Isosorbide Dinitrate

Indications

INDICATIONS AND USAGE Isosorbide Dinitrate Tablets, USP are 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.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION As noted under CLINICAL PHARMACOLOGY , multiple-dose studies with ISDN and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for isosorbide dinitrate tablets must provide a daily dose-free interval to minimize the development of this tolerance. With immediate-release ISDN, it appears that one daily dose-free interval must be at least 14 hours long. As also noted under CLINICAL PHARMACOLOGY , the effects of the second and later doses have been smaller and shorter-lasting than the effects of the first.

Contraindications

CONTRAINDICATIONS Isosorbide dinitrate tablets are contraindicated in patients who are allergic to isosorbide dinitrate or any of its other ingredients. Do not use isosorbide dinitrate tablets 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.

Warnings and precautions

WARNINGS Amplification of the vasodilatory effects of isosorbide dinitrate tablets by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion. The benefits of immediate-release oral isosorbide dinitrate in patients with acute myocardial infarction or congestive heart failure have not been established.

Pregnancy

Pregnancy Category C At oral doses 35 and 150 times the maximum recommended human daily dose, isosorbide dinitrate has been shown to cause a dose-related increase in embryotoxicity (increase in mummified pups) in rabbits. There are no adequate, well-controlled studies in pregnant women.

Storage and supply

HOW SUPPLIED Isosorbide Dinitrate Tablets, USP 10 mg: White, Round, Scored Tablets Debossed “WW” on one side and “771” on the other side. Overbagged with 10 tablets per bag, NDC 55154-7990-0 Isosorbide Dinitrate Tablets, USP 20 mg: Green, Round, Scored Tablets Debossed “WW” on one side and “772” on the other side.

Source: Isosorbide Dinitrate (Isosorbide Dinitrate) — US FDA prescribing information, 2026-05-19, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.