EXODUS MULTI-DOSE- pyrantel pamoate paste

Exodus Multi-Dose by

Drug Labeling and Warnings

Exodus Multi-Dose 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

ANADA 200-350, Approved by FDA  

Exodus® Multi-Dose

(pyrantel pamoate)

Equine Anthelmintic

For Oral Use in Horses Only

Read Entire Package Insert Carefully Before Using This Product

DESCRIPTION: Exodus® Multi-Dose Paste (pyrantel pamoate) is a pale yellow to buff paste containing 43.9% w/w pyrantel pamoate in an inert vehicle. Each syringe contains 7.2 grams pyrantel base in 47.2 grams paste. Each mL contains 171 mg pyrantel base as pyrantel pamoate.

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

INDICATIONS & USAGE

INDICATIONS FOR USE: 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.

PRECAUTIONS

CAUTION: Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

DOSAGE & ADMINISTRATION

DOSAGE AND TREATMENT: Exodus® Multi-Dose Paste (pyrantel pamoate) is to be administered as a single oral dose of 3 mg pyrantel base per pound of body weight. The syringe has eight weight mark increments. Each weight mark indicates the recommended dose for 300 pounds of body weight. One-half syringe treats a 1200 lb horse.

DOSAGE 

Body Weight Range	Quantity	mg Pyrantel Base
up to 300 lb	1/8 syringe	900 mg
301 to 600 lb	1/4 syringe	1800 mg
601 to 900 lb	3/8 syringe	2700 mg
901 to 1200lb	1/2 syringe	3600 mg

NOTE: Position ring-gauge over appropriate mark on plunger. Each mL contains 171 mg pyrantel base as pyrantel pamoate.

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 followed by re-treatment 10 days to 2 weeks after birth of 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 backwards 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 horse's 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 infections 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.

FOR ORAL USE IN HORSES ONLY. KEEP OUT OF REACH OF CHILDREN.

STORAGE AND HANDLING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXODUS MULTI-DOSE 
pyrantel pamoate paste

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 61133-6011
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7)	PYRANTEL	7.2 g  in 47.2 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61133-6011-1	47.2 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