RVP

Drug Catalog - Product Detail

NAPROXEN SOD CR TABS 500MG 75CT

NDC Mfr Size Str Form
62037-0826-75 ACTAVIS PHARMA 75 500MG TABLET
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Description
11 DESCRIPTION Naproxen sodium extended-release tablets are a nonsteroidal anti-inflammatory drug, available as extended-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C 14 H 13 NaO 3 , and it has the following chemical structure. Naproxen sodium, USP is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. Naproxen sodium extended-release tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, USP equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each naproxen sodium extended-release tablet also contains the following inactive ingredients: black iron oxide, colloidal silicon dioxide, ethyl acrylate/methyl methacrylate copolymer, fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, and propylene glycol. The tablet coating contains hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Naproxen sodium extended-release tablets are available as follows: 375 mg: white, unscored, round tablet imprinted with “ Andrx 825 ”, in bottles of 100, NDC 62037-825-01. Each tablet contains 412.5 mg naproxen sodium, USP equivalent to 375 mg naproxen. 500 mg: white, unscored, capsule-shaped tablet imprinted with “ Andrx 826 ”; in bottles of 75, NDC 62037-826-75. Each tablet contains 550 mg naproxen sodium, USP equivalent to 500 mg naproxen. 750 mg: white, unscored, capsule-shaped, film-coated tablets printed with “ A750 ” on one side and plain on the other side, in bottles of 30, NDC 62037-827-30. Each tablet contains 825 mg naproxen sodium, USP equivalent to 750 mg naproxen. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PHARMACIST: Dispense in a well-closed container.
Indications & Usage
1 INDICATIONS AND USAGE Naproxen sodium extended-release tablets are indicated for the treatment of: rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain [see Warnings and Precautions (5) ] . Naproxen sodium extended-release tablets are a nonsteroidal anti-inflammatory drug indicated for the treatment of: rheumatoid arthritis (RA)( 1 ) osteoarthritis (OA)( 1 ) ankylosing spondylitis (AS)( 1 ) tendinitis, bursitis ( 1 ) acute gout ( 1 ) primary dysmenorrhea (PD)( 1 ) the relief of mild to moderate pain ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2 ) RA, OA, and AS: The dosage is two 375 mg or 500 mg tablets once daily, or one 750 mg tablet once daily. Management of Pain, PD, and Acute Tendinitis and Bursitis: The dosage is two 500 mg tablets once daily. For patients requiring greater analgesic benefit, two 750 mg tablets or three 500 mg tablets may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets. For the treatment of Acute Gout: The dosage is two to three 500 mg tablets once daily on the first day, followed by two 500 mg tablets once daily, until the attack has subsided. 2.1 General Dosing Instructions Carefully consider the potential benefits and risks of naproxen and other treatment options before deciding to use naproxen sodium extended-release tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ] . After observing the response to initial therapy with naproxen sodium extended-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs. 2.2 Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis The recommended starting dose of naproxen sodium extended-release tablets in adults is two naproxen sodium extended-release 375 mg tablets (750 mg) once daily, one naproxen sodium extended-release 750 mg (750 mg) once daily, or two naproxen sodium extended-release 500 mg tablets (1,000 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 naproxen sodium extended-release tablets as a single daily dose. During long-term administration, the dose of naproxen sodium extended-release tablets may be adjusted up or down depending on the clinical response of the patient. In patients who tolerate lower doses of naproxen sodium extended-release tablets well, the dose may be increased to two naproxen sodium extended-release 750 mg tablets (1,500 mg), or three naproxen sodium extended-release 500 mg tablets (1,500 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 (12.3) ] . 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. 2.3 Management of Pain, Primary Dysmenorrhea, and Acute Tendinitis and Bursitis The recommended starting dose is two naproxen sodium extended-release 500 mg tablets (1,000 mg) once daily. For patients requiring greater analgesic benefit, two naproxen sodium extended-release 750 mg tablets (1,500 mg) or three naproxen sodium extended-release 500 mg tablets (1,500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two naproxen sodium extended-release 500 mg tablets (1,000 mg). 2.4 Acute Gout The recommended dose on the first day is two to three naproxen sodium extended-release 500 mg tablets (1,000 to 1,500 mg) once daily, followed by two naproxen sodium extended-release 500 mg tablets (1,000 mg) once daily, until the attack has subsided. 2.5 Dosage Adjustments in Patients with Hepatic Impairment A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients [see Warnings and Precautions (5.3) ] . 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.