Naproxen

Naproxen Suspension is indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis tendonitis bursitis acute gout the management of: pain primary dysmenorrhea Naproxen Suspension is a non-steroidal anti-inflammatory drug indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis tendonitis bursitis acute gout the management of: pain primary dysmenorrhea

Naproxen has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of naproxen, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Naproxen is a potent inhibitor of prostaglandin synthesis in vitro. Naproxen 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 is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

Use the lowest effective dose for shortest duration consistent with individual patient treatment goals. Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis Naproxen Suspension 250 mg (10 mL) or 375 mg (15 mL) or 500 mg (20 mL) twice daily twice daily twice daily The dose may be adjusted up or down depending on the clinical response of the patient. In patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/day for up to 6 months. Polyarticular Juvenile Idiopathic Arthritis Recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses.

Naproxen Suspension is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients In the setting of coronary artery bypass graft (CABG) surgery 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

Boxed warning: Nonsteroidal 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. Naproxen Suspension is contraindicated in the setting of coronary artery bypass graft (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. (

The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [ see Warnings and Precautions (

See Table 2 for clinically significant drug interactions with naproxen. Table 2: Clinically Significant Drug Interactions with Naproxen. Drugs That Interfere with Hemostasis Clinical Impact: Naproxen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of naproxen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.

Storage Store at 20° to 25°C (68° to 77°F). Avoid excessive heat above 40°C (104°F).