Rheumatoid Arthritis, Degenerative Arthritis, Ankylosing Spondylitis, Juvenile Rheumatoid Arthritis, Tendinitis, Bursitis, acute gout, acute musculoskeletal disorders (such as sprains, direct trauma & fibrositis), migraine & dysmenorrhoea.
Propionic Acid Derivatives; NSAID
As with other non-selective NSAIDs, naproxen exerts it's clinical effects by blocking COX-1 and COX-2 enzymes leading to decreased prostaglandin synthesis. Although both enzymes contribute to prostaglandin production, they have unique functional differences. The COX-1 enzymes is constitutively active and can be found in normal tissues such as the stomach lining, while the COX-2 enzyme is inducible and produces prostaglandins that mediate pain, fever and inflammation. The COX-2 enzyme mediates the desired antipyretic, analgesic and anti-inflammatory properties offered by Naproxen, while undesired adverse effects such as gastrointestinal upset and renal toxicities are linked to the COX-1 enzyme.
Tablet & Suppository - Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis: 250 to 500 mg twice daily. May be increased to 1.50 gm for limiting periods. Mild to moderate pain, primary dysmenorrhoea, acute tendinitis, bursitis, & dysmenorrhoea: 500 mg initially, followed by every 250 mg every 6 to 8 hours as required. Do not exceed a 1.375 gm total daily dose. Acute gout: 750 mg, then 250 mg every6 8 hours until attack subsides. Juvenile arthritis (Children over 5 years): 10 gm/kg daily in two divided doses is recommended.
ACE inhibitors: diminish the antihypertensive effect of ACE inhibitors.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.
Naproxen should be used with caution in patients with cardiac, hepatic & renal impairment, coagulation defect, & 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. 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 & in patients with recent history of rectal or anal bleeding.
Nausea, diarrhoea, occasionally bleeding & ulceration. Hypersensitivity reactions : bronchospasm, rashes & angioedema. CNS side Effects : drowsiness, headache, fluid retention, vertigo, tinnitus, & photosensitivity. A few instances of jaundice, impairment of renal function, thrombocytopenia, & agranulocytosis.
The drug should not be used during pregnancy unless clearly needed. Use in nursing mothers must be avoided.
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.