Cestex

Pfizer Animal Health
Pfizer Inc.

Cestex (epsiprantel) Veterinary Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*

• CAUTION
• CESTEX DESCRIPTION
• ACTION
• INDICATIONS
• CESTEX DOSAGE AND ADMINISTRATION
• SAFETY
• CESTEX CONTRAINDICATIONS
• WARNINGS
• PRECAUTION
• STORAGE
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 50 12.5 mg Tablet Bottle Label
• PRINCIPAL DISPLAY PANEL - 100 12.5 Tablet Bottle Label
• PRINCIPAL DISPLAY PANEL - 50 25 mg Tablet Bottle Label
• PRINCIPAL DISPLAY PANEL - 100 25 mg Tablet Bottle Label
• PRINCIPAL DISPLAY PANEL - 25 50 mg Tablet Bottle Label
• PRINCIPAL DISPLAY PANEL - 50 50 mg Tablet Bottle Label
• PRINCIPAL DISPLAY PANEL - 25 100 mg Tablet Bottle Label
• PRINCIPAL DISPLAY PANEL - 50 100 mg Tablet Bottle Label

FULL PRESCRIBING INFORMATION

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).

CESTEX 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.

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

CESTEX 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:

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.

CESTEX 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.

STORAGE

Store at controlled room temperature 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:

NADA #140-893, Approved by FDA

75-8032-10
January 2004

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 - 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 - 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 - 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 - 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 - 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 - 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 - 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