Label: FLUNAZINE-S- flunixin meglumine injection, suspension

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

Drug Label Information

Updated November 29, 2018

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  • DESCRIPTION

    Flunazine®-S

    (flunixin meglumine)

    INJECTABLE SOLUTION

    50 mg/mL         Sterile Solution

    Veterinary         Multi-Dose Vial

    NOT FOR USE IN HUMANS

    KEEP OUT OF REACH OF CHILDREN

    For intramuscular use in swine.

    Not for use in breeding swine.

  • PRECAUTIONS

    CAUTION

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

  • DESCRIPTION

    DESCRIPTION

    Each mL of Flunazine®-S contains flunixin meglumine equivalent to 50 mg flunixin, 0.1 mg edetate disodium, 2.2 mg sodium formaldehyde sulfoxylate, 4.0 mg diethanolamine, 207.2 mg propylene glycol, 5.0 mg phenol as preservative, hydrochloric acid, water for injection q.s.

  • CLINICAL PHARMACOLOGY

    CLINICAL PHARMACOLOGY

    Flunixin meglumine is a potent non-narcotic, non-steroidal, analgesic agent with anti-inflammatory and antipyretic activity. It is significantly more potent that pentazocine, meperidine, and codeine as an analgesic in the rat yeast paw test.


    Flunixin is known to persist in inflammatory tissues1 and is associated with anti-inflammatory properties which extend well beyond the period associated with detectable plasma drug concentrations2. Therefore, prediction of drug concentrations based upon estimated plasma terminal elimination half-life will likely underestimate both the duration of drug action and the concentration of drug remaining at the site of activity.

    The pharmacokinetic profiles were found to follow a 2-compartmental model, although a deep (third) compartment was observed in some animals. The mean terminal elimination half-life (β half-life) of flunixin after a single intramuscular injection of flunixin (2.2 mg/kg) to pigs was between 3 and 4 hours. The mean observed maximum plasma concentration was 2944 ng/mL, achieved at a mean time of approximately 0.4 hours. The mean AUC(0-LOQ) was 6431 ng*hr/mL. Following IM administration of flunixin, quantifiable drug concentration could be measured up to 18 hours post dose. The mean volume of distribution was 2003 mL/kg and the mean total clearance was 390 mL/hr/kg. The mean absolute bioavailability of flunixin following an intramuscular injection in the neck was 87%.

  • INDICATIONS & USAGE

    INDICATION

    Flunazine®-S is indicated for the control of pyrexia associated with swine respiratory disease.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION

    The recommended dose for swine is 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) body weight given by a single intramuscular administration. The injection should be given only in the neck musculature with a maximum of 10 mL per site.

    Note: Intramuscular injection may cause local tissue irritation and damage. In an injection-site irritation study, the tissue damage did not resolve in all animals by Day 28 post-injection. This may result in trim loss of edible tissue at slaughter.

  • CONTRAINDICATIONS

    CONTRAINDICATIONS

    There are no known contraindications to this drug in swine when used as directed. Do not use in animals showing hypersensitivity to flunixin meglumine. Use judiciously when renal impairment or gastric ulceration is suspected

  • RESIDUE WARNING

    RESIDUE WARNINGS

    Swine must not be slaughtered for human consumption within 12 days of the last treatment.

  • PRECAUTIONS

    PRECAUTIONS

    As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Patients at greatest risk for adverse events are those that are dehydrated, on concomitant diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached. NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that has not been previously diagnosed.

    Since many NSAIDs possess the potential to produce gastrointestinal ulceration, concomitant use of flunixin meglumine with other anti-inflammatory drugs, such as other NSAIDs and corticosteroids, should be avoided.

    Not for use in breeding swine. The reproductive effects of Flunazine®-S have not been investigated in this class of swine. Intramuscular injection may cause local tissue irritation and damage. In an injection-site irritation study, the tissue damage did not resolve in all animals by Day 28 post-injection. This may result in trim loss of edible tissue at slaughter.

  • ADVERSE REACTIONS

    ADVERSE REACTIONS

    Flunixin was mildly irritating at the injection sites. No other flunixin-related changes (adverse reactions) were noted in swine administered a 1X (2.2 mg/kg; 1.0 mg/lb) dose for 9 days.

  • OTHER SAFETY INFORMATION

    ANIMAL SAFETY

    Minimal toxicity manifested itself as statistically significant increased spleen weight at elevated doses (5X or higher daily for 9 days) with no change in microscopic architecture.

  • HOW SUPPLIED

    HOW SUPPLIED

    Flunazine®-S, 50 mg/mL, is available in 100 mL multi-dose vial.

  • STORAGE AND HANDLING

    STORE BETWEEN 2°C - 30°C (36°F - 86°F).

    PROTECT FROM FREEZING

  • REFERENCES

    REFERENCES

    1. Lees P, Higgins AJ. Flunixin inhibits prostaglandin E2 production in equine inflammation. Res Vet Sci. 1984; 37:347-349.

    2. Odensvik K. Pharmacokinetics of flunixin and its effect on prostaglandin F2α metabolite concentrations after oral and intravenous administration in heifers. J Vet Pharmacol Ther. 1995; 18:254-259

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    FLUNAZINE-S 
    flunixin meglumine injection, suspension
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:61133-6015
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Flunixin Meglumine (UNII: 8Y3JK0JW3U) (Flunixin - UNII:356IB1O400) Flunixin Meglumine50 mg  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61133-6015-2100 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20048903/01/2010
    Labeler - Bimeda, Inc. (060492923)
    Registrant - Bimeda, Inc. (060492923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bimeda-MTC Animal Health256232216manufacture