Isosorbide mononitrate: uses, appearance and warnings

Isosorbide mononitrate extended-release tablets, USP are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

Isosorbide mononitrate extended-release tablets, USP 30 mg are white to off-white, oval shaped, film coated tablets having breakline on one side and debossed ‘3-0’ across breakline and ‘1104’ on other side. They are supplied as follows: Bottles of 100 NDC 13668-104-01 Bottles of 500 NDC 13668-104-05 Bottles of 1000 NDC 13668-104-10 Isosorbide mononitrate extended-release tablets, USP 60 mg are white to off-white, oval shaped, film coated tablets having breakline on one side and ‘60-60’ debossing across breakline and ‘1105’ on the other side. Bottles of 100 NDC 13668-105-01 Bottles of 1000 NDC 13668-105-10 Isosorbide mononitrate extended-release tablets, USP 120 mg are white to off-white, oval shaped, film coated tablets having debossed ‘120’ on one side and ‘1106’ on the other side. Bottles of 100 NDC 13668-106-01 Bottles of 1000 NDC 13668-106-10 Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature] Manufactured by: Torrent Pharmaceuticals LTