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]

Disclaimer

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Overview

Naproxen sodium is an analgesic, anti-inflammatory agent that is FDA approved for the treatment of ankylosing spondylitis, bursitis, acute gout, osteoarthritis, pain, primary dysmenorrhea, rheumatoid arthritis, tendinitis. Common adverse reactions include edema, ecchymosis, pruritus, rash, abdominal pain, constipation, heartburn, nausea, dizziness, headache, somnolence, ototoxicity, tinnitus, dyspnea.

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.
• 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

• There is limited information regarding Off-Label Guideline-Supported Use of Naproxen sodium in adult patients.

Non–Guideline-Supported Use

• 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

• There is limited information regarding Off-Label Guideline-Supported Use of Naproxen sodium in pediatric patients.

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Naproxen sodium in pediatric patients.

Contraindications

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

Warnings

Allergy alert

• Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives
• facial swelling
• asthma (wheezing)
• shock
• skin reddening
• rash
• blisters

• If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

• This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

• Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery

• Ask a doctor before use if

• the stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have asthma

• Ask a doctor or pharmacist before use if you are

• under a doctor's care for any serious condition
• taking any other drug

• When using this product

• take with food or milk if stomach upset occurs
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

• Stop use and ask a doctor if:

• you experience any of the following signs of stomach bleeding:

• feel faint
• vomit blood
• have bloody or black stools
• have stomach pain that does not get better

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• you have difficulty swallowing
• it feels like the pill is stuck in your throat
• redness or swelling is present in the painful area
• any new symptoms appear

• If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

• There is limited information regarding Clinical Trial Experience of Naproxen sodium in the drug label.

Postmarketing Experience

• There is limited information regarding Postmarketing Experience of Naproxen sodium in the drug label

Drug Interactions

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

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

• 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

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

Pharmacology

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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Patient Counseling Information

• Do not take more than directed
• The smallest effective dose should be used
• Drink a full glass of water with each dose

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

EC Naprosyn, Naprosyn.

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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