1

CeftazidimeCeftazidime, Fortaz, Taxidime

Approved B L1

Ceftriaxone Rocephin Approved B L2Ciprofloxacin [more] Cipro Approved C L3Clindamycin Cleocin Approved B L3

Page 9: Daftar Obat Aman Dan Berbahaya Untuk Ibu Hamil Dan Menyusui

ErythromycinE-Mycin, Ery-tab, ERYC, Ilosone

Approved BL1

L3 early postnatal

Fleroxacin - Approved - NRGentamicin Garamycin Approved C L2

KanamycinKebecil, Kantrex

Approved D L2

Moxalactam Moxam Approved - NRNitrofurantoin Macrobid Approved B L2Ofloxacin Floxin Approved C L2Penicillin - Approved B L1Streptomycin Streptomycin Approved D L3Sulbactam - Approved - NR

SulfisoxazoleGantrisin, Azo-Gantrisin

Approved C L2

TetracyclineAchromycin, Sumycin, Terramycin

Approved D L2

TicarcillinTicarcillin, Ticar, Timentin

Approved B L1

Trimethoprim/sulfamethoxazole

Proloprim, Trimpex

Approved C L3

Antikoagulan [contents]Bishydroxycoumarin (dicumarol)

- Approved - NR

WarfarinCoumadin, Panwarfin

Approved D L2

Antikonvulsan (Anti kejang) [contents]Carbamazepine Tegretol, Epitol Approved C L2Ethosuximide Zarontin Approved C L4Magnesium sulfate Epsom salt Approved B L1Phenytoin Dilantin Approved D L2

Valproic acidDepakene, Depakote

Approved D L2

Anti Jamur [contents]Fluconazole [more] Diflucan Approved C L2

KetoconazoleNizoral Shampoo, Nizoral

Approved C L2

Antivirus [contents]Acyclovir [more] Zovirax Approved C L2

Interferon-alpha [more]Alferon N, Interferon Alpha

Approved C L2

Page 10: Daftar Obat Aman Dan Berbahaya Untuk Ibu Hamil Dan Menyusui

Arthritis meds (see also: pain meds) [contents]

Gold saltsRidaura, Myochrysine, Solganal

Approved C L5

Kontrasepsi, Hormon [contents]

EstradiolEstratab, Permarin, Menest

Approved X

L3 (may interfere with milk

production)Clogestone - Approved - NR

Contraceptive pill with estrogen/progesterone

Preven, Seasonale, Norinyl, Norlestin, Ortho-Novum, Ovral, Lunelle injection, Ortho-Evra patch, etc.

Approved X

L3 (may interfere with milk

production)

LevonorgestrelNorplant, Mirena, Plan B

Approved X L2

MedroxyprogesteroneProvera, Depo-Provera, Cycrin

Approved D

L1L4 (if used first 3 days postpartum)

Norethynodrel Enovid Approved X L2

ProgesteroneCrinone, Prometrium

Approved - L3

Obat Diabetes [contents]Note: Insulin has not been reviewed by the AAP. Pregnancy risk category = B; Lactation risk category = L1.

TolbutamideOramide, Orinase

Approved D L3

Obat Diare [contents]

Loperamide

Imodium, Pepto Diarrhea Control, Maalox Antidiarrheal Caplets, Kaopectate II Caplets, Immodium Advanced

Approved B L2

** Note: Pepto-Bismol & Kaopectate (bismuth subsalicylate is the active ingredient in both) are not recommended for routine use by nursing moms, due to the association of salicylates with Reyes syndrome in children. [more]

Page 11: Daftar Obat Aman Dan Berbahaya Untuk Ibu Hamil Dan Menyusui

Diuretik (Peluruh Kencing) [contents]

AcetazolamideDazamide, Diamox

Approved C L2

Bendroflumethiazide Naturetin Approved DL4 (may inhibit

lactation)Chlorothiazide Hydrodiuril Approved D L3Chlorthalidone Hygroton Approved D L3

Hydrochlorothiazide (HCT)Hydrodiuril, Esidrix, Oretic

Approved D L2

Spironolactone Aldactone Approved D L2Anti Muntah  [more] [contents]Domperidone Motilum Approved - L1Anti Hipertensi, Obat Jantung [contents]     Anti aritmia

DisopyramideNorpace, Napamide

Approved C L2

Flecainide Tambocor Approved C L3Mexiletine Mexitil Approved B L2

ProcainamidePronestyl, Procan

Approved C L3

QuinidineQuinaglute, Quinidex

Approved C L2

   Anti Hipertensi

Captopril Capoten Approved DL3 (if used

after 30 days)

