Label: EXODUS- pyrantel pamoate paste

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

Drug Label Information

Updated November 28, 2018

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  • 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 structure1.jpg

    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 Quantitymg 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

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  • INGREDIENTS AND APPEARANCE
    EXODUS 
    pyrantel pamoate paste
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:61133-0141
    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
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61133-0141-123.6 g in 1 SYRINGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20035003/25/2003
    Labeler - Bimeda Inc. (060492923)
    Registrant - Bimeda Inc. (060492923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bimeda-MTC Animal Health256232216manufacture