Label: FLU-NIX- flunixin meglumine injection, solution

  • NDC Code(s): 23243-0120-4, 23243-0120-5
  • Packager: Huvepharma, Inc
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated June 30, 2022

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

  • SPL UNCLASSIFIED SECTION

    Sterile NDC 23243-0120-4

    Flu-Nix™
    (flunixin meglumine injection)
    50 mg/mL

  • GENERAL PRECAUTIONS

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

    Approved by FDA under ANADA # 200-061

    NET CONTENTS: 100 mL

  • INDICATIONS & USAGE

    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.


    Before using this drug, read package outsert for complete
    product information.

  • ADVERSE REACTIONS

    To report suspected adverse drug events, for technical
    assistance or to obtain a copy of the Safety Data Sheet (SDS),
    contact Huvepharma, Inc. at 1-877-994-4883 or
    www.huvepharma.us. For additional information about adverse
    drug experience reporting for animal drugs, contact FDA at
    1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

    Take Time
    ®Registered trademark of Huvepharma, Inc.
    Manufactured for
    Huvepharma, Inc.                      Rev. 09-2021
    Peachtree City, GA 30269               F-2847-04

  • RESIDUE WARNING

    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. Do not use in horses intended for food. Approved only for intravenous
    administration in cattle. Intramuscular administration has resulted in
    violative residues in the edible tissues of cattle sent to slaughter.

  • STORAGE AND HANDLING

    Store at Controlled
    Room Temperature,
    20º to 25º C (68º to
    77º F) [See USP].

    Lot No.:            Exp. Date:

  • SPL UNCLASSIFIED SECTION

    Flu-Nix™
    (flunixin meglumine injection)
    50 mg/mL

  • INDICATIONS & USAGE

    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.

  • GENERAL PRECAUTIONS

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

  • DESCRIPTION

    Description
    Each milliliter of Flu-Nix™ (flunixin meglumine
    injection) contains flunixin meglumine equivalent
    to 50 mg flunixin, 0.1 mg edetate disodium, 2.5
    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.

  • ANIMAL PHARMACOLOGY & OR TOXICOLOGY

    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
    excretion.7 This may, at least in part, explain the presence of multiple peaks in the blood
    concentration/time profile following IV administration.2
    In healthy cattle, total body clearance has been reported to range from 90 to 151 mL/kg/hr.2-5
    These studies also report a large discrepancy between the volume of distribution at a 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 concentrations.4,9
    These observations account for the counterclock-wise 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 & USAGE

    Indications
       Horse: Flu-Nix™ (flunixin meglumine 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: Flu-Nix™ (flunixin meglumine injection) is indicated for the control of pyrexia associated
    with bovine respiratory disease, endotoxemia and acute bovine mastitis. Flu-Nix™ (flunixin
    meglumine injection) is also indicated for the control of inflammation in endotoxemia.

  • DOSAGE & ADMINISTRATION

    Dose and Administration
       Horse: The recommended dose for musculoskeletal disorders is 0.5 mg per pound (1
    mL/100 lbs) of body weight once daily. Treatment may be given by intravenous or intramuscular
    injection and repeated for up to 5 days. Studies show onset of activity is within 2 hours. Peak
    response occurs between 12 and 16 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 body weight. 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 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 1 mg/lb;1 to 2 mL per 100 lbs) of body weight 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 body weight.
    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 body
    weight given once by intravenous administration.

  • CONTRAINDICATIONS

    Contraindications
       Horse: There are no known contraindications 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 Flu-Nix™ (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 WARNING

    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. Do not use in horses intended for food. Approved only for
    intravenous administration in cattle. Intramuscular administration has resulted in
    violative residues in the edible tissues of cattle sent to slaughter.

  • PRECAUTIONS

    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 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 Meglumine Injection is used within 24 hours after parturition.

  • SUMMARY OF SAFETY AND EFFECTIVENESS

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

    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 Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us.
    For additional information about adverse drug experience reporting for animal drugs, contact
    FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

  • HOW SUPPLIED

    How Supplied
    Flu-Nix™ (flunixin meglumine injection),
    50 mg/mL, is available in 100 mL and 250 mL
    multi-dose vials.

