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Naproxen Sodium

NAPROXEN SODIUM

Manufacturer: SA3, LLC

Score: 141.0

Quick Summary

Naproxen sodium is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain, reduce inflammation, and lower fever. It is commonly used to treat conditions such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, and bursitis. The drug works by inhibiting the production of prostaglandins, which are chemicals in the body that cause pain and inflammation. Naproxen sodium is available in tablet form and is usually taken every 8-12 hours. The recommended dose varies depending on the condition being treated, but it should not exceed 1100 mg per day. Naproxen sodium can cause serious side effects, including stomach ulcers, bleeding, and kidney damage, so it is essential to use the lowest effective dose for the shortest duration necessary.

Key Clinical Findings and Indications

  • Relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis
  • Management of pain, primary dysmenorrhea, and acute tendonitis and bursitis
  • Treatment of acute gout

Important Safety Information

Warning

Increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, and gastrointestinal bleeding, ulceration, and perforation

Contraindications

  • Known hypersensitivity to naproxen or any components of the drug product
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
  • In the setting of coronary artery bypass graft (CABG) surgery

Adverse Reactions

  • Dyspepsia, abdominal pain, nausea, headache, rash, ecchymosis, and edema
  • Gastrointestinal bleeding, ulceration, and perforation
  • Hepatotoxicity, hypertension, heart failure, and edema

Dosing Recommendations

General Guidance

Use the lowest effective dose for the shortest duration necessary

Rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis

Adult Dose

275-550 mg twice daily

Pediatric Dose

Not recommended for children under 2 years

Pain, primary dysmenorrhea, and acute tendonitis and bursitis

Adult Dose

550 mg every 12 hours or 275 mg every 6-8 hours

Pediatric Dose

Not recommended for children under 2 years

Special Population Considerations

Pregnancy

  • Use with caution, as naproxen sodium can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction

Nursing Mothers

  • Naproxen is excreted in breast milk, so use with caution

Pediatric Use

  • Safety and effectiveness have not been established in children under 2 years

Geriatric Use

  • Elderly patients may be more sensitive to the effects of naproxen sodium, so use with caution