Uses
Consider potential benefits and risks of naproxen therapy as well as alternative therapies before initiating therapy with the drug. Use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals.
Inflammatory Diseases
Symptomatic treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. May be used in combination with lansoprazole in patients with these conditions who have a history of documented gastric ulcer and require continued NSAIA use.
Symptomatic treatment of tendinitis, bursitis, and acute gout.
Management of juvenile rheumatoid arthritis in children ≥2 years of age.
Pain
Relief of pain.
NSAIAs considered first-line agents for mild to moderate migraine attacks or for severe attacks that have responded in the past to NSAIAs or nonopiate analgesics.
Self-medication in children ≥12 years of age and adults for the temporary relief of minor aches and pain associated with the common cold, headache, toothache, muscular aches, backache, and minor pain of arthritis.
Dysmenorrhea
Symptomatic management of primary dysmenorrhea.
Self-medication for the temporary relief of minor aches and pain associated with menstrual cramps.
Fever
Self-medication for reduction of fever in children ≥12 years of age and adults.
Dosage and Administration
General
- Consider potential benefits and risks of naproxen therapy as well as alternative therapies before initiating therapy with the drug.
Administration
Oral Administration
Conventional (immediate-release) tablets, delayed-release tablets, and suspension formulations of naproxen or naproxen sodium usually are administered orally twice daily. When used for the management of osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis, the morning and evening doses may be unequal in size. When used in combination with lansoprazole, the morning dose of naproxen is administered with lansoprazole before eating.
Naproxen sodium extended-release tablets are administered orally once daily.
Do not break, crush, or chew naproxen delayed-release tablets.
Administration with meal, milk, or antacids may minimize adverse GI effects.
Formulation Considerations
Naproxen oral suspension is the preferred dosage form for children because of suitability for providing the calculated dosage.
Naproxen sodium is preferred for management of acute painful conditions when prompt onset of pain relief is desired.
Naproxen delayed-release tablets are not recommended for management of acute gout, tendinitis, bursitis, acute pain, or dysmenorrhea because of slow onset of action.
Dosage
Available as naproxen or naproxen sodium; each 220, 275, 412.5, or 550 mg of naproxen sodium is approximately equivalent to 200, 250, 375, or 500 mg of naproxen, respectively.
If changing from one strength to another or one dosage form to another, be aware that different dose strengths and formulations are not necessarily bioequivalent.
To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals. Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.
Pediatric Patients
Inflammatory Diseases
Juvenile Rheumatoid Arthritis
Oral
Naproxen 10 mg/kg daily in 2 divided doses.
Pain
Oral
Naproxen sodium self-medication in children ≥12 years of age: Initially, 440 mg; usual dosage is 220 mg every 8–12 hours.
Fever
Oral
Naproxen sodium self-medication in children ≥12 years of age: Initially, 440 mg; usual dosage is 220 mg every 8–12 hours.
Adults
Inflammatory Diseases
Osteoarthritis, Rheumatoid Arthritis, or Ankylosing Spondylitis
Oral
| Preparation |
Dosage |
| Naproxen conventional tablets, delayed-release tablets, or suspension |
250–500 mg twice daily; may increase dosage to 1.5 g daily for up to 6 months |
| Naproxen sodium conventional tablets |
275–550 mg twice daily; may increase dosage to 1.65 g daily for up to 6 months |
| Naproxen sodium extended-release tablets |
825 mg or 1.1 g once daily; may increase dosage to 1.65 g daily for up to 6 months |
When naproxen conventional tablets are used in combination with lansoprazole (15 mg once daily), usual naproxen dosage is 375 or 500 mg twice daily.
