ISOSORBIDE DINITRATE tablet extended release

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

ISOSORBIDE DINITRATE (UNII: IA7306519N) (ISOSORBIDE - UNII:WXR179L51S)

Verfügbar ab:

KAISER FOUNDATION HOSPITALS

INN (Internationale Bezeichnung):

ISOSORBIDE DINITRATE

Zusammensetzung:

ISOSORBIDE DINITRATE 40 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

ISOSORBIDE DINITRATE - ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE
KAISER FOUNDATION HOSPITALS
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DESCRIPTION
Isosorbide dinitrate (ISDN), an organic nitrate, is a vasodilator with
effects on both arteries and veins.
Isosorbide dinitrate is available as 40 mg extended-release tablets.
The chemical name for isosorbide
dinitrate 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 Extended-release tablet, for oral
administration, contains 40 mg of isosorbide
dinitrate, in a matrix that causes the active drug to be released over
a sustained period. In addition, each
tablet also contains the following inactive ingredients: anhydrous
lactose, colloidal silicon dioxide,
FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, and
stearic acid.
The product meets USP Dissolution Test 2.
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