Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Ketoprofen is a non-steroidal anti-inflammatory 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.
KETOFEN is a non-narcotic, non-steroidal anti-inflammatory agent with analgesic and antipyretic properties.
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.
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.
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.
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.
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.
Not for use in horses intended for food.
During investigational studies, no significant side effects were reported.
KETOFEN (ketoprofen) Solution 100 mg/mL is available in 50 mL and 100 mL multidose bottles.
NDC 0856-4396-01 - 50 mL - multidose bottle
NDC 0856-4396-02- 100 mL - multidose bottle
Store at controlled room temperature 15° to 30°C (59° to 86°F).
© 2004 Fort Dodge Animal Health.
All Rights Reserved.
Fort Dodge Animal Health
Fort Dodge, Iowa 50501 USA
By arrangement with Rhone-Poulenc France
U.S. Patent No. 3,641,127
Rev. October 2004
NAC No.: 10031024