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All dosage forms of isosorbide dinitrate may be used prophylactically to decrease frequency and severity of anginal attacks and can be expected to decrease the need for sublingual nitroglycerin The sublingual and chewable forms of the drug are indicated for acute prophylaxis of angina pectoris when taken a few minutes before situations likely to provoke anginal attacks Because of a slower onset of effect, the oral forms of isosorbide dinitrate are not indicated for acute CONTRAINDICATIONS: SORBITRATE is contraindicated in patients who have shown purported hypersensitivity or idiosyncrasy to it or other nitrates or nitrites Epinephrine and related compounds are ineffective in reversing the severe hypotensive events associated with overdose and are contraindicated in this situation WARNINGS: The benefits of SORBITRATE during the early days of an acute myocardial infarction have not been established If one elects to use organic nitrates in early infarction, hemodynamic monitoring and frequent clinical assessment should be used because of the potential deleterious effects of hypotension PRECAUTIONS: General: Severe hypotensive response, particularly with upright posture, may occur with even small doses of SORBITRATE The drug should therefore be used with caution in subjects who may have blood volume depletion from diuretic therapy or in subjects who have angina pectoris may accompany nitrate-induced hypotension Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy Marked symptomatic, orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination Dose adjustment of either class of Tolerance to this drug and cross-tolerance to other nitrates and nitrites may occur Tolerance to the vascular and antiangmal effects of isosorbide dinitrate or nitroglycerin has been demonstrated in clinical trials, experience through occupational exposure, and in isolated tissue experiments in the laboratory The importance of tolerance to the appropriate use of isosorbide dinitrate in the management of patients with angina pectoris has not been determined However, one clinical trial using treadmill exercise tolerance (as an end point) found repetitive dosing at conventional dosing intervals On the other hand, several trials have been trials, an effect seems detectable for as long as several months Tolerance clearly occurs in industrial workers continuously exposed to nitroglycerin Moreover, physical dependence also occurs since chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitroglycerin from the workers In clinical trials in angina patients, there are reports of anginal attacks being more easily provoked and of rebound in the hemodynamic effects soon after nitrate withdrawal The relative importance of these observations to the routine, clinical use of isosorbide dinitrate is not known However, it seems prudent to gradually withdraw patients from isosorbide dinitrate when the therapy is being terminated, rather than stopping the drug abruptly Information for Patients: Headache may occur during initial therapy with SORBITRATE Headache is usually relieved by the use of standard headache remedies or by lowering the dose and tends to disappear after the first week or two of use Drug Interactions: Alcohol may enhance any marked sensitivity to the hypotensive effect of Isosorbide dinitrate acts directly on vascular smooth muscle; therefore, any other agent that depends on vascular smooth muscle as the final common path can be expected to have decreased or increased effect depending on the agent Carcinogenesis, Mutagenesis, Impairment of Fertility: No long term studies in animals have been performed to evaluate the carcinogenic potential of this drug A modified two-litter effects on fertility or gestation or any remarkable gross pathology in any parent or offspring fed isosorbide dinitrate as compared with rats fed a basal-controlled diet Pregnancy Category C: Isosorbide dinitrate has been shown to cause a dose-related times the maximum recommended human daily dose There are no adequate and well-controlled studies in pregnant women SORBITRATE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus Nursing Mothers: 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 SORBITRATE is administered to a nursing woman Pediatric Use: The safety and effectiveness of SORBITRATE in children has not been ADVERSE REACTIONS: Adverse reactions, particularly headache and hypotension, are dose-related In clinical trials at various doses, the following have been observed Headache is the most common (reported incidence varies widely, apparently being and persistent Cutaneous vasodilation with flushing may occur Transient episodes of dizziness and weakness, as well as other signs of cerebral ischemia associated with postural hypotension, may occasionally develop (the incidence of reported symptomatic hypotension hypotensive effects of nitrates and severe responses (nausea, vomiting, weakness, restlessness, pallor, perspiration, and collapse) may occur even with the usual therapeutic dose Drug uncommon Case reports of clinically significant methemoglobinemia are rare at conventional doses of organic nitrates The formation of methemoglobin is dose-related and, in the case of genetic abnormalities of hemoglobin that favor methemoglobin formation, even conventional doses of organic nitrate could produce harmful concentrations of methemoglobin DOSAGE AND ADMINISTRATION: For the treatment of angina pectoris, the usual starting SORBITRATE should be titrated upward until angina is relieved or side effects limit the dose In ambulatory patients, the magnitude of the incremental dose increase should be guided by measurements of standing blood pressure The initial dosage of sublingual or chewable SORBITRATE for prophylactic therapy in angina demonstrating the effectiveness of chronic maintenance therapy with these dosage forms development of tolerance should modify the dosage program has not been defined The oral controlled-release forms of isosorbide dinitrate should not be chewed See previous page for brief summary of prescribing information: neurontin 300 mg capsule dosage.
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