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Dilatrate-SR (Isosorbide Dinitrate) - Indications and Dosage



dilatrate®-SR sustained release capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of controlled-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.


As noted above (CLINICAL PHARMACOLOGY), multiple studies with ISDN and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for organic nitrates including dilatrate®-SR must provide a daily nitrate-free interval to avoid the development of tolerance. To achieve the necessary nitrate-free interval with immediate-release oral ISDN, it appears that at least one of the daily interdose intervals must be at least 14 hours long. The necessary interdose interval for dilatrate®-SR has not been clearly identified, but it must be greater than 18 hours.

As noted under Clinical Pharmacology, only one trial has ever studied the use of extended-release isosorbide dinitrate for more than one dose. In that trial, 40 mg of dilatrate®-SR was administered twice daily in doses given 6 hours apart. After 4 weeks, dilatrate®-SR could not be distinguished from placebo.

Large controlled studies with other nitrates suggest that no dosing regimen with dilatrate®-SR should be expected to provide more than about 12 hours of continuous antianginal 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 to 480 mg.

Do not exceed 160 mg (4 capsules) per day.


dilatrate®-SR (isosorbide dinitrate) 40 mg sustained-release capsules are opaque pink and colorless capsules with white beadlets and are imprinted "AP" and "0920". They are supplied as follows:

Bottles of 100
       NDC 66887-005-10

Store at 20° - 25°C (68° - 77°F); excursions permitted between 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature].

Manufactured for:
Auxilium Pharmaceuticals, Inc.
Chesterbrook, PA 19087

Revised 10/2014

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