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Drug Catalog - Product Detail

ISOSORBIDE DINITRATE ORAL TB 20MG 100

NDC Mfr Size Str Form
00143-1772-01 HIKMA 100 20MG TABLET
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Description
DESCRIPTION Isosorbide dinitrate (ISDN) 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 Tablet, USP contains 5 mg, 10 mg, or 20 mg of isosorbide dinitrate. Inactive ingredients are as follows: 5 mg and 10 mg: Ammonium phosphate dibasic, anhydrous lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. 20 mg: Ammonium phosphate dibasic, anhydrous lactose, D&C Yellow No. 10 Lake, FD&C Blue No. 1 Lake, FD&C Yellow No. 6 Lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Isosorbide Dinitrate Chemical Structurre
How Supplied
HOW SUPPLIED Isosorbide Dinitrate Tablets, USP 5 mg: White, Round, Scored Tablets Debossed “West-ward 769”. Bottles of 100 tablets NDC 0143-1769-01 Isosorbide Dinitrate Tablets, USP 10 mg: White, Round, Scored Tablets Debossed “WW” on one side and “771” on the other side. Bottles of 100 tablets NDC 0143-1771-01 Isosorbide Dinitrate Tablets, USP 20 mg: Green, Round, Scored Tablets Debossed “WW” on one side and “772” on the other side. Bottles of 100 tablets NDC 0143-1772-01 Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Manufactured by: HIKMA Pharmaceuticals P.O. Box 182400 Amman 11118 – Jordan Distributed by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 USA Revised December 2017
Indications & Usage
INDICATIONS AND USAGE: Isosorbide Dinitrate Tablets, USP are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-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 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. As also noted under CLINICAL PHARMACOLOGY , the effects of the second and later doses have been smaller and shorter-lasting than the effects of the first. Large controlled studies with other nitrates suggest that no dosing regimen with isosorbide dinitrate tablets should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day. As with all titratable drugs, it is important to administer the minimum dose which produces the desired clinical effect. The usual starting dose of isosorbide dinitrate tablets is 5 mg to 20 mg, two or three times daily. For maintenance therapy, 10 mg to 40 mg, two or three times daily is recommended. Some patients may require higher doses. A daily dose-free interval of at least 14 hours is advisable to minimize tolerance. The optimal interval will vary with the individual patient, dose and regimen.