Overview
DESCRIPTION: Each capsule for oral administration contains 492 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 400 mg of tolmetin. Each capsule contains 36 mg (1.568 mEq) of sodium and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate.
Mechanism of Action
CLINICAL PHARMACOLOGY: Studies in animals have shown TOLECTIN (tolmetin sodium) to possess anti-inflammatory, analgesic, and antipyretic activity. In the rat, TOLECTIN prevents the development of experimentally induced polyarthritis and also decreases established inflammation. The mode of action of TOLECTIN is not known. However, studies in laboratory animals and man have demonstrated that the anti-inflammatory action of TOLECTIN is not due to pituitary-adrenal stimulation. TOLECTIN inhibits prostaglandin synthetase in vitro and lowers the plasma level of prostaglandin E in man. This reduction in prostaglandin synthesis may be responsible for the anti-inflammatory action. TOLECTIN does not appear to alter the course of the underlying disease in man.
Indications
- INDICATIONS AND USAGE: Carefully consider the potential benefits and risks of TOLECTIN capsules, USP and other treatment options before deciding to use TOLECTIN capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). TOLECTIN capsules are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. TOLECTIN capsules are indicated in the treatment of acute flares and the long-term management of the chronic disease.
Common Doses
- 400 mg
- 1200 mg
- 600 mg
- 1800 mg
Dosage
DOSAGE AND ADMINISTRATION: Carefully consider the potential benefits and risks of TOLECTIN capsules and other treatment options before deciding to use TOLECTIN capsules. 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 capsules, the dose and frequency should be adjusted to suit an individual patient’s needs.
Black Box 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 capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS ).
Contraindications
- CONTRAINDICATIONS: TOLECTIN capsules 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. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactoid Reactions and PRECAUTIONS: General: Preexisting Asthma ). TOLECTIN is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).
Side Effects
- 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 TOLECTIN, about 10% of patients dropped out because of adverse reactions, mostly gastrointestinal in nature.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.