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Drug Catalog - Product Detail

NAPROXEN 375MG TB 100

NDC Mfr Size Str Form
68462-0189-01 GLENMARK PHARMACEUTICALS 100 375MG TABLET
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Description
DESCRIPTION Naproxen USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen USP and naproxen sodium USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen USP and naproxen sodium USP have the following structures, respectively: Naproxen USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen sodium USP has a molecular weight of 252.23 and a molecular formula of C 14 H 13 NaO 3 . Naproxen USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen USP at pH 7.4 is 1.6 to 1.8. Naproxen sodium USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen tablets USP are available as light orange colored tablets containing 250 mg of naproxen USP, light orange colored tablets containing 375 mg of naproxen USP and light orange colored tablets containing 500 mg of naproxen USP for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxides, povidone and magnesium stearate. Naproxen sodium tablets USP are available as blue tablets containing 275 mg of naproxen sodium USP and as blue tablets containing 550 mg of naproxen sodium USP for oral administration. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg tablet may contain Opadry blue 03F50544. The coating suspension for the naproxen sodium 550 mg tablet may contain Opadry blue 03F50544.
How Supplied
HOW SUPPLIED Naproxen tablets USP: 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of break line on one side and ‘250’ on the other side. Packaged in light-resistant bottles of 100 and 500. 100’s (bottle): NDC 68462-188-01 500’s (bottle): NDC 68462-188-05 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32” on one side and ‘375” on the other side. Packaged in light-resistant bottles of 60, 100 and 500. 60’s (bottle): NDC 68462-189-60 100’s (bottle): NDC 68462-189-01 500’s (bottle): NDC 68462-189-05 500 mg: capsule shaped, light orange colored, uncoated tablets, having debossed with ‘G’ and ‘32’ on either side of break line on one side and ‘500’ on the other side. Packaged in light-resistant bottles of 30, 50, 60, 100 and 500. 30’s (bottle): NDC 68462-190-30 50’s (bottle): NDC 68462-190-50 60’s (bottle): NDC 68462-190-60 100’s (bottle): NDC 68462-190-01 500’s (bottle): NDC 68462-190-05
Indications & Usage
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Naproxen as naproxen or naproxen sodium tablets are indicated: For the relief of the signs and symptoms of rheumatoid arthritis For the relief of the signs and symptoms of osteoarthritis For the relief of the signs and symptoms of ankylosing spondylitis For the relief of the signs and symptoms of juvenile arthritis Naproxen as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight. Naproxen as naproxen and naproxen sodium tablets are also indicated: For relief of the signs and symptoms of tendonitis For relief of the signs and symptoms of bursitis For relief of the signs and symptoms of acute gout For the management of pain For the management of primary dysmenorrhea
Dosage and Administration
DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. 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 naproxen or naproxen sodium the dose and frequency should be adjusted to suit an individual patient's needs. Different dose strengths and formulations (ie, tablets, suspension) of the drug are not necessarily bioequivalent. This difference should be taken into consideration when changing formulation. Although naproxen and naproxen sodium circulate in the plasma as naproxen, they have pharmacokinetic differences that may affect onset of action. Onset of pain relief can begin within 30 minutes in patients taking naproxen sodium and within 1 hour in patients taking naproxen. The recommended strategy for initiating therapy is to choose a formulation and a starting dose likely to be effective for the patient and then adjust the dosage based on observation of benefit and/or adverse events. A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see WARNINGS and PRECAUTIONS ). Geriatric Patients 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. Patients With Moderate to Severe Renal Impairment Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 mL/min) (see WARNINGS: Renal Effects ). Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis Naproxen 250 mg or 375 mg or 500 mg twice daily twice daily twice daily Naproxen sodium 275 mg (naproxen 250 mg with 25 mg sodium) 550 mg (naproxen 500 mg with 50 mg sodium) twice daily twice daily During long-term administration, the dose of naproxen may be adjusted up or down depending on the clinical response of the patient. A lower daily dose may suffice for long-term administration. The morning and evening doses do not have to be equal in size and the administration of the drug more frequently than twice daily is not necessary. In patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/day for limited periods of up to 6 months when a higher level of anti-inflammatory/ analgesic activity is required. When treating such patients with naproxen 1500 mg/day, the physician should observe sufficient increased clinical benefits to offset the potential increased risk. The morning and evening doses do not have to be equal in size and administration of the drug more frequently than twice daily does not generally make a difference in response (see CLINICAL PHARMACOLOGY ). Juvenile Arthritis The recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses (ie, 5 mg/kg given twice a day). Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis The recommended starting dose is 550 mg of naproxen sodium as naproxen sodium tablet followed by 550 mg every 12 hours or 275 mg every 6 to 8 hours as required. The initial total daily dose should not exceed 1375 mg of naproxen sodium. Thereafter, the total daily dose should not exceed 1100 mg of naproxen sodium. Because the sodium salt of naproxen is more rapidly absorbed, naproxen sodium tablets are recommended for the management of acute painful conditions when prompt onset of pain relief is desired. Naproxen may also be used for initial treatment of acute pain (see CLINICAL PHARMACOLOGY , INDICATIONS AND USAGE ). Acute Gout The recommended starting dose is 750 mg of naproxen followed by 250 mg every 8 hours until the attack has subsided. Naproxen sodium may also be used at a starting dose of 825 mg followed by 275 mg every 8 hours.