EQUISTRENGTH- pyrantel pamoate paste

Equistrength by

Drug Labeling and Warnings

Equistrength by is a Animal medication manufactured, distributed, or labeled by Aspen Veterinary, Bimeda, Inc., Bimeda-MTC, Moehs, Minsheng Group Shaoxing Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Equistrength® 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 milligrams pyrantel base as pyrantel pamoate.

READ ENTIRE DIRECTIONS CAREFULLY BEFORE USING THIS CARTON.

COMPONENTS

COMPOSITION:  Pyrantel pamoate is a compound belonging to a family classifed 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 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 assistance in the diagnosis, treatment, and control of parasitism.

DOSAGE & ADMINISTRATION

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

DOSAGE

Body Weight Range       Quantity                 mg Pyrantel Base

up to 300 lb                  1/4 syringe             900 mg

301 to 600 lb                1/2 syringe             1800 mg

601 to 900 lb                3/4 syringe             2700 mg

901 to 1200 lb              1 full syringe           3600 mg

NOTE:  Position ringe-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 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.

SUMMARY OF SAFETY AND EFFECTIVENESS

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%), Oxyuris equi (81%), Parascaris equorum (>90%), and small strongyles (>90%).

WARNINGS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EQUISTRENGTH 
pyrantel pamoate paste

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-912
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46066-912-01	23.6 g in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA200350	01/19/2005

Labeler - Aspen Veterinary (627265361)

Registrant - Bimeda, Inc. (060492923)

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

Establishment
Name	Address	ID/FEI	Business Operations
Moehs		460021629	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Minsheng Group Shaoxing Pharmaceutical Co., Ltd.		544607919	api manufacture