Naxsil 500Tablet

Generic

Naproxen Sodium

Indications

Naproxen Sodium is indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile rheumatoid arthritis, acute gout and acute musculoskeletal disorder (such as sprains and strains, direct trauma, lumbosacral pain, cervical spondylitis, tenosynovitis and fibrositis), migraine, post-operative pain and dysmenorrhoea.

Pharmacology

Naproxen is an anti-inflammatory, analgesic, and antipyretic non-steroidal anti-inflammatory medication (NSAID). It is quickly absorbed from the gastrointestinal tract and has a bioavailability of 95%.

Dosage & Administration

Naproxen Tablet-

• Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: The usual dose is 500-1000 mg daily in two divided doses after meals.
• Management of pain, primary dysmenorrhea, acute tendonitis & bursitis: Recommended starting dose is 500 mg followed by 500 mg every 12 hours or 250 mg every 6-8 hours. The initial total daily dose should not exceed 1250 mg and thereafter, the total daily dose should not exceed 1000 mg.
• Acute gout: Recommended starting dose is 750 mg followed by 250 mg every 8 hours until the attack has subsided.

Naproxen Suspension-

• For Juvenile rheumatoid arthritis: The usual dose for children over 2 years is 10 mg/kg/day given as two divided doses at 12-hours intervals. Therapy in children under 2 years of age is not recommended.

Naproxen Gel-

• Is to be applied 2-6 times a day as required and is not recommended for use in children.

Interaction

ACE inhibitors: ACE inhibitors have a reduced antihypertensive impact.

Naproxen absorption is slowed by antacids and sucralfate.

Aspirin increases the risk of side effects.

Furosemide and Thiazides' natriuretic effects are reduced by diuretics.

Methotrexate: increases Methotrexate toxicity.

Warfarin raises the risk of gastrointestinal bleeding.

SSRIs (Selective Serotonin Reuptake Inhibitors) raise the risk of gastrointestinal bleeding.

Contraindications

Naproxen is contraindicated in patients’ active peptic ulceration, hypersensitivity to naproxen or naproxen sodium formulations, aspirin/other NSAIDs.

Side Effects

Gastro-intestinal: Nausea, vomiting, pain, occasionally bleeding and ulceration and colitis. Only for the use of Medical Professionals

Dermatological: Skin rashes, urticaria, angioedema rarely anaphylactic reactions and eosinophilic pneumonitis.

Haematological: Thrombocytopenia, granulocytopenia, including agranulocytosis, aplastic anaemia.

Other: Tinnitus, hearing impairment, vertigo, mild peripheral oedema (patients with compromised cardiac function may be at a higher risk on naproxen), rarely jaundice, fatal hepatitis, nephropathy, haematuria, visual disturbances, vasculitis, aseptic meningitis and ulcerative stomatitis.

Pregnancy & Lactation

The safety of naproxen administration during pregnancy and for use in nursing mothers has not been established. Therefore, the possible hazards should be weighed against the potential benefits.

Precautions & Warnings

Naproxen should be used with care in patients with a history of GI disease, asthma, or allergic disease, impaired renal and hepatic function. Naproxen decreases platelet aggregation and prolongs bleeding time.

Therapeutic Class

Non-steroidal anti-inflammatory drugs (NSAIDs), drugs for osteoarthritis, drugs for rheumatoid arthritis (NSAIDs)

Storage Conditions

Keep the temperature below 30°C and keep it away from light and moisture. Keep out of children's reach.

Pharmaceutical Name

Silco Pharmaceutical Ltd.