Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
ISOSORBIDE DINITRATE (UNII: IA7306519N) (ISOSORBIDE DINITRATE - UNII:IA7306519N)
BluePoint Laboratories
ORAL
PRESCRIPTION DRUG
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. Isosorbide dinitrate tablets are contraindicated in patients who are allergic to isosorbide dinitrate or any of its ingredients. Do not use isosorbide dinitrate tablets in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not use isosorbide dinitrate tablets in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.
Isosorbide Dinitrate Tablets, USP 5 mg: White, Round, Scored Tablets Debossed "West-ward 769". NDC 68001-373-00 Bottles of 100 Isosorbide Dinitrate Tablets, USP 10 mg: White, Round, Scored Tablets Debossed "WW" on one side and "771" on the other side. NDC 68001-374-00 Bottles of 100 Isosorbide Dinitrate Tablets, USP 20 mg: Green, Round, Scored Tablets Debossed "WW" on one side and "772" on the other side. NDC 68001-375-00 Bottles of 100 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 For BluePoint Laboratories
Abbreviated New Drug Application
ISOSORBIDE- ISOSORBIDE DINITRATE TABLET BLUEPOINT LABORATORIES ---------- ISOSORBIDE DINITRATE TABLETS, USP Rev 10/08 R ONLY 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. CLINICAL PHARMACOLOGY The principal pharmacological action of isosorbide dinitrate 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 X are continuously greater than a minimally effective concentration. This stra Прочетете целия документ