国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ISOSORBIDE DINITRATE (UNII: IA7306519N) (ISOSORBIDE DINITRATE - UNII:IA7306519N)
BluePoint Laboratories
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. Isosorbide dinitrate tablets are contraindicated in patients who are allergic to isosorbide dinitrate or any of its ingredients. Do not use isosorbide dinitrate 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 in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.
Isosorbide dinitrate tablets, USP are available as follows: Isosorbide dinitrate tablets USP, 30 mg, light blue to blue colored, spotted, round shaped, biconvex, uncoated tablets debossed with "1151" on one side and score on other side. NDC 68001-562-00 in bottles of 100 tablets with child-resistant closure Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from Light. Dispense in a light-resistant, tight container. Keep bottles tightly closed. Manufactured by: Zydus Lifesciences Ltd., Baddi, India For Bluepoint Laboratories Rev. 11/22
Abbreviated New Drug Application
ISOSORBIDE DINITRATE- ISOSORBIDE DINITRATE TABLET BLUEPOINT LABORATORIES ---------- ISOSORBIDE DINITRATE TABLETS, USP RX 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 compound, has a melting point of 70°C and has an optical rotation of +140° (c=1, alcohol, 20°C). Isosorbide dinitrate is very slightly soluble in water; very soluble in acetone and sparingly soluble in alcohol. Each isosorbide dinitrate tablet, USP contains 30 mg of isosorbide dinitrate. The inactive ingredients in each tablet are lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate and FD&C blue no. 1 aluminium lake. 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 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 effective than placebo after 阅读完整的文件