RiteMED Naproxen Sodium

Each tablet contains: Naproxen, USP 500 mg (as sodium, 550 mg).

Non-Steroidal Anti-Inflammatory Drug.
Pharmacology: Pharmacokinetics: Naproxen and naproxen sodium are readily absorbed from the gastrointestinal tract. Peak plasma concentrations are attained about 1 to 2 hours after ingestion of naproxen sodium and in about 2 to 4 hours after ingestion of naproxen. Food reduces the rate but not the extent of absorption. Naproxen and naproxen sodium are also well absorbed rectally. At therapeutic concentrations naproxen is more than 99% bound to plasma proteins. Plasma concentrations of naproxen increase proportionally with dose up to about 500 mg daily; at higher doses there is an increase in clearance caused by saturation of plasma proteins. Naproxen diffuses into synovial fluid; it crosses the placenta and is distributed into breast milk in small amounts. Naproxen has a plasma elimination half-life of about 12 to 17 hours. About 95% of a dose is excreted in urine as naproxen and 6-O-desmethylnaproxen and their conjugates. Less than 5% of a dose appears in the feces.

Naproxen is used in musculoskeletal and joint disorders such as ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis including juvenile idiopathic arthritis. It is also used in dysmenorrhea, headache including migraine, postoperative pain, soft-tissue disorders, acute gout, and to reduce fever.

Rheumatic disorders: 500 mg to 1 g Naproxen daily either as single or in divided doses, or as prescribed by the physician.
Dysmenorrhoea and acute musculoskeletal disorders: 500 mg Naproxen initially, followed by 250 mg every 6 to 8 hours, or as prescribed by the physician.
Acute gout: 750 mg Naproxen followed by 250 mg every 8 hours, or as prescribed by the physician.
Migraine: 750 mg of Naproxen given at the first symptom of an impending attack, or as prescribed by the physician.
Children 2 years and over: Juvenile idiopathic arthritis: A dose of 10 mg/kg of body weight daily of naproxen in 2 divided doses, or as prescribed by the physician.

Absolute Contraindications: Not to be given to those patients who have history of: Stroke: cerebrovascular accident, CVA; Heart attack; Myocardial infarction, MI. Coronary artery bypass graft, CABG; Uncontrolled hypertension; Congestive heart failure (CHF) NYHA II-IV.

Contraindication in patients with history of hypersensitivity to ASA or any other NSAIDs.
NSAIDs are contraindicated in patients with previous or active peptic ulceration.
Use with caution in patients with cardiac, liver and renal disease, dose adjustment like using the lowest effective dose and monitoring of renal and liver functions should be instituted.

Naproxen should be used with caution in renal impairment, and use is not recommended in patients whose creatinine clearance is less than 20 mL/min; Contraindicated in patients with active peptic ulceration; Should be used with caution in patients with hypertension, infections, asthma or allergic disorders or impaired renal or hepatic function; Should be used with caution in the elderly and may need to be given in reduced doses.

The commonest adverse effects are generally gastrointestinal disturbances, such as gastrointestinal discomfort, nausea, and diarrhea; these are usually mild and reversible but in some patients peptic ulceration and severe gastrointestinal bleeding may occur.

Store at temperatures not exceeding 30°C.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AE02 - naproxen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.

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