Label: BUTEQUINE- phenylbutazone paste

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated August 4, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    NDC 17030 100 60
    ANADA 200-266, Approved by the FDA.

    For Veterinary Use Only

  • DESCRIPTION

    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 the compound's anti-inflammatory properties. Chemically, phenylbutazone is 4-butyl-1, 2-diphenyl-3, 5-pyrazolidinedione. It is a pyrazolone derivative, entirely unrelated to the steroid hormones.

    Chemical Structure
  • VETERINARY INDICATIONS

    INDICATIONS: For the relief of inflammatory conditions associated with the musculoskeletal systems 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 PHENYLBUTAZONE 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.
      Figure 1
    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 PHENYLBUTAZONE 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 PHENYLBUTAZONE 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

  • 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:

    Contact Vetoquinol USA, Inc. at 1-800-267-5707 for customer service or to obtain product information, including a SDS. After hours or to report adverse reactions, call 1-800-835-9496.

    For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.

  • SPL UNCLASSIFIED SECTION

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

    439185
    Rev 09/17

  • PRINCIPAL DISPLAY PANEL - 60 mL Syringe Carton

    FOR VETERINARY USE ONLY

    NDC 17030 100 60
    ANADA 200-266, Approved by FDA

    Butequine™

    (Phenylbutazone)

    Paste for
    Horses

    Apple
    Flavor

    Each 3 mL marking on the plunger contains: Phenylbutazone: 1 g

    Net Volume: 60 mL

    vetoquinol

    PRINCIPAL DISPLAY PANEL - 60 mL Syringe Carton
  • INGREDIENTS AND APPEARANCE
    BUTEQUINE 
    phenylbutazone paste
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:17030-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLBUTAZONE (UNII: GN5P7K3T8S) (PHENYLBUTAZONE - UNII:GN5P7K3T8S) PHENYLBUTAZONE1 g  in 3 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17030-100-601 in 1 CARTON
    160 mL in 1 SYRINGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20026601/15/2020
    Labeler - Vetoquinol USA, Inc. (106824209)
    Establishment
    NameAddressID/FEIBusiness Operations
    SINTENOVO S.A. DE C.V.812039808API MANUFACTURE, ANALYSIS
    Establishment
    NameAddressID/FEIBusiness Operations
    Med-Pharmex, Inc025353699MANUFACTURE