Cestex Tablets (25 mg) (Canada)

Company: Zoetis

epsiprantel tablets

DIN 01913034

DIN 01913026

Veterinary Use Only

Description

Cestex tablets are film-coated and contains 12.5 mg or 25 mg of epsiprantel per tablet. Epsiprantel is an anthelmintic that is highly active as a single dose against the common tapeworms of dogs and cats. Epsiprantel has a molecular weight of 326 and is chemically 2-(cyclohexyl-carbonyl)-4-oxo-1,2,3,4,6,7,8,12b-octa-hydropyrazino[2,1-a][2]benzazepine. It is a stable white solid which is sparingly soluble in water.

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 proglottides may not be readily visible in the stool.

Cestex Tablets (25 mg) Indications

Cestex tablets are indicated for the removal of tapeworms in dogs (Dipylidium caninum and Taenia pisiformis) and cats (Dipylidium caninum and Taenia taeniaeformis).

Dosage and Administration

Cestex tablets should be administered orally. In dogs, the recommended dosage of epsiprantel is 5.5 mg/kg of body weight; in cats, the recommended dosage of epsiprantel is 2.75 mg/kg of body weight. 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: Dogs: The results of a tolerance trial showed that doses up to 100 mg of epsiprantel per kg of body weight (≈18 times the recommended level) produced no overt toxicity in either 7- to 10-week-old puppies, or in adult dogs.

Doses up to 27.5 mg of epsiprantel per kg of body weight (5 times the recommended level) were administered for three consecutive days to 5- to 6-month-old Beagle dogs; and doses up to 16.5 mg of epsiprantel per kg of body weight (3 times the recommended level) were administered for three consecutive days to 7-week-old Beagle and Collie puppies and adult Greyhound dogs. These treatments had no visible effects on clinical signs, hematologic and clinical chemistry values, or gross and microscopic findings at necropsy.

Epsiprantel has also been evaluated in reproductive toxicity studies in breeding and pregnant dogs. There were no adverse effects noted in these studies.

Epsiprantel is not a cholinesterase inhibitor. During the course of clinical field studies, Cestex was administered concurrently with diethylcarbamazine citrate, anti-inflammatory agents, insecticides, and nematocides with no drug incompatibilities noted.

Based on the above results and those of an extensive field trial, it can be concluded that a single oral dose of 5.5 mg of epsiprantel per kg of body weight is safe and efficacious for the removal of Dipylidium caninum and Taenia pisiformis in dogs.

Cats: Doses up to 30 mg of epsiprantel per kg of body weight (≈11 times the recommended dosage) produced no overt toxicity in either 7-week-old kittens, or in adult cats. Vomiting and trembling were observed in one of 5 kittens given a single dose of 50 mg/kg (≈18 times the recommended dosage) and vomiting was observed within a day of treatment in two of 13 cats given a single dose of 100 mg/kg (≈36 times the recommended dosage).

Doses up to 13.75 mg of epsiprantel per kg of body weight (5 times the recommended level), administered for three consecutive days to 4- to 5-month-old cats, had no visible effects on clinical signs, hematologic and clinical chemistry values, or gross and microscopic findings at necropsy.

The results of an extensive field trial conducted with 18 investigators in 9 states in the USA, in which a total of 263 evaluable cases were enrolled, confirmed the safety of epsiprantel when administered at the recommended level to cats. During the course of clinical field studies, epsiprantel was administered concurrently with anti-inflammatory agents, insecticides and nematocides with no drug incompatibilities noted.

It is expected from the above data that the recommended level of epsiprantel, administered as a single treatment, will be very well tolerated by dogs and cats.

Warnings

Keep out of reach of children.

Cautions: 1. Do not administer to puppies or kittens less than 7 weeks of age. 2. Do not administer to breeding or pregnant cats, as the safety of use in these types of cats has not been determined.

Note: Consult a veterinarian for the diagnosis, treatment and control of parasitism in companion animals.

Storage

Store between 15 and 30°C.

Presentation: Cestex epsiprantel tablets are film-coated and contains 12.5 mg or 25 mg of epsiprantel per tablet. Cestex is supplied as described below:

Zoetis is a trademark and Cestex is a registered trademark of Zoetis or its licensors, used under license by Zoetis Canada Inc.

Zoetis Canada Inc., Kirkland QC H9J 2M5

8026-17-1

30436700

CPN: 1198024.5