Cestex
Cestex (epsiprantel)
FULL PRESCRIBING INFORMATION: CONTENTS*
- Veterinary Tablets
- PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Bottle Label
- PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label
- PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label
- PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
FULL PRESCRIBING INFORMATION
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.
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.
Uses
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:
| 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.
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 | ||
|---|---|---|---|
| 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
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 - 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 - 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 - 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
Cestexepsiprantel TABLET, FILM COATED
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Cestexepsiprantel TABLET, FILM COATED
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Cestexepsiprantel TABLET, FILM COATED
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Cestexepsiprantel TABLET, FILM COATED
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