Label: EQUISTRENGTH- pyrantel pamoate paste

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated December 10, 2018

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  • 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:

    chemicalstructure

    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

    carton1carton

  • INGREDIENTS AND APPEARANCE
    EQUISTRENGTH 
    pyrantel pamoate paste
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:46066-912
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL3.6 g  in 23.6 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46066-912-0123.6 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA20035001/19/2005
    Labeler - Aspen Veterinary (627265361)
    Registrant - Bimeda, Inc. (060492923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bimeda-MTC256232216manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Moehs460021629api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Minsheng Group Shaoxing Pharmaceutical Co., Ltd.544607919api manufacture