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Imdur
Generic Name: Isosorbide Mononitrate
Drug Category: Nitrate
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 1 year.
| Approved Uses |
|
Brand name discontinued. Generic alternatives (isosorbide mononitrate tablet, extended release). 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. 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. Severe hypotension, particularly with upright posture, may occur with even small doses of isosorbide mononitrate. This drug should therefore be used with caution in patients who may be volume depleted or who, for whatever reason, are already hypotensive. Isosorbide mononitrate extended-release tablets should therefore be used with caution in elderly patients who may be volume depleted, on multiple medications or who, for whatever reason, are already hypotensive. Hypotension induced by isosorbide mononitrate may be accompanied by paradoxical bradycardia and increased angina pectoris. Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy. As with other nitrates, daily headaches sometimes accompany treatment with isosorbide mononitrate. Do not use isosorbide mononitrate 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 mononitrate in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension. Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. The vasodilating effects of isosorbide mononitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety. Nitrates and nitrites may interfere with the Zlatkis-Zak color reaction, causing falsely low readings in serum cholesterol determinations. There are no adequate and well-controlled studies in pregnant women. Animal studies: stillbirths. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ISMN is administered to a nursing mother. |
| Off-label Uses |
|
• Dosage greater than 240 mg per day. GoToSource • Use in patients under the age of 18. GoToSource • Acute myocardial infarction or congestive heart failure. GoToSource • Prevention of first variceal bleeding in patients with cirrhosis. GoToSource |
| Adverse Events |
|
Long-term oral nitrate therapy associated with major adverse cardiovascular events following elective coronary artery revascularization by PCI in patients with type II diabetes. GoToSource Hypotension (low blood pressure). GoToSource Headache. GoToSource |
| Litigation |
|
No major injury lawsuits reported. |
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