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Veterinary Drugs
Product and
NADA/ANADA NumberTrade Name Ingredients
Albendazole
110-048Valbazen; Albendazole
128-070VALBAZEN; Albendazole
140-934VALBAZEN® Albendazole
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Summary of
FDA Information:
Approval Date: November 10, 1994
Freedom of Information Summary
NADA 140-934
I. GENERAL INFORMATION:
NADA 140-934
Sponsor: SmithKline Beecham Animal Health
1600 Paoli Pike
West Chester, PA 19380
Generic Name: Albendazole
Trade Name: VALBAZEN®
Marketing Status: OTC
II. INDICATIONS FOR USE
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For the removal andcontrol of the following endoparasites infecting sheep:
A. Liver flukes:
Fasciola hepatica, Fascioloides magna(adults)
B. Tapeworms: Common tapeworms: Moniezia expansa
Fringed tapeworms: Thysanosoma actinioides(heads andsegments)
C. Lungworms:
Dictyocaulus filaria(adults and4th stage larvae)
D. Stomach worms: Barberpole worms: Haemonchus contortus (adults and4th stage larvae)
Brown stomach worms: Ostertagia circumcincta, Marshallagia marshalli(adults and4th stage larvae)
Small stomach worms: Trichostrongylus axei(adults and4th stage larvae)
E. Intestinal worms: Thread-necked intestinal worms: Nematodirus spathiger, N. filicollis(adults and4th stage larvae)
Cooper's worms: Cooperia oncophora (adults and4th stage larvae)
Bankrupt worms: T. colubriformis (adults and
4th stage larvae)
Nodular worms: Oesophagostomum columbianum(adults and4th stage larvae)
Large-Mouth Bowel Worms: Chabertia ovina(adults and4th stage larvae)
III. DOSAGE
A. DOSAGE FORM Suspension 4.55% (45.5 mg/mL)
B. ROUTE OF ADMINISTRATION Oral
C. RECOMMENDED DOSAGES: Seven andone-half (7.5) mg of albendazole per kg of body weight (3.4 mg/lb) administered orally with a suitable syringe ordosing gun.
IV. EFFECTIVENESS
This NADA relies on adequate well-controlled studies demonstrating the anthelmintic effectiveness of albendazole in cattle included in approved NADA 110-048 (Albendazole Suspension, 54 FR 25114, June 13, 1989) and
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NADA 128-070 (Albendazole Paste, 54 FR 51385, November 17, 1989).
In these studies, thecattle wereeither experimentally ornaturally infected with one or
more species of nematodes, cestodes and
/or trematodes.The claim foreach major parasitic species is supported by adequate andwell-controlled studies.
Arithmetic means werecalculated to determine efficacy andefficacy wasexpressed in percent removal of worms as compared to controls.The percent reduction wascalculated as follows:
Arithmetic mean no. parasites in control animals
Percentage minus
Reduction of = Arithmetic mean no. parasites in treated animals X 100
Parasites ________________________________________________
Arithmetic mean no. parasites in control animals
As a product foruse in sheep, albendazole qualifies forreview underthe "Minor Use Drug Program." NADA 110-048 (oral suspension) and
NADA 128-070 (oral paste) serve as representative formulations approved foruse in a major species (cattle). Since there wereno drugs approved fortreatment of liver fluke infections, albendazole wasmade available fortreatment of cattle and
sheep from1980 to 1985 on an emergency investigational new animal drug basis in thestates where liver fluke disease prevailed.
Developmental research in sheep wasconducted in nine pivotal studies consisting of six dose-titration andthree dose-confirmation efficacy trials in four different geographic locations in the
United States as well as internationally. Doses ranging from2.5 to 15 mg albendazole per kg body weight, weregiven orally.The results fromthese studies wereused to determine the most effective dose.A dose of
7.5 mg/kg waseffective against the greatest number of parasite species infecting sheep.
Albendazole, in a suspension formulation, was
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administered orally as a drench, and
was evaluated forefficacy using the controlled test, as recommended by the Center forVeterinary Medicine in its "Guidelines forEvaluation of Bovine Anthelmintics," which
serves as a guide forall ruminant species. Briefly stated, a certain number of
infected sheep remain untreated; the remainder receive medication. After a suitable period of time post-treatment (usually 5 to 7 days, but longer in some circumstances), treated anduntreated (control) animals are killed andnecropsied. Remaining parasites are identified andcounted foreach animal.
