Generic

Naproxen Sodium

Indications

Naproxen is used to relieve the signs and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, tendinitis, bursitis and acute gout. It is also suitable for the treatment of primary pain and dysmenorrhea.

Pharmacology

Naproxen is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties. It is rapidly absorbed by the gastrointestinal tract and reaches 95% bioavailability.

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.

Interactions

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.

Contraindications

Patients known to be allergic to naproxen should not use naproxen. Patients with asthma, hives, or allergic reactions after taking aspirin or other non-steroidal anti-inflammatory drugs should not take this product. It is prohibited to treat perioperative pain during coronary artery bypass graft surgery (CABG).

Side Effects

Most frequently reported side effects include following:

• Gastrointestinal: Heartburn, abdominal pain, nausea, diarrhea, dyspepsia.
• Central Nervous System: Headache, vertigo, drowsiness.
• Dermatological: Pruritus (itching), purpura.
• Cardiovascular: Edema, palpitation.
• Others: Visual disturbances, hearing disturbances.

Pregnancy & Lactation

The US FDA classifies naproxen as C for pregnancy. Therefore, naproxen should be avoided during pregnancy and breastfeeding unless the potential benefit to the other party outweighs the possible risk to the fetus.

Therapeutic Class

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Storage Conditions

Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

Pharmaceutical Name

Healthcare Pharmaceuticals Ltd.