Label: FLUNIXIN- flunixin meglumine injection, solution

  • NDC Code(s): 55529-006-01, 55529-006-02, 55529-006-04
  • Packager: Norbrook Laboratories Limited
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated January 5, 2021

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  • SPL UNCLASSIFIED SECTION

    Only for Intravenous Use in Beef and Dairy Cattle.

    Not for Use in Dry Dairy Cows and Veal Calves.

    For Intravenous and Intramuscular Use in Horses.

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

  • DESCRIPTION

    Each milliliter of Flunixin Injection contains 50 mg flunixin (equivalent to 83 mg flunixin meglumine), 0.1 mg edetate disodium, 2.5 mg sodium formaldehyde sulphoxylate, 4.0 mg diethanolamine, 207.2 mg propylene glycol, 5.0 mg phenol as preservative, hydrochloric acid, water for injection q.s.

  • PHARMACOLOGY

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

    Horse: Flunixin is four times as potent on a mg-per-mg basis as phenylbutazone as measured by the reduction in lameness and swelling in the horse. Plasma half-life in horse serum is 1.6 hours following a single dose of 1.1 mg/kg. Measurable amounts are detectable in horse plasma at 8 hours post injection.

    Cattle: Flunixin meglumine is a weak acid (pKa=5.82)1 which exhibits a high degree of plasma protein binding (approximately 99%)2. However, free (unbound) drug appears to readily partition into body tissues (VSS predictions range from 297 to 782 mL/kg.2-5 Total body water is approximately equal to 570 mL/kg)6. In cattle, elimination occurs primarily through biliary excretion7. This may, at least in part, explain the presence of multiple peaks in the blood concentration/time profile following IV administration2.

    In healthy cattle, total body clearance has been reported to range from 90 to 151 mL/kg/hr2-5. These studies also report a large discrepancy between the volume of distribution at steady state (VSS) and the volume of distribution associated with the terminal elimination phase (Vß). This discrepancy appears to be attributable to extended drug elimination from a deep compartment.8 The terminal half-life has been shown to vary from 3.14 to 8.12 hours. 2-5

    Flunixin persists in inflammatory tissues9 and is associated with anti-inflammatory properties which extend well beyond the period associated with detectable plasma drug concentration.4,9 These observations account for the counterclockwise hysteresis associated with flunixin's pharmacokinetic/pharmacodynamic relationships.10 Therefore, prediction of drug concentrations based upon the 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.

  • INDICATIONS

    Horse: Flunixin Injection is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse.

    Cattle: Flunixin Injection is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. Flunixin Injection is also indicated for the control of inflammation in endotoxemia.

  • DOSE AND ADMINISTRATION

    Horse: The recommended dose for musculoskeletal disorders is 0.5 mg per pound (1 mL/100 lbs) of bodyweight once daily. Treatment may be given by intravenous or intramuscular injection and repeated for up to five days. Studies show onset of activity is within 2 hours. Peak response occurs between 12 and 16 hours and duration of activity is 24-36 hours.

    The recommended dose for the alleviation of pain associated with equine colic is 0.5 mg per pound of bodyweight. Intravenous administration is recommended for prompt relief. Clinical studies show pain is alleviated in less than 15 minutes in many cases. Treatment may be repeated when signs of colic recur. During clinical studies approximately 10% of the horses required one or two additional treatments. The cause of the colic should be determined and treated with concomitant therapy.

    Cattle: The recommended dose for control of pyrexia associated with bovine respiratory disease and endotoxemia and control of inflammation in endotoxemia is 1.1 to 2.2 mg/kg (0.5 to 1mg/lb; 1 to 2 mL per 100 lbs) of bodyweight given by slow intravenous administration either once a day as a single dose or divided into two doses administered at 12 hour intervals for up to 3 days. The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb) of bodyweight. Avoid rapid intravenous administration of the drug.

    The recommended dose for acute bovine mastitis is 2.2 mg/kg (1.0 mg/lb: 2 mL per 100 lbs) of bodyweight given once by intravenous administration.

