Isorbide Dinitrate
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Questions & Answers
Side Effects & Adverse Reactions
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 nitrate overdose, with elevation of the extremities and with central volume expansion.
The benefits of controlled-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 controlled-release oral isosorbide dinitrate are so difficult to terminate rapidly, this formulation is not recommended in these settings.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
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.
Uses
Isosorbide Dinitrate Extended-release Tablets 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.
History
There is currently no drug history available for this drug.
Other Information
Isosorbide dinitrate (ISDN), an organic nitrate, is a vasodilator with effects on both arteries and veins. Isosorbide dinitrate is available as 40 mg extended-release tablets. The chemical name for isosorbide dinitrate 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.
Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1.0, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents, such as acetone, alcohol, and ether, but is only sparingly soluble in water.
Each Isosorbide Dinitrate Extended-release tablet, for oral administration, contains 40 mg of isosorbide dinitrate, in a matrix that causes the active drug to be released over a sustained period. In addition, each tablet also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, FD&C Yellow #6 Aluminum Lake, hydroxypropyl methylcellulose, magnesium stearate, and stearic acid.
Conformance of Isosorbide Dinitrate Extended-release Tablets with the USP release test is pending.
Sources
Isorbide Dinitrate Manufacturers
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Inwood Laboratories, Inc.
![Isorbide Dinitrate (Isorbide Dinitrate) Tablet, Extended Release [Inwood Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Isorbide Dinitrate | Inwood Laboratories, Inc.
As noted under “CLINICAL PHARMACOLOGY” multiple-dose studies with ISDN and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for Isosorbide Dinitrate Extended-release Tablets must provide a daily dose-free interval to minimize the development of this tolerance. With immediate-release ISDN, it appears that one daily dose-free interval must be at least 14 hours long. The necessary dose-free interval for Isosorbide Dinitrate Extended-release Tablets has not been clearly identified, but is presumably somewhat longer.
As also noted under “CLINICAL PHARMACOLOGY” only one trial has ever studied the use of controlled-release isosorbide dinitrate for more than one dose. In that trial, 40 mg of a different formulation of controlled-release ISDN was administered twice daily in doses given 6 hours apart. After 4 weeks, active treatment could not be distinguished from placebo.
Large controlled studies with other nitrates suggest that no dosing regimen with Isosorbide Dinitrate Extended-release Tablets should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day.
In clinical trials, immediate-release oral isosorbide dinitrate has been administered in a variety of regimens, with total daily doses ranging from 30 mg to 480 mg.
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