Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
ISOSORBIDE DINITRATE (UNII: IA7306519N) (ISOSORBIDE DINITRATE - UNII:IA7306519N)
West-ward Pharmaceutical Corp
ISOSORBIDE DINITRATE
ISOSORBIDE DINITRATE 2.5 mg
SUBLINGUAL
PRESCRIPTION DRUG
Isosorbide dinitrate sublingual tablets are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. However, because the onset of action of sublingual ISDN is significantly slower than that of sublingual nitroglycerin, sublingual ISDN is not the drug of first choice for abortion of an acute anginal episode. Allergic reactions to organic nitrates are extremely rare, but they do occur. The isosorbide dinitrate sublingual tablet is contraindicated in patients who are allergic to ISDN or any of its other ingredients.
Isosorbide Dinitrate Sublingual Tablets USP 2.5 mg: Yellow, round, compressed tablet imprinted "W1". Isosorbide Dinitrate Sublingual Tablets USP 5 mg: White, round, compressed tablet engraved with "W3". Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. 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 November 2007
Abbreviated New Drug Application
ISOSORBIDE DINITRATE- ISOSORBIDE DINITRATE TABLET WEST-WARD PHARMACEUTICAL CORP ---------- ISOSORBIDE DINITRATE SUBLINGUAL TABLETS, USP Rev 11/07 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. ISDN 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). ISDN is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Each isosorbide dinitrate sublingual tablet contains 2.5 mg or 5 mg of ISDN. Inactive ingredients are as follows: 2.5 MG SUBLINGUAL: Ammonium phosphate dibasic, anhydrous lactose, colloidal silicon dioxide, corn starch, D&C Yellow No. 10 Lake, FD&C Yellow No. 6 Lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. 5 MG SUBLINGUAL: Ammonium phosphate dibasic, anhydrous lactose, colloidal silicon dioxide, corn starch, magnesium stearate, 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 lesistance, 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. T Preberite celoten dokument