Naxin® 250 mg Tablet: Each film coated tablet contains Naproxen BP 250 mg.
Naxin® 500 mg Tablet: Each enteric coated tablet contains Naproxen BP 500 mg.
Naxin® SR 500 mg Tablet: Each sustained release tablet contains Naproxen BP 500 mg.
Dosage & administration: Adults: Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: The recommended dose of naproxen is 250 mg or 500 mg, taken twice daily or naproxen 500 mg SR tablet once daily. During long-term treatment the dose of naproxen may be adjusted up or down depending on the clinical response of the patient. The initial total daily dose should not exceed 1500 mg. Juvenile arthritis: The recommended total daily dose is approximately 10 mg/kg given in two divided doses. Dysmenorrhoea, bursitis and tendinitis: The recommended starting dose is 500 mg every 12 hours or 250 mg every 6 to 8 hours as required. The initial total daily dose should not exceed 1000 mg. Acute gout: The recommended starting dose is 750 mg, followed by 250 mg every 8 hours until the attack has passed.
Children: The safety and efficacy of naproxen in children has not been established and its use in children is therefore not recommended. But in pediatric patients aged 5 to 16 years with arthritis, 10 mg/kg daily in 2 divided doses may be given.
Contraindications: Hypersensitivity to naproxen, gastrointestinal ulceration, asthma, nasal polyps, urticaria and hypotension.
Use in pregnancy & lactation: USFDA pregnancy category C. So Naproxen should be avoided during pregnancy because it may cause premature closure of the ductus arteriosus. Naproxen should be avoided during lactation because of the possible adverse effects of prostaglandin inhibiting drugs on neonates.
Precautions: History of gastrointestinal disease; fluid retention and oedema; cardiac, hepatic and renal impairment; allergic disorder.
Storage: Store in a cool and dry place, protected from light.
Naproxen (Naxin ) is a member of the arylacetic acid group of non-steroidal anti-inflammatory drug, which is widely used to treat patients with rheumatic diseases. It has potent anti-inflammatory, antipyretic and analgesic action.
Mode of action:
Naproxen reduces the prostaglandin synthesis by inhibiting the enzyme, cyclo-oxygenase. Thus it produces anti-inflammatory, antipyretic and analgesic actions. It also inhibits leukocyte migration.
Pharmacokinetics:
Naproxen (Naxin ) is completely absorbed from the gastrointestinal tract with bioavailability of 95%. After oral administration of tablet, peak plasma level is attained within 1 to 2 hours for immediate release tablet & 5 to 7 hours for sustained release tablet. It has a volume of distribution of 0.16 litre/kg. At therapeutic levels, naproxen is greater than 99% albumin-bound. The plasma half-life of naproxen ranges from 12 to 17 hours. Approximately 95% of naproxen from any dose is excreted in the urine.
Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, tendinitis, bursitis and acute gout. Management of mild to moderate pain associated with post-operation, orthopedic, postpartum episiotomy, uterine contraction and dysmenorrhoea.
Adults: Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: The recommended dose of naproxen is 250 mg or 500 mg, taken twice daily or naproxen 500 mg SR tablet once daily. During long-term treatment the dose of naproxen may be adjusted up or down depending on the clinical response of the patient. The initial total daily dose should not exceed 1500 mg. Juvenile arthritis: The recommended total daily dose is approximately 10 mg/kg given in two divided doses. Dysmenorrhoea, bursitis and tendinitis: The recommended starting dose is 500 mg every 12 hours or 250 mg every 6 to 8 hours as required. The initial total daily dose should not exceed 1000 mg. Acute gout: The recommended starting dose is 750 mg, followed by 250 mg every 8 hours until the attack has passed. Children: The safety and efficacy of naproxen in children has not been established and its use in children is therefore not recommended. But in pediatric patients aged 5 to 16 years with arthritis, 10 mg/kg daily in 2 divided doses may be given.
Concomitant administration of certain drugs should be avoided during naproxen therapy i.e. aspirin, methotrexate, ACE inhibitors, frusemide, lithium, warfarin, sulphonylureas, etc.
USFDA pregnancy category C. So Naproxen should be avoided during pregnancy because it may cause premature closure of the ductus arteriosus. Naproxen should be avoided during lactation because of the possible.
History of gastrointestinal disease; fluid retention and oedema; cardiac, hepatic and renal impairment; allergic disorder.
Store in a cool and dry place, protected from light.