Each tablet contains 275 mg of naproxen sodium equivalent to 250 mg of naproxen.
It is indicated in the relief of mild to moderate pain including post operative pain, post partum pain and pain due to orthopaedic surgery. It is also used for treatment of primary dysmenorrhoea, musculoskeletal and soft tissue inflammation and acute gout.
For mild to moderate pain: 550 mg initially, then 275 mg 6-8 hourly when necessary. Total daily dose should not exceed 1,375 mg. To be taken after food.
For musculoskeletal and soft tissue inflammation: 275 mg twice daily or 275 mg in the morning and 275 mg in the evening. To be taken after food.
For acute gout: 825 mg initially, then 275 mg every 8 hourly until attack subsided. To be taken after food.
Naproxen sodium should not be given to patients in whom aspirin or other non-steroidal anti-inflammatory drugs induce the syndrome of asthma, rhinitis or urticuria. Acute peptic ulceration. Sensitivity to naproxen or naproxen sodium.
Use of this class of therapeutic agent requires cautious balancing of possible benefits against potential risks to the mother and foetus, especially in the first and third trimester. It should be avoided in patients who are breast-feeding.
Occasional skin rashes and angio-edema have been reported. Nausea, vomiting, abdominal discomfort, epigastric distress, headache, inability to concentrate, insomnia, tinnitus and vertigo may occur. Patients who have exhibited aspirin hypersensitivity in the past may exhibit the same phenomenon on naproxen sodium. Bronchospasm may be precipitated in patients who have history of bronchial asthma or allergic disease. Thrombocytopenia, granulocytopenia, jaundice, peptic ulceration, nephropathy, aplastic anaemia, haemolytic anaemia and hearing impairment may occur.
The natriuretic effect of frusemide has been reported to be inhibited by some drugs in this class. Inhibition of renal lithium clearance leading to increase in plasma lithium concentrations has also been reported. Due to the high plasma protein binding of naproxen sodium, patients simultaneously receiving hydantoins should be closely monitored for adjustments of dose if required. Probenecid given concurrently increases naproxen plasma levels and extends its plasma half life significantly. Naproxen sodium can reduce the anti-hypertensive effect of propanolol and other beta-blockers.
Incompatibilities: There is no known incompatibilities.
Store in a cool and dry place.
M01AE02 - naproxen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.