isosorbide mononitrate
Drug Details
- Generic Name
- isosorbide mononitrate
- Brand Names
- isosorbide mononitrate
- Application Number
- NDA020215
- Sponsor
- Proficient Rx LP
- NDC Codes
- 7
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- ISOSORBIDE MONONITRATE
Indications and Usage
INDICATIONS AND USAGE Isosorbide mononitrate extended-release tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate 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 mononitrate 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 ISMN in patients with acute myocardial infarction or congestive heart failure have not been established; because the effects of isosorbide mononitrate are difficult to terminate rapidly, this drug is not recommended in these settings. If isosorbide mononitrate is used in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.