Ketofen Tablets

Introduction

Company name: Merial Animal Health Ltd

Address: PO Box 327

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

Telephone: Companion Animals 0870 6000123

Production Animals 0800 592699

Fax: 01279 775888

Email: ukenquiry@merial.com

Website: www.merial.com

Presentation

White coloured tablets each containing 5 mg or 20 mg ketoprofen.

Uses

Ketoprofen is a potent non-steroidal anti-inflammatory and anti-pyretic analgesic for the relief of pain in dogs associated with chronic osteoarthritic conditions and the relief of acute pain and inflammation associated with musculo-skeletal and other painful disorders in the dog and cat.

Dosage and administration

For chronic pain in dogs, the recommended dosage is 0.25 mg of ketoprofen per kg bodyweight administered once daily (one 5 mg tablet per 20 kg bodyweight). The recommended duration of treatment is up to 30 days. If continued treatment is indicated beyond the thirty days, the animal should first be re-examined by the veterinary surgeon.

For acute indications in dogs and cats, the recommended dosage is 1 mg of ketoprofen per kg bodyweight (one 5 mg tablet per 5 kg bodyweight, or one 20 mg tablet per 20 kg bodyweight) administered orally once daily for up to five days. KETOFEN tablets may be given on the day following administration of KETOFEN® 1% injection to maintain treatment for up to a total of five days.

Contra-indications, warnings, etc

For animal treatment only. When treating acute pain or inflammation, do not exceed the stated dose of 1mg/kg or 5 day duration of treatment. Do not administer with diuretics or anti-coagulants. Use is contra-indicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding, where there is evidence of a blood dyscrasia or hypersensitivity to the product. Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects. Use in any animal less than six weeks of age or in aged animals may involve additional risk. If such use cannot be avoided animals may require a reduced dosage and careful clinical management. Avoid use in any dehydrated, hypovolaemic or hypotensive animal as there is a potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be avoided. Do not administer to pregnant animals. Vomiting and diarrhoea rarely, but occasionally occur following treatment. These effects rapidly disappear when the treatment is discontinued. The product is well tolerated by dogs and cats at three times the recommended dose of 1 mg/kg, i.e., at 3 mg/kg. Ketoprofen is well tolerated in dogs at five times the recommended dose of 0.25 mg/kg for up to 90 days, i.e., at 1.25 mg/kg.

Wash hands after use.

In the event of accidental ingestion, seek medical advice and show the doctor what has been taken.

Disposal advice

Dispose of used packaging in the household refuse. Unused product should be returned to the veterinary surgeon.

Pharmaceutical precautions

Do not store above 25°C.

Keep out of reach of children.

Legal category

POM-V

Packaging Quantities

10 tablets per blister, packed in boxes of 5 or 10 blisters.

Further information

Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) belonging to the propionic acid subclass of carboxylic acid derivatives. The primary mechanism of action is inhibition of prostaglandin synthesis through interference with the cyclo-oxygenase pathway of arachidonic acid metabolism.

Ketoprofen exerts three main pharmacological effects which are common to all NSAIDs: anti-inflammatory, analgesic and antipyretic. Ketoprofen has been shown to have potent activity against acute, subacute and chronic inflammation in the classical models of inflammation.

Marketing authorisation number

 .

Vm 08327/4074: 5 mg tablets.

Vm 08327/4076: 20 mg tablets.