Exodus Multi-Dose description, usages, side effects, indications, overdosage, supplying and lots more!

Exodus Multi-Dose

Bimeda Inc.,Animal Health, Division of Cross Vetpharm Group
Bimeda Inc., Animal Health, Division of Cross Vetpharm Group

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert



FULL PRESCRIBING INFORMATION

ANADA 200-350, Approved by FDA                           FOR ORAL USE IN HORSES ONLY

Net Wt. 42.7 g

Exodus® Multi-Dose

(pyrantel pamoate)

Equine Anthelmintic Paste

See Package Insert For Complete Use Direction

FOR ORAL USE ONLY. FOR ANIMAL USE ONLY. KEEP OUT OF REACH OF CHILDREN.

WARNING: Do not use in horses indended for human consumption.

CAUTION: Consult a veterinarian for asistance in the diagnosis, treatment, and control of parasitism.

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-naptholate] (1:1)

Uses

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.

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

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 1200 lb  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%).

WARNING: Do not use in horses intended for human consumption.

FOR ORAL USE ONLY. FOR ANIMAL USE ONLY. KEEP OUT OF REACH OF CHILDREN.

RECOMMENDED STORAGE: Store at 20⁰C TO 25⁰C (68⁰F-77⁰F); excursions permitted between 15⁰C-30⁰C (between 59⁰F-86⁰ F).

Exodus Multi-Dose

Pyrantel Pamoate PASTE

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:61133-6011
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Pyrantel Pamoate pyrantel 7.2 g

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61133-6011-1 47.2 in 1 SYRINGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200350 2003-03-25


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