Vetoquinol USA, Inc. Nantong Jinghua Pharmaceutical Co., Ltd Med-Pharmex, Inc Vetoquinol N.-A. INC

BUTEQUINE PHENYLBUTAZONE PHENYLBUTAZONE PHENYLBUTAZONE

NDC 17030 100 60
Approved by FDA under ANADA # 200-266 For Veterinary Use Only

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: Chemical Structure

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: Do not use in horses intended for human consumption.

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.

Important - To avoid overdosing and to ensure the correct first dose, move ring on plunger to the appropriate dosage position before administration (see Figure 1). The edge of the ring closest to the syringe barrel should be aligned to the gram/dosage mark on the plunger. When administering Butequine™ paste the oral cavity should be empty. Set ring on plunger to deliver the appropriate dosage based on weight (see Figure 1). Deposit paste on the back of tongue by depressing plunger.
Use a relatively high dose for the first 48 hours (not to exceed 4 g daily), then reduce gradually to a maintenance dose. Maintain lowest dose capable of producing desired clinical response. Response to Butequine™ paste therapy is prompt, usually occuring within 24 hours. If no significant clinical response is evident after 5 days, reevaluate diagnosis and therapeutic approach. Many chronic conditions will respond to Butequine™ paste therapy, but discontinuance of treatment may result in recurrence of symptoms. Figure 1

STORAGE: Store at 15°-25°C (59°-77°F).

HOW SUPPLIED: Syringes containing 20 g phenylbutazone.

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 PRINCIPAL DISPLAY PANEL - 60 mL Syringe Carton