CESTEX- epsiprantel tablet, film coated 
Pfizer Animal Health

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Cestex® (epsiprantel) Veterinary Tablets

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 Weight Dose
Seven weeks old up to 10 lb 12.5 mg
11–20 lb 25.0 mg
Canine
Body Weight Dose
Seven weeks old up to 5 lb 12.5 mg
6–10 lb 25.0 mg
11–20 lb 50.0 mg
21–40 lb 100.0 mg
41–50 lb 125.0 mg
51–60 lb 150.0 mg
61–80 lb 200.0 mg
81–90 lb 225.0 mg
91–100 lb 250.0 mg
101+ lb 2.5 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
Concentration Cat Dog
12.5 mg 10 5 50, 100
25.0 mg 20 10 50, 100
50.0 mg – – 20 25, 50
100.0 mg – – 40 25, 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 Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:61106-8032
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
epsiprantel (UNII: 0C1SPQ0FSR) (epsiprantel - UNII:0C1SPQ0FSR) epsiprantel 12.5 mg
Product Characteristics
Color RED Score 2 pieces
Shape ROUND (bi-convex) Size 6mm
Flavor Imprint Code 219
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61106-8032-3 50 in 1 BOTTLE
2 NDC:61106-8032-2 100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA140893 12/01/1989
CESTEX 
epsiprantel tablet, film coated
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:61106-8033
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
epsiprantel (UNII: 0C1SPQ0FSR) (epsiprantel - UNII:0C1SPQ0FSR) epsiprantel 25 mg
Product Characteristics
Color BROWN Score 2 pieces
Shape ROUND (bi-convex) Size 8mm
Flavor Imprint Code 220
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61106-8033-4 50 in 1 BOTTLE
2 NDC:61106-8033-3 100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA140893 12/01/1989
CESTEX 
epsiprantel tablet, film coated
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:61106-8034
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
epsiprantel (UNII: 0C1SPQ0FSR) (epsiprantel - UNII:0C1SPQ0FSR) epsiprantel 50 mg
Product Characteristics
Color GRAY Score 2 pieces
Shape ROUND (bi-convex) Size 10mm
Flavor Imprint Code 221
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61106-8034-1 25 in 1 BOTTLE
2 NDC:61106-8034-2 50 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA140893 12/01/1989
CESTEX 
epsiprantel tablet, film coated
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:61106-8035
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
epsiprantel (UNII: 0C1SPQ0FSR) (epsiprantel - UNII:0C1SPQ0FSR) epsiprantel 100 mg
Product Characteristics
Color ORANGE (peach) Score 2 pieces
Shape ROUND (bi-convex) Size 13mm
Flavor Imprint Code 222
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61106-8035-6 25 in 1 BOTTLE
2 NDC:61106-8035-5 50 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA140893 12/01/1989
Labeler - Pfizer Animal Health (039055157)
Registrant - Pfizer Inc. (943955690)
Establishment
Name Address ID/FEI Business Operations
Pfizer Animal Health 039055157 MANUFACTURE
Establishment
Name Address ID/FEI Business Operations
Emcure Pharmaceuticals Ltd., India, Pune 862602830 MANUFACTURE
Establishment
Name Address ID/FEI Business Operations
UQUIFA MEXICO S.A. DE. C.V. 810105874 API MANUFACTURE

Revised: 10/2012
Document Id: 207b421b-74b4-4494-8bcd-14b7f37ec73e
Set id: f0ab837d-0dea-4404-822c-84f1d9a8ec21
Version: 2
Effective Time: 20121001
 
Pfizer Animal Health