Albendazole waseffective foreach parasite claimed.The studyconducted against the deer fluke, Fascioloides magnademonstrated 57% efficacy. Albendazole will become the onlyapproved therapy forthis highly pathogenic parasite in sheep.
The results frommajor controlled efficacy studies supported the conclusion that whengiven orally to sheep at 7.5 mg/kg body weight, albendazole is an effective anthelmintic with a wide spectrum of activity against adult andlarval stages of gastrointestinal roundworms, lungworms, tapeworms andliver flukes infecting sheep.The investigators andefficacy against individual parasitic species are given in Tables I, II, III andIV.
(Eds. note: The following table consists of 3 columns.)
Table I
SUMMARY OF PIVOTAL DOSE-TITRATION STUDIES
Efficacy of Albendazole Against Adult Parasites
Parasite % Removal Investigator
(Range)
F. magna 22-64 Stromberg
5.0-15.0 mg/kg
F. hepatica 94-99 Gurnell
5.0-15.0 mg/kg
M. expansa 100 Theodorides
10.0-15.0 mg/kg
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T. actinioides 54-98 Craig
3.8-7.5 mg/kg
D. filaria 51-94 Theodorides
2.5-10.0 mg/kg
H. contortus 85-99 Craig
3.8-10.0 mg/kg Theodorides
T. axei 100 Craig
3.8-10.0 mg/kg
N. spathiger 94-99 Theodorides
2.5-10.0 mg/kg
(Eds. note: The following table consists of 3 columns.)
Table II
SUMMARY OF PIVOTAL DOSE-TITRATION STUDIES
Efficacy of Albendazole Against Fourth-Stage
Nematode Larvae
Parasite %Removal Investigator
(Range)
D. filaria 89-96 van Schalkwyk
3.8-7.6 mg/kg
O. circumcincta 99-100 Gurnell
5.0-10.0
Oe. columbianum 94-100 Gurnell
5.0-10.0 mg/kg
N. spathiger 100 Gurnell
5.0-10.0 mg/kg
(Eds. note: The following table consists of 3 columns.)
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Table III
SUMMARY OF PIVOTAL DOSE-CONFIRMATION STUDIES
Efficacy of
Albendazole Against Trematodes, Cestodes and
Adult Nematodes
Parasite (dose) % Removal Investigator
(Range)
F. hepatica 83-86 Johns
4.75 mg/kg
T. actinioides 100 Bergstrom
7.5 mg/kg
H. contortus 100 Craig
7.5 mg/kg
T. axei 100 Craig
7.5 mg/kg
(Eds. note: The following table consists of 3 columns.)
Table IV
SUMMARY OF DOSE-CONFIRMATION STUDIES
Efficacy of Albendazole Against Fourth-Stage
Nematode Larvae
Parasite % Removal Investigator
(Range)
H. contortus 100 Craig
7.5 mg/kg
Location of Investigators in Tables I, II, III andIV Dr. R. C. Bergstrom, Laramie, WY.
Dr. T. M. Craig, College Station, TX.
Dr. T. O. Gurnell, Terenure, South Africa
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Dr. D. R. Johns, New South Wales, Australia
Dr. B. E. Stromberg, St. Paul, MN.
Dr. V. J.
Theodorides, West Chester, PA.
Dr. P. C. van Schalkwyk, Terenure, South Africa
A. Dose Titration
Pivotal dose-titration studies werecarried out to determine the dose of albendazole needed to control trematodes, cestodes, gastrointestinal andpulmonary nematodes. Approximately 170 sheep wereused, three-fourths of
whichweretreated with albendazole.The remaining sheep served as untreated controls. An oral suspension formulation wasutilized with dosages ranging from
2.5 to 15 mg/kg. Accepted husbandry practices wereduplicated with respect to breeds of sheep, diets, and
grazing conditions. Standard procedures werefollowed forallocating, dosing, collecting samples, enumerating andidentifying parasites, and
performing necropsies.The parasitic infections wereexperimentally induced in four (4) of
the trials andnaturally acquired in theremaining two (2) trials. Based on the data collected, an optimum effective dose of 7.5 mg albendazole per kg body weight wasdetermined.
