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Animal NDC 17030-100-60 Butequine

Phenylbutazone

Animal Product Information

Field Name Field Value
Animal NDC Code 17030-100-60
Proprietary Name Butequine What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Phenylbutazone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Vetoquinol Usa, Inc.
Product Type Prescription Animal Drug
Usage Information
    INDICATIONS: For the relief of inflammatory conditions associated with the musculoskeletal system in horses.
Active Ingredient(s)
  • Phenylbutazone
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200266 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Butequine Images

Butequine Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



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

For Veterinary Use Only

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.

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

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


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:



  • 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.

Storage And Handling



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


How Supplied



HOW SUPPLIED: Syringes containing 20 g phenylbutazone.


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


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


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.