Dilatrate Sr Recall
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Questions & Answers
Side Effects & Adverse Reactions
Amplification of the vasodilatory effects of dilatrate®-SR 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 extended-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 extended-release oral isosorbide dinitrate are so difficult to terminate rapidly, this formulation is not recommended in these settings.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
dilatrate®-SR sustained release capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of controlled-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
There is currently no drug history available for this drug.
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. Each dilatrate®-SR sustained release capsule contains 40 mg of isosorbide dinitrate, in a microdialysis delivery system that causes the active drug to be released over an extended period. Each capsule also contains ethylcellulose, lactose, pharmaceutical glaze, starch, sucrose and talc. The capsule shells contain D&C Red 33, D&C Yellow 10, gelatin and titanium dioxide.