The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
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]benza-zepine. It is a stable white solid which is sparingly soluble in water. Its chemical structure is presented below.
Mechanism Of Action
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 & Usage
INDICATIONS AND USAGE: Cestex tablets are indicated for the removal of the following:Feline cestodes: Dipylidium caninum and Taenia taeniaeformisCanine 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 & 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 ScheduleFelineBody WeightDoseSeven weeks old up to 10 lb12.5 mg 11–20 lb 25.0 mgCanineBody WeightDoseSeven 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 mg91–100 lb250.0 mg 101+ lb2.5 mg/lb, rounding up to next whole tablet combinationFasting 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 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)NumberConcentrationCatDogTablets/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