Label: PHENYLBUTE - phenylbutazone paste
- NDC Code(s): 57319-602-73
- Packager: Clipper Distributing Company LLC
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Updated September 29, 2012
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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 & USAGE
INDICATIONS: For the relief of inflammatory conditions associated with the musculoskeletal system in horses.Close
CONTRAINDICATIONS: Use with caution in patients who have a history of drug allergy. Close
WARNING: Not for use in horses intended for food.Close
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.
- DOSAGE & ADMINISTRATION
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.Close
- STORAGE AND HANDLING
STORAGE: Store at 15oC - 30oC (59o-86oF)
KEEP OUT OF REACH OF CHILDRENClose
- HOW SUPPLIED
HOW SUPPLIED: Syringes containing 20 g of PhenylbutazoneClose
- PRINCIPAL DISPLAY PANEL
Phenylbutazone Paste for Horses
- INGREDIENTS AND APPEARANCE
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:57319-602 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Phenylbutazone (UNII: GN5P7K3T8S) (Phenylbutazone - UNII:GN5P7K3T8S) Phenylbutazone 35.1 g in 100 g Product Characteristics Color Score Shape Size Flavor APPLE (Apple Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57319-602-73 60 g in 1 SYRINGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200266 08/31/2012 Labeler - Clipper Distributing Company LLC (150711039) Registrant - Med-Pharmex, Inc (025353699) Establishment Name Address ID/FEI Business Operations Med-Pharmex, Inc 025353699 manufacture