Acute Tendinitis/Bursitis
Oral
| Preparation |
Dosage |
| Naproxen conventional tablets or suspension |
500 mg initially, followed by 500 mg every 12 hours or 250 mg every 6–8 hours as needed |
| Naproxen sodium conventional tablets |
550 mg initially, followed by 550 mg every 12 hours or 275 mg every 6–8 hours as needed |
| Naproxen sodium extended-release tablets |
1.1 g once daily; may increase dosage to 1.65 g once daily for limited period |
Gout
Oral
| Preparation |
Dosage |
| Naproxen conventional tablets or suspension |
750 mg initially, followed by 250 mg every 8 hours until attack subsides |
| Naproxen sodium conventional tablets |
825 mg initially, followed by 275 mg every 8 hours until attack subsides |
| Naproxen sodium extended-release tablets |
1.1–1.65 g once on first day, followed by 1.1 g once daily until attack subsides |
Pain
Oral
| Preparation |
Dosage |
| Naproxen conventional tablets or suspension |
500 mg initially, followed by 500 mg every 12 hours or 250 mg every 6–8 hours as needed |
| Naproxen sodium conventional tablets |
550 mg initially, followed by 550 mg every 12 hours or 275 mg every 6–8 hours as needed |
| Naproxen sodium extended-release tablets |
1.1 g once daily; may increase dosage to 1.65 g once daily for limited period |
Naproxen sodium for self-medication of minor aches and pain: Initially, 440 mg; usual dosage is 220 mg every 8–12 hours.
Dysmenorrhea
Oral
| Preparation |
Dosage |
| Naproxen conventional tablets or suspension |
500 mg initially, followed by 500 mg every 12 hours or 250 mg every 6–8 hours as needed |
| Naproxen sodium conventional tablets |
550 mg initially, followed by 550 mg every 12 hours or 275 mg every 6–8 hours as needed |
| Naproxen sodium extended-release tablets |
1.1 g once daily; may increase dosage to 1.65 g once daily for limited period |
Naproxen sodium self-medication: Initially, 440 mg; usual dosage is 220 mg every 8–12 hours.
Fever
Oral
Naproxen sodium self-medication: Initially, 440 mg; usual dosage is 220 mg every 8–12 hours.
Prescribing Limits
Pediatric Patients
Pain
Oral
Naproxen sodium self-medication in children ≥12 years of age: Maximum 440 mg in 8–12 hours; 660 mg in 24 hours. Self-medication should not exceed 10 days.
Fever
Oral
Naproxen sodium self-medication in children ≥12 years of age: Maximum 440 mg in 8–12 hours; 660 mg in 24 hours. Self-medication should not exceed 3 days.
Adults
Inflammatory Diseases
Osteoarthritis, Rheumatoid Arthritis, or Ankylosing Spondylitis
Oral
As naproxen, maximum 1.5 g daily.
As naproxen sodium, maximum 1.65 g daily.
Acute Tendinitis/Bursitis
Oral
As naproxen, maximum 1.25 g on the first day; thereafter, 1 g daily. Maximum 1.5 g daily for limited period.
As naproxen sodium, maximum 1.375 g on the first day; thereafter, 1.1 g daily. Maximum 1.65 g daily for limited period.
Pain
Oral
As naproxen, maximum 1.25 g on the first day; thereafter, 1 g daily. Maximum 1.5 g daily for limited period.
As naproxen sodium, maximum 1.375 g on the first day; thereafter, 1.1 g daily. Maximum 1.65 g daily for limited period.
Naproxen sodium for self-medication of minor aches and pain: Maximum 440 mg in 8–12 hours; 660 mg in 24 hours. Self-medication should not exceed 10 days.
Dysmenorrhea
Oral
As naproxen, maximum 1.25 g on the first day; thereafter, 1 g daily.
As naproxen sodium, maximum 1.375 g on the first day; thereafter, 1.1 g daily.
Naproxen sodium self-medication: Maximum 440 mg in 8–12 hours; 660 mg in 24 hours.
Fever
Oral
Naproxen sodium self-medication: Maximum 440 mg in 8–12 hours; 660 mg in 24 hours. Self-medication should not exceed 3 days.
Special Populations
Dosage in Hepatic Impairment
Dosage adjustment may be needed if high doses required. Consider reduced initial dosage. Use lowest effective dosage.
Dosage in Renal Impairment
Consider reduced initial dosage.
Not recommended for use in patients with moderate to severe renal impairment (Clcr <30 mL/minute).
Geriatric Patients
Dosage adjustment may be needed if high doses required. Consider reduced initial dosage. Use lowest effective dosage.
Maximum for self-medication, naproxen sodium 220 mg twice daily unless otherwise directed by a clinician.
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