Diltiazem/Diltiazem HCL

Cardizem Sr, Dilacor-XR, Diltiazem, Cardizem CD

Approved C L3

Enalapril/Enalapril Maleate Vasotec ApprovedC (1st trim.)D (2nd, 3rd

trim.)L2

Hydralazine Apresoline Approved C L2

LabetalolTrandate, Normodyne

Approved C L2

Methyldopa Aldomet Approved C L2

MetoprololToprol XL, Lopressor

Approved B L3

MinoxidilLoniten, Minodyl, Rogaine

Approved CL2

(topically)L3 (orally)

Page 12: Daftar Obat Aman Dan Berbahaya Untuk Ibu Hamil Dan Menyusui

NadololCorgard, Nadolol

Approved C L4

NifedipineAdalat, Procardia

Approved C L2

OxprenololApsolox, Slow-Trasicor, Trasicor

Approved - NR

Propranolol Inderol Approved C L2Sotalol Betapace Approved B L3Timolol Blocadren Approved C L2

VerapamilCalan, Isoptin, Covera-HS

Approved C L2

     Cardiac stimulants

DigoxinLanoxin, Lanoxicaps

Approved C L2

Laksan (Pelancar BAB) [more] [contents]Cascara/Cascara Sagrada - Approved C L3Danthron - Approved - NRMagnesium sulfate Epsom salt Approved B L1Senna - Approved - L3Obat malaria [contents]

ChloroquineAralen, Novo-chloroquine

Approved C L3

Hydroxychloroquine Plaquenil Approved C L2Pyrimethamine Daraprim Approved C L4Quinine Quinamm Approved D L2Medical Testing [more] [contents]Diatrizoate - Approved - NRFluorescein - Approved C L3Gadopentetic (Gadolinium) - Approved C L2Iohexol Omnipaque Approved B L2Iopanoic acid Telepaque Approved D L2Metrizamide Amipaque Approved B L2Metrizoate Isopaque Approved B L2Obat Migren [more] [contents]Sumatriptan Imitrex Approved C L3Obat Sedativ [more] [contents]

Chloral hydrateAquachloral, Noctec

Approved C L3

Methyprylon (withdrawn from use in US & Canada)

- Approved - NR

Bromide - Approved D L5Secobarbital Seconal Approved D L3

Page 13: Daftar Obat Aman Dan Berbahaya Untuk Ibu Hamil Dan Menyusui

Obat Tidur [contents]Zolpidem/Zolpidem Tartrate Ambien Approved B L3Obat Anti Tiroid  [more] [contents]Carbimazole - Approved D L3Methimazole (active metabolite of carbimazole)

Tapazole Approved D L3

Propylthiouracil PTU Approved D L2Thiouracil - Approved - NR

Levothyroxine

Synthroid, Levothroid, Thyroid, Levo-T, Levoxyl

Approved A L1

Obat TBC [contents]Cycloserine Seromycin Approved C L3

EthambutolEthambutol, Myambutol

Approved B L2

Isoniazid INH, Laniazid Approved C L3

RifampinRifadin, Rimactane

Approved C L2

VITAMIN [more] [contents]B-1 (thiamin) - Approved - NRB-12 (Cyanocobalamin) - Approved A L1

B-6 (pyridoxine) - Approved A

L2; L4 in high doses

(may inhibit lactation)

D, vitaminCalciferol, Delta-d

Approved AL3 (do not overdose)

Folic acid - ApprovedA (1st, 2nd

trim.)C (3rd trim.)

L1

K-1, vitamin (Phytonadione) - Approved C L1Riboflavin/B2  - Approved A L1Lain-lain [contents]Acitretin (Anti-psoriasis) Soriatane Approved - NRAlcohol/Ethanol [more] - Approved D L3

AllopurinolZyloprim, Lopurin

Approved C L2

Antimony - Approved - NRAtropine (Anticholinergic, drying agent)

Belladonna, Atropine

Approved C L3

Azapropazone/apazone (Antirheumatic)

Rheumox Approved - L2

Page 14: Daftar Obat Aman Dan Berbahaya Untuk Ibu Hamil Dan Menyusui

Baclofen (muscle relaxant)Lioresal, Atrofen

Approved C L2

Barbiturate - Approved - NR

Caffeine [more]Vivarin, NoDoz, Coffee

Approved B L2

Carbetocin (Antihemorrhagic) Duratocin Approved - NRChloroform - Approved - NRCisplatin (Anti-cancer) Platinol Approved D L4

Dapsone (Antileprosy)Avlosulfon, DDS

Approved C L4

Hydroxychloroquine (Antirheumatic, lupus)

