Naproxen is indicated for the relief of signs and symptoms of

• rheumatoid arthritis,
• osteoarthritis,
• ankylosing spondylitis,
• juvenile arthritis,
• tendonitis,
• bursitis,
• and acute gout.

It is also used in the management of primary dysmenorrhea and pain.

Like other non-selective NSAIDs, Naproxen exerts its therapeutic effects by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, resulting in reduced prostaglandin synthesis. Although both enzymes are involved in prostaglandin production, they have different roles. COX-1 is constitutively active and present in normal tissues such as the gastric mucosa, while COX-2 is inducible and primarily responsible for producing prostaglandins that mediate pain, fever, and inflammation. The inhibition of COX-2 accounts for Naproxen’s antipyretic, analgesic, and anti-inflammatory effects, whereas COX-1 inhibition is associated with adverse effects such as gastrointestinal irritation and renal toxicity.

Naproxen oral preparations should be taken with water preferably after meals.

Naproxen Enteric Coated Tablet: Adult:

• For rheumatoid arthritis/ osteoarthritis/ ankylosing spondylitis: For adults 500-1000 mg per day taken in two divided doses at 12-hour intervals. The maintenance dose is usually 500 mg per day taken in two divided doses at 12-hour intervals. The total daily dose of Naproxen should not exceed 1000 mg maintaining 12-hour intervals.
• For acute gout: 750 mg should be given initially, then 250 mg every 8 hours until the attack has passed.
• Children under 16 years are not recommended.
• For dysmenorrhoea: For adults 500 mg should be given initially, followed by 250 mg at 6-8 hour intervals for up to 5 days, if necessary.
• For other indications like analgesia and acute musculoskeletal disorders: 500 mg should be given initially, followed by 250 mg at 6-8 hour intervals, if necessary.

Naproxen Enteric Coated Tablet: Children: Children under 16 years are not recommended.

Naproxen Suspension: Children:
For juvenile rheumatoid arthritis: The usual dose for children over 2 years is 10 mg/kg/day given as two divided doses at 12-hour intervals. Therapy in children under 2 years of age is not recommended. The following may be used as a guide for dosage of suspension:

• 13 kg (29 lb) — 2.5 mL b.i.d.
• 25 kg (55 lb) — 5 mL b.i.d.
• 38 kg (84 lb) — 7.5 mL b.i.d.

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

ACE inhibitors: may reduce the antihypertensive effect of ACE inhibitors.
Antacids & Sucralfate: may delay absorption of Naproxen.
Aspirin: increases the risk of adverse effects.
Diuretics: may reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: may increase toxicity of Methotrexate.
Warfarin: increases the risk of gastrointestinal bleeding.
SSRIs: increase the risk of GI bleeding.

Naproxen is contraindicated in patients with known hypersensitivity to Naproxen. It should not be given to patients who develop asthma, urticaria, or allergic reactions after taking aspirin or other NSAIDs. It is contraindicated for perioperative pain management in coronary artery bypass graft (CABG) surgery.

Most frequently reported side effects include:

• Gastrointestinal: heartburn, abdominal pain, nausea, diarrhea, dyspepsia.
• Central Nervous System: headache, vertigo, drowsiness.
• Dermatological: pruritus, purpura.
• Cardiovascular: edema, palpitation.
• Others: visual disturbances, hearing disturbances.

NSAIDs may have adverse effects on the fetus due to pharmacological actions. Naproxen may delay labor in animals and has been associated with premature closure of ductus arteriosus and pulmonary hypertension in newborns. Use in the first and third trimesters requires careful risk–benefit evaluation. Naproxen is excreted in small amounts in breast milk; use during lactation only if clearly necessary.

Renal effects: Long-term use may cause renal papillary necrosis and other kidney damage. Reports include interstitial nephritis, hematuria, proteinuria, and nephrotic syndrome. Use with caution in renal impairment and monitor renal function. Avoid use in patients with creatinine clearance below 20 ml/min due to risk of accumulation.
Hepatic effects: Rare cases of jaundice have been reported.

Drugs for osteoarthritis, drugs for rheumatoid arthritis, NSAIDs.

Store below 30°C, protect from light and moisture. Keep out of reach of children.