Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
ISOSORBIDE DINITRATE (UNII: IA7306519N) (ISOSORBIDE DINITRATE - UNII:IA7306519N)
West-ward Pharmaceutical Corp
ISOSORBIDE DINITRATE
ISOSORBIDE DINITRATE 30 mg
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. 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; Debossed “WW 773” on Scored side. Bottles of 30 tablets. Bottles of 100 tablets. Bottles of 500 tablets. Bottles of 1000 tablets. 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 Revised December 2010
Abbreviated New Drug Application
ISOSORRBIDE DINITRATE- ISOSORBDIE DINITRATE TABLET WEST-WARD PHARMACEUTICAL CORP ---------- ISOSORBIDE DINITRATE TABLETS DESCRIPTION Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate, an organic nitrate whose structural formula is: 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). Isosorbidedinitrate is freely soluble in organic solvents such as acetone, alcohol, and, 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 Aluminum 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 effective than placebo after 24 hours (or less) of continuous therapy.Attempts to overcome nitrate toler Lugege kogu dokumenti