1) Dose-Titration Study, No.A -8008-75
T. O. Gurnell
Terenure Research Farm
Isando, South Africa
A total of
46 lambs wasexperimentally infected with metacercariae of F. hepaticaand divided intofive groups.
The controls andthe first three treatment groups werealso experimentally infected with larvae of O. circumcincta, N. spathiger andOe. columbianum. One group of nine lambs remained untreated andserved as a control.The remaining four groups received albendazole suspension as a single oral dose of
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5.0, 7.5, 10.0 or15.0 mg/kg (8, 11, 11 and7 lambs, respectively). Ten days after treatment the animals werenecropsied.The percent removal in thetreatment groups is given below. No adverse reaction wasreported.
(Eds. note: The following table consists of 5 columns.)
Percentage Reduction Relative to Controls
Albendazole
Parasite 5.0 7.5 10.0 15.0
mg/kg mg/kg mg/kg mg/kg
F. hepatica (adult) 94 97 98 99
O. circumcincta (larvae) 100 99 99 --
N. spathiger (larvae) 100 100 100 --
Oe. columbianum (larvae) 98 95 99 --
2) Dose-Titration Study, No.A -5180-82A-5180-82 B. E. Stromberg
University of Minnesota
St. Paul, Minnesota
Thirty lambs wereexperimentally infected with metacercariae of F. magnaand divided intofive groups of six. Albendazole will become the only approved therapy forthis highly pathogenic parasite in sheep. Four of the groups received a single oral dose of albendazole suspension at 5.0, 7.5, 10.0 or15.0 mg/kg.The remaining group remained untreated andserved as a control. All animals werenecropsied six weeks after treatment andthe percent removal as listed below wasrecorded. No adverse reaction wasreported.
(Eds. note: The following table consists of 5 columns.)
Percentage Reduction Relative to Controls
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Albendazole
Parasite 5.0 7.5 10.0 15.0
mg/kg mg/kg mg/kg mg/kg
F. magna (adult) 22 57 64 64
3) Dose-Titration Study, No.A -374-78 T. M. Craig
Texas A&M University
College Station, Texas
Thirty lambs harboring natural infections of T. actinioides, H. contortusand T. axeiwere divided intothree equal groups. Two of the groups weretreated with a single oral dose of
albendazole suspension at 3.8 or7.5 mg/kg.The third group remained untreated andserved as a control. At necropsy, thefollowing results wererecorded. No adverse reaction wasreported.
(Eds. note: The following table consists of 3 columns.)
Percentage Reduction Relative to Controls
Albendazole
Parasite 3.8 7.5
mg/kg mg/kg
H. contortus (adult) 85 99
T. axei (adult) 100 100
T. actinioides (adult) 54 98
4) Dose-Titration Study, No.
A -206-74 V. J.Theodorides
Applebrook Center
West Chester, Pennsylvania
A total of 23 lambs wasexperimentally infected with H. contortus, N. spathiger,and D. filariaand divided into
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four groups. One group of five lambs remained untreated, theother groups of six lambs each received a single oral dose of albendazole suspension at 2.5, 5.0, or10.0 mg/kg. At necropsy, thefollowing results were
reported. No adverse reaction wasreported.
(Eds. note: The following table consists of 4 columns.)
Percentage Reduction Relative to Controls
Albendazole
Parasite 2.5 5.0 10.0
mg/kg mg/kg mg/kg
H. contortus (adult) 96 99 99
N. spathiger (adult) 94 95 99
D. filaria (adult) 51 83 94
5) Dose-Titration Study, No. Study A-208-74 V. J.Theodorides
Applebrook Center
West Chester, Pennsylvania
Twelve lambs, naturally infected with M. expansa, weredivided intothree groups of
four animals each. One group served as an untreated control andthe remaining two groups received a single oral dose of albendazole suspension at either 10 or15 mg/kg. Seven days later the animals werenecropsied.The percent removal in thetreatment groups is given below. No adverse reaction wasreported.
(Eds. note: The following table consists of 3 columns.)
Percentage Reduction Relative to Controls
Albendazole
Parasite 10 mg/kg 15 mg/kg
M. expansa (adult) 100 100
6)Dose-Titration Study, N0.
