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Basic Drug Info
Drug Name:Isosorbide Dinitrate
Manufacturer:Sandoz Inc.
Other Info:

Rev.

04-2004M7185Manufactured bySandoz Inc.Broomfield, CO 80020



Clinical Trials:


Indications and Usage

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.
Angina Pectoris -- The symptom of paroxysmal pain consequent to MYOCARDIAL ISCHEMIA usually of distinctive character, location and radiation. It is thought to be provoked by a transient stressful situation during which the oxygen requirements of the MYOCARDIUM exceed that supplied by the CORONARY CIRCULATION.

Coronary Artery Disease -- Pathological processes of CORONARY ARTERIES that may derive from a congenital abnormality, atherosclerotic, or non-atherosclerotic cause.

Contraindications

Allergic reactions to organic nitrates are extremely rare, but they do occur.

Isosorbide dinitrate tablets are contraindicated in patients who are allergic to isosorbide dinitrate or any other component of the product.
Allergic Reaction --

Warnings

Amplification of the vasodilatory effects of isosorbide dinitrate by sildenafil can result in severe hypotension.

The time course and dose dependence of this interaction have not been studied.

Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.The benefits of immediate release oral isosorbide dinitrate in patients with acute myocardial infarction or congestive heart failure have not been established.

If one elects to use isosorbide dinitrate in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.

Because the effects of oral isosorbide dinitrate are so difficult to terminate rapidly, this formulation is not recommended in these settings.
Branded Drugs
The following US Branded drugs contain Isosorbide Dinitrate


BIDIL -- NITROMED INC

DILATRATE-SR -- SCHWARZ PHARMA INC

ISORDIL -- WYETH AYERST LABORATORIES

SORBITRATE -- ASTRAZENECA PHARMACEUTICALS LP

ISORDIL -- BIOVAIL LABORATORIES INC


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