  • STORAGE AND HANDLING

    Store at Controlled Room Temperature,
    20º to 25º C (68º to 77º F) [See USP].
    When used as labeled, there is no limit on the
    number of punctures throughout the full expiry
    period.

  • REFERENCES

    REFERENCES
    1. Johansson M, Anler EL. Gas chromatographic
    analysis of flunixin in equine urine after
    extractive methylation. J Chromatogr.
    1988;427:55-66.
    2. Oldensvik 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. Oldensvik K. Pharmacokinetics of flunixin and
    its effect on prostaglandin F2a 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, Ahi AS. Experimental use of flunixin
    meglumine and phenylbutazone in
    food-producing animals. J Am Vet
    Med Assoc. 1989;194:45-49.
    8. Wagner JG. Significance of ratios of different
    volumes of distribution in pharmacokinetics.
    Biopharm & Drug Dispos. 1983;4:263-270.
    9. Lees P, Higgins AJ. Flunixin inhibits
    prostaglandin E2 production in equine
    inflammation. Res Vet Sci. 1984;37:347-349.
    10. 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.

  • INDICATIONS & USAGE

    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.
    Read accompanying directions for use.

    Take Time 1

    Approved by FDA under ANADA # 200-061
    ®Registered trademark of Huvepharma, Inc.
    Manufactured for
    Huvepharma, Inc.
    Peachtree City, GA 30269
    Rev. 05-2022                      F-2847-05

  • SPL UNCLASSIFIED SECTION

    Sterile NDC 23243-0120-5

    Flu-Nix™
    (flunixin meglumine injection)
    50 mg/mL

  • GENERAL PRECAUTIONS

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

    Approved by FDA under ANADA # 200-061

    NET CONTENTS: 250 mL

  • INDICATIONS & USAGE

    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.

    Before using this drug, read package outsert for complete
    product information.

  • ADVERSE REACTIONS

    To report suspected adverse drug events, for technical
    assistance or to obtain a copy of the Safety Data Sheet (SDS),
    contact Huvepharma, Inc. at 1-877-994-4883 or
    www.huvepharma.us. For additional information about adverse
    drug experience reporting for animal drugs, contact FDA at
    1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

    Take Time

    ®Registered trademark of Huvepharma, Inc.
    Manufactured for
    Huvepharma, Inc.
    Peachtree City, GA 30269

    Rev. 09-2021
    F-2847-05

  • RESIDUE WARNING

    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. Do not use in horses intended for food. Approved only for intravenous
    administration in cattle. Intramuscular administration has resulted in
    violative residues in the edible tissues of cattle sent to slaughter.

  • STORAGE AND HANDLING

    Store at Controlled
    Room Temperature,
    20º to 25º C (68º to
    77º F) [See USP].

    Lot No.:          Exp. Date:

  • SPL UNCLASSIFIED SECTION

    Flu-Nix™
    (flunixin meglumine injection)
    50 mg/mL Multiple-Dose Vial

  • INDICATIONS & USAGE

    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.

  • PRECAUTIONS

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

  • DESCRIPTION

    Description
    Each milliliter of Flu-Nix™ (flunixin meglumine injection)
    contains flunixin meglumine equivalent to 50 mg flunixin,
    0.1 mg edetate disodium, 2.5 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.

  • ANIMAL PHARMACOLOGY & OR TOXICOLOGY

    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
    excretion.7 This may, at least in part, explain the presence of multiple peaks in the blood
    concentration/time profile following IV administration.2
    In healthy cattle, total body clearance has been reported to range from 90 to 151 mL/kg/hr.2-5
    These studies also report a large discrepancy between the volume of distribution at a 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 concentrations.4,9
    These observations account for the counterclock-wise 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 & USAGE

    Indications
       Horse: Flu-Nix™ (flunixin meglumine 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: Flu-Nix™ (flunixin meglumine injection) is indicated for the control of pyrexia associated
    with bovine respiratory disease, endotoxemia and acute bovine mastitis. Flu-Nix™ (flunixin
    meglumine injection) is also indicated for the control of inflammation in endotoxemia.

