COMPOSITION
Ultranax 500Tablet : Each enteric coated tablet contains Naproxen Sodium USP equivalent to Naproxen USP 500mg.
INDICATIONS
Ultranax (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.
DOSAGE AND ADMINISTRATION
Rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis: 250 to 500 mg twice daily. May be increased to 1.50 gm for limiting periods. Morning and evening doses do not have to be equal, and use of the drug more frequently than twice daily is not necessary.
Mild to moderate pain, primary dysmenorrhoea, acute tendinitis, bursitis, and dysmenorrhoea: 500 mg initially, followed by 250 mg every 6 to 8 hours as required.
Acute gout: 750 mg, then 250 mg every 8 hours until attack subsides.
Juvenile arthritis (children over 5 years): 10 mg/kg daily in two divided doses is recommended
CONTRAINDICATION
The drug is contraindicated in patients with a history of hypersensitivity to aspirin or any other NSAIDs – which includes those in whom attacks of asthma, angioedema, urticaria or rhinitis have been precipitated by aspirin or any other NSAIDs.
PRECAUTION
Ultranax (Naproxen) should be used with caution in patients with cardiac, hepatic and renal impairment, coagulation defect, and previous history of gastro-intestinal ulceration.
SIDE EFFECTS
Gastro-intestinal discomforts – nausea, diarrhoea and occasionally bleeding and ulceration.
Hypersensitivity reactions – notably with bronchospasm, rashes and angioedema.
CNS side effects – 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.
DRUG INTERACTION
Use with caution when given concomitantly with coumarin type anticoagulants, hydantion sulfonamides, or sulfonylureas. Concomitant administration is not recommended because reduction in the antihypertensive effect of propranolol and other beta-blockers may occur.
USE IN PREGNANCY AND LACTATION
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.
STORAGE
Protect from light and store below 30°C temperature in a dry place. Keep out of the reach of children.
PACKING
Ultranax 500 Tablet: Box containing 10 X 3’s enteric coated tablets in blister pack.
