BUTEQUINE- phenylbutazone paste
Vetoquinol USA, Inc.
----------
DESCRIPTION: Butequine™ 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 the compound's anti-inflammatory properties. Chemically, phenylbutazone is 4-butyl-1, 2-diphenyl-3, 5-pyrazolidinedione. It is a pyrazalone derivative, entirely unrelated to the steroid hormones, and has the following structural formula:
INDICATIONS: For the relief of inflammatory conditions associated with the musculoskeletal system in horses.
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 the 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.
ADMINISTRATION AND DOSAGE: Orally – 1 to 2 g of phenylbutazone per 500 lb. (227 kg) of body weight daily. Do not exceed 4 g daily. 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.
KEEP OUT OF REACH OF CHILDREN
Keep Butequine™ in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.
CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
To report suspected adverse events, contact Vetoquinol USA, Inc. at 1-800-835-9496. For technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Vetoquinol USA, Inc. at 1-800-267-5707. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS or online at www.fda.gov/reportanimalae
Manufactured for:
Vetoquinol USA, Inc.
Ft. Worth, TX (USA) 76137
www.vetoquinolusa.com
439185
Rev 01/2023
Hold for Canada
Reference #####
FOR VETERINARY USE ONLY
Butequine™
(phenylbutazone)
Paste for Horses
NDC 17030 100 60
Approved by FDA under ANADA # 200-266
vetoquinol
Each syringe contains 20 g phenylbutazone
Each 3 mL marking on the plunger contains: phenylbutazone: 1 g
Net Volume: 60 mL
BUTEQUINE
phenylbutazone paste |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
Labeler - Vetoquinol USA, Inc. (106824209) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Nantong Jinghua Pharmaceutical Co., Ltd | 421303119 | API MANUFACTURE |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Med-Pharmex, Inc | 025353699 | MANUFACTURE |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Vetoquinol N.-A. INC | 202919940 | ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK |