isosorbide dinitrate
isosorbide dinitrate is listed in the FDA National Drug Code directory with 19 NDC codes, marketed under brand names including Isosorbide Dinitrate, ISOSORBIDE DINITRATE. Available dosage form: tablet.
Drug Details
- Generic Name
- isosorbide dinitrate
- Brand Names
- Isosorbide Dinitrate, ISOSORBIDE DINITRATE
- Application Number
- ANDA086923
- Sponsor
- AvPAK
- NDC Codes
- 19
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- ISOSORBIDE DINITRATE
Indications and Usage
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.
Warnings
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.