Naproxen sodium

Naproxen sodium
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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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

• Dosage

Pain(12 years and older)

• Dosing Information

• Dosage

Primary dysmenorrhea(12 years and older)

• Dosing Information

• Dosage

Headache(12 years and older)

• Dosing Information

• Dosage

Rheumatoid arthritis

• Dosing Information

• Dosage

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.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Naproxen sodium in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Naproxen sodium during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Naproxen sodium with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Naproxen sodium with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Naproxen sodium with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Naproxen sodium with respect to specific gender populations.

Race

There is no FDA guidance on the use of Naproxen sodium with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Naproxen sodium in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Naproxen sodium in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Naproxen sodium in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Naproxen sodium in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Naproxen sodium in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Naproxen sodium in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Naproxen sodium in the drug label.

Pharmacology

There is limited information regarding Naproxen sodium Pharmacology in the drug label.

Mechanism of Action

Structure

File:Naproxen sodium01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Naproxen sodium in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Naproxen sodium in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Naproxen sodium in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Naproxen sodium in the drug label.

How Supplied

Storage

There is limited information regarding Naproxen sodium Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Naproxen sodium in the drug label.

Precautions with Alcohol

• Alcohol-Naproxen sodium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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