What is the recommended dosing for Naproxen (Nonsteroidal Anti-Inflammatory Drug, NSAID)?

From the Guidelines

Naproxen is recommended to be dosed at 275 to 550 mg every two to six hours, with a maximal initial dose of 825 mg and a maximal daily dosage of 1.5 g. This dosing regimen is based on the evidence from the American Family Physician study 1, which provides guidance on the management of acute migraine headaches. The study suggests that NSAIDs, including naproxen, can be used for mild to moderate migraine attacks or severe attacks that have been responsive in the past to similar agents.

Key Considerations

• The dosing frequency and maximum daily dose should be carefully considered to minimize the risk of adverse reactions, such as gastrointestinal upset, dizziness, and rash.
• Patients with aspirin/NSAID-induced asthma should avoid taking naproxen.
• The medication should be taken with food to minimize gastrointestinal side effects.

Special Populations

• Elderly patients and those with renal impairment may require lower doses, but the study does not provide specific guidance on dosing adjustments for these populations.
• Patients with a history of gastrointestinal bleeding, heart disease, or hypertension should use naproxen cautiously and consult their healthcare provider before starting treatment.

Mechanism of Action

• Naproxen works by inhibiting cyclooxygenase enzymes, reducing prostaglandin production and thereby decreasing inflammation, pain, and fever.
• Common side effects include stomach upset, heartburn, and increased risk of cardiovascular events with prolonged use.

From the FDA Drug Label

The recommended dose is 250 mg, 375 mg, or 500 mg twice daily The recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses (i.e., 5 mg/kg given twice a day) The recommended starting dose of naproxen is 500 mg, followed by 500 mg every 12 hours or 250 mg every 6 to 8 hours as required The initial total daily dose should not exceed 1250 mg of naproxen The recommended starting dose is 750 mg of naproxen followed by 250 mg every 8 hours until the attack has subsided

The recommended dosing for Naproxen varies depending on the condition being treated:

• For Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis: 250 mg, 375 mg, or 500 mg twice daily
• For Juvenile Arthritis: approximately 10 mg/kg given in 2 divided doses
• For Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis: 500 mg, followed by 500 mg every 12 hours or 250 mg every 6 to 8 hours as required
• For Acute Gout: 750 mg, followed by 250 mg every 8 hours until the attack has subsided 2

From the Research

Recommended Dosing for Naproxen

The recommended dosing for Naproxen, a Nonsteroidal Anti-Inflammatory Drug (NSAID), varies depending on the condition being treated.

• For acute postoperative pain, studies have shown that naproxen sodium 550 mg (equivalent to 500 mg of naproxen) is an effective dose 3, 4.
• The number-needed-to-treat (NNT) for at least 50% pain relief over 4 to 6 hours was 2.6 (95% CI 2.2 to 3.2) for naproxen sodium 550 mg 3.
• For acute migraine headaches, naproxen 500 mg and 825 mg were found to be effective, with a NNT of 11 for pain-free response at two hours 5.
• For osteoarthritis, a double-blind study found that enteric coated 500 mg naproxen tablets given as a single daily dose of 2 tablets at night were equally efficacious and well tolerated as normal release 500 mg naproxen given twice daily 6.
• A study on the pharmacokinetics of a controlled-release tablet of naproxen found that a 750 mg dose given once daily achieved steady-state plasma concentrations comparable to those of 500 mg conventional tablets administered twice daily 7.

Dose Response

• No dose response was demonstrated over the range 200/220 mg to 500/550 mg of naproxen or naproxen sodium for acute postoperative pain 4.
• Limited data is available on the dose response of naproxen for acute migraine headaches 5.

Adverse Events

• Associated adverse events were generally of mild to moderate severity and rarely led to withdrawal 3, 4.
• Adverse events were more common with naproxen than with placebo when the 500 mg and 825 mg doses were considered together, but not when the 500 mg dose was analysed alone 5.