|Drug Name:||TOLMETIN SODIUM|
|Manufacturer:||MUTUAL PHARMACEUTICAL COMPANY, INC.|
|Other Info:||Manufactured by:MUTUAL PHARMACEUTICAL COMPANY, INC.Philadelphia, PA 19124 USARevised: January 2008S|
Carefully consider the potential benefits and risks of tolmetin sodium and other treatment options before deciding to use tolmetin sodium.
Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Tolmetin sodium is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis.
Tolmetin sodium is indicated in the treatment of acute flares and the long-term management of the chronic disease.Tolmetin sodium is also indicated for treatment of juvenile rheumatoid arthritis.The safety and effectiveness of tolmetin sodium have not been established in pediatric patients under 2 years of age (see PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION).
Tolmetin sodium is contraindicated in patients with known hypersensitivity to tolmetin sodium.Tolmetin sodium should not be given to patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs.Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactoid Reactions and PRECAUTIONS: Preexisting Asthma).Tolmetin sodium is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal.
All NSAIDs, both COX-2 selective and nonselective, may have a similar risk.
Patients with known CV disease or risk factors for CV disease may be at greater risk.
To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible.
Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms.
Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see WARNINGS: Gastrointestinal (GI) Effects–Risk of Ulceration, Bleeding, and Perforation).Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).