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A -8008-77 P. C. van Schalkwyk
Terenure Research Farm
Isando, South Africa
A total of 31 lambs, experimentally infected with Oe. columbianumand D. filarialarvae, wasdivided intothree groups. Two of the groups received albendazole suspension as a single oral dose of 3.8 or7.6 mg/kg (11 lambs each).The third group of nine lambs remained untreated andserved as a control.The following results werereported at necropsy. No adverse reaction wasreported.
(Eds. note: The following table consists of
3 columns.)
Percentage Reduction Relative to Controls
Albendazole
Parasite 3.8 mg/kg 7.6 mg/kg
Oe. columbianum (larvae) 84 88
D. filaria (larvae) 89 96
Doses ranging from2.5 to 15 mg albendazole per kg body weight, were
given orally.The results fromthese studies wereused to determine the most effective dose.A dose of
7.5 mg/kg wasselected as the most effective level against the greatest number of parasite species infecting sheep. Albendazole will become the only approved therapy forthis highly pathogenic parasite in sheep. B. Dose-Confirmation
Confirmation of the dose selected forgastrointestinal andpulmonary nematodes, trematodes, and
cestodes was
ascertained in three pivotal controlled trials.A total of 47 sheep wasused, approximately one-half of
whichweretreated with albendazole; the remaining sheep served as untreated controls. Infections wereacquired naturally in two (2) trials andwereexperimentally induced in theother trial. All of the sheep were
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necropsied andparasites remaining wererecovered.
1) Dose-Confirmation Study, No.A -8211-76
D. R. Johns
SmithKline Research Station
Cobbitty, New South Wales
Australia.
Twenty lambs wereexperimentally infected with F. hepaticametacercariae anddivided intotwo groups. One group of eleven sheep received a single oral dose of
albendazole suspension at 4.75 mg/kg; the other group of nine sheep wasleft untreated andserved as a control. At necropsy, thepercent removal of the worms wasrecorded andis given below. No adverse reaction wasobserved.
(Eds. note: The following table consists of 2 columns.)
Percentage Reduction Relative to Controls
Albendazole
Parasite 4.75 mg/kg
F. hepatica (adult) 83
2) Dose-Confirmation Study, No. Study A-368-78 T. M. Craig
Texas A&M University
College Station, Texas
Seven lambs, naturally infected with H. contortus, were
divided into
two groups. One group of three animals received a single oral 7.5 mg/kg dose of albendazole; the remaining four animals wereleft untreated andserved as controls. At necropsy, theresults wereas follows. No adverse reaction wasreported.
(Eds. note: The following table consists of
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2 columns.)
Percentage Reduction Relative to Controls
Albendazole
Parasite 7.5 mg/kg
H. contortus (adult) 100
H. contortus (larvae) 99
T. axei (adult) 100
C. oncophora (adult) 100
N. spathiger (adult) 100
3) Dose-Confirmation Study, No.
A -294-77 R. C. Bergstrom
University of Wyoming
Laramie, Wyoming
Twenty sheep, naturally infected with the fringe tapeworm (T. actinioides) weredivided intotwo equal groups. One group received a single oral 7.5 mg/kg dose of albendazole suspension.The other group remained untreated andserved as a control. At necropsy, 21 days after treatment, theresults wereas follows. No adverse reaction was
reported.
(Eds. note: The following table consists of 2 columns.)
Percentage Reduction Relative to Controls
Albendazole
Parasite 7.5 mg/kg
T. actinioidies (adult) 100
C. Field Trials Well-documented clinical field trials wereconducted in theUnited States according to an approved protocol whichwasmodified to accommodate the parasite(s) of interest andlocal management conditions. Groups of sheep with at least a moderate worm infection, as determined by egg counts in their feces, wereselected. In one of the trials the same number of animals wastreated with albendazole or
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was left untreated andserved as controls. In the other four trials, due to the severity of the infection andthe death losses that had occurred, all animals in theflock weretreated with albendazole. Worm eggs in fecal samples werecounted before and
after treatment, and
animals werevisually observed forside effects.
Five investigators studied albendazole suspension in four states. Sheep of various breeds weretreated. Investigators, trial locations andnumbers of animals in these studies are tabulated on the following pages.The results of these clinical field trials confirm the results of the studies indicating elimination orreduction of fecal egg counts in virtually all treated sheep.
