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
ConcentrationCatDogTablets/Bottle
  12.5 mg10550, 100
  25.0 mg201050, 100
  50.0 mg– –2025, 50  
100.0 mg– –4025, 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 TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:54771-8032
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: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 DRUG LABELItem Code (Source)NDC:54771-8033
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: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 DRUG LABELItem Code (Source)NDC:54771-8034
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: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 DRUG LABELItem Code (Source)NDC:54771-8035
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: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)
Establishment
NameAddressID/FEIBusiness Operations
Zoetis LLC039055157MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Emcure Pharmaceuticals Ltd862602830MANUFACTURE, 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.