BUTEQUINE- phenylbutazone paste

BUTEQUINE by

Drug Labeling and Warnings

BUTEQUINE by is a Animal medication manufactured, distributed, or labeled by Vetoquinol USA, Inc., SINTENOVO S.A. DE C.V., Med-Pharmex, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

NDC 17030 100 60
Approved by FDA under ANADA # 200-266

For Veterinary Use Only

DESCRIPTION

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:

VETERINARY INDICATIONS

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

CONTRAINDICATIONS

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

WARNINGS

WARNING: Do not use in horses intended for human consumption.

PRECAUTIONS

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.

DOSAGE & ADMINISTRATION

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.

Guidelines to Successful Therapy:

1. 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.
2. 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.
   
   
3. 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.
4. 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.
5. Many chronic conditions will respond to Butequine™ paste therapy, but discontinuance of treatment may result in recurrence of symptoms.

STORAGE AND HANDLING

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

HOW SUPPLIED

HOW SUPPLIED: Syringes containing 20 g phenylbutazone.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

CONTACT INFORMATION:

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

SPL UNCLASSIFIED SECTION

Manufactured for:
Vetoquinol USA, Inc.
Ft. Worth, TX (USA) 76137
www.vetoquinolusa.com

439185
Rev 01/2023
Hold for Canada
Reference #####

PRINCIPAL DISPLAY PANEL - 60 mL Syringe Carton

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

INGREDIENTS AND APPEARANCE

BUTEQUINE 
phenylbutazone paste

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 17030-100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLBUTAZONE (UNII: GN5P7K3T8S) (PHENYLBUTAZONE - UNII:GN5P7K3T8S)	PHENYLBUTAZONE	1 g  in 3 mL

Product Characteristics
Color		Score
Shape		Size
Flavor	APPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17030-100-60	1 in 1 CARTON
1		60 mL in 1 SYRINGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200266	01/15/2020

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