FENOPROFEN- fenoprofen calcium capsule
KLE 2, Inc.
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. Benzeneacetic acid, ?-methyl-3-phenoxy-,calcium salt dihydrate, (�)-
Fenoprofen Calcium is a white crystalline powder that has the structural formula C30 H26 CaO6 �2H2 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.
CLINICAL PHARMACOLOGY
Fenoprofen Calcium is a nonsteroidal, anti-inflammatory, antiarthritic drug that also possesses analgesic and antipyretic activities. Its exact mode of action is unknown, but it is thought that prostaglandin synthetase inhibition is involved. INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Fenoprofen Calcium and other treatment options before deciding to use Fenoprofen Calcium. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Fenoprofen Calcium is indicated:
For relief of mild to moderate pain in adults.
For relief of the signs and symptoms of rheumatoid arthritis.
For relief of the signs and symptoms of osteoarthritis.
