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Overview
Naproxen sodium is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of ankylosing spondylitis, bursitis, acute gout, osteoarthritis, pain, primary dysmenorrhea, rheumatoid arthritis, tendinitis. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Ankylosing spondylitis
Dosing Information
The recommended dosage of naproxen sodium for ankylosing spondylitis is 275 or 550 milligrams (mg) twice daily in the morning and evening. The dosage should be adjusted depending on the clinical response. For long-term administration, lower doses may be adequate. A dose of 1650 mg/day may be used for up to 6 months in patients tolerating lower doses well. Patients should be observed to ensure the clinical benefits outweigh the increased risks.
The recommended dosage of controlled-release naproxen sodium for treating ankylosing spondylitis is 750 to 1000 milligrams (mg) orally once daily. If clinical response is not achieved initially, the dosage may be increased to 1500 mg once daily for a limited period of time. The dosage should be adjusted for each patient to provide adequate pain relief utilizing the smallest effective dose.
Bursitis
Dosing Information
The recommended dose of naproxen sodium for bursitis is 550 milligrams (mg) initially, followed by 550 mg every 12 hours or 275 mg every 6 to 8 hours as needed. The maximum daily dose should not exceed 1375 mg on the initial day of treatment; thereafter it should not exceed 1100 mg per day.
The recommended dosage of controlled-release naproxen sodium for bursitis is 1000 milligrams (mg) orally once daily. If adequate pain relief is not achieved initially, the dosage may be increased to 1500 mg once daily for a limited period of time. Once adequate pain control is achieved, the dosage should not exceed 1000 mg orally daily.
Over the counter naproxen should not be taken for longer than 10 days unless directed by a physician. The smallest effective dose should be used.
Acute gout
Dosing Information
The recommended dose of naproxen sodium for acute gout is 825 milligrams (mg) initially, followed by 275 mg every 8 hours until the attack has subsided.
The recommended dosage of controlled-release naproxen sodium for acute gout is 1000 to 1500 milligrams orally once a day on the first day, followed by 1000 mg orally once daily until the attack subsides.
Over the counter naproxen sodium should not be taken for longer than 10 days unless directed by a physician. The smallest effective dose should be used.
Osteoarthritis
Dosing Information
The recommended dosage of naproxen sodium for osteoarthritis is 275 or 550 milligrams (mg) twice daily in the morning and evening. The dosage should be adjusted depending on the clinical response. For long-term administration, lower doses may be adequate . A dose of 1650 mg/day may be used for up to 6 months in patients tolerating lower doses well. Patients should be observed to ensure the clinical benefits outweigh the increased risks.
The recommended dosage of controlled-release naproxen sodium for treating osteoarthritis is 750 to 1000 milligrams (mg) orally once daily. If clinical response is not achieved initially, the dosage may be increased to 1500 mg once daily for a limited period of time. The dosage should be adjusted for each patient to provide adequate pain relief, utilizing the smallest effective dose.
Over the counter naproxen sodium should not be taken for longer than 10 days unless directed by a physician. The smallest effective dose should be used.
Single daily doses:
In an open, controlled study of 40 patients lasting 3 months, oral controlled-release naproxen sodium 750 milligrams (mg) daily was compared with regular naproxen 500 mg twice daily. Clinical effectiveness, as determined by improvement in signs and symptoms of arthritis, was similar for both regimens.
Pain
Dosing Information
The recommended dose of naproxen sodium for mild to moderate pain, and acute tendonitis and bursitis is 550 milligrams (mg) initially, followed by 550 mg every 12 hours or 275 mg every 6 to 8 hours as needed. The maximum daily dose should not exceed 1375 mg on the initial day of treatment; thereafter it should not exceed 1100 mg per day.
The recommended dosage of controlled-release naproxen sodium for the treatment of mild to moderate pain is 1000 milligrams (mg) orally once daily. If adequate pain relief is not achieved initially, the dosage may be increased to 1500 mg once daily for a limited period of time. Once adequate pain control is achieved, the dosage should not exceed 1000 mg orally daily.
The recommended dose of over-the-counter naproxen sodium (Aleve(R)) for minor aches and pain is 220 to 440 milligrams (mg) initially, followed by 220 mg every 8 to 12 hours as needed while symptoms persist. The daily dose should not exceed 440 mg in any 8 to 12 hour period, and 660 mg in 24 hours. The duration of therapy should not be longer than 10 days unless directed by physician.
Primary dysmenorrhea
Dosing Information
The recommended dose of naproxen sodium for primary dysmenorrhea is 550 mg initially, followed by 550 mg every 12 hours or 275 mg every 6 to 8 hours as needed. The maximum daily dose should not exceed 1375 mg on the initial day of treatment; thereafter it should not exceed 1100 mg per day.
The recommended dosage of controlled-release naproxen sodium for primary dysmenorrhea is 1000 mg orally once daily. If adequate pain relief is NOT achieved initially, the dosage may be increased to 1500 mg once daily for a limited period of time. Once adequate pain control is achieved, the dosage should not exceed 1000 mg orally daily [48].
3) The recommended dose of over-the-counter naproxen sodium (Aleve(R)) is 220 to 440 milligrams (mg) initially, followed by 220 mg every 8 to 12 hours as needed while symptoms persist. The daily dose should not exceed 440 mg in any 8 to 12 hour period, and 660 mg in 24 hours. The duration of therapy should not be longer than 10 days unless directed by physician.