The recommended treatment wasfound to be safe andpractical underfield conditions.
Clinical field trials conducted by foreign investigators werealso submitted.They further confirm the efficacy of albendazole against a broad spectrum of gastrointestinal roundworm, lungworm, tapeworm andliver fluke infections in sheep.
(Eds. note: The following table consists of
8 columns.)
CLINICAL FIELD TRIALS
WITH ALBENDAZOLE SUSPENSION IN SHEEP
United States
Average Average
Total Type of Worm Eggs Worm Eggs
Study# Investigator/ No. of Parasite No. of Before/After No. of
Before/After
(mg/kg) Location Animals Infection Treated Treatment Controls Treatment
A-370 Dr. R. W. Randall 140 F. hepatica 140 298.0/6.60 -- --/--
(7.5) Bridger, MT
A-5090 Dr. D.E. Worley 150 F. hepatica 150 1020.0/164.0 -- --/--
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(7.5) Bozeman, MT
A-5108 Dr. H.R. Sherman 100 Tapeworm, 100 >400.0/-- -- --/--
(5.0) Dover, MA G.I. 300.0/<1.0
Nematode
A-5121 Dr. R.W. Fish 70 F. magna 70 * -- --/--
(7.5) Granton, WI --/--
A-5099 Dr. R.B. Wescott 50 Tapeworm, 25 0.4/0.04 25 0.5/0.7
(7.5) Pullman, WA G.I. 109.0/1.0 107.0/140.0
Nematode
*Since worms do not achieve sexual maturity in this host, no eggs were
produced;
death losses prior to treatment were20-40%, no deaths occurred post-treatment.
V. ANIMAL SAFETY
Studies to evaluate the safety of albendazole in sheep wereconducted at SmithKline Animal Health Products in West Chester, Pennsylvania; French's Forest, Brookvale, Australia;andIsando, Transvaal, South Africa, as well as in thelaboratories of independent investigators in theUnited States and
other countries.
Acute Oral Toxicity Study of Albendazole in Sheep
Investigator:
D. R. Johns
SmithKline Animal Health Products
Cobbitty, New South Wales,
Australia
A-77/3
Purpose:
The objective of this studywas to determine the maximum tolerated dose of
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albendazole in sheep.
Methods:
Sixteen Merino sheep were
divided into
four equal groups andreceived a single oral dose of 26.5 (3.5x), 37.5 (5.0x), 53.0 (7.1x) or75.0 (10.0x) mg/kg of albendazole suspension. After administration of the compound, all animals wereobserved daily forclinical signs fora 14-day period.
Results:
All animals in the75 mg/kg group had diarrhea at Day 7.Three of
the four animals in thegroup had wool break and1 animal died by Day 14. In the 53 mg/kg group, 1 animal exhibited diarrhea. No adverse effects wereobserved in the37.5 or26.5 mg/kg groups.
Conclusion:
The maximum tolerated dose in this study
was 37.5 mg/kg (5X recommended dose).
Acute Oral Toxicity Study of Albendazole in Sheep
Investigator:
P. C. Van Schalkwyk
SmithKline Animal Health Products
Isando, South Africa
Study A-76/2
Purpose:
The objective of this study
was to determine the maximum tolerated dose of albendazole, defined here as that dose at whichno observable clinical symptoms orgross pathology are noted during a 14 day period, in sheep.
Methods:
Twenty Merino male andfemale lambs weighing 18.5 - 43 kg wereassigned to five groups of four lambs each. Albendazole suspension was
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administered as a single oral dose of 26.5 (3.5x), 37.5 (5.0x), 53.0 (7.1x) or75.0 910.0x) mg/kg.A similar group of four lambs received the suspension vehicle andserved as an untreated control. After administration of the compound, the
animals wereobserved daily for
14 days, then euthanized andnecropsied.
Results:
No adverse sign wasobserved in thetwo lower dose groups. In the two higher dose groups, two of the four animals in each group had appetite depression anddecreased activity. One female in thehighest dose group had slight wool break. No pathogenic change attributable to administration of albendazole wasseen in any of
the animals.
Conclusion:
The maximum tolerated dose in this studywas 37.5 mg/kg (5X recommended dose).
