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Naproxen

NAPROXEN

Manufacturer: Camber Pharmaceuticals, Inc.

Score: 148.0

Quick Summary

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) used for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, tendonitis, bursitis, acute gout, pain, and primary dysmenorrhea. It works by inhibiting the production of prostaglandins, which cause pain and inflammation. The recommended dose varies depending on the condition being treated, and it is essential to use the lowest effective dose for the shortest duration possible to minimize the risk of adverse reactions. Naproxen is contraindicated in patients with known hypersensitivity to the drug, asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs, and in the setting of coronary artery bypass graft (CABG) surgery. Special considerations are necessary for use in pregnancy, nursing mothers, pediatric patients, and geriatric patients due to potential risks and side effects.

Key Clinical Findings and Indications

  • Relief of signs and symptoms of rheumatoid arthritis
  • Relief of signs and symptoms of osteoarthritis
  • Relief of signs and symptoms of ankylosing spondylitis
  • Relief of signs and symptoms of polyarticular juvenile idiopathic arthritis
  • Relief of signs and symptoms of tendonitis
  • Relief of signs and symptoms of bursitis
  • Relief of signs and symptoms of acute gout
  • Management of pain
  • Management of primary dysmenorrhea

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

  • Cardiovascular thrombotic events
  • Gastrointestinal bleeding, ulceration, and perforation
  • Hepatotoxicity
  • Hypertension
  • Heart failure and edema
  • Renal toxicity and hyperkalemia
  • Anaphylactic reactions
  • Serious skin reactions
  • Hematologic toxicity

Dosing Recommendations

General Guidance

Use the lowest effective dose for the shortest duration possible to minimize the risk of adverse reactions.

Rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis

Adult Dose

250 mg (10 mL) or 375 mg (15 mL) or 500 mg (20 mL) twice daily

Pediatric Dose

Not established for patients under 2 years of age; for patients 2 years and older, 5 mg/kg/day given in 2 divided doses

Polyarticular juvenile idiopathic arthritis

Adult Dose

Not applicable

Pediatric Dose

10 mg/kg/day given in 2 divided doses

Management of pain, primary dysmenorrhea, and acute tendonitis and bursitis

Adult Dose

500 mg (20 mL) initially, followed by 250 mg (10 mL) every 6 to 8 hours as required

Pediatric Dose

Not established

Acute gout

Adult Dose

750 mg (30 mL) initially, followed by 250 mg (10 mL) every 8 hours until the attack has subsided

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Use of naproxen during pregnancy can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction
  • Limit dose and duration of use between 20 and 30 weeks of gestation
  • Avoid use at 30 weeks of gestation and later in pregnancy

Nursing Mothers

  • Naproxen is excreted in breast milk
  • Use with caution in nursing mothers

Pediatric Use

  • Safety and effectiveness have not been established in patients under 2 years of age
  • Use with caution in pediatric patients 2 years and older

Geriatric Use

  • Elderly patients are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions
  • Use with caution in elderly patients
  • Monitor renal function and adjust dose as necessary