Label: FLUNAZINE- flunixin meglumine paste

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

Drug Label Information

Updated November 28, 2018

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

  • WARNINGS AND PRECAUTIONS

    SYRINGE CONTAINS FLUNIXIN MEGLUMINE EQUIVALENT TO 1500 mg FLUNIXIN

    FOR ORAL USE IN HORSES ONLY

    KEEP OUT OF REACH OF CHILDREN

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

    CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    CONTRAINDICATIONS: There are no known contraindications to this drug when used as directed.

    PRECAUTIONS: The effect of flunixin meglumine on pregnancy has not been determined. Studies to date show there is no detrimental effect on stallion spermatogenesis with or following the recommended dose of flunixin meglumine.

    SIDE EFFECTS: During field studies with flunixin meglumine, no significant side effects were reported.

  • INDICATIONS & USAGE

    INDICATIONS: For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.

    DOSE: 0.5 mg per pound of body weight per day for up to 5 days. Each calibration on the syringe' doses 250 lbs of body weight. Administer orally by inserting the nozzle of the syringe through the interdental space and depositing the required amount of paste on the back of the tongue by depressing the plunger. *Use dial edge nearest syringe barrel to mark dose.

    ACTIVITY: Flunixin meglumine is a potent, nonnarcotic, nonsteroidal , analgesic agent with 1 anti-inflammatory and antipyretic activity. It is significantly more potent than pentazocine, meperidine, and codeine as an analgesic in the rat yeast paw test. Oral studies in the horse show 1 onset of flunixin activity occurs within 2 hours of administration. Peak response occurs between 12 and 16 hours and duration of activity is 24 to 36 hours.

  • STORAGE AND HANDLING

    STORAGE: Store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (between 59°F - 86°F)

    See product information sheet for additional information.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: The recommended dose of flunixin meglumine is 0.5 mg per lb of body weight once daily. The Flunazine® Equine Paste syringe, calibrated in twelve 250-lb weight increments, delivers 125 mg of flunixin for each 250 lbs (see dosage table). One syringe will treat a 1000-lb horse once daily for 3 days, or three 1000-lb horses one time.

    DOSAGE TABLE

     Syringe Mark* Horse Weight (lbs) Flunazine® Equine Paste Delevered (g)mg Flunixin Delivered 
     0 --- --- ---
     250 250 2.5 125
     500 500 5.0 250
     750 750 7.5 375
     1000 1000 10.0 500

    * Use dial edge nearest syringe barrel to mark dose.

    The paste is orally administered by inserting the nozzle of the syringe through the interdental space, and depositing the required amount of paste on the back of the tongue by depressing the plunger.

    Treatment may be given initially by intravenous or intramuscular injection of Flunazine Injectable Solution, followed by Flunazine® Equine Paste on Days 2 to 5. Flunixin meglumine treatment should not exceed 5 consecutive days.

    TOXICITY: No toxic effects were observed in rats given oral flunixin meglumine 2 mg/kg per day for 42 days. Higher doses produced ulceration of the gastrointestinal tract. The emetic dose in dogs is between 150 and 250 mg/kg. Flunixin was well tolerated in monkeys dosed daily with 4 mg/kg for 56 days. No adverse effects occurred in horses dosed orally with 1.0 or 1.5 mg/lb for 5 consecutive days.

  • PRINCIPAL DISPLAY PANEL

    image description

    image description

  • INGREDIENTS AND APPEARANCE
    FLUNAZINE 
    flunixin meglumine paste
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:61133-6007
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FLUNIXIN MEGLUMINE (UNII: 8Y3JK0JW3U) (FLUNIXIN - UNII:356IB1O400) FLUNIXIN MEGLUMINE1500 mg  in 30 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61133-6007-130 g in 1 SYRINGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20058102/26/2015
    Labeler - Bimeda Inc. (060492923)
    Registrant - Bimeda Inc. (060492923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bimeda-MTC Animal Health256232216manufacture