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 WeightDose
Seven weeks old up to 10 lb12.5 mg
  11–20 lb 25.0 mg
Canine
Body WeightDose
Seven weeks old up to 5 lb  12.5 mg
   6–10 lb  25.0 mg
  11–20 lb  50.0 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.

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 mg10550, 100
  25.0 mg201050, 100
  50.0 mg– –2025, 50  
100.0 mg– –4025, 50  

Approved by FDA under NADA # 140-893

zoetis

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

40027642

Revised: May 2019

PRINCIPAL DISPLAY PANEL - 12.5 mg 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

Approved by FDA under NADA # 140-893

zoetis

12.5 mg bottle label

PRINCIPAL DISPLAY PANEL - 25 mg Bottle Label

25 mg bottle label

PRINCIPAL DISPLAY PANEL - 50 mg Bottle Label

50 mg bottle label

PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label

100 mg bottle label

CESTEX 
epsiprantel tablet, film coated
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:54771-8032
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
epsiprantel (UNII: 0C1SPQ0FSR) (epsiprantel - UNII:0C1SPQ0FSR) epsiprantel12.5 mg
Product Characteristics
ColorREDScore2 pieces
ShapeROUND (bi-convex) Size6mm
FlavorImprint Code 219
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54771-8032-150 in 1 BOTTLE
2NDC:54771-8032-2100 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 DRUGItem Code (Source)NDC:54771-8033
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
epsiprantel (UNII: 0C1SPQ0FSR) (epsiprantel - UNII:0C1SPQ0FSR) epsiprantel25 mg
Product Characteristics
ColorBROWNScore2 pieces
ShapeROUND (bi-convex) Size8mm
FlavorImprint Code 220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54771-8033-150 in 1 BOTTLE
2NDC:54771-8033-2100 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 DRUGItem Code (Source)NDC:54771-8034
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
epsiprantel (UNII: 0C1SPQ0FSR) (epsiprantel - UNII:0C1SPQ0FSR) epsiprantel50 mg
Product Characteristics
ColorGRAYScore2 pieces
ShapeROUND (bi-convex) Size10mm
FlavorImprint Code 221
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54771-8034-125 in 1 BOTTLE
2NDC:54771-8034-250 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 DRUGItem Code (Source)NDC:54771-8035
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
epsiprantel (UNII: 0C1SPQ0FSR) (epsiprantel - UNII:0C1SPQ0FSR) 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:54771-8035-125 in 1 BOTTLE
2NDC:54771-8035-250 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA14089312/01/1989
Labeler - Zoetis Inc. (828851555)

Revised: 10/2019
Document Id: 36fdacff-4451-42cf-a587-0118f0334bc5
Set id: 3e3b495a-d45f-4499-97e8-3ea244e0f490
Version: 4
Effective Time: 20191002
 
Zoetis Inc.