Generic name: ISOSORBIDE DINITRATE 40mg
Dosage form: tablet, extended release
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As noted under “CLINICAL PHARMACOLOGY”, multiple-dose studies with isosorbide dinitrate and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for IsoDitrate ER tablets must provide a daily dose-free interval to minimize the development of this tolerance. With immediate-release isosorbide dinitrate, it appears that one daily dose-free interval must be at least 14 hours long. The necessary dose-free interval for IsoDitrate ER 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 isosorbide dinitrate 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 IsoDitrate ER 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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