Naproxen: Uses,Dosage,Side Effects

Generic Name

Naproxen Sodium
Therapeutic Group: Analgesic, Anti Inflammatory 

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

Indications:
Naproxen is indicated for its anti-inflammatory and analgesic action in the treatment of rheumatoid arthritis, osteoarthritis (degenerative arthritis), ankylosing spondylitis, juvenile rheumatoid arthritis, acute gout, acute musculoskeletal disorders, post-operative pain, and dysmenorrhoea. It is also indicated in the relief of mild to moderate pain, and for the treatment of tendonitis and bursitis.

Presentation:
Naproxen 250 tablet: Each tablet contains Naproxen BP 250 mg.
Naproxen 500 tablet: Each tablet contains Naproxen BP 500 mg.
Naproxen suspension: Each 5 ml suspension contains Naproxen BP 125 mg.
Naproxen 15 gm gel: Each gram gel contains Naproxen BP 100 mg.
Naproxen SR 500 tablet: Each SR tablet contains Naproxen BP 500 mg.

Description:
Naproxen is a nonsteroidal anti-inflammatory drug with analgesic and antipyretic properties. Naproxen works by reducing the levels of prostaglandins, chemicals that are responsible for pain, fever, and inflammation. Naproxen blocks the enzyme that makes prostaglandins (cyclooxygenase), resulting in lower concentrations of prostaglandins. As a consequence, inflammation, pain, and fever are reduced.

Dosage & Administration:
Naproxen tablet
Adults
For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis

• The usual dose is 500-1000 mg per day taken in 2 doses at 12 hours intervals after meals.

For acute gout

• 750 mg should be given initially, followed in 8 hours with 500 mg, and thereafter 250 mg at 12 hours intervals until the attack has passed.

For dysmenorrhoea

• 500 mg should be given initially, followed by 250 mg at 6-8 hour intervals for up to 5 days.

For analgesia and acute muscular-skeletal disorders

• 500 mg should be given initially, followed by 250 mg at 6-8 hour intervals.

Children over 5 years
For juvenile rheumatoid arthritis

• 10mg/kg/day given as 2 divided doses at 12-hour intervals.
• SR tablet: For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis
• 500mg or 1000mg (500mg × 2) SR tablet once daily (morning or evening) after meals.
• SR tablet is also indicated after the acute condition is subsided for long-term use.

Naproxen suspension
Adults

• Dosage is the same as Naproxen tablet.

Children over 5 years

• 10 mg/kg/day given as 2 divided doses at 12 hours intervals.

Naproxen gel

• 2-6 times a day as required.

Side Effects:
The most frequently reported side effects include the 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.

Precautions:
Serious GI toxicity such as bleeding, ulceration, and perforation, can occur at any time, with or without warning symptoms, in patients treated chronically with NSAID therapy. Although minor upper GI problems, such as dyspepsia, are common, usually developing early in therapy, physicians should remain alert for ulceration and bleeding in patients treated chronically with NSAIDs even in the absence of previous GI tract symptoms

Use in Pregnancy & Lactation:
Pregnancy: Pregnancy Category B
Naproxen should be used during pregnancy only if the potential benefits justify the potential risks to the fetus.
Nursing mother: Naproxen has been found in the milk of lactating women. Because of the possible adverse effects of prostaglandin-inhibiting drugs on neonates, use in nursing mothers should be avoided.

Interaction:
Naproxen may increase the blood levels of lithium by reducing the excretion of lithium by the kidneys. Increased levels of lithium may lead to lithium toxicity.
Naproxen may reduce the blood pressure lowering effects of blood pressure medications.
When naproxen is used in combination with aminoglycosides (e.g., gentamicin) the blood levels of the aminoglycoside may increase. This may lead to more aminoglycoside-related side effects.
Individuals taking anticoagulants (e.g., Warfarin) should avoid naproxen because naproxen also thins the blood, and excessive blood thinning may lead to bleeding.

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.

Overdose:
Naproxen overdosage may be characterized by drowsiness, heartburn, indigestion, nausea, or vomiting. In animals 0.5 g/kg of activated charcoal was effective in reducing plasma levels of Naproxen. Hemodialysis does not decrease the plasma concentration of Naproxen.

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