Drug Catalog - Product Detail
SALSALATE TABS 750MG 100CT
NDC | Mfr | Size | Str | Form |
---|---|---|---|---|
69367-0161-04 | WESTMINSTER PHARMACEUTICALS | 100 | 750MG | TABLET |
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Description
DESCRIPTION Salsalate, USP is a nonsteroidal anti-inflammatory agent for oral administration. Chemically, salsalate (salicylsalicylic acid or 2-hydroxybenzoic acid, 2-carboxyphenyl ester) is a dimer of salicylic acid; its structural formula is shown below. Chemical Structure: Inactive Ingredients: D&C Yellow No. 10 Aluminum Lake, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Polyethylene Glycol, Polysorbate 80, Polyvinyl Alcohol, Silicon Dioxide, Talc. Chemical Structure
How Supplied
HOW SUPPLIED 500 mg Tablets in bottles of 100 ct (NDC 69367-160-04) 500 mg Tablets in bottles of 500 ct (NDC 69367-160-06) Appearance, 500 mg: Yellow Colored, round, film-coated tablets debossed '809' on one side and plain on the other. 750 mg Tablets in bottles of 100 ct (NDC 69367-161-04) 750 mg Tablets in bottles of 500 ct (NDC 69367-161-06) Appearance, 750 mg: Yellow colored, capsule-shaped, filmcoated tablets debossed '810' on one side and bisect 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, and related rheumatic disorder.
Dosage and Administration
DOSAGE AND ADMINISTRATION 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 ). After observing the response to initial therapy with Salsalate Tablets, 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.