Nitrate Vasodilator
Isordil
The FDA lists this product in 10 strengths and forms.
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.
Contraindications
Isosorbide Dinitrate is contraindicated in patients who are allergic to isosorbide dinitrate or any of its ingredients. Do not use Isosorbide Dinitrate in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not use Isosorbide Dinitrate in patients who are taking the soluble guanylate cyclase stimulator riociguat.
Concomitant use can cause hypotension.
Warnings and precautions
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.
Interactions
Drug Interactions The vasodilating effects of isosorbide dinitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety. Concomitant use of Isosorbide Dinitrate with phosphodiesterase inhibitors in any form is contraindicated (see CONTRAINDICATIONS ). Concomitant use of Isosorbide Dinitrate with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see CONTRAINDICATIONS ).
At a glance
- Brand name
- Isordil
- Active substance
- isosorbide dinitrate
- Pharmacologic class
- Nitrate Vasodilator
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Bausch
- Status
- Discontinued
- FDA approval
- 9 Nov 1959
- Application
- NDA012093-002