  • DOSAGE & ADMINISTRATION

    Dose and Administration
       Horse: The recommended dose for musculoskeletal disorders is 0.5 mg per pound (1
    mL/100 lbs) of body weight once daily. Treatment may be given by intravenous or intramuscular
    injection and repeated for up to 5 days. Studies show onset of activity is within 2 hours. Peak
    response occurs between 12 and 16 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 body weight. 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 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 1 mg/lb;1 to 2 mL per 100 lbs) of body weight 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 body weight.
    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 body
    weight given once by intravenous administration.

  • CONTRAINDICATIONS

    Contraindications
       Horse: There are no known contraindications 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 Flu-Nix™ (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 WARNING

    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. Do not use in horses intended for food. Approved only for
    intravenous administration in cattle. Intramuscular administration has resulted in
    violative residues in the edible tissues of cattle sent to slaughter.

  • PRECAUTIONS

    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 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 Meglumine Injection is used within 24 hours after parturition.

  • SUMMARY OF SAFETY AND EFFECTIVENESS

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

    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 Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us.
    For additional information about adverse drug experience reporting for animal drugs, contact
    FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

  • HOW SUPPLIED

    How Supplied
    Flu-Nix™ (flunixin meglumine injection),
    50 mg/mL, is available in 100 mL and 250 mL
    multi-dose vials.

  • STORAGE AND HANDLING

    Store at Controlled Room Temperature,
    20º to 25º C (68º to 77º F) [See USP].
    When used as labeled, there is no limit on the
    number of punctures throughout the full expiry
    period.

  • REFERENCES

    REFERENCES
    1. Johansson M, Anler EL. Gas chromatographic
    analysis of flunixin in equine urine after
    extractive methylation. J Chromatogr.
    1988;427:55-66.
    2. Oldensvik 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. Oldensvik K. Pharmacokinetics of flunixin and
    its effect on prostaglandin F2a 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, Ahi AS. Experimental use of flunixin
    meglumine and phenylbutazone in
    food-producing animals. J Am Vet
    Med Assoc. 1989;194:45-49.
    8. Wagner JG. Significance of ratios of different
    volumes of distribution in pharmacokinetics.
    Biopharm & Drug Dispos. 1983;4:263-270.
    9. Lees P, Higgins AJ. Flunixin inhibits
    prostaglandin E2 production in equine
    inflammation. Res Vet Sci. 1984;37:347-349.
    10. Landoni MF, Cunningham FM, Lees P.
    Determination of pharmacokinetics and
    pharmacodynamics of flunixin incalves by
    use of pharmacokinetic/ pharmacodynamic
    modeling. Am J Vet Res. 1995;56:786-794.

  • INDICATIONS & USAGE

    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.
    Read accompanying directions for use.

    Take Time

    Approved by FDA under ANADA # 200-061
    ®Registered trademark of Huvepharma, Inc.

    Manufactured for
    Huvepharma, Inc.
    Peachtree City, GA 30269

    Rev. 05-2022                            F-2847-06

  • PRINCIPAL DISPLAY PANEL

    100 mL Bottle

    100 mL Onsert

    250 mL Bottle

    250 mL Onsert

  • INGREDIENTS AND APPEARANCE
    FLU-NIX 
    flunixin meglumine injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:23243-0120
    Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FLUNIXIN MEGLUMINE (UNII: 8Y3JK0JW3U) (FLUNIXIN - UNII:356IB1O400) FLUNIXIN50 mg  in 1 mL
    phenol (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) phenol5 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23243-0120-4100 mL in 1 VIAL, MULTI-DOSE
    2NDC:23243-0120-5200 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20006102/10/2015
    Labeler - Huvepharma, Inc (619153559)
    Registrant - Huvepharma EOOD (552691651)