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Drug Catalog - Product Detail

DIFLUNISAL TB 500MG 100

NDC Mfr Size Str Form
64980-0181-01 RISING PHARMACEUTICALS 100 500MG TABLET
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Description
DESCRIPTION Diflunisal is [1, 1'-Biphenyl]-3-carboxylic acid, 2', 4'-difluoro-4-hydroxy. Its structural formula is: Molecular Formula: C 13 H 8 F 2 O 3 Molecular Weight: 250.20 g/mol Diflunisal is a stable, white, crystalline compound with a melting point of 211° to 213°C. It is practically insoluble in water at neutral or acidic pH. Because it is an organic acid, it dissolves readily in dilute alkali to give a moderately stable solution at room temperature. It is soluble in most organic solvents including ethanol, methanol, and acetone. Each tablet, for oral administration, contains 500 mg diflunisal. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Blue No. 2, hypromellose, microcrystalline cellulose, pregelatinized starch, propylene glycol, sodium stearyl fumarate and titanium dioxide. structure
How Supplied
HOW SUPPLIED Diflunisal tablets USP are supplied as follows: 500 mg tablets: Modified Capsule shaped, blue film coated tablets, Debossed "EP 170" on one side and plain on the reverse side. Bottles of 60: NDC 64980-181-06 Bottles of 100: NDC 64980-181-01 Bottles of 500: NDC 64980-181-05 Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Keep tightly closed. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401 Manufactured by: Heritage Pharma Labs Inc. East Brunswick, NJ 08816 Revised: 05/2016
Indications & Usage
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diflunisal tablets and other treatment options before deciding to use diflunisal tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Diflunisal tablets are indicated for acute or long-term use for symptomatic treatment of the following: Mild to moderate pain Osteoarthritis Rheumatoid arthritis
Dosage and Administration
DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of diflunisal tablets and other treatment options before deciding to use diflunisal 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 diflunisal tablets, the dose and frequency should be adjusted to suit an individual patient's needs. Concentration-dependent pharmacokinetics prevail when diflunisal is administered; a doubling of dosage produces a greater than doubling of drug accumulation. The effect becomes more apparent with repetitive doses. For mild to moderate pain, an initial dose of 1000 mg followed by 500 mg every 12 hours is recommended for most patients. Following the initial dose, some patients may require 500 mg every 8 hours. A lower dosage may be appropriate depending on such factors as pain severity, patient response, weight, or advanced age; for example, 500 mg initially, followed by 250 mg every 8 to 12 hours. For osteoarthritis and rheumatoid arthritis, the suggested dosage range is 500 mg to 1000 mg daily in two divided doses. The dosage of diflunisal may be increased or decreased according to patient response. Maintenance doses higher than 1500 mg a day are not recommended. Tablets should be swallowed whole, not crushed or chewed.