Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
Isosorbide Dinitrate (UNII: IA7306519N) (Isosorbide Dinitrate - UNII:IA7306519N)
West-ward Pharmaceutical Corp.
Isosorbide Dinitrate
TABLET
30 mg
ORAL
PRESCRIPTION DRUG
Isosorbide dinitrate tablets 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. Allergic reactions to organic nitrates are extremely rare, but they do occur. The isosorbide dinitrate tablet is contraindicated in patients who are allergic to ISDN or any of its other ingredients.
Isosorbide Dinitrate Tablets USP (Oral) 30 mg: Blue, round, scored tablets embossed “WW 773” on scored side.. Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Also available: Isosorbide Dinitrate Sublingual Tablets in the following dosage strengths: 2.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets. 5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets. Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths: 5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets. 10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets. 20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets. Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Issued August 2004
ISOSORBIDE DINITRATE- ISOSORBIDE DINITRATE TABLET WEST-WARD PHARMACEUTICAL CORP. ---------- ISOSORBIDE DINITRATE TABLETS, USP (ORAL) Iss. 08/04 RX ONLY DESCRIPTION Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate, an organic nitrate whose structural formula is: 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 contains 30 mg of ISDN. Inactive ingredients are as follows: Ammonium phosphate dibasic, colloidal silicon dioxide, FD&C Blue No. 1 Lake, lactose monohydrate, magnesium stearate and microcrystalline cellulose. CLINICAL PHARMACOLOGY The principal pharmacological action of ISDN is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins, especially the latter. Dilatation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (afterload). Dilatation of the coronary arteries also occurs. The relative importance of preload reduction, afterload reduction, and coronary dilatation remains undefined. Dosing regimens for most chronically used drugs are designed to provide plasma concentrations that are continuously greater than a minimally effective concentration. This strategy is inappropriate for organic nitrates. Several well-controlled clinical trials have used exercise testing to assess the anti- anginal efficacy of continuously-delivered nitrates. In the large majority of these trials, active agents were no more Aqra d-dokument sħiħ