VETRIBUTE - phenylbutazone paste 
MWI

----------

Phenylbutazone Paste

DESCRIPTION: Phenylbutazone Paste is a synthetic, non-hormonal anti-inflammatory, antipyretic compound useful in the management of inflammatory conditions. The apparent analgesic effect is probably related mainly to he compound's anti-inflammatory properties.
Chemically, Phenylbtazone Paste is 4-butyl-1,2-diphenyl-3-,5-pyrazolidinedione. It is a pyrazolone derivative, entirely unrelated to the steroid hormones.

INDICATIONS: For the relief of inflammatory conditions associated with the musculoskeletal system in horses.



CONTRAINDICATIONS:  Use with caution in patients who have a history of drug allergy.

WARNING: Not for use in horses intended for food.



PRECAUTIONS: Stop medication at the first sign of gastrointestinal upset, jaundice or blood dyscrasia. Authenticated cases of agranulocytosis associated with the drug have occurred in man; fatal reactions, although rare, have been reported in dogs after long-term therapy. To guard against this possibility, conduct routine blood counts at weekly intervals during the early phase of therapy and at intervals of two weeks thereafter. Any significant fall in the total white blood cell count, relative decrease in granulocytes, or black or tarry stools should be regarded as a signal for immediate cessation of therapy and institution of appropriate counter-measures.In the treatment of inflammatory conditions associated with infections, specific anti-infective therapy is required.

CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

ADMINISTRATION AND DOSAGE: Orally - 1 to 2 g of phenylbutazone per 500 lb. of body weight daily. Do not exceed 4 g daily.

Guidelines to Successful Therapy: Use a relatively high dose for the first 48 hours, then reduce gradually to a maintenance dose. Maintain lowest dose capable of producing desired clinical response. Response to Phenylbutazone Paste therapy is prompt, usually occurring within 24 hours. If no significant clinical effect is evident after five days, re-evaluate diagnosis and therapeutic approach.

When administering Phenylbutazone Paste, the oral cavity should be empty. Deposit paste on back of tongue by depressing plunger that has been previously set to deliver the correct dose. Many chronic conditions will respond to Phenylbutazone Paste therapy, but discontinuance of treatment may result in recurrence of symptoms.

STORAGE: Store at 15oC - 30oC (59o-86oF)

KEEP OUT OF REACH OF CHILDREN

HOW SUPPLIED: Syringes containing 20 g of Phenylbutazone

Phenylbutazone Paste for Horses
Syringe label
Package Insert



VETRIBUTE 
phenylbutazone paste
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:13985-544
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phenylbutazone (Phenylbutazone) Phenylbutazone35.1 g  in 100 g
Product Characteristics
Color    Score    
ShapeSize
FlavorAPPLE (Apple Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13985-544-0160 g in 1 SYRINGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20026608/31/2012
Labeler - MWI (019926120)
Registrant - Med-Pharmex, Inc (025353699)
Establishment
NameAddressID/FEIBusiness Operations
Med-Pharmex, Inc025353699manufacture

Revised: 9/2012
Document Id: 52dda847-5144-4f52-9feb-19792b0ba5c0
Set id: 42df091d-6a66-4540-b8bd-0ffb40c7ca86
Version: 2
Effective Time: 20120929
 
MWI