  • CONTRAINDICATIONS

    Horse: There are no known contra-indications to this drug when used as directed. Intra-arterial injection should be avoided. Horses inadvertently injected intra-arterially can show adverse reactions. Signs can be ataxia, incoordination, hyperventilation, hysteria and muscle weakness. Signs are transient and disappear without antidotal medication within a few minutes. Do not use in horses showing hypersensitivity to flunixin meglumine.

    Cattle: NSAIDs inhibit production of prostaglandins which are important in signaling the initiation of parturition. The use of flunixin can delay parturition and prolong labor which may increase the risk of stillbirth. Do not use Flunixin Injection (flunixin meglumine injection) within 48 hours of expected parturition. Do not use in animals showing hypersensitivity to flunixin meglumine. Use judiciously when renal impairment or gastric ulceration are suspected.

  • RESIDUE WARNINGS:

    Cattle must not be slaughtered for human consumption within 4 days of the last treatment. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Not for use in dry dairy cows. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Not for use in horses intended for food. Approved only for intravenous administration. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter.

  • PRECAUTIONS

    As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal and renal toxicity. Sensitivity to drug-associated adverse effects varies with the individual patient. Patients at greatest risk for renal toxicity are those that are dehydrated, on concomitant diuretic therapy, or those with renal, cardiovascular, and/or hepatic dysfunction.

    Since many NSAIDs possess the potential to induce gastrointestinal ulceration, concomitant use of Flunixin Injection (flunixin meglumine injection) with other anti-inflammatory drugs, such as other NSAIDs and corticosteroids, should be avoided or closely monitored.

    Horse: The effect of flunixin meglumine injection on pregnancy has not been determined. Studies to determine activity of flunixin meglumine injection when administered concomitantly with other drugs have not been conducted. Drug compatibility should be monitored closely in patients requiring adjunctive therapy.

    Cattle: Do not use in bulls intended for breeding, as reproductive effects of flunixin meglumine injection in these classes of cattle have not been investigated. NSAIDs are known to have potential effects on both parturition (See Contraindications) and the estrous cycle. There may be a delay in the onset of estrus if flunixin is administered during the prostaglandin phase of the estrous cycle. NSAIDs are known to have the potential to delay parturition through a tocolytic effect. The use of NSAIDs in the immediate post-partum period may interfere with uterine involution and expulsion of fetal membranes. Cows should be monitored carefully for placental retention and metritis if Flunixin Injection is used within 24 hours after parturition.

  • SAFETY

    Horse: A 3-fold intramuscular dose of 1.5mg/lb of bodyweight daily for 10 consecutive days was safe. No changes were observed in hematology, serum chemistry, or urinalysis values. Intravenous dosages of 0.5mg/lb daily for 15 days; 1.5mg/lb daily for 10 days; and 2.5mg/lb daily for 5 days produced no changes in blood or urine parameters. No injection site irritation was observed following intramuscular injection of the 0.5mg/lb recommended dose. Some irritation was observed following a 3-fold dose administered intramuscularly.

    Cattle: No flunixin-related changes (adverse reactions) were noted in cattle administered at 1X (2.2 mg/kg; 1.0 mg/lb) dose for 9 days (three times the maximum clinical duration). Minimal toxicity manifested itself at moderately elevated doses (3X and 5X) when flunixin was administered daily for 9 days, with occasional findings of blood in the feces and/or urine. Discontinue use if hematuria or fecal blood are observed.

  • ADVERSE REACTIONS

    In horses, isolated reports of local reactions following intramuscular injection, particularly in the neck, have been received. These include localized swelling, sweating, induration, and stiffness. In rare instances in horses, fatal or nonfatal clostridial infections or other infections have been reported in association with intramuscular use of flunixin meglumine injection. In horses and cattle, rare instances of anaphylactic-like reactions, some of which have been fatal, have been reported, primarily following intravenous use. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Norbrook at 1-866-591-5777. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

  • HOW SUPPLIED

    Flunixin Injection (flunixin meglumine injection), 50 mg/mL, is available in 50 mL, 100 mL and 250 mL multi-dose vials.

    Store between 2° and 30°C (36° and 86°F).

