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CESTEX (epsiprantel) tablet, film coated
[Pfizer Animal Health]


Category DEA Schedule Marketing Status
PRESCRIPTION ANIMAL DRUG LABEL New Animal Drug Application
Drug Label Sections

CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cestex (epsiprantel) tablets are indicated for the removal of tapeworms in the cat (Dipylidium caninum and Taenia taeniaeformis) and dog (Dipylidium caninum and Taenia pisiformis).

DESCRIPTION

Cestex tablets are film-coated and contain 12.5 mg, 25 mg, 50 mg or 100 mg of epsiprantel per tablet.

Epsiprantel is an anthelmintic that is active as a single dose against the common tapeworms of cats and dogs. Epsiprantel has a molecular weight of 326 and is chemically 2-(cyclohexyl-carbonyl)-4-oxo 1,2,3,4,6,7,8,12b-octahydropyrazino[2,1-a][2]benza-zepine. It is a stable white solid which is sparingly soluble in water. Its chemical structure is presented below.

Chemical Structure

ACTION

Epsiprantel acts directly on the tapeworm. Since it is minimally absorbed following oral administration, epsiprantel remains at the site of action within the gastrointestinal tract. Due to digestive process, tapeworm fragments or proglottids may not be readily visible in the stool.

INDICATIONS

Cestex tablets are indicated for the removal of the following:

Feline cestodes: Dipylidium caninum and Taenia taeniaeformis
Canine cestodes: Dipylidium caninum and Taenia pisiformis

DOSAGE AND ADMINISTRATION

Cestex tablets should be administered orally.

The recommended dosage of epsiprantel is: cats, 1.25 mg/lb of body weight; dogs, 2.5 mg/lb of body weight. The following table may be used as a guide:

Dosage Schedule
Feline
Body WeightDose
Seven weeks old up to 10 lb12.5 mg
11–20 lb25.0 mg
Canine
Body WeightDose
Seven weeks old up to 5 lb12.5 mg
6–10 lb25.0 mg
11–20 lb50.0 mg
21–40 lb100.0 mg
41–50 lb125.0 mg
51–60 lb150.0 mg
61–80 lb200.0 mg
81–90 lb225.0 mg
91–100 lb250.0 mg
101+ lb2.5 mg/lb, rounding up to next whole tablet combination

Fasting is not necessary or recommended.

Unless exposure to the infected intermediate hosts is controlled, reinfection is likely and retreatment may be required. In the case of D. caninum, an effective flea control program should be instituted.

SAFETY

Epsiprantel has been evaluated in cats at 5 times the recommended dose given once daily for 3 days with no adverse effects noted. In tolerance studies, epsiprantel produced minimal clinical signs in cats given 40 times the recommended dose once daily for 4 days.

Epsiprantel has been evaluated in 14-day repeat dose studies in dogs at 500 mg/kg (90 times recommended dosage) with no significant adverse results. No side effects were observed during the clinical field studies.

Epsiprantel is not a cholinesterase inhibitor. During the course of clinical field studies, Cestex was administered concurrently with diethylcarbamazine citrate (dogs only), anti-inflammatory agents, insecticides, and nematocides with no drug incompatibilities noted.

CONTRAINDICATIONS

There are no known contraindications to the use of this drug.

WARNINGS

For use in cats and dogs only. Safety of use in pregnant or breeding animals has not been determined. Keep out of reach of children. Not for use in humans.

PRECAUTION

Do not use in kittens or puppies less than 7 weeks of age.

STORAGE

Store at controlled room temperature 15°–30°C (59°–86°F).

HOW SUPPLIED

Cestex tablets are film-coated and contain 12.5 mg, 25 mg, 50 mg or 100 mg of epsiprantel per tablet. Cestex is supplied as described below:

Weight (lbs)Number Tablets/Bottle
ConcentrationCatDog
12.5 mg10550, 100
25.0 mg201050, 100
50.0 mg– –2025, 50
100.0 mg– –4025, 50

NADA #140-893, Approved by FDA

Pfizer Animal Health

75-8032-10
January 2004

PRINCIPAL DISPLAY PANEL - 50 12.5 mg Tablet Bottle Label

Cestex®
(epsiprantel)

Caution: Federal law restricts this
drug to use by or on the order of
a licensed veterinarian.