Plaquenil Approved C L2

Iodides - Approved - NRIodine - Approved - NRIodine (povidone-iodine, eg, in a vaginal douche)

- Approved - NR

Ivermectin (Antiparasitic) Mectizan Approved C L3Nalidixic acid (Urinary Anti-infective)

NegGram Approved B L4

Norsteroids - Approved - NRPyridostigmine (Muscle stimulant)

Mestinon, Regonol

Approved C L2

Scopolamine (Motion sickness)Transderm Scope

Approved C L3

Sulfapyridine Dagenan Approved - NRTimolol (glaucoma med) Blocadren Approved D L3*  Per the AAP Policy Statement The Transfer of Drugs and Other Chemicals Into Human Milk, revised September 2001.

Approved: (Table 6) Maternal Medication Usually Compatible With Breastfeeding Caution: (Table 5) Drugs That Have Been Associated With Significant Effects on

Some Nursing Infants and Should Be Given to Nursing Mothers With Caution NR: Not Reviewed. This drug has not yet been reviewed by the AAP.

** Per Medications’ and Mothers’ Milk by Thomas Hale, PhD (2004 edition).

 Lactation Risk Categories  Pregnancy Risk Categories 

L1 (safest) L2 (safer) L3 (moderately safe) L4 (possibly hazardous) L5 (contraindicated)

A (controlled studies show no risk) B (no evidence of risk in humans) C (risk cannot be ruled out) D (positive evidence of risk) X (contraindicated in pregnancy)

Page 15: Daftar Obat Aman Dan Berbahaya Untuk Ibu Hamil Dan Menyusui

NR: Not Reviewed. This drug has not yet been reviewed by Hale

Keamanan obat pada kehamilan

Diterbitkan Juni 3, 2008 Artikel , Gaya Hidup , Health , Informasi , Kedokteran , Kesehatan , Reviews 42   Komentar Tag:Artikel, Gaya Hidup, Hamil, Health, Informasi, Kedokteran, Kesehatan, Obat, Reviews, Wanita

Pada umumnya para ibu hamil akan memberitahu dokter saat berobat bahwa dirinya hamil sekian bulan. Demikian pula jika berobat saat menyusui (ASI bayinya. Informasi tersebut diberikan si ibu dengan harapan dokter akan memberikan obat yang aman bagi janin yang dikandungnya. Itupun tak jarang si ibu masih mananyakan kepada dokter apakah obat yang dgunakan benar-benar aman. Hal ini sangat wajar dan kita patut menghargainya.

Di sisi lain, ketika seorang ibu hamil sakit adakalanya enggan ke dokter lantaran takut menggunakan obat. Alhasil keluhannya makin bertambah dan akhirnya

datang juga ke dokter untuk berobat.

Seorang dokter tentu sangat paham bahwa saat memberikan(meresepkan) obat  bagi wanita hamil akan dipilihkan obat yang aman, baik dalam hal jenis obat (berdasarkan indeks keamanan obat), dosis maupun lamanya penggunaan. Selain itu akan dipertimbangkan pula aspek-aspek lain berdasarkan penyakitnya, misalnya: resiko penularan kepada anggota keluarga lain, dan pertimbangan lain terkait kondisi janin maupun si ibu sendiri.

Pun manakala seorang dokter dihadapkan pada 2 pilihan sulit yang menyangkut life saving, aspek manfaat akan dikedepankan dibanding resiko yang bakal dihadapi baik bagi janin maupun ibunya.

Sebagai contoh, seorang ibu hamil yang kebetulan menderita asma, justru seyogyanya segera berobat agar tidak mengalami sesak berkepanjangan yang justru tidak baik bagi janin karena beresiko terjadinya hipoksia (kekurangan oksigen) yang akan mempengaruhi pasokan oksigen bagi janin.

INDEKS KEAMANAN OBAT PADA KEHAMILAN

Hingga kini kita di Indonesia masih menggunakan kriteria keamanan obat bagi ibu hamil yang dilansir oleh FDA (Food and Drug Administration) sebagai pedoman dalam memberikan obat pada ibu hamil.

Pada posting ini penulis hanya menampilkan garis-garis besar batasan keamanan obat bagi ibu hamil yang tersusun dalam 5 kategori (kategori A, B, C, D dan X) beserta contoh-contohnya agar diketahui khalayak dengan harapan dapat memberikan informasi yang bermanfaat.

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Kategori-kategori tersebut dibuat berdasarkan ada tidaknya (besar kecilnya) resiko terhadap sistem reproduksi, efek samping dan manfaat yag diharapkan.

