Fenoprofen Calcium Capsules, USP 300 mg

Resources & forms

PrescribingInformation

Details below are provided from the product labeling.

Warning

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

See full prescribing information for complete boxed warning.

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.
Fenoprofen is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

INDICATIONS & USAGE

Fenoprofen calcium is indicated for:

Relief of mild to moderate pain in adults
Relief of the signs and symptoms of rheumatoid arthritis
Relief of the signs and symptoms of osteoarthritis

DOSAGE AND ADMINISTRATION

General Dosing Instructions

Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Fenoprofen may be administered with meals or with milk. Although the total amount absorbed is not affected, peak blood levels are delayed and diminished.

Analgesia

For the treatment of mild to moderate pain, the recommended dosage is 200 mg given orally every 4 to 6 hours, as needed.

Rheumatoid Arthritis and Osteoarthritis

For the relief of signs and symptoms of rheumatoid arthritis or osteoarthritis the recommended dose is 400 to 600 mg given orally, 3 or 4 times a day. The dose should be tailored to the needs of the patient and may be increased or decreased depending on the severity of the symptoms. Total daily dosage should not exceed 3,200 mg.

CONTRAINDICATIONS

Known hypersensitivity (anaphylactic reactions, serious skin reactions) to fenoprofen or any components of the drug product
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
In the setting of CABG surgery

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop
Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure
Heart Failure and Edema: Avoid use in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure
Renal Toxicity and Hyperkalemia: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs
Exacerbation of Asthma Related to Aspirin Sensitivity: Contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity)
Serious Skin Reactions: Discontinue at first appearance of skin rash or other signs of hypersensitivity
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically
Fetal Toxicity: Limit use of NSAIDs between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use at about 30 weeks gestation and later due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus
Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia
Masking of Inflammation and Fever: Reduced inflammation, and possibly fever, may diminish the utility of these diagnostic signs
Ocular Effects: Discontinue and perform an ophthalmologic examination if visual disturbances occur
Central Nervous System Effects: Caution patients who experience drowsiness, dizziness, or depression about activities requiring alertness
Hearing Impairment: Perform periodic auditory testing during prolonged therapy

ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Cardiovascular Thrombotic Events
GI Bleeding, Ulceration and Perforation
Hepatotoxicity
Hypertension
Heart Failure and Edema
Renal Toxicity and Hyperkalemia
Anaphylactic Reactions
Serious Skin Reactions
Hematologic Toxicity

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

HOW SUPPLIED / STORAGE AND HANDLING

The 300 mg capsule is a size “0el” hard gelatin capsule with a brown opaque cap imprinted with “FENO 300” in black and a yellow opaque body imprinted with “ZN07” in black, filled with white to off-white granular powder.

NDC 85437-502-10 — Bottles of 100

Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Preserve in well-closed containers.

Full Prescribing Information: DailyMed