Evaluation of the Safety of Albendazole When Administered Orally to Ewes During Early Pregnancy
Investigator:
J.M. Tesh
G.A. Harper
Life Science Research
Essex, England
Study 77/SAF20/205/UK
Purpose:
The objective of this studywas to examine the effects of
albendazole on the progress andoutcome of pregnancy in sheep whenadministered as a single dose on Day 17 of gestation.
Methods:
Approximately 360 Dorset Horn Cross andClun ewes weremated naturally. After mating, the
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ewes wererandomly assigned to one of five groups.There wasa control group andfour treatment groups receiving a single dose of albendazole at 7.5 mg/kg, 10 mg/kg, 15 mg/kg, or
20 mg/kg 17 days after mating.The numbers of
lambs born, mortality rates fromthe neonatal period through slaughter, initial lamb examination (bodyweight, general condition, viability estimation, external malformations), lamb index, viability index, mean litter size, livebirth, and
lamb birth weights wererecorded. Maternal factors werepregnancy rate, gestation length, and
parturition difficulties.
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Albendazole
The Elephant Formulary© 2003-06 Susan K. Mikota DVM and Donald C. Plumb, Pharm.D.Published by Elephant Care International - www.elephantcare.org
Elephant specific information, if available, is in blue.
Chemistry - A benzimidazole anthelmintic structurally related to mebendazole,albendazole has a molecular weight of 265. It is insoluble in water and soluble in alcohol. Storage/Stability/Compatibility- Albendazole suspension should be stored at roomtemperature(15-30°C); avoid freezing. Shake well before using. Uses/Indications - Albendazole is approved for the following endoparasites of cattle:Ostertagia ostertagi , Haemonchus spp., Trichostrongylus spp., Nematodius spp.,Cooperia spp., Bunostomum phlebotomum, Oesphagostomum spp., Dictacaulus spp.,
Fasciola hepatica (adults), and Moniezia spp. It is also used in sheep, goats and swinefor endoparasite control. In cats, albendazole has been used to treat Paragonimus kellicotti infections. In dogsand cats, albendazole has been used to treat capillariasis. In dogs, albendazole hasbeen used to treat Filaroides infections. Albendazole was implicated as being an oncogen in 1984, but subsequent studies wereunable to demonstrate any oncogenic or carcinogenic activity of the drug. Pharmacokinetics - Pharmacokinetic data for albendazole in cattle, dogs and cats werenot located. The drug is thought to be better absorbed orally than other benzimidazoles.
Approximately 47% of an oral dose was recovered (as metabolites) in the urine over a 9day period. After oral dosing in sheep, the parent compound was either not detectable or onlytransiently detectable in the plasma due to a very rapid first-pass effect. The activemetabolites, albendazole sulphoxide and albendazole sulfone reached peak plasmaconcentrations 20 hours after dosing. Contraindications/Precautions - The drug is not approved for use in lactating dairycattle. The manufacturer recommends not administering to female cattle during the first45 days of pregnancy or for 45 days after removal of bulls. Albendazole has beenassociated with teratogenic and embryotoxic effects in rats, rabbits and sheep when
given early in pregnancy. In humans, albendazole is recommended to be used with caution in patients with liver or hematologic diseases. Adverse Effects/Warnings - Albendazole is tolerated without significant adverse effectswhen dosed in cattle at recommended dosages.
