Naproxen has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of NAPRELAN, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Naproxen sodium is a potent inhibitor of prostaglandin synthesis in vitro. Naproxen sodium concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because naproxen sodium is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

NAPRELAN is a nonsteroidal anti-inflammatory drug indicated for the treatment of:
• rheumatoid arthritis (RA).
• osteoarthritis (OA).
• ankylosing spondylitis (AS).
• tendinitis, bursitis.
• acute gout.
• primary dysmenorrhea (PD).
• the relief of mild to moderate pain.

• Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals.
• RA, OA, and AS: The dosage is two 375 mg or 500 mg tablets once daily, or one 750 mg tablet once daily.
• Management of Pain, PD, and Acute Tendinitis and Bursitis: The dosage is two 500 mg tablets once daily. For patients requiring greater analgesic benefit, two 750 mg tablets or three 500 mg tablets may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets.
• For the treatment of Acute Gout: The dosage is two to three 500 mg tablets once daily on the first day, followed by two 500 mg tablets once daily, until the attack has subsided.

The most frequent adverse events were headache (15%), followed by dyspepsia (14%), and flu syndrome (10%).

• Known hypersensitivity to naproxen 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.

• 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 of NAPRELAN in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
• Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. See package insert for complete information.