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:

West-ward Pharmaceutical Corp

INN (International Name):

ISOSORBIDE DINITRATE

Composition:

ISOSORBIDE DINITRATE 2.5 mg

Administration route:

SUBLINGUAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE DINITRATE- ISOSORBIDE DINITRATE TABLET
WEST-WARD PHARMACEUTICAL CORP
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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.
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