Friday, July 6, 2012

Strongid Paste





Dosage Form: FOR ANIMAL USE ONLY
Strongid® Paste

(pyrantel pamoate)

Equine Anthelmintic


Read Entire Package Insert Carefully Before Using This Product



Strongid Paste 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 RangeVolumemg Pyrantel Base
up to 300 lb1/4 syringe (5 mL)900 mg
301–600 lb1/2 syringe (10 mL)1800 mg
601–900 lb3/4 syringe (15 mL)2700 mg
901–1200 lb1 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.


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.



RECOMMENDED STORAGE


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



NADA #129-831, Approved by FDA


Distributed by:

Pfizer Animal Health

Div. of Pfizer Inc

NY, NY 10017


10105701

81019739

October 2009


81460281, R.1



PRINCIPAL DISPLAY PANEL - 20 mL Carton


Strongid® Paste

(pyrantel pamoate)


Equine Anthelmintic


For animal use only


Net Weight: 20 mL (23.6 g)


NADA #129-831, Approved by FDA










STRONGID 
pyrantel pamoate  paste










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)61106-2410
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
pyrantel pamoate (pyrantel)pyrantel pamoate180 mg  in 1 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
161106-2410-11 SYRINGE In 1 CARTONcontains a SYRINGE, PLASTIC
120 mL In 1 SYRINGE, PLASTICThis package is contained within the CARTON (61106-2410-1)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA12983110/26/1982


Labeler - Pfizer Animal Health (039055157)









Establishment
NameAddressID/FEIOperations
Pfizer Animal Health039055157MANUFACTURE
Revised: 08/2010Pfizer Animal Health




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