tolectin
tolmetin sodium · by ortho mcneil janssen
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Overview
Each tablet for oral administration contains 738 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 600 mg of tolmetin. Each tablet contains 54 mg (2.35 mEq) of sodium and the following inactive ingredients: black iron oxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch (maize), sodium lauryl sulfate, titanium dioxide, triacetin and yellow iron oxide. The pKa of tolmetin is 3.5 and tolmetin sodium is freely soluble in water, soluble in methanol and slightly soluble in alcohol. Tolmetin sodium is a nonselective nonsteroidal anti-inflammatory agent. The structural formula is: (C 15 H 14 NNaO 3 • 2H 2 O) M.W. 315.30 Sodium 1-methyl-5 p -toluoylpyrrole-2-acetate dihydrate. tolmetin-struct
How to use
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 1 or 2 weeks. Control is usually achieved at doses of 600 mg to 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 can be expected in a few days to a week. Progressive improvement can be anticipated during succeeding weeks of therapy.…
Side effects
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. Incidence Greater Than 1%: The following adverse reactions which occurred more frequently than 1 in 100 were reported in controlled clinical trials: Gastrointestinal: nausea (11%), dyspepsia*, gastrointestinal distress*, abdominal pain*, diarrhea*, flatulence*, vomiting*, constipation, gastritis, and peptic ulcer. Forty percent of the ulcer patients had a prior history of peptic ulcer disease and/or were receiving concomitant anti-inflammatory drugs including corticosteroids, which are known to produce peptic ulceration. Body as a Whole: headache*, asthenia*, chest pain Cardiovascular: elevated blood pressure*, edema* Central Nervous System: dizziness*, drowsiness, depression Metabolic/Nutritional: weight gain*, weight loss* Dermatologic: skin irritation Special Senses: tinnitus, visual disturbance Hematologic: Small and transient decreases in hemoglobin and hematocrit…
Warnings
Important safety information
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 ). Gastrointestinal Risk • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS ).
Interactions
Inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE Inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE Inhibitors. Aspirin: As with other NSAIDs, concomitant administration of TOLECTIN sodium and aspirin is not generally recommended because of the potential of increased adverse effects. Diuretics: Clinical studies, as well as post-marketing observations have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy. Lithium: NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. Methotrexate: NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the…
May treat
Dosage forms
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Frequently asked questions
- What is Tolectin?
- Each tablet for oral administration contains 738 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 600 mg of tolmetin. Each tablet contains 54 mg (2.35 mEq) of sodium and the following inactive ingredients: black iron oxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch (maize), sodium lauryl sulfate, titanium dioxide, triacetin and yellow iron oxide. The pKa of tolmetin is 3.5 and tolmetin sodium is freely soluble in water, soluble in methanol and slightly soluble in alcohol. Tolmetin sodium is a nonselective nonsteroidal anti-inflammatory agent. The structural formula is: (C 15 H 14 NNaO 3 • 2H 2 O) M.W. 315.30 Sodium 1-methyl-5 p -toluoylpyrrole-2-acetate dihydrate. tolmetin-struct
- What does Tolectin treat?
- Tolectin (Tolmetin Sodium) is indicated for arthritis, juvenile, arthritis, rheumatoid, osteoarthritis, per its drug-label indications. This is general reference, not medical advice.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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