Carefully consider the potential benefits and risks of TOLECTIN and other treatment options before deciding to use TOLECTIN. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ).

TOLECTIN (tolmetin sodium) is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. TOLECTIN is indicated in the treatment of acute flares and the long-term management of the chronic disease.

TOLECTIN is also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of TOLECTIN have not been established in pediatric patients under 2 years of age (see PRECAUTIONS : Pediatric Use and DOSAGE AND ADMINSTRATION).

Carefully consider the potential benefits and risks of TOLECTIN and other treatment options before deciding to use TOLECTIN. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with TOLECTIN, the dose and frequency should be adjusted to suit an individual patient's needs.

For the relief of rheumatoid arthritis or osteoarthritis, the recommended starting dose for adults is 400 mg three times daily (1200 mg daily), preferably including a dose on arising and a dose at bedtime. To achieve optimal therapeutic effect the dose should be adjusted according to the patient's response after one or two weeks. Control is usually achieved at doses of 600-1800 mg daily in divided doses (generally t.i.d.). Doses larger than 1800 mg/day have not been studied and are not recommended.

For the relief of juvenile rheumatoid arthritis, the recommended starting dose for pediatric patients (2 years and older) is 20 mg/kg/day in divided doses (t.i.d. or q.i.d.). When control has been achieved, the usual dose ranges from 15 to 30 mg/kg/day. Doses higher than 30 mg/kg/day have not been studied, and, therefore, are not recommended.

A therapeutic response to TOLECTIN (tolmetin sodium) can be expected in a few days to a week. Progressive improvement can be anticipated during succeeding weeks of therapy. If gastrointestinal symptoms occur, TOLECTIN can be administered with antacids other than sodium bicarbonate. TOLECTIN bioavailability and pharmacokinetics are not significantly affected by acute or chronic administration of magnesium and aluminum hydroxides; however, bioavailability is affected by food or milk (see PRECAUTIONS: Drug-Food Interaction).

TOLECTINÒ DS (tolmetin sodium) capsules 400 mg (colored orange opaque with contrasting parallel bands, imprinted “TOLECTIN DS” and “McNEIL”), NDC 0045-0414, bottles of 100 and 500.

TOLECTIN® 600 (tolmetin sodium) tablets 600 mg (colored orange, film coated, imprinted “TOLECTIN 600” and “McNEIL”), NDC 0045-0416, bottles of 100 and 500.

Dispense in tight, light- resistant container as defined in the official compendium.

Store at controlled room temperature (15°-30°C, 59°-86°F). Protect from light.

OMP DIVISION, ORTHO-McNEIL PHARMACEUTICAL, INC. Raritan, NJ 08869. Revised February 2006. FDA Rev date: 1/22/2008

Bookmark this page: