Label: KETOFEN- ketoprofen injection, solution

  • NDC Code(s): 54771-4396-1, 54771-4396-2
  • Packager: Zoetis Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated December 28, 2016

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  • SPL UNCLASSIFIED SECTION

    Sterile Solution, 100 mg/mL

    For intravenous use in horses only.

  • CAUTION

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

  • DESCRIPTION

    Ketoprofen is a non-steroidal antiinflammatory agent of the propionic acid class that includes ibuprofen, naproxen and fenoprofen. Each mL of KETOFEN (ketoprofen) contains 100 mg of ketoprofen in an aqueous formulation containing: L-Arginine, 70 mg; citric acid (to adjust pH); benzyl alcohol, 0.025 g (as preservative).

    It is packaged in a multiple dose bottle.

    .

  • PHARMACOLOGY

    KETOFEN is a non-narcotic, non-steroidal anti-inflammatory agent with analgesic and antipyretic properties.

    In horses, intravenous dosages of ketoprofen ranging from 0.5 to 1.5 mg/lb resulted in dosage dependent anti-inflammatory effects in the chronic adjuvant carpitis model as depicted in the following graph.

     n = number of animals
    *
    sem = standard error of the mean
     MAXIMUM FLEXION (intravenous ketoprofen, mean ± sem, n = 4)*
     Figure

    Additional studies using the same model in horses have shown that the effects of ketoprofen are maximal by 12 hours and still measurable at 24 hours after each dosage as depicted in the following graph.

     n = number of animals
    *
    sem = standard error of the mean
     MAXIMUM FLEXION (mean ± sem, n = 6)*
     Figure
  • TOXICITY

    Horses were found to tolerate ketoprofen given intravenously at dosages of 0, 1, 3 and 5 mg/lb once daily for 15 consecutive days (up to five times the recommended dosage for three times the usual duration) with no evidence of toxic effects. In clinical studies, intravenous injection of 1 mg/lb/day for five days resulted in no injection site irritation or other side effects.

    At 15-fold overdose (15 mg/lb/day) for five days one of two horses developed severe laminitis, but no gross lesions or histologic changes were observed. The toxic effects observed in the horses given a 25-fold overdose (25 mg/ lb/day) for five days included inappetence, depression, icterus, abdominal swelling and postmortem findings of gastritis, nephritis and hepatitis.

  • INDICATION

    KETOFEN® (ketoprofen) is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.

  • ADMINISTRATION AND DOSAGE

    The recommended dosage is 1 mg/lb (1 mL/100 lbs) of body weight once daily. Treatment is administered by intravenous injection and may be repeated for up to five days. Onset of activity is within two hours with peak response by 12 hours.

  • CONTRAINDICATIONS

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

    Intra-arterial injection should be avoided.

    Do not use in a horse if it has previously shown hypersensitivity to ketoprofen.

  • CAUTION

    This product should not be used in breeding animals since the effects of KETOFEN on fertility, pregnancy or fetal health in horses have not been determined.

  • PRECAUTIONS

    Studies to determine activity of KETOFEN when administered concomitantly with other drugs have not been conducted. Drug compatibility should be monitored closely in patients requiring adjunctive therapy.

  • WARNING

    Do not use in horses intended for human consumption.

  • SIDE EFFECTS

    During investigational studies, no significant side effects were reported.

  • HOW SUPPLIED

    KETOFEN ( ketoprofen) Solution 100 mg/mL is available in 50 mL and 100 mL multidose bottles.

    Store below 25°C (77°F), with brief excursions permitted between 0°C - 40°C (32°F - 104°F). Use contents within 4 months of first vial puncture.

  • SPL UNCLASSIFIED SECTION

    NADA 140-269, Approved by FDA

    Distributed by:

    Zoetis Inc.

    Kalamazoo, MI 49007

    Made in Spain

    January 2015

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

    KETOFEN®
    (ketoprofen)

    Sterile Solution

    100 mg/mL

    For intravenous use in horses only.

    50 mL Multiple Dose Bottle

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

    NADA 140-269, Approved by FDA

    zoetis

     

    Ketofen 50 mL Carton label

  • PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

    KETOFEN®
    (ketoprofen)

    Sterile Solution

    100 mg/mL

    For intravenous use in horses only.

    100 mL Multiple Dose Bottle

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

    NADA 140-269, Approved by FDA

    zoetis

     

    Ketofen 100 mL Carton Label

  • INGREDIENTS AND APPEARANCE
    KETOFEN 
    ketoprofen injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:54771-4396
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOPROFEN (UNII: 90Y4QC304K) (KETOPROFEN - UNII:90Y4QC304K) KETOPROFEN100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARGININE (UNII: 94ZLA3W45F) 70 mg  in 1 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-4396-11 in 1 CARTON
    150 mL in 1 BOTTLE
    2NDC:54771-4396-21 in 1 CARTON
    2100 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14026909/26/1990
    Labeler - Zoetis Inc. (828851555)