מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
tolmetin sodium (UNII: 02N1TZF99F) (tolmetin - UNII:D8K2JPN18B)
Mutual Pharmaceutical Company, Inc.
tolmetin sodium
tolmetin 400 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of tolmetin sodium and other treatment options before deciding to use tolmetin sodium. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Tolmetin sodium is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. Tolmetin sodium is indicated in the treatment of acute flares and the long-term management of the chronic disease. Tolmetin sodium is also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of tolmetin sodium have not been established in pediatric patients under 2 years of age (see PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION ). Tolmetin sodium is contraindicated in patients with known hypersensitivity to tolmetin sodium. Tolmetin sodium should not be given to patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, an
Tolmetin sodium capsules and tablets are supplied as follows: Tolmetin sodium capsules equivalent to 400 mg tolmetin, orange/orange imprinted: Mutual 179 Tolmetin sodium tablets equivalent to 200 mg tolmetin, off white, round scored, debossed: MP 50 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Abbreviated New Drug Application
TOLMETIN SODIUM- TOLMETIN SODIUM TABLET Mutual Pharmaceutical Company, Inc. ---------- MEDICATION GUIDE FOR NON-STEROIDAL ANTI- INFLAMMATORY DRUGS (NSAIDS) (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non-Steroidal Anti- Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: • with longer use of NSAID medicines • in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG)." NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: • can happen without warning symptoms • may cause death The chance of a person getting an ulcer or bleeding increases with: • taking medicines called "corticosteroids" and "anticoagulants" • longer use • smoking • drinking alcohol • older age • having poor health NSAID medicines should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: • different types of arthritis • menstrual cramps and other types of short-term pain Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine • for pain right before or after heart bypass surgery Tell your healthcare provider: • about all of your medical conditions. • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. קרא את המסמך השלם
TOLMETIN SODIUM- TOLMETIN SODIUM CAPSULE TOLMETIN SODIUM- TOLMETIN SODIUM TABLET MUTUAL PHARMACEUTICAL COMPANY, INC. ---------- TOLMETIN SODIUM CAPSULES USP TOLMETIN SODIUM TABLETS USP RX ONLY 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). 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 anytime during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (See WARNINGS). DESCRIPTION Each tolmetin sodium capsule, for oral administration, contains 492 mg of tolmetin sodium (as the dihydrate), equivalent to 400 mg of tolmetin. Each capsule contains 36 mg (1.568 mEq) of sodium and the following inactive ingredients: FD&C Red No. 3, FD&C Yellow No. 6, gelatin, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Each tolmetin sodium tablet, for oral administration, contains 246 mg of tolmetin sodium (as the dihydrate), equivalent to 200 mg of tolmetin (scored for 100 mg). Each tablet contains 18 mg (0.784 mEq) of sodium and the following inactive ingredients: magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and talc. 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)-1_H_-pyrrole-2-acetate dihydrate. CLINICAL PHARMACOLOGY Studies in animals קרא את המסמך השלם