CESTEX- epsiprantel tablet, film coated 
Zoetis Inc.

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Cestex®
(epsiprantel)

Veterinary Tablets

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).

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

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 AND USAGE: Cestex tablets are indicated for the removal of the following:

Feline cestodes: Dipylidium caninum and Taenia taeniaeformis

Canine cestodes: Dipylidium caninum and Taenia pisiformis

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.

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.

STORAGE: Store at controlled room temperature 20°-25°C (68°-77°F) with excursions between 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
Concentration Cat Dog Tablets/Bottle
  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

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

13915900

Revised: January 2013

PRINCIPAL DISPLAY PANEL - 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

zoetis

PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 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

zoetis

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 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

zoetis

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 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

zoetis

PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
CESTEX 
epsiprantel tablet, film coated
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-8032
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:54771-8032-1 50 in 1 BOTTLE
2 NDC:54771-8032-2 100 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:54771-8033
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:54771-8033-1 50 in 1 BOTTLE
2 NDC:54771-8033-2 100 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:54771-8034
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:54771-8034-1 25 in 1 BOTTLE
2 NDC:54771-8034-2 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:54771-8035
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:54771-8035-1 25 in 1 BOTTLE
2 NDC:54771-8035-2 50 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA140893 12/01/1989
Labeler - Zoetis Inc. (828851555)
Establishment
Name Address ID/FEI Business Operations
Zoetis LLC 039055157 MANUFACTURE
Establishment
Name Address ID/FEI Business Operations
Emcure Pharmaceuticals Ltd 862602830 MANUFACTURE, API MANUFACTURE

Revised: 3/2014
Document Id: 10029dff-fc96-4aed-a2e6-8cb9b835afdd
Set id: 3e3b495a-d45f-4499-97e8-3ea244e0f490
Version: 1
Effective Time: 20140327
 
Zoetis Inc.