Napro-A 500

Generic

Naproxen Sodium

 

Indications

Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, tendonitis, bursitis, and acute gout are among the conditions for which naproxen is prescribed. It's also used to treat pain and dysmenorrhea in women with primary dysmenorrhea.

 

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: 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

Naproxen is contraindicated in patients with known hypersensitivity to Naproxen. It should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. It is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

 

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

Naproxen is classified as a pregnancy category C by the US Food and Drug Administration. So, unless the potential benefits to the other outweigh the potential hazards to the unborn, Naproxen should be avoided during pregnancy and nursing.

 

Therapeutic Class

Non-steroidal anti-inflammatory drugs, 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

ACME Laboratories Ltd.