Ketofen: Product Information

KETOFEN- ketoprofen injection, solution
Zoetis Inc.

zoetis

See other side for instructions for use in cattle.

KETOFEN®

(ketoprofen)
Injectable Solution, 100 mg/mL

For intravenous use in horses.

CAUTION

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

DESCRIPTION

Ketoprofen is a non-steroidal anti-inflammatory agent of the propionic acid class that includes ibuprofen, naproxen, and fenoprofen. Active Ingredient: Each mL contains 100 mg ketoprofen/mL of aqueous solution. Inactive Ingredients: 70 mg L-Arginine/mL; citric acid (to adjust pH); benzyl alcohol, 0.025 g (as preservative).
It is packaged in a multiple dose bottle.

INDICATION

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

DOSAGE AND ADMINISTRATION

The recommended dosage is 1 mg/lb (1 mL/100 lbs) of body weight administered intravenously once daily. Treatment may be repeated for up to five days. Onset of activity is within two hours with peak response by 12 hours.
Use contents within 4 months of first vial puncture.

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.

USER SAFETY WARNINGS

Not for human use. Keep this and all drugs out of the reach of children.
The Safety Data Sheet (SDS) provides more detailed occupational safety information. To obtain a Safety Data Sheet contact Zoetis Inc. at 1-888-963-8471.

OTHER WARNINGS

Do not use in horses intended for human consumption.

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. Consider stopping therapy if adverse reactions, such as prolonged inappetence or abnormal feces, could be attributed to gastrointestinal toxicity. Patients at greatest risk for adverse events are those that are dehydrated, on diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached. Since many NSAIDs possess the potential to produce gastrointestinal ulcerations and/or gastrointestinal perforation, concomitant use of ketoprofen with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided or closely monitored.
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.
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.

SIDE EFFECTS

During investigational studies, no significant side effects were reported.

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
(click image for full-size original)

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
(click image for full-size original)

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.

HOW SUPPLIED

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

STORAGE CONDITIONS

Store below 25°C (77°F), with brief excursions permitted between 0°C — 40°C (32°F — 104°F).

CONTACT INFORMATION

For a copy of the Safety Data Sheet or to report adverse reactions, call Zoetis Inc. at 1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.

Approved by FDA under NADA # 140-269
zoetis
Manufactured by:
Zoetis Manufacturing and Research Spain, S.L.
Girona, Spain
Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007
April 2021
40029077

zoetis

See other side for instructions for use in horses.

KETOFEN®

(ketoprofen)
Injectable Solution, 100 mg/mL

For subcutaneous use in certain classes of cattle.
See INDICATIONS below.

CAUTION

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

DESCRIPTION

Ketoprofen is a non-steroidal anti-inflammatory agent of the propionic acid class that includes ibuprofen, naproxen, and fenoprofen. Active Ingredient: Each mL contains 100 mg ketoprofen/mL of aqueous solution. Inactive Ingredients: 70 mg L-Arginine/mL; citric acid (to adjust pH); benzyl alcohol, 0.025 g (as preservative).
It is packaged in a multiple dose bottle.

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