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Exodus

Bimeda Division of Cross Vetpharm Group
Bimeda Inc., Division of Cross Vetpharm Group




FULL PRESCRIBING INFORMATION

Exodus®

(pyrantel pamoate) Paste

EQUINE ANTHELMINTIC

FOR ORAL USE IN HORSES ONLY

ANADA 200-350, Approved by FDA

Net Wt. 23.6 g

DESCRIPTION: Exodus Paste (pyrantel pamoate) is a pale yellow to buff paste containing 43.9% w/w pyrantel pamoate in an inert vehicle. Each syringe contains 3.6 grams pyrantel base in 23.6 grams paste. Each milliliter contains 171 mg pyrantel base as pyrantel pamoate.

READ ENTIRE CARTON CAREFULLY BEFORE USING THIS PRODUCT.


COMPOSITION: Pyrantel pamoate is a compound belonging to a family classified chemically as tetrahydropyrimidines. It is a yellow, water-insoluble crystalline salt of the tetrahydropyrimidine base and pamoic acid containing 34.7% base activity. The chemical structure and name are given below.

CHEMICAL STRUCTURE:

Exodus

CHEMICAL NAME: (E)-1,4,5,6-tetrahydro-1-methyl-2-[2-(2-thienyl)-vinyl]-pyrimidine 4,4' methylenebis [3-hydroxy-2-naptholate] (1:1)

Uses

INDICATIONS:

For the removal and control of mature infections of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small strongyles; pinworms (Oxyuris equi); and large roundworms (Parascaris equorum) in horses and ponies. Consult your veterinarian for asistance in the diagnosis, treatment, and control of parasitism.

DOSAGE AND TREATMENT: Pyrantel Paste (pyrantel pamoate) is to be adminitered as a single oral dose of 3 milligrams pytantel base per pound of body weight. The syringe has four weight mark increments. Each weight mark indicated the recommended dose for 300 pounds of body weight.

DOSAGE

Body Weight Range Quantity mg Pyrantel Base
                     up to 300 lb                 ¼ syringe                            900 mg
                    301 to 600lb                 ½ syringe                           1800 mg
                   601 to 900 lb                 ¾ syringe                           2700 mg
                   901 to 1200 lb               1 full syringe                           3600 mg

NOTE: Position ring-gauge over appropriate mark on plunger.

For maximum control of parasitism it is recommended that foals(2-8 months of age) be dosed every 4 weeks. To minimize the potential source of infection that the mare may pose to the foal, the mare should be treated 1 month prior to anticipated foaling date by re-treating 10 days to 2 weeks after birth of the foal. Horses and ponies over 8 months of age should be routinely dosed every 6 weeks.

It is recommended that severely debilitated animals not be treated with this preparation.

ADMINISTRATION:

After removing the cap, the paste should be deposited on the dorsum of the tongue. Introduce the nozzle end of the syringe at the corner of the mouth. Direct the syringe backward and depress the plunger to deposit the paste onto the tongue. Given in this manner, it is unlikely that rejection of the paste will occur.

Raising the horses head sometimes assists in the swallowing process. When only part of the paste has been used, replace the cap on the syringe nozzle.

EFFICACY: Critical (worm count) studies in horses demonstrated that pyrantel pamoate administered at the recommended dosage was efficacious against mature infection of Strongylus vulgaris (>90%), S.edentatus (69%), S.equinus (>90%), Oxyuris equi (81%), Parascaris equorum (>90%), and small strongyles (>90%).

WARNING: Do not use in horses intended for human consumption.

KEEP OUT OF REACH OF CHILDREN

FOR ORAL USE ONLY

FOR ANIMAL USE ONLY

STORAGE: Store at 20⁰C TO 25⁰C (68⁰F-77⁰F); excursions permitted between 15⁰C-30⁰C (between 59⁰F-86⁰ F).

Exodus Exodus

Exodus

Pyrantel Pamoate PASTE

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:61133-0141
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Pyrantel Pamoate pyrantel 3.6 g

Product Characteristics

Color
yellow

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61133-0141-1 23.6 in 1 SYRINGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200350 2003-03-25


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