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 May 6, 2021

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  • DESCRIPTION

    Approved by FDA under ANADA # 200-350

    Exodus® Multi-Dose

    (pyrantel pamoate) Paste

    Horse Dewormer

    Read Entire Carton Carefully Before Using This Product

    DESCRIPTION:

    Exodus® Multi-Dose (pyrantel pamoate) Paste 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.

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    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.

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

  • DOSAGE & ADMINISTRATION

    DOSAGE AND TREATMENT:

    Exodus® Multi-Dose (pyrantel pamoate) Paste is to be administered as a single oral dose of 3 mg pyrantel base per lb of body weight. The syringe has 8 weight mark increments. Each weight mark indicates the recommended dose for 300 lb of body weight. One-half syringe treats a 1200 lb horse.

    DOSAGE

    Body Weight Range

    Volume

    mg Pyrantel Base

    up to 300 lb 

    1/8 syringe

    900 mg

    301 - 600 lb

    1/4 syringe

    1800 mg

    601 - 900 lb

    3/8 syringe

    2700 mg

    901 - 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.

    Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.

    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 retreatment 10 days to 2 weeks after birth of foal. Horses and ponies over 8 months of age should be routinely dosed every 6 weeks.

    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 paste 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

    WARNINGS

    For oral animal use only. Do not use in horses intended for human consumption.

    HUMAN WARNINGS

    Keep out of the reach of children.

    It is recommended that severely debilitated animals not be treated with this preparation.

    OTHER WARNINGS: Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance. Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.

    To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

  • STORAGE AND HANDLING

    RECOMMENDED STORAGE: Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°C-30°C (59°F-86°F).

  • 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