Label: EXODUS MULTI-DOSE- pyrantel pamoate paste
- NDC Code(s): 61133-6011-1
- Packager: Bimeda Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Updated November 28, 2018
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ANADA 200-350, Approved by FDA
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.
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
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 Range Quantity mg 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%).
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
pyrantel pamoate paste
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:61133-6011 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL 7.2 g in 47.2 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61133-6011-1 47.2 g in 1 SYRINGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200350 03/25/2003 Labeler - Bimeda Inc. (060492923) Registrant - Bimeda Inc. (060492923) Establishment Name Address ID/FEI Business Operations Bimeda-MTC Animal Health 256232216 manufacture