Obat Kategori A: adalah golongan obat yang pada studi (terkontrol) pada kehamilan tidak menunjukkan resiko bagi janin pada trimester 1 dan trimester berikutnya. Obat dalam kategori ini amat kecil kemungkinannya bagi keselamatan janin.

Obat Kategori B: adalah golongan obat yang pada studi terhadap sistem reproduksi binatang percobaan tidak menunjukkan resiko bagi janin. Belum ada studi terkontrol pada wanita hamil yang menunjukkan adanya efek samping, kecuali adanya penurunan fertilitas pada kehamilan trimester pertama, sedangkan pada trimester berikutnya tidak didapatkan bukti adanya resiko.

Obat Kategori C: adalah golongan obat yang pada studi terhadap sistem reproduksi binatang percobaan menunjukkan adanya efek samping bagi janin. Sedangkan pada wanita hamil belum ada study terkontrol. Obat golongan ini hanya dapat dipergunakan jika manfaatnya lebih besar ketimbang resiko yang mungkin terjadi pada janin.

Obat Kategoti D: adalah golongan obat yang menunjukkan adanya resiko bagi janin. Pada keadaan khusus obat ini digunakan jika manfaatnya kemungkinan lebih besar dibanding resikonya. Penggunaan obat golongan ini terutama untuk mengatasi keadaan yang mengancam jiwa atau jika tidak ada obat lain yang lebih aman.

Obat Kategori X: adalah golongan obat yang pada studi terhadap binatang percobaan maupun pada manusia menunjukkan bukti adanya resiko bagi janin. Obat golongan ini tidak boleh dipergunakan (kontra indikasi) untuk wanita hamil, atau kemungkinan dalam keadaan hamil.

CONTOH OBAT KATEGORI A (nama generik): Ascorbic acid (vitamin C) *masuk kategori C jika dosisnya melebihi US RDA*, Doxylamine, Ergocalciferol *masuk kategori D jika dosisnya melebihi US RDA*, Folic acid *masuk kategori C jika dosisnya melebihi 0,8 mg per hari*, Hydroxocobalamine *masuk kategori C jika dosisnya melebihi US RDA*, Liothyronine, Nystatin vaginal sup *masuk kategori C jika digunakan per oral dan topikal*, Pantothenic acid *masuk kategori C jika dosisnya melebihi US RDA*, Potassium chloride, Potassium citrate, Potassium gluconate, Pyridoxine (vitamin B6), Riboflavin *masuk kategori C jika dosisnya melebihi US RDA*, Thiamine (vitamin B1) *masuk kategori C jika dosisnya melebihi US RDA*, Thyroglobulin, Thyroid hormones, Vitamin D *masuk kategori D jika dosisnya melebihi US RDA*, Vitamin E *masuk kategori C jika dosisnya melebihi US RDA*.

CONTOH OBAT KATEGORI B (nama generik): Acetylcysteine, Acyclovir, Amiloride *masuk kategori D jika digunakan untuk hipertensi yang diinduksi oleh kehamilan*, Ammonium chloride, Ammonium lactate *topical*, Amoxicillin, Amphotericin B, Ampicillin, Atazanavir, Azatadine, Azelaic acid, Benzylpenicillin, Bisacodyl, Budesonide *inhalasi, nasal*, Buspiron, Caffeine, Carbenicillin, Camitine, Cefaclor, Cefadroxil, Cefalexin, Cefalotin, Cefamandole, Cefapirin, Cefatrizine, Cefazolin, Cefdinir, Cefditoren, Cefepime, Cefixime, Cefmetazole, Cefonicid, Cefoperazone, Ceforanide, Cefotaxime, Cefotetan disodium, Cefoxitin, Cefpodoxime, Cefprozil, Cefradine, Ceftazidime, Ceftibuten, Ceftizoxime, Ceftriaxone, Cefuroxime, Cetirizine, Chlorhexidine *mulut dan tenggorokan*, Chlorpenamine, Chlortalidone *masuk kategori D jika

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digunakan untuk hipertensi yang diinduksi oleh kehamilan*, Ciclacillin, Ciclipirox, Cimetidine, Clemastine, Clindamycin, Clotrimazole, Cloxacillin, Clozapine, Colestyramine, …. dll ….. dll