  • REFERENCES

    1. Johansson M, Anler EL. Gas chromatographic analysis of flunixin in equine urine after extractive methylation. J Chromatogr. 1988; 427:55-66
    2. Odensvik K, Johansson M. High-performance liquid chromatography method for determination of flunixin in bovine plasma and pharmacokinetics after single and repeated doses of the drug. Am J Vet Res. 1995; 56:489-495.
    3. Anderson KL, Neff-Davis CA, Davis LE, Bass VD. Pharmacokinetics of flunixin meglumine in lactating cattle after single and multiple intramuscular and intravenous administrations. Am J Vet Res. 1990;51:1464-1467
    4. 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.
    5. Hardee GE, Smith JA, Harris SJ. Pharmacokinetics of flunixin meglumine in the cow. Res Vet Sci. 1985;39: 110-112
    6. Ruckebusch Y, Phaneuf LP, Dunlop R. Physiology of Small and Large Animals. Chapter 2: “Body Fluid Compartments,” Philadelphia, Pa: B.C. Decker, 1991:8-18 7. Kopcha M, Ahl AS. Experimental uses of flunixin meglumine and phenylbutazone in food-producing animals. J Am Vet Med Assoc. 1989;194:45-49
    7. Wagner JG. Significance of ratios of different volumes of distribution in pharmacokinetics. Biopharm & Drug Dispos. 1983;4:263-270
    8. Lees P, Higgins AJ. Flunixin Inhibits prostaglandin E2 production in equine inflammation. Res Vet Sci. 1984;37:347-349
    9. Landoni MF, Cunningham FM, Lees P. Determination of pharmacokinetics and pharmacodynamics of flunixin in calves by use of pharmacokinetic/pharmacodynamic modeling. Am J Vet Res. 1995:56:786-794.

    Approved by FDA under ANADA # 200-308

    Made in the UK

    Manufactured by:

    Norbrook Laboratories Limited
    Newry, Co. Down, BT35 6PU
    Northern Ireland

    Oct 2019

    005670I03

    Norbrook®

  • Principal Display Panel - 250 mL Carton Label

    NDC 55529-006-04

    Sterile

    Multiple-Dose Vial

    50 mg/mL

    Flunixin Injection

    (flunixin meglumine injection)

    Only for Intravenous Use in Beef and
    Dairy Cattle.

    Not for Use in Dry Dairy Cows and
    Veal Calves.

    For Intravenous and Intramuscular
    Use in Horses.

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

    Approved by FDA under ANADA # 200-308

    Net Contents: 250 mL

    Norbrook®

    Principal Display Panel - 250 mL Carton Label
  • Principal Display Panel - 250 mL Bottle Label

    NDC 55529-006-04

    Sterile

    Multiple-Dose Vial

    50 mg/mL

    Flunixin Injection

    (flunixin meglumine injection)

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

    Approved by FDA under ANADA # 200-308

    Net Contents: 250 mL

    Norbrook®

    Principal Display Panel - 250 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    FLUNIXIN 
    flunixin meglumine injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:55529-006
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    flunixin meglumine (UNII: 8Y3JK0JW3U) (flunixin - UNII:356IB1O400) flunixin meglumine50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    sodium formaldehyde sulfoxylate (UNII: X4ZGP7K714) 2.5 mg  in 1 mL
    edetate disodium (UNII: 7FLD91C86K) 0.1 mg  in 1 mL
    diethanolamine (UNII: AZE05TDV2V) 4.0 mg  in 1 mL
    propylene glycol (UNII: 6DC9Q167V3) 207.2 mg  in 1 mL
    phenol (UNII: 339NCG44TV) 5.0 mg  in 1 mL
    hydrochloric acid (UNII: QTT17582CB)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55529-006-011 in 1 CARTON
    150 mL in 1 BOTTLE, GLASS
    2NDC:55529-006-021 in 1 CARTON
    2100 mL in 1 BOTTLE, GLASS
    3NDC:55529-006-041 in 1 CARTON
    3250 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20030811/17/2003
    Labeler - Norbrook Laboratories Limited (214580029)
    Establishment
    NameAddressID/FEIBusiness Operations
    Norbrook Laboratories Limited232880554API MANUFACTURE, MANUFACTURE, ANALYSIS