Tolmetin Sodium

INDICATIONS & USAGE Carefully consider the potential benefits and risks of TOLECTIN tablets, USP and other treatment options before deciding to use TOLECTIN tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). TOLECTIN tablets are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. TOLECTIN tablets are indicated in the treatment of acute flares and the long-term management of the chronic disease. TOLECTIN tablets are also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of TOLECTIN tablets have not been established in pediatric patients under 2 years of age (see PRECAUTIONS : Pediatric Use and DOSAGE AND ADMINISTRATION ).

ADVERSE REACTIONS The adverse reactions which have been observed in clinical trials encompass observations in about 4,370 patients treated with TOLECTIN, over 800 of whom have undergone at least one year of therapy. These adverse reactions, reported below by body system, are among those typical of nonsteroidal anti-inflammatory drugs and, as expected, gastrointestinal complaints were most frequent. In clinical trials with tolmetin, about 10% of patients dropped out because of adverse reactions, mostly gastrointestinal in nature.

PREGNANCY Risk Summary: Use of NSAIDs, including TOLECTIN, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of TOLECTIN use between about 20 and 30 weeks of gestation, and avoid TOLECTIN use at about 30 weeks of gestation and later in pregnancy (see WARNINGS: Fetal Toxicity ).

BOXED WARNING Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS ). • TOLECTIN tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS ). WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to 3 years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. CONTRAINDICATIONS TOLECTIN tablets are contraindicated in patients with known hypersensitivity to tolmetin sodium. TOLECTIN should not be given to patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs.