EXODUS- pyrantel pamoate paste

Exodus by

Drug Labeling and Warnings

Exodus by is a Animal medication manufactured, distributed, or labeled by Bimeda Inc., Bimeda-MTC Animal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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:

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)

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 & ADMINISTRATION

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%).

WARNINGS

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 AND HANDLING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXODUS 
pyrantel pamoate paste

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 61133-0141
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7)	PYRANTEL	3.6 g  in 23.6 g

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

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

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

Labeler - Bimeda Inc. (060492923)

Registrant - Bimeda Inc. (060492923)

Establishment
Name	Address	ID/FEI	Business Operations
Bimeda-MTC Animal Health		256232216	manufacture