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Dogs treated at 50 mg/kg twice daily may develop anorexia. Cats may exhibit symptomsof mild lethargy, depression, anorexia, and resistance to taking the medication whenalbendazole is used to treat Paragonimus. Overdosage/Toxicity - Doses of 300 mg/kg (30X recommended) and 200 mg/kg havecaused death in cattle and sheep, respectively. Doses of 45 mg/kg (4.5X) those
recommended did not cause any adverse effects in cattle tested. Cats receiving 100mg/kg/day for 14-21 days showed signs of weight loss, neutropenia and mental dullness. Drug Interactions - In humans, dexamethasone and praziquantal both have beendemonstrated to increase albendazole serum levels. Cimetidine increased albendazolelevels in bile and cystic fluid. Veterinary clinical relevance is unknown. Doses -Cattle:
For susceptible parasites:a) 10 mg/kg PO (Labeled directions; Valbazen® —SKB)b) 7.5 mg/kg PO; 15 mg/kg PO for adult liver flukes. (Roberson 1988b)
c) For adult liver flukes: 10 mg/kg PO; best used in fall when the majority areadults (little or no efficacy against immature forms). A second treatment inwinter may be beneficial. (Herd 1986b)
Elephants:a) 2.5 mg/kg orally as a single dose (Chandrasekharan, 2002) (Chandrasekharan et.al.,1995), (Chandrasekharan, 1992). Elephant References:a) Chandrasekharan,K. 2002. Specific diseases of Asian elephants. Journal of IndianVeterinary Association Kerala 7:(3):31-34
a) Chandrasekharan,K., Radhakrishnan,K., Cheeran,J.V., Nair,K.N.M., andPrabhakaran,T., 1995. Review of the Incidence, Etiology and Control of CommonDiseases of Asian Elephants with Special Reference to Kerala. In: Daniel,J.C.(Editor), A Week with Elephants; Proceedings of the International Seminar on AsianElephants. Bombay Natural History Society; Oxford University Press, Bombay, India pp.439-449
a) Chandrasekharan,K., 1992. Prevalence of infectious diseases in elephants inKerala and their treatment. In: Silas,E.G., Nair,M.K., and Nirmalan,G. (Editors), TheAsian Elephant: Ecology, Biology, Diseases, Conservation and Management(Proceedings of the National Symposium on the Asian Elephant held at the KeralaAgricultural University, Trichur, India, January 1989). Kerala Agricultural University,
Trichur, India pp. 148-155
Monitoring Parameters -1) Efficacy2) Adverse effects if used in non-approved species or at dosages higher than
recommended. Client Information - Shake well before administering. Contact veterinarian if adverseeffects occur.
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Dosage Forms/Preparations/FDA Approval Status - Veterinary-Approved Products:
Albendazole Suspension 113.6 mg/ml (11.36%) in 500 ml, 1 liter, 5 liter Albendazole Paste 205 g (7.2 oz); Valbazen "Valbazen" ® (Pfizer); (OTC) Approved
for use in cattle (not female cattle of breeding age). Slaughter withdrawal=27 days.
Human-Approved Products:Albendazole Tablets 200 mg Albenza ® "Albenza ®" (SmithKline Beecham), (Rx)
Disclaimer: the information on this page is used entirely at the reader's discretion,and is made available on the express condition that no liability, expressed or implied,
is accepted by the authors or publisher for the accuracy, content, or use thereof.
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VALBAZEN® SUSPENSION
Pfizer Animal Health
(albendazole)
Broad-Spectrum Dewormer
Oral Suspension for Use in Cattle, Sheep, and Goats for removal and control of liver
flukes, tapeworms, stomach worms (including 4th stage inhibited larvae of Ostertagia
ostertagi), intestinal worms, and lungworms in cattle and sheep and for the treatment of
adult liver flukes in nonlactating goats
NADA #110-048, Approved by FDA
Active Ingredient:
Albendazole 11.36%
(Equivalent to 113.6 mg/mL)
Indications:
Cattle and sheep: Valbazen is a broad-spectrum anthelmintic effective in the removaland control of liver flukes, tapeworms, stomach worms (including 4th stage inhibited
larvae of Ostertagia ostertagi), intestinal worms, and lungworms as indicated below.
Goats: For the treatment of adult liver flukes in nonlactating goats.
Parasite Cattle Sheep Goats
Adult Liver
Flukes
Fasciola hepatica Fasciola hepatica , Fascioloides
magna
Fasciola
hepatica
Heads andSegments of
Tapeworms
Moniezia benedeni, M.
expansaCommon Tapeworm (Moniezia
expansa), Fringed Tapeworm
(Thysanosoma actinioides)
Adult and 4thStage Larvaeof Stomach
Worms
Brown Stomach Worm,including 4th stage inhibitedlarvae (Ostertagia ostertagi),
Barberpole Worm(Haemonchus contortus, H.