… buanyak

CONTOH OBAT KATEGORI C (nama generik): Acetazolamide, Acetylcholine chloride, Adenosine, Albendazole, Albumin, Alclometasone, Allopurinol, Aluminium hydrochloride, Aminophylline, Amitriptyline, Amlodipine, Antazoline, Astemizole, Atropin, Bacitracin, Beclometasone, Belladonna, Benzatropine mesilate, Benzocaine, Buclizine, Butoconazole, Calcitonin, Calcium acetate, Calcium ascorbate, Calcium carbonate, Calcium chloride, Calcium citrate, Calcium folinate, Calcium glucoheptonade, Calcium gluconate, Calcium lactate, Calcium phosphate, Calcium polystyrene sulfonate, Capreomycin, Captopril, Carbachol, Carbidopa, Carbinoxamine, Chloral hydrate, Chloramphenicol, Chloroquine, Chlorothiazide, Chlorpromazine, Choline theophyllinate, Cidofovir, Cilastatin, Cinnarizine, Cyprofloxacin, Cisapride, Clarithromycin, Clinidium bromide, Clonidine, Co-trimoxazole, Codeine, Cyanocobalamin, Deserpidine, Desonide, Desoximetasone, Dexamethasone, Dextromethorphan, Digitoxin, Digoxin, Diltiazem, Dopamine, Ephedrine, Epinephrine, Fluconazole, Fluocinolone, Fosinopril, Furosemide, Gemfibrozil, Gentamicin, Glibenclamide, Glimepiride, Glipizide, Griseofulvin, Hydralazine, Hydrocortisone, Hyoscine, Hyoscyamine, Isoniazid, Isoprenaline,

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Isosorbid dinitrate, Ketoconazole, Ketotifen fumarate, Magaldrate, Mefenamic acid, Methyl

prednisolone, …dll …dll …

CONTOH OBAT KATEGORI D (nama generik): Amikacin, Amobarbital, Atenolol, Carbamazepine, Carbimazole, Chlordizepoxide, Cilazapril, Clonazepam, Diazepam, Doxycycline, Imipramine, Kanamycin, Lorazepam, Lynestrenol, Meprobamate, Methimazole, Minocycline, Oxazepam, Oxytetracycline, Tamoxifen, Tetracycline, Uracil, Voriconazole… dll … dll.

CONTOH OBAT KATEGORI X (nama generik): Acitretin, Alprotadil *parenteral*, Atorvastatin, Bicalutamide, Bosentan, Cerivastatin disodium, Cetrorelix, Chenodeoxycholic acid, Chlorotrianisene, Chorionic gonadotrophin, Clomifen, Coumarin, Danazol, Desogestrel, Dienestrol, Diethylstilbestrol, Dihydro ergotamin, Dutasteride, Ergometrin, Ergotamin, Estazolam, Etradiol, Estramustine, Estriol succinate, Estrone, Estropipate, Ethinyl estradiol, Etretinate, Finasteride, Fluorescein *parenteral*, Flurouracil, Fluoxymesterone, Flurazepam, Fluvastatin, Floritropin, Ganirelix, Gestodene, Goserelin, Human menopausal gonadotrophin, Iodinated glycerol, Isotretinoin, Leflunomide, Leuprorelin, Levonorgestrel, Lovastatin, Medrogestrone, Medroxyprogesterone, Menotrophin, Mestranol, Methotrexate, Methyl testosterone, Mifeprestone, Miglustat, Misoprostol, Nafarelin, nandrolone, Nicotine *po*, Norethisterone, Noretynodrel, Norgestrel, Oxandrolone,Oxymetholone,  Oxytocin, Pravastatin, Quinine, Raloxifene, Ribavirin, Rosuvastatin, Simvastatin, Stanozolol, Tazarotene, Temazepam, tetosterone, Thalidomide, Triazolam, Triproretin, Urofolitropin, Warfarin.

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Ooopsss … banyak banget, mana namanya rumit pula. … hehehe, maaf

Obat-obat kategori A (yang paling aman pada kehamilan) dan obat kategori X (kontra indikasi pada kehamilan) sengaja ditulis lengkap agar dapat diketahui oleh khalayak. *padahal alasan

sebenarnya karena itemnya ga banyak* …sedangkan obat kategori B, C dan D hanya ditulis sebagian kecil saja karena saking banyaknya item dan jenisnya.

PESAN-PESAN:

Bagi khalayak, penggunaan obat menyangkut jenis, dosis dan lamanya pemakaian seyogyanya atas petunjuk dokter.

Tawaran obat (dengan jargon apapun) disertai klaim-klaim aduhai (seolah paling aman dan paling ampuh) tanpa diketahui dengan jelas kandungan yang ada di dalamnya, patut diwaspadai,

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… apalagi jika tidak mencantumkan efek samping, peringatan hati-hati pada kondisi tertentu dan kontra-indikasi.

Obat hanya akan bermanfaat jika digunakan dengan tepat sesuai indikasi, dosis dan lamanya pengobatan berlandaskan pengetahuan yang dapat dipertanggung jawabkan.

Semoga bermanfaat.