ISOSORBIDE DINITRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

ISOSORBIDE DINITRATE

Composition:

ISOSORBIDE DINITRATE 30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Allergic reactions to organic nitrates are extremely rare, but they do occur. Isosorbide dinitrate is contraindicated in patients who are allergic to isosorbide dinitrate or any of its other ingredients.

Product summary:

Isosorbide dinitrate tablets, USP are available as follows: 30 mg oral, blue, round, bisected tablets, debossed "PAR 009" on one side and supplied in blisterpacks of 30 tablets. Store at room temperature, approximately 25°C (77°F). Protect from light. Keep bottles tightly closed. Dispense in a light-resistant, tight container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE DINITRATE- ISOSORBIDE DINITRATE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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ISOSORBIDE DINITRATE TABLET 30MG
DESCRIPTION
Isosorbide dinitrate, an organic nitrate, is a vasodilator with
effects on both arteries and veins. The
chemical name for isosorbide dinitrate is 1,4:3,6-dianhydro-D-glucitol
2, 5-dinitrate. The compound
has the following structural formula:
C H N 0
MW 236.14
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.
Isosorbide dinitrate tablets are available for oral administration as
5 mg, 10 mg, 20 mg, or 30 mg tablets.
Each tablet contains the following inactive ingredients: lactose
anhydrous, magnesium stearate,
microcrystalline cellulose, sodium starch glycolate and stearic acid.
In addition, the 20 mg tablet
contains D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6; the 30 mg
tablet contains FD&C
Blue #1.
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