Label: CESTEX- epsiprantel tablet, film coated

  • NDC Code(s): 54771-8032-1, 54771-8032-2, 54771-8033-1, 54771-8033-2, view more
    54771-8034-1, 54771-8034-2, 54771-8035-1, 54771-8035-2
  • Packager: Zoetis Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated 03/14

If you are a consumer or patient please visit this version.

  • 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).

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  • RESIDUE WARNING

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

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  • DESCRIPTION

    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
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  • CLINICAL PHARMACOLOGY

    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.

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  • INDICATIONS & USAGE

    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

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  • CONTRAINDICATIONS

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

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  • WARNINGS

    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.

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  • PRECAUTIONS

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

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  • DOSAGE & ADMINISTRATION

    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.

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  • SPL UNCLASSIFIED SECTION

    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.

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  • STORAGE AND HANDLING

    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

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    13915900

    Revised: January 2013

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  • 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
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  • 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
    Close
  • 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
    Close
  • 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
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  • INGREDIENTS AND APPEARANCE
    CESTEX 
    epsiprantel tablet, film coated
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:54771-8032
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    epsiprantel (epsiprantel) 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 LABEL Item Code (Source) NDC:54771-8033
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    epsiprantel (epsiprantel) 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 LABEL Item Code (Source) NDC:54771-8034
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    epsiprantel (epsiprantel) 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 LABEL Item Code (Source) NDC:54771-8035
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    epsiprantel (epsiprantel) 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
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