Isosorrbide Dinitrate
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Questions & Answers
Side Effects & Adverse Reactions
Amplification of the vasodilatory effects of ISDN 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 ISDN in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use ISDN in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia. Because the effects of oral ISDN 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 Tablets, USP, 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.
History
There is currently no drug history available for this drug.
Other Information
Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate, an organic nitrate whose structural formula is:
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). Isosorbidedinitrate is freely soluble in organic solvents such as acetone, alcohol, and, but is only sparingly soluble in water.
Each isosorbide dinitrate tablet contains 30 mg of ISDN.
Inactive ingredients are as follows: Ammonium Phosphate Dibasic, Colloidal Silicon Dioxide, FD&C Blue No. 1 Aluminum Lake, Lactose Monohydrate, Magnesium Stearate and Microcrystalline Cellulose.
Sources
Isosorrbide Dinitrate Manufacturers
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West-ward Pharmaceutical Corp
![Isosorrbide Dinitrate (Isosorbdie Dinitrate) Tablet [West-ward Pharmaceutical Corp]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Isosorrbide Dinitrate | West-ward Pharmaceutical Corp
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 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.
As also noted under CLINICAL PHARMACOLOGY , the effects of the second and later doses have been smaller and shorter-lasting than the effects of the first.
Large controlled studies with other nitrates suggest that no dosing regimen with isosorbide dinitrate oral tablets should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day.
As with all titratable drugs, it is important to administer minimum dose which produces the desired clinical effect. The usual starting dose of isosorbide dinitrate tablets is 5 mg to 40 mg, two or three times daily. For maintenance therapy, 10 mg to 40 mg, two or three times daily is recommended. Some patients may require higher doses. A daily dose-free interval of at least 14 hours is advisable to minimize tolerance. The optimal interval will vary with the individual patient, dose and regimen.
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