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Isordil Titradose/isoDitrate/Dilatrate-SR
Generic Name: Isosorbide Dinitrate
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 0 year.
| Approved Uses |
|
• 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. Severe hypotension, particularly with upright posture, may occur with even small doses of isosorbide dinitrate. This drug should therefore be used with caution in patients who may be volume depleted or who, for whatever reason, are already hypotensive. Hypotension induced by isosorbide dinitrate may be accompanied by paradoxical bradycardia and increased angina pectoris. Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy. 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. In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence. Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients. No dosing regimen with Isordil Titradose tablets should be expected to provide more than about 12 hours of continuous antianginal efficacy per day. Do not use Isordil Titradose 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 Isordil Titradose in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension. There are no adequate, well-controlled studies in pregnant women. Animal studies: embryotoxicity.–It is not known whether isosorbide dinitrate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when isosorbide dinitrate is administered to a nursing woman. |
| Off-label Uses |
|
• Use in patients under the age of 18. GoToSource • Use with hydralazine for heart failure. GoToSource • Use with ibuprofen duchenne muscular dystrophy. GoToSource • Prevention of osteoporotic fractures. GoToSource • Inhibit mechanical stress-induced cardiac hypertrophy and autophagy. GoToSource • Stable exercise-induced angina pectoris. GoToSource |
| Adverse Events |
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Severe hypotension (low blood pressures) bradycardia (slow heart rate) and lipothymia (condition or feeling of faintness). GoToSource Cluster headaches. GoToSource Syncope (fainting). GoToSource Methemoglobinemia (higher-than-normal amount of methemoglobin in the blood. Methemoglobin is a form of hemoglobin that cannot carry oxygen). GoToSource Tolerance and endothelial dysfunction. GoToSource |
| Litigation |
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No major injury lawsuits reported. |
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