placei), Small Stomach
Worm (Trichostrongylus
Brown Stomach Worm(Ostertagia circumcincta,Marshallagia marshalli),
Barberpole Worm (Haemonchuscontortus), Small Stomach Worm(Trichostrongylus axei)
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axei)
Adult and 4th
Stage Larvae
of Intestinal
Worms
Thread-necked Intestinal
Worm (Nematodirus spathiger , N. helvetianus),
Small Intestinal Worm(Cooperia punctata, C.oncophora)
Thread-necked Intestinal Worm
(Nematodirus spathiger , N. fificollis), Cooper's Worms
(Cooperia oncophora), BankruptWorm (Trichostrongyluscolubriformis), Nodular Worm(Oesophagostomum
columbianum), Large-mouth
Bowel Worm (Chabertia ovina)
Adult Stages
of IntestinalWorms
Hookworm (Bunostomum phlebotomum), BankruptWorm (Trichostrongylus
colubriformis), Nodular
Worm (Oesophagostomum
radiatum)
Adult and 4th
Stage Larvae
of
Lungworms
Dictyocaulus viviparus
Adult andLarval Stages
of
Lungworms
Dictyocaulus filaria
Dosage and Administration: Valbazen Suspension should be administered to cattle andgoats at the recommended rate of 4 mL/100 lb of body weight (equivalent to 4.54 mg of albendazole/lb, 10 mg/kg) and to sheep at the recommended rate of 0.75 mL/25 lb of
body weight (equivalent to 3.4 mg of albendazole/lb, 7.5 mg/kg). The following table
indicates recommended dosing schedules.
Cattle Sheep Goats
Body Weight Dosage Body Weight Dosage Body Weight Dosage
250 lb 10 mL 25 lb 0.75 mL 25 lb 1 mL
500 lb 20 mL 50 lb 1.5 mL 50 lb 2 mL
750 lb 30 mL 75 lb 2.25 mL 75 lb 3 mL
1000 lb 40 mL 100 lb 3.0 mL 100 lb 4 mL
1250 lb 50 mL 200 lb 6.0 mL 200 lb 5 mL
1500 lb 60 mL 300 lb 9.0 mL 300 lb 6 mL
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Cattle: 500 mL of Valbazen 11.36% Suspension will treat 25 animals weighing 500 lb. 1
liter of Valbazen 11.36% Suspension will treat 50 animals weighing 500 lb. 5 liters of
Valbazen 11.36% Suspension will treat 250 animals weighing 500 lb.
Sheep: 500 mL of Valbazen 11.36% Suspension will treat 332 animals weighing 50 lb. 1
liter of Valbazen 11.36% Suspension will treat 664 animals weighing 50 lb. 5 liters of Valbazen 11.36% Suspension will treat 3320 animals weighing 50 lb.
Goats: 500 mL of Valbazen 11.36% Suspension will treat 250 animals weighing 50 lb. 1liter of Valbazen 11.36% Suspension will treat 500 animals weighing 50 lb. 5 liters of
Valbazen 11.36% Suspension will treat 2500 animals weighing 50 lb.
Valbazen 11.36% Suspension should be given orally using any type of standard dosing
gun or dose syringe.
Important: Accurate estimates of the weight of the cattle, sheep, and goats to be treated
are essential for most effective results with this product. Animals constantly exposed tointernal parasites should be retreated as necessary.
Residue Warnings: Cattle must not be slaughtered within 27 days followinglast treatment. Sheep and Goats must not be slaughtered within 7 days
following last treatment. Because a withdrawal time in milk has not been
established, do not use in female dairy cattle of breeding age. Do not use in
lactating does.
Precaution: Do not administer to female cattle during first 45 days of pregnancy or for 45 days after removal of bulls. Do not administer to ewes during the first 30 days of
pregnancy or for 30 days after removal of rams. Consult your veterinarian for assistancein the diagnosis, treatment, and control of parasitism.
Keep This and All Medication Out of Reach of Children
Shake Well Before Using
For Use in Animals Only
Store at Controlled Room Temperature 15°-30°C (59°-86°F)
Protect From Freezing
Not for human use
Restricted Drug (California) - Use only as directed
Distributed by: Pfizer Animal Health, Div. of Pfizer Inc, NY, NY 10017
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12x500 mL/16.9 fl oz (1 pt 1 fl oz) bottles 8783000 85-8783-07
3x4x1 L/33.8 fl oz (1 qt 1.8 fl oz) bottles 85-8784-06, 8784000 80-8784-08
2x5 L/189 fl oz (1 gal 1 qt 9 fl oz) bottles 85-8785-06, 8785000 80-8785-08