Each tablet contains Naproxen 250 mg.
Pharmacology: Naproxen is a propionic acid derivative with antiinflammatory, analgesic and antipyretic actions. It acts by inhibiting cyclooxygenase enzyme which is responsible for the synthesis of prostaglandins and thromboxanes. Although the resultant decrease in prostanglandin synthesis and activity in various tissues may be responsible for many of the therapeutic effects, other actions such as inhibition of leukocyte migration, inhibition of the release and/or actions of lysosomal enzymes, and actions on other cellular and immunological processes etc. may also contribute significantly to its therapeutic effects.
Naproxen is readily absorbed when administered orally, peak plasma level occurs within 2-4 hours and steady state are normally achieved after 2-2.5 days. It is 99% bound to plasma protein and has elimination half-life of approximately 13 hours. Approximately 30% of naproxen is metabolised in the liver, and both unchanged naproxen and metabolites are almost entirely excreted in the urine. Naproxen crosses the placenta and appears in the milk of lactating woman at approximately 1% of the maternal plasma concentration.
Naproxen is indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, musculoskeletal disease, tendinitis, acute gouty arthritis and dysmenorrhea. It can also be used for relief of mild to moderate pain.
Adult Dose: For arthritis (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis): 250 mg twice daily, morning and evening.
For mild to moderate pain, 500 mg initially, then 250 mg every six to eight hours.
For acute gout, 750 mg initially, then 250 mg every eight hours until the attack has subsided.
For dysmenorrhea: 500 mg initially, then 250 mg every six to eight hours.
Pediatric Dose: 10 mg/kg/day in two divided doses.
(based on the Ministry of Public Health Announcement) It is contraindicated in patients hypersensitive to this drug or patients who have experienced asthma, urticaria or acute sinusitis due to aspirin or NSAIDs hypersensitivity.
Avoid using this medication during the third trimester of pregnancy, unless prescribed by a physicians.
It is contraindicated in patients with gastrointestinal (GI) bleeding or perforation.
It is contraindicated in patients with severe hepatic, renal impairment.
It is contraindicated in patients with haemorrhagic fever.
This drug may increase the risk of gastrointestinal (GI) bleeding or ulceration.
This drug may increase the risk of cerebrovascular disease and coronary heart disease, especially when a high dose was given for a prolonged period.
This drug may cause edema. Therefore, it should be used with caution in patients with heart disease or impaired renal function.
This drug is cautiously used in patients with hypertension or the elderly.
This drug has an effect on platelet aggregation. Therefore using in suspected patients with haemorrhagic fever or platelet abnormalities should be avoided.
Use in Pregnancy: Avoid using this medication during the third trimester of pregnancy, unless prescribed by the physician.
Naproxen may cause abdominal discomfort, gastrointestinal ulceration and blood dyscrasia, skin rash, drowsiness, headache and dizziness.
M01AE02 - naproxen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.