Rheumatoid arthritis
Dosing Information
The recommended dosage of naproxen sodium for rheumatoid arthritis is 275 or 550 milligrams (mg) twice daily in the morning and evening. The dosage should be adjusted depending on the clinical response and the morning and evening doses do not need to be equal in size. Administration more frequently than twice daily has not shown benefit. For long-term administration, lower doses may be adequate. A dose of 1650 mg/day may be used for up to 6 months in patients who have tolerated lower doses well. Patients should be observed to ensure the clinical benefits outweigh the increased risks.
The recommended dosage of controlled-release naproxen sodium for treating rheumatoid arthritis is 750 to 1000 milligrams (mg) orally once daily. If clinical response is not achieved initially, the dosage may be increased to 1500 mg once daily for a limited period of time. The dosage should be adjusted for each patient utilizing the smallest effective dose.
Single daily doses:
In an open, controlled study of 40 patients lasting 3 months, oral controlled-release naproxen 750 milligrams (mg) daily was compared with regular naproxen 500 mg twice daily. Clinical effectiveness, as determined by improvement in signs and symptoms of arthritis, was similar for both regimens.
Tendinitis
Dosing Information
The recommended dose of naproxen sodium for acute tendinitis is 550 milligrams (mg) initially, followed by 550 mg every 12 hours or 275 mg every 6 to 8 hours as needed. The maximum daily dose should not exceed 1375 mg on the initial day of treatment; thereafter it should not exceed 1100 mg per day.
The recommended dosage of controlled-release naproxen sodium for acute tendinitis is 1000 milligrams (mg) orally once daily. If adequate pain relief is not achieved initially, the dosage may be increased to 1500 mg once daily for a limited period of time. Once adequate pain control is achieved, the dosage should not exceed 1000 mg orally daily.
Over the counter naproxen sodium should not be taken for longer than 10 days unless directed by a physician. The smallest effective dose should be used.
Fever
Dosing Information
The recommended dose of over-the-counter naproxen sodium (Aleve(R)) for fever is 220 to 440 milligrams (mg) initially, followed by 220 mg every 8 to 12 hours as needed while symptoms persist. The daily dose should not exceed 440 mg in any 8 to 12 hour period, and 660 mg in 24 hours. The duration of therapy should not be longer than 10 days unless directed by physician.
Headache
Dosing Information
The recommended dose of over-the-counter naproxen sodium (Aleve(R)) for temporary relief of minor aches and pains due to headache is 220 to 440 milligrams (mg) initially, followed by 220 mg every 8 to 12 hours as needed while symptoms persist. The daily dose should not exceed 440 mg in any 8 to 12 hour period, and 660 mg in 24 hours. The duration of therapy should not be longer than 10 days unless directed by physician.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Naproxen sodium in adult patients.
Non–Guideline-Supported Use
condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Naproxen sodium in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Fever
Dosing Information
The recommended dose of over-the-counter naproxen sodium (Aleve(R)) in pediatric patients 12 years of age and older for fever is 220 to 440 milligrams (mg) initially, followed by 220 mg every 8 to 12 hours as needed while symptoms persist. The daily dose should not exceed 440 mg in any 8 to 12 hour period, and 660 mg in 24 hours. The duration of therapy should not be longer than 10 days unless directed by physician.
Pain(12 years and older)
Dosing Information
The recommended dose of over-the-counter naproxen sodium (Aleve(R)) in pediatric patients 12 years of age and older for minor aches and pain is 220 to 440 milligrams (mg) initially, followed by 220 mg every 8 to 12 hours as needed while symptoms persist. The daily dose should not exceed 440 mg in any 8 to 12 hour period, and 660 mg in 24 hours. The duration of therapy should not be longer than 10 days unless directed by physician.
Primary dysmenorrhea(12 years and older)
Dosing information
The recommended dose of over-the-counter naproxen sodium (Aleve(R)) in pediatric patients 12 years of age and older for primary dysmenorrhea is 220 to 440 milligrams (mg) initially, followed by 220 mg every 8 to 12 hours as needed while symptoms persist. The daily dose should not exceed 440 mg in any 8 to 12 hour period, and 660 mg in 24 hours. The duration of therapy should not be longer than 10 days unless directed by physician.
Headache(12 years and older)
Dosing Information
The recommended dose of over-the-counter naproxen sodium (Aleve(R)) in pediatric patients 12 years of age and older for temporary relief of minor aches and pains due to headache is 220 to 440 milligrams (mg) initially, followed by 220 mg every 8 to 12 hours as needed while symptoms persist. The daily dose should not exceed 440 mg in any 8 to 12 hour period, and 660 mg in 24 hours. The duration of therapy should not be longer than 10 days unless directed by physician.
Rheumatoid arthritis
Dosing Information
For children 2 years of age and older, the recommended total daily dose of naproxen sodium in juvenile arthritis is approximately 10 milligrams/kilogram (mg/kg) given in 2 divided doses (5 mg/kg given twice a day). Generally naproxen suspension is recommended in children because it allows more flexibility in dosing.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Naproxen sodium in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Naproxen sodium in pediatric patients.
Contraindications
Condition1
Warnings
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Naproxen sodium in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Naproxen sodium in the drug label.
