Label: CESTEX- epsiprantel tablet, film coated 

  • Label RSS
  • NDC Code(s): 61106-8032-2, 61106-8032-3, 61106-8033-3, 61106-8033-4, view more
    61106-8034-1, 61106-8034-2, 61106-8035-5, 61106-8035-6
  • Packager: Pfizer Animal Health
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated 10/12

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

  • 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).

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  • 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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  • 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

    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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  • 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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  • 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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  • CONTRAINDICATIONS

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

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  • 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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  • PRECAUTION

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

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  • STORAGE

    Store at controlled room temperature 15°–30°C (59°–86°F).

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  • 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
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  • SPL UNCLASSIFIED SECTION

    NADA #140-893, Approved by FDA

    Pfizer Animal Health

    75-8032-10
    January 2004

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  • 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
    Close
  • 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
    Close
  • 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
    Close
  • 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
    Close
  • 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
    Close
  • 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
    Close
  • 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
    Close
  • 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
    Close
  • INGREDIENTS AND APPEARANCE
    CESTEX 
    epsiprantel tablet, film coated
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:61106-8032
    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: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 LABEL Item Code (Source) NDC:61106-8033
    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: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 LABEL Item Code (Source) NDC:61106-8034
    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: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 LABEL Item Code (Source) NDC:61106-8035
    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: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
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