Label: EXODUS MULTI-DOSE- 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

    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.

    image description

    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 RangeQuantitymg 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

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  • INGREDIENTS AND APPEARANCE
    EXODUS MULTI-DOSE 
    pyrantel pamoate paste
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:61133-6011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL7.2 g  in 47.2 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61133-6011-147.2 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