What it's for (Indications)
- Naproxen is primarily used for the relief of pain and inflammation.
- Specific indications include rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, musculoskeletal disorders, acute gout, dysmenorrhea (painful menstrual cramps), migraine headaches, and post-operative pain.
- It is not a muscle relaxer.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | Dosage should be individualized, using the lowest effective dosage for the shortest duration consistent with treatment goals. * **Adults (e.g., Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis)**: * Naproxen Tablets: Typically 250 mg to 500 mg administered twice daily. * Naproxen Sodium: Typically 275 mg to 550 mg administered twice daily. * EC-Naproxen: Typically 375 mg or 500 mg administered twice daily. * The dose may be adjusted based on the patient's clinical response. In patients who tolerate lower doses well, the dose may be increased up to 1,500 mg per day for up to 6 months. When using 500 mg tablets, a common regimen involves taking one 500 mg tablet twice daily. Some regimens may allow for total daily doses (e.g., 1000 mg to 1500 mg) to be taken once or in divided doses; however, the daily dose should generally not exceed 1375 mg to 1500 mg. * **Pediatric Patients (Polyarticular Juvenile Idiopathic Arthritis)**: The recommended total daily dose of naproxen is approximately 10 mg/kg, administered in divided doses. A liquid formulation may be more appropriate for flexible dose titration in children. * **Administration**: Take this medicine by mouth with a full glass of water. It is recommended to take it with or after food, milk, or an antacid to reduce the risk of gastrointestinal upset. Do not take two doses at one time. Do not break or chew the tablet (especially enteric-coated formulations), swallow it whole. Take this medicine regularly and at the same time each day to help remember and achieve the full therapeutic benefit. Do not exceed the recommended dosage. After taking the medicine, wait at least 10 minutes before lying down. |
Safety & Warnings
Common Side Effects
- Common adverse reactions include dyspepsia, abdominal pain, nausea, vomiting, constipation, diarrhea, heartburn, headache, dizziness, drowsiness, fatigue, rash, ecchymosis, and edema (fluid retention).
- Less common but serious side effects can include stomach bleeding, ulceration, perforation, troubled breathing (dyspnea), tinnitus (perception of noise or ringing in the ears), vertigo, hypertension (high blood pressure), cardiac effects, impaired hearing, visual disturbances, thirst, and, in rare cases, depression.
- Some patients have reported difficulty conceiving.
- More severe adverse reactions include cardiovascular thrombotic events, hepatotoxicity, heart failure, renal toxicity, hyperkalemia, anaphylactic reactions, serious skin reactions, and hematologic toxicity.
Serious Warnings
- Black Box Warning: **WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS** * **Cardiovascular Thrombotic Events**: Nonsteroidal anti-inflammatory drugs (NSAIDs), including naproxen, cause an increased risk of serious cardiovascular thrombotic events, such as myocardial infarction (heart attack) and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use, particularly in patients with pre-existing heart diseases or high blood pressure. Naproxen is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (before or after). * **Gastrointestinal Bleeding, Ulceration, and Perforation**: NSAIDs, including naproxen, increase the risk of serious gastrointestinal (GI) 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 (over 65 years) are at a greater risk for serious GI events.
- Patients should always use the lowest effective dosage for the shortest duration consistent with their individual treatment goals.
- Do not stop this medicine abruptly or without consulting a doctor.
- It is advised to drink plenty of water during treatment.
- Take this medicine with or after food, milk, or an antacid to minimize gastrointestinal upset.
- Do not lie down for at least 10 minutes after taking the medicine.
- Do not alter the prescribed dosage, and do not break, crush, or chew enteric-coated tablets.
- Inform your doctor if your condition worsens, shows no improvement, or if you experience any intense or severe side effects.
- **Specific Patient Groups and Conditions:** * **Pregnancy**: This medicine is not recommended during pregnancy and is contraindicated in the third trimester due to potential fetal harm.
- It should only be used during the first two trimesters if no safer alternative is available, and only after a thorough discussion of risks and benefits with a doctor.
- * **Lactation**: Not recommended or contraindicated for use in nursing females.
- * **Liver/Kidney Impairment**: Caution is advised.
- Naproxen is contraindicated in patients with severe liver or kidney diseases.
- * **Alcohol Consumption**: Avoid consuming alcohol as it increases the risk of stomach bleeding and may intensify other side effects.
- * **Driving/Operating Machinery**: Naproxen may cause dizziness, drowsiness, or fatigue.
- Avoid tasks requiring alertness, such as driving or operating machinery, until you know how the medicine affects you.
- * **Elderly Patients**: Elderly patients (over 65 years) are at a higher risk for serious gastrointestinal bleeding and ulcers and should be monitored closely.
- * **Cardiovascular Conditions**: Use with extreme caution in patients with heart disease, high blood pressure, or heart failure.
- Long-term use or high doses can elevate cardiovascular risk.
- Patients may experience water retention and swelling.
- It is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
- * **Gastrointestinal Conditions**: Caution is advised in patients with a history of stomach ulcers, bleeding, or Crohn's disease.
- * **Respiratory Conditions**: Naproxen can trigger asthma attacks; it should be avoided in patients with asthma or a history of allergic-type reactions (e.
- g.
- , asthma, urticaria) to aspirin or other NSAIDs due to the risk of severe anaphylactic reactions.
- * **Blood Disorders**: Caution is advised in patients with blood disorders due to potential hematologic toxicity.
- * **Other**: Caution is advised in patients with cerebrovascular disease, peripheral vascular disease, hypovolemia (decrease in blood volume), or visual disturbances.
- **Drug Interactions:** Inform your doctor or pharmacist of all medications you are currently taking, as naproxen can interact with and cause serious side effects with other drugs.
- Key interactions include: * **Anticoagulants**: Warfarin (increased bleeding risk).
- * **Antihypertensives**: ACE inhibitors (e.
- g.
- , Captopril, Lisinopril), Angiotensin Receptor Blockers (e.
- g.
- , Losartan, Valsartan), Aliskiren, and diuretics (may reduce their effectiveness and increase renal toxicity).
- * **Other NSAIDs/Aspirin**: Concomitant use with other NSAIDs or aspirin significantly increases the risk of gastrointestinal and renal adverse effects.
- * **Corticosteroids**: Prednisone (increased risk of GI ulceration/bleeding).
- * **Antidepressants**: Selective Serotonin Reuptake Inhibitors (SSRIs) (increased risk of GI bleeding).
- * **Lithium**: May increase lithium plasma levels, leading to toxicity.
- * **Methotrexate**: May increase methotrexate toxicity.
- * **Heartburn Drugs**: Aluminum hydroxide, sucralfate (may affect naproxen absorption).
- * **Cholestyramine**.
How it Works (Mechanism of Action)
Naproxen has analgesic, anti-inflammatory, and antipyretic properties. Its mechanism of action, like that of other NSAIDs, involves the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. This inhibition leads to a decrease in the synthesis of prostaglandins in peripheral tissues, which are mediators of inflammation and pain.