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Drug Catalog - Product Detail

SALSALATE 750MG TAB 100CT

NDC Mfr Size Str Form
51293-0804-01 ECI PHARMACEUTICALS 100 750MG TABLET
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Description
DESCRIPTION Salsalate, is a nonsteroidal anti-inflammatory agent for oral administration. Chemically, salsalate (salicylsalicylic acid or 2-hydroxy-benzoic acid, 2-carboxyphenyl ester) is a dimer of salicylic acid; its structural formula is shown below. Chemical Structure: Tablets: Inactive Ingredients: Carnauba wax, Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Yellow #10, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Stearic Acid, Titanium Dioxide, 401aea08-figure-01
How Supplied
HOW SUPPLIED 500mg Tablets: Supplied in bottles of 100ct (NDC 51293-803-01) 500ct (NDC 51293-803-05) 1000ct (NDC 51293-803-10) Appearance: Yellow colored, round, film-coated tablets debossed “AN” over “512” on one side and plain on the other. 750mg Tablets: Supplied in bottles of 100ct (NDC 51293-804-01) 500ct (NDC 51293-804-05) 1000ct (NDC 51293-804-10) Appearance: Yellow colored, capsule-shaped, scored, film-coated tablets debossed “AN 513” on one side and plain on the other. Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Rx only
Indications & Usage
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Salsalate tablets, USP and other treatment options before deciding to use Salsalate tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Salsalate is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorder.
Dosage and Administration
DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of Salsalate tablet, USP and other treatment options before deciding to use Salsalate tablet, USP. 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 Salsalate tablet, USP, the dose and frequency should be adjusted to suit an individual patient's needs. Salsalate is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorder. Adults: The usual dosage is 3000 mg daily, given in divided doses as follows: 1) two doses of two 750 mg tablets; 2) two doses of three 500 mg tablets; or 3) three doses of two 500 mg tablets. Some patients, e.g., the elderly, may require a lower dosage to achieve therapeutic blood concentrations and to avoid the more common side effects such as auditory. Alleviation of symptoms is gradual, and full benefit may not be evident for 3 to 4 days, when plasma salicylate levels have achieved steady state. There is no evidence for development of tissue tolerance (tachyphylaxis), but salicylate therapy may induce increased activity of metabolizing liver enzymes, causing a greater rate of salicyluric acid production and excretion, with a resultant increase in dosage requirement for maintenance of therapeutic serum salicylate levels. Children: Dosage recommendations and indications for salsalate use in children have not been established.