Animal NDC 54771-8032-2 Cestex

Epsiprantel

Animal NDC Product Code 54771-8032-2

Field Name Field Value
Animal NDC Code 54771-8032-2
Proprietary Name Cestex What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Epsiprantel What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Zoetis Inc.
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Epsiprantel
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA140893 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Cestex Animal Product Labeling Information

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.

Product Labeling Index

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).

Residue Warning

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description

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.

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

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

Warnings

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.

Precautions

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.

Other

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

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

* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.

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