País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
FENOPROFEN CALCIUM (UNII: 0X2CW1QABJ) (FENOPROFEN - UNII:RA33EAC7KY)
Medsource Pharmaceuticals
FENOPROFEN CALCIUM
FENOPROFEN 400 mg
PRESCRIPTION DRUG
New Drug Application
FENOPROFEN- FENOPROFEN CAPSULE MEDSOURCE PHARMACEUTICALS ---------- FENOPROFEN CALCIUM CAPSULES, USP 200 MG AND 400 MG RX ONLY CARDIOVASCULAR RISK Non-Steroidal Anti-Inflammatory Drugs (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). Fenoprofen Calcium is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS). GASTROINTESTINAL RISK NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of 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). DESCRIPTION Fenoprofen Calcium capsules, USP is a nonsteroidal, anti-inflammatory, antiarthritic drug. Fenoprofen Calcium capsules contain fenoprofen calcium as the dihydrate in an amount equivalent to 200 mg (0.826 mmol) or 400 mg (1.65 mmol) of fenoprofen. The 200 mg capsules contain cellulose, gelatin, iron oxides, silicone, titanium dioxide and other inactive ingredients. The 400 mg capsules contain crospovidone, FD&C Blue 1, FD&C Red 40, gelatin, iron oxide yellow, magnesium stearate, sodium lauryl sulfate, talc, and titanium dioxide. Chemically, Fenoprofen Calcium is an arylacetic acid derivative. The structural formula is as follows: Benzeneacetic acid, α-methyl-3-phenoxy-,calcium salt dihydrate, (±)- Fenoprofen Calcium is a white crystalline powder that has the structural formula C H CaO •2H O representing a molecular weight of 558.65. At 25°C, it dissolves to a 15 mg/mL solution in alcohol (95%). It is slightly soluble in water and insoluble in benzene. 30 26 6 2 CLINICAL PHARMACOLOGY Fenoprofen Calcium is a nonsteroidal Leia o documento completo