Tolectin
TOLECTIN® DS
(tolmetin sodium) Capsules
TOLECTIN® 600
(tolmetin sodium) Tablets
For Oral Administration
Cardiovascular Risk
- NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS).
- TOLECTIN (tolmetin sodium) is contraindicated for the treatment of peri-operative pain 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).
DRUG DESCRIPTION
TOLECTIN DS (tolmetin sodium) capsules for oral administration contain tolmetin sodium 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: gelatin, magnesium stearate, corn starch, talc, FD&C Red No. 3, FD&C Yellow No. 6 and titanium dioxide.
TOLECTIN 600 (tolmetin sodium) tablets for oral administration contain tolmetin sodium 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: cellulose, silicon dioxide, crospovidone, hydroxypropyl methyl cellulose, magnesium stearate, polyethylene glycol, corn starch, titanium dioxide, FD&C Yellow No. 6 and D&C Yellow No. 10.
The pKa of tolmetin is 3.5 and tolmetin sodium is freely soluble in water.
Tolmetin sodium is a nonselective nonsteroidal anti- inflammatory agent. The structural formula is:
 |
Sodium 1- methyl-5-(4-methylbenzoyl)-1H-pyrrole-2-acetate dihydrate.
Last reviewed on RxList: 2/11/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Tolectin Information
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