Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ISOSORBIDE MONONITRATE (UNII: LX1OH63030) (ISOSORBIDE MONONITRATE - UNII:LX1OH63030)
NCS HealthCare of KY, Inc dba Vangard Labs
ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATE 10 mg
ORAL
PRESCRIPTION DRUG
Isosorbide mononitrate tablets are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate 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. Isosorbide mononitrate is contraindicated in patients who are allergic to it.
Isosorbide mononitrate tablets, USP are available as follows: 10 mg — Each blue, round, tablet imprinted with and 631 on one side and scored on the other side, contains 10 mg of isosorbide mononitrate (diluted), USP. Tablets are supplied in blisterpacks of 30 (NDC 0615-5549-39). 20 mg — Each blue, round, tablet imprinted with and 620 on one side and scored on the other side, contains 20 mg of isosorbide mononitrate (diluted), USP. Tablets are supplied in blisterpacks of 30 (NDC 0615-5550-39). Dispense in tight containers as defined in the USP. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep tightly closed. Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA 40-8813 Revised — August 2008
Abbreviated New Drug Application
ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- ISOSORBIDE MONONITRATE TABLETS, USP 40-8813 REVISED — AUGUST 2008 RX ONLY DESCRIPTION Isosorbide mononitrate (diluted), USP, an organic nitrate, is a vasodilator with effects on both arteries and veins. The molecular formula is C H NO and the molecular weight is 191.14. The chemical name for isosorbide mononitrate is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate and the compound has the following structural formula: Isosorbide mononitrate tablets, USP, for oral administration, contain 10 mg or 20 mg of isosorbide mononitrate (diluted), USP. In addition, each tablet contains the following inactive ingredients: calcium stearate, colloidal silicon dioxide, corn starch, FD&C Blue #1HT Aluminum Lake, lactose monohydrate, microcrystalline cellulose, and talc. CLINICAL PHARMACOLOGY Isosorbide mononitrate is the major active metabolite of isosorbide dinitrate (ISDN), and most of the clinical activity of the dinitrate is attributable to the mononitrate. The principal pharmacological action of isosorbide mononitrate 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. PHARMACODYNAMICS: 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 Přečtěte si celý dokument