Drug Catalog - Product Detail
ISOSORBIDE DINITRATE E.R. TB 40MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 57664-0600-88 | SUN PHARMACEUTICALS | 100 | 40MG | TABLET |
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Description
DESCRIPTION Isosorbide dinitrate (ISDN), an organic nitrate, is a vasodilator with effects on both arteries and veins. Isosorbide dinitrate is available as 40 mg extended-release tablets. The chemical name for isosorbide dinitrate is 1 ,4:3,6–dianhydro–D–glucitol 2, 5-dinitrate, an organic nitrate whose structural formula is and whose molecular weight is 236.14. The organic nitrates are vasodilators, active on both arteries and veins. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1.0, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents, such as acetone, alcohol, and ether, but is only sparingly soluble in water. Each Isosorbide Dinitrate Extended-release tablet, for oral administration, contains 40 mg of isosorbide dinitrate, in a matrix that causes the active drug to be released over a sustained period. In addition, each tablet also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, and stearic acid. The product meets USP Dissolution Test 2. chemical-strucure
How Supplied
HOW SUPPLIED Isosorbide Dinitrate Extended–release Tablets, USP 40 mg are available as round, scored, peach colored tablets, debossed IL/3613, in bottles of 100 (NDC 57664–600–88) and 1000 (NDC 57664–600–18). STORAGE Store at 25°C (77°F); excursions permitted to 15-30°C (59–86°F) [see USP Controlled Room Temperature]. Dispense in well closed container. Manufactured by: Forest Pharmaceuticals, Inc. St. Louis, MO 63045 USA Distributed by: Caraco Pharmaceutical Laboratories, Ltd. 1150 Elijah McCoy Drive Detroit, MI 48202 C.S. No.: 7103T01 Rev. 09/09 MG #28542
Indications & Usage
INDICATIONS AND USAGE Isosorbide Dinitrate Extended-release Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of controlled- release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
Dosage and Administration
DOSAGE AND ADMINISTRATION As noted under “ CLINICAL PHARMACOLOGY ” multiple-dose studies with ISDN and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for Isosorbide Dinitrate Extended-release Tablets must provide a daily dose-free interval to minimize the development of this tolerance. With immediate-release ISDN, it appears that one daily dose-free interval must be at least 14 hours long. The necessary dose- free interval for Isosorbide Dinitrate Extended-release Tablets has not been clearly identified, but is presumably somewhat longer. As also noted under “ CLINICAL PHARMACOLOGY” , only one trial has ever studied the use of controlled-release isosorbide dinitrate for more than one dose. In that trial, 40 mg of a different formulation of controlled-release ISDN was administered twice daily in doses given 6 hours apart. After 4 weeks, active treatment could not be distinguished from placebo. Large controlled studies with other nitrates suggest that no dosing regimen with Isosorbide Dinitrate Extended-release Tablets should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day. In clinical trials, immediate-release oral isosorbide dinitrate has been administered in a variety of regimens, with total daily doses ranging from 30 mg to 480 mg.