What it's for (Indications)
- Naproxen is used for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, musculoskeletal disorders, acute gout, dysmenorrhea (painful menstrual cramps), migraine, and post-operative pain.
- It possesses analgesic, anti-inflammatory, and antipyretic properties.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. For Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis, typical dosages are NAPROXEN Tablets 250 mg or 500 mg twice daily, NAPROXEN SODIUM 275 mg or 550 mg twice daily, or EC-NAPROXEN 375 mg or 500 mg twice daily. The dose may be adjusted based on clinical response; in patients who tolerate lower doses well, the dose may be increased to naproxen 1,500 mg/day for up to 6 months. For Polyarticular Juvenile Idiopathic Arthritis, the recommended total daily dose of naproxen is approximately 10 mg/kg; a liquid formulation may be more appropriate for pediatric patients. EC-NAPROXEN tablets should not be broken, crushed, or chewed during ingestion to maintain the integrity of the enteric coating. Always consult a doctor for specific dosage instructions. |
Safety & Warnings
Common Side Effects
- Common side effects include GI upset, dyspepsia, abdominal pain, nausea, headache, rash, ecchymosis, edema, dizziness, tinnitus (ringing in the ear), vertigo (head-spinning), fatigue, dyspnea (shortness of breath), impaired hearing, visual disturbances, and thirst.
- More serious adverse reactions can include GI bleeding, ulceration, and perforation, cardiovascular thrombotic events (e.
- g.
- , myocardial infarction, stroke), hepatotoxicity (altered LFTs, inadequate liver profile), hypertension (increased blood pressure), cardiac failure/heart failure, renal toxicity, hyperkalemia, blood disorders/hematologic toxicity, anaphylactic reactions, serious skin reactions, and CNS disturbances (decreased nervous system response).
Serious Warnings
- Black Box Warning: WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS. Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Naproxen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
- Caution is advised in patients with kidney and liver impairment, asthma, allergies, cardiovascular risk factors, increased blood pressure, congestive heart failure, hypovolemia (low extracellular fluid in the body), ulcerative colitis, Crohn's disease, visual disturbances, and Systemic Lupus Erythematosus (SLE).
- Increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal, especially with prolonged use.
- Risk of GI bleeding, ulceration, and perforation.
- Use with caution in patients with a history of heart failure or edema.
- Renal toxicity and hyperkalemia may occur.
- Anaphylactic reactions and serious skin reactions have been reported.
- Hematologic toxicity may occur.
- Contraindicated in pregnant females and prohibited in nursing females.
How it Works (Mechanism of Action)
The mechanism of action of naproxen, like that of other NSAIDs, involves the inhibition of cyclooxygenase (COX-1 and COX-2). Naproxen is a potent inhibitor of prostaglandin synthesis. Prostaglandins sensitize afferent nerves, potentiate bradykinin in pain induction, and are mediators of inflammation. The drug's therapeutic effects are believed to be due to a decrease in prostaglandin synthesis in peripheral tissues.