Animal NDC 54771-2410-2 Strongid

Pyrantel Pamoate

Animal Product Information

Field Name Field Value
Animal NDC Code 54771-2410-2
Proprietary Name Strongid What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Pyrantel Pamoate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Zoetis Inc.
Product Type Otc Animal Drug
Usage Information
    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.
Active Ingredient(s)
  • Pyrantel Pamoate
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA129831 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Strongid Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Description



Strongid Paste is a pale yellow to buff paste containing 43.9% w/w pyrantel pamoate in an inert vehicle. Each syringe contains 3.6 grams of pyrantel base in 23.6 grams (20 mL) paste. Each mL contains 180 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 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 And Treatment



Strongid Paste is to be administered as a single oral dose of 3 mg pyrantel base per lb of body weight. The syringe has 4 weight mark increments. Each weight mark indicates the recommended dose for 300 lb of body weight.

Dosage
Body Weight Range Volume mg Pyrantel Base
 up to 300 lb 1/4 syringe (5 mL) 900 mg
 301–600 lb 1/2 syringe (10 mL) 1800 mg
 601–900 lb 3/4 syringe (15 mL) 2700 mg
 901–1200 lb 1 full syringe (20 mL) 3600 mg

Note: Position screw-gauge over appropriate mark on plunger. Each mL contains 180 mg of 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 Strongid 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



Do not use in horses intended for human consumption. Keep out of 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.




Store at controlled room temperature 15°–25°C (59°–77°F).


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.