May 6, 2016
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Naprelan

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Naprelan

Indications
Dosage
How Supplied

INDICATIONS

Carefully consider the potential benefits and risks of NAPRELAN® Tablets and other treatment options before deciding to use NAPRELAN® Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

NAPRELAN® Tablets are indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis, and acute gout. It is also indicated in the relief of mild to moderate pain and the treatment of primary dysmenorrhea.

DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of NAPRELAN® and other treatment options before deciding to use NAPRELAN®. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). After observing the response to initial therapy with NAPRELAN®, the dose and frequency should be adjusted to suit an individual patient's needs.

For The Relief Of

Rheumatoidarthritis, Osteoarthritis, Andankylosing Spondylitis

The recommended starting dose of NAPRELAN® Tablets in adults is two NAPRELAN® 375 mg tablets (750 mg) once daily, one NAPRELAN® 750 mg tablet (750 mg) once daily, or two NAPRELAN® 500 mg tablets (1000 mg) once daily. Patients already taking naproxen 250 mg, 375 mg, or 500 mg twice daily (morning and evening) may have their total daily dose replaced with NAPRELAN Tablets as a single daily dose.

During long-term administration, the dose of NAPRELAN® Tablets may be adjusted up or down depending on the clinical response of the patient. In patients who tolerate lower doses of NAPRELAN® Tablets well, the dose may be increased to two NAPRELAN® 750 mg tablets (1500 mg), or three NAPRELAN® 500 mg tablets (1500 mg) once daily for limited periods when a higher level of anti-inflammatory/analgesic activity is required. When treating patients, especially at the higher dose levels, the physician should observe sufficient increased clinical benefit to offset the potential increased risk (see CLINICAL PHARMACOLOGY). The lowest effective dose should be sought and used in every patient. Symptomatic improvement in arthritis usually begins within one week; however, treatment for two weeks may be required to achieve a therapeutic benefit. A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see PRECAUTIONS). Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly it is prudent to use the lowest effective dose.

Management Of Pain, Primary Dysmenorrhea, And Acute Tendinitis And Bursitis

The recommended starting dose is two NAPRELAN® 500 mg tablets (1000 mg) once daily. For patients requiring greater analgesic benefit, two NAPRELAN® 750 mg tablets (1500 mg) or three NAPRELAN® 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two NAPRELAN® 500 mg tablets (1000 mg).

Acute Gout

The recommended dose on the first day is two to three NAPRELAN® 500 mg tablets (1000 - 1500 mg) once daily, followed by two NAPRELAN® 500 mg tablets (1000 mg) once daily, until the attack has subsided.

HOW SUPPLIED

NAPRELAN® (naproxen sodium) Controlled-Release Tablets are available as follows: NAPRELAN® 375: white, capsule-shaped tablet with “N” on one side and “375” on the reverse; in bottles of 100; NDC 52427-272-01. Each tablet contains 412.5 mg naproxen sodium equivalent to 375 mg naproxen.

NAPRELAN® 500: white, capsule-shaped tablet with “N” on one side and “500” on the reverse; in bottles of 75; NDC 52427-273-75. Each tablet contains 550 mg naproxen sodium equivalent to 500 mg naproxen.

NAPRELAN® 750: white, capsule-shaped tablet with “N” on one side and “750” on the reverse; in bottles of 30; NDC 52427-274-30, Each tablet contains 825 mg naproxen sodium equivalent to 750 mg naproxen.

Store at controlled room temperature, 20° - 25° C (68° - 77° F).

PHARMACIST Dispense in a well-closed container.

To request medical information or to report SUSPECTED ADVERSE REACTIONS, contact Alvogen, Inc. at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Manufactured by: Alkermes Pharma Ireland Limited (APIL), Athlone, Ireland. Distributed by: Almatica Pharma, Inc., Pine Brook, NJ 07058 USA. Rev. Oct 2014

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/25/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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