nvKetoprofen Tablets (5 mg) (Canada)

(ketoprofen)

5 mg and 20 mg

Nonsteroidal Anti-Inflammatory Analgesic for Dogs and Cats

FOR VETERINARY USE ONLY

Description: Each white to off-white, round biconvex compressed ^nvKetoprofen tablet is scored on one side, engraved nv on the other side and contains:

PHARMACOLOGY

Ketoprofen, 2-(3-benzoyl phenyl) propionic acid, is a nonsteroidal anti-inflammatory drug (NSAID) belonging to the propionic acid subclass of carboxylic acid derivative nonsteroidal anti-inflammatory drugs. Other propionic acid derivative NSAIDS include ibuprofen, naproxen and fenoprofen. Ketoprofen exerts three main pharmacological effects which are common to all NSAIDS: anti-inflammatory, analgesic and antipyretic. The primary mechanism of action is inhibition of prostaglandin synthesis through interference with the cyclo-oxygenase pathway of arachidonic acid metabolism. Ketoprofen has been shown to have potent activity against acute, subacute and chronic inflammation in the classical models of inflammation.

Ketoprofen has a high affinity for inflamed tissue leading to greater concentrations and longer residence time in inflamed tissues than in plasma. For this reason, ketoprofen can be administered once a day to dogs and cats despite the relatively short plasma half-life (approximately 5 hours in dogs and 1.6 hours in cats). Onset of activity is rapid with peak plasma concentrations occurring within one half hour after parenteral administration and within 1 hour of oral administration. ^nvKetoprofen tablets are virtually completely absorbed from the gastrointestinal tract of dogs and cats and can be given without regard to meal time.

Toxicity

^nvKetoprofen has a wide margin of safety in dogs and cats. At deliberate overdoses up to 10 times the recommended dose and up to 90 consecutive days of administration in dogs, gastrointestinal disturbances such as diarrhea, anorexia, melena, and weight loss were mild and self-limiting. At higher doses up to 36 mg/kg/day toxic effects were observed clinically and histologically on the gastrointestinal tract, the liver and the kidneys. Cats treated with up to 4 times the recommended dose of ketoprofen did not exhibit clinical signs of gastrointestinal toxicity and necropsy revealed comparable lesions in both ketoprofen-treated and untreated control cats.

The incidence of side effects observed in clinical efficacy studies involving 432 dogs and 112 cats was:

INCIDENCE OF SIDE EFFECTS WITH KETOPROFEN TREATMENT IN CLINICAL STUDIES:

A direct drug relationship could not be established in most cases.

INDICATIONS

^nvKetoprofen is a nonsteroidal anti-inflammatory analgesic indicated for dogs and cats for the alleviation of inflammation, lameness and pain due to osteoarthritis, hip dysplasia, disc disease, spondylosis, panosteitis, trauma, and related musculoskeletal diseases; for the management of post-surgical pain; for the symptomatic treatment of fever. When inflammation and/or fever are associated with a primary infectious process, ^nvKetoprofen should be used in conjunction with appropriate anti-infective therapy.

CONTRAINDICATIONS

Do not use in animals with gastroduodenal ulcers, impaired liver and/or kidney function, and coagulation disorders. Do not use in animals with known hypersensitivity to NSAIDS. Do not use in breeding animals as effects on fertility and reproductive function in dogs and cats have not been established. Do not mix ketoprofen injection(*) with other drugs in the same syringe. Avoid inadvertent intra-arterial injection.

DOSAGE AND ADMINISTRATION

Dogs: Administer a ketoprofen injection(*) at a dose of 2 mg/kg (0.2 mL/kg) body weight by intramuscular, intravenous or subcutaneous injection for one day, and continue with ^nvKetoprofen tablets per os at a lower maintenance dose of 1 mg/kg once a day for four more days. In severe cases, the parenteral loading dose of 2 mg/kg can be given for up to three consecutive days.

Cats: Administer a ketoprofen injection(*) at a dose of 2 mg/kg (0.2 mL/kg) body weight by subcutaneous injection for one day, and continue with ^nvKetoprofen tablets per os at a lower maintenance dose of 1 mg/kg once a day for four more days. In severe cases, the parenteral loading dose of 2 mg/kg can be given for up to three consecutive days.

CAUTIONS

Gastrointestinal, renal and hepatic function should be monitored periodically in animals on prolonged ^nvKetoprofen therapy, and a drug withdrawal period should be instituted prior to elective surgery.

PRESENTATION

^nvKetoprofen (ketoprofen) 5 mg and 20 mg Tablets are supplied in bottles of 100.

STORAGE CONDITIONS

Store between 15° and 30°C. Protect from light. Keep this and all medication out of the reach of children.

*Injectable product not currently supplied by Teva Canada Animal Health, a division of Teva Canada Limited.

^® - Reg’d Trademark of Teva Canada Animal Health, a division of Teva Canada Limited

Manufactured by: Teva Canada Animal Health, a division of Teva Canada Limited, 30 Novopharm Court, Toronto, Canada M1B 2K9

DIN 02245966 (5 mg), 02245967 (20 mg)

75305IN Rev. 00

NAC No.: 11560152