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Fenoprofen Capsules
  • Professionals
  • FDA PI

Fenoprofen Capsules

Generic name: fenoprofen calcium
Dosage form: capsule
Drug class:Nonsteroidal anti-inflammatory drugs

Medically reviewed by Drugs.com. Last updated on Feb 1, 2022.

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombic Events

Non-Steroidal 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 ( 5.1) ].

FENOPROFEN CALCIUM ® is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications ( 4) and Warnings and precautions ( 5.1) ].

Gastrointestinal Bleeding, Ulceration, and Perforation

NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [ see Warnings and Precautions ( 5.2) ].

1. INDICATIONS AND USAGE

FENOPROFEN CALCIUM is indicated for:

Relief of mild to moderate pain in adults.

Relief of the signs and symptoms of rheumatoid arthrites.

Relief of the signs and symptoms of osteoarthritis.

2. DOSAGE AND ADMINISTRATION

2.1 General Dosing

Carefully consider the potential benefits and risks of FENOPROFEN CALCIUM and other treatment options before deciding to use FENOPROFEN CALCIUM. Use lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions ( 5) ].

Fenoprofen Calcium may be administered with meals or with milk. Although the total amount absorbed is not affected, peak blood levels are del..