Naproxen is indicated for the relief of symptoms of rheumatoid arthritis, both of acute flares and long term management of the disease. It is also used in the diseases of rheumatoid osteoarthritis (degenerative arthritis), ankylosing spondylitis, juvenile rheumatoid arthritis, tendinitis, brusitis, acute gout, acute musculoskeletal disorders (such as sprains, direct trauma and fibrositis), migraine and dysmenorrhoea.
Drugs for Osteoarthritis,
Drugs used for Rheumatoid Arthritis,
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Naproxen, a propionic acid derivative, is a prototypical NSAID. It reversibly inhibits the cyclooxygenase-1 and -2 (COX-1 and -2) enzymes, thus resulting in reduced synthesis of prostaglandin precursors. It can inhibit platelet aggregation, has anti-inflammatory, analgesic and antipyretic actions.
Tablet & Suppository (Adult)-
Rheumatic disorders: The usual initial dose of naproxen is 250 mg twice daily adjusted to 500 mg to 1000 mg daily in 2 divided doses.
Juvenile arthritis: A dose of 10 mg/kg body weight daily in 2 divided doses is used for children over 5 years of age.
Acute gout: An initial dose of 750 mg followed by 250 mg every 8 hours.
Dysmenorrhoea: 500 mg may be given initially followed by 250 mg in every 6-8 hours.
Syrup (Children over 5 years)-
In juvenile arthritis: The usual dosage of Naproxen is 10 mg/kg/day taken in two doses at 12-hour intervals is recommended.
Gel: Naproxen gel is to be applied 2-6 times a day as required and is not recommended for use in children.
Antacid: The absorption of naproxen can be altered by antacids.
Aspirin: Plasma concentration of Naproxen can be reduced when aspirin is given concomitantly, this appeared to be due to increased exeretion of naproxen.
Diuretics: Naproxen diminish the effect of frusemide.
Probenecid: It increase the plasma concentration of Naproxen.
Naproxen suppository in contraindicated in children under 12 years of age. The suppository is contraindicated also in patients with any inflammatory lesions of rectum or anus and in patients with recent history of rectal or anal bleeding.
: nausea, diarrhoea and occasionally bleeding and ulceration.
Hypersensitivity reactions: notably with bronchospasm, rashes and angioedema.
CNS side effect: drowsiness, headache, fluid retention, vertigo, hearing disturbances such as tinnitus, photosensitivity.
A few instances of jaundice, impairment of renal function, thrombocytopenia, and agranulocytosis have been reported.
There are no well controlled studies in pregnant women. The drug should not be used during pregnancy unless clearly needed. Because of the possible adverse effects of prostaglandin inhibiting drugs on neonates, use in nursing mothers must be avoided.
Naproxen should be used with caution in patients with cardiac, hepatic and renal impairment, coagulation defect, and previous history of gastro-intestinal ulceration. The drug is contraindicated in patients with a history of hypersensitivity to aspirin or any other NSAID – which includes those in whom attacks of asthma, angioedema, urticaria or rhinitis have been precipitated by aspirin or any other NSAID.
Significant overdosage of the drug may be characterized by drowsiness, heartburn, indigestion, and nausea or vomiting. It is not known what dose of the drug would be life threatening.
: Protect from light and store below 30° C temperature in a dry place.
Suppository: Store below 25°C temperature.
Gel: Store in a cool and dry place protected from light.