12.5 mg

50 tablets

NADA #140-893, Approved by FDA

Pfizer

PRINCIPAL DISPLAY PANEL - 50 12.5 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 100 12.5 Tablet Bottle Label

Cestex®
(epsiprantel)

Caution: Federal law restricts this
drug to use by or on the order of
a licensed veterinarian.

12.5 mg

100 tablets

NADA #140-893, Approved by FDA

Pfizer

PRINCIPAL DISPLAY PANEL - 100 12.5 Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 50 25 mg Tablet Bottle Label

Cestex®
(epsiprantel)

Caution: Federal law restricts this
drug to use by or on the order of
a licensed veterinarian.

25 mg

50 tablets

NADA #140-893, Approved by FDA

Pfizer

PRINCIPAL DISPLAY PANEL - 50 25 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 100 25 mg Tablet Bottle Label

Cestex®
(epsiprantel)

Caution: Federal law restricts this
drug to use by or on the order of
a licensed veterinarian.

25 mg

100 tablets

NADA #140-893, Approved by FDA

Pfizer

PRINCIPAL DISPLAY PANEL - 100 25 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 25 50 mg Tablet Bottle Label

Cestex®
(epsiprantel)

Caution: Federal law restricts this
drug to use by or on the order of
a licensed veterinarian.

50 mg

25 tablets

NADA #140-893, Approved by FDA

Pfizer

PRINCIPAL DISPLAY PANEL - 25 50 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 50 50 mg Tablet Bottle Label

Cestex®
(epsiprantel)

Caution: Federal law restricts this
drug to use by or on the order of
a licensed veterinarian.

50 mg

50 tablets

NADA #140-893, Approved by FDA

Pfizer

PRINCIPAL DISPLAY PANEL - 50 50 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 25 100 mg Tablet Bottle Label

Cestex®
(epsiprantel)

Caution: Federal law restricts this
drug to use by or on the order of
a licensed veterinarian.

100 mg

25 tablets

NADA #140-893, Approved by FDA

Pfizer

PRINCIPAL DISPLAY PANEL - 25 100 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 50 100 mg Tablet Bottle Label

Cestex®
(epsiprantel)

Caution: Federal law restricts this
drug to use by or on the order of
a licensed veterinarian.

100 mg

50 tablets

NADA #140-893, Approved by FDA

Pfizer

PRINCIPAL DISPLAY PANEL - 50 100 mg Tablet Bottle Label
CESTEX 
epsiprantel tablet, film coated
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:61106-8032
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
epsiprantel (epsiprantel) epsiprantel12.5 mg
Product Characteristics
ColorREDScore2 pieces
ShapeROUND (bi-convex) Size6mm
FlavorImprint Code 219
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61106-8032-350 in 1 BOTTLE
2NDC:61106-8032-2100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA14089312/01/1989
CESTEX 
epsiprantel tablet, film coated
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:61106-8033
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
epsiprantel (epsiprantel) epsiprantel25 mg
Product Characteristics
ColorBROWNScore2 pieces
ShapeROUND (bi-convex) Size8mm
FlavorImprint Code 220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61106-8033-450 in 1 BOTTLE
2NDC:61106-8033-3100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA14089312/01/1989
CESTEX 
epsiprantel tablet, film coated
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:61106-8034
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
epsiprantel (epsiprantel) epsiprantel50 mg
Product Characteristics
ColorGRAYScore2 pieces
ShapeROUND (bi-convex) Size10mm
FlavorImprint Code 221
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61106-8034-125 in 1 BOTTLE
2NDC:61106-8034-250 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA14089312/01/1989
CESTEX 
epsiprantel tablet, film coated
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:61106-8035
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
epsiprantel (epsiprantel) epsiprantel100 mg
Product Characteristics
ColorORANGE (peach) Score2 pieces
ShapeROUND (bi-convex) Size13mm
FlavorImprint Code 222
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61106-8035-625 in 1 BOTTLE
2NDC:61106-8035-550 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA14089312/01/1989
Labeler - Pfizer Animal Health (039055157)
Registrant - Pfizer Inc. (943955690)
Establishment
NameAddressID/FEIBusiness Operations
Pfizer Animal Health039055157MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Emcure Pharmaceuticals Ltd., India, Pune862602830MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
UQUIFA MEXICO S.A. DE. C.V.810105874API MANUFACTURE

Revised: 10/2012
 
Pfizer Animal Health

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