KetoMed (ketoprofen)

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.

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.

KetoMed (ketoprofen) Indication

KetoMed (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.

KetoMed (ketoprofen) Caution

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

Precautions

Studies to determine activity of KetoMed 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.

To report suspected adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. 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

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

Store at 20°C - 25°C (68° - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F). Do not freeze.

Use within 28 days of first puncture.

Approved by FDA under ANADA # 200-625

Manufactured for:

Bimeda, Inc., Le Sueur, MN 56058

www.bimeda.com

KetoMed™ is a trademark of Bimeda, Inc.

8KET013 Rev. 12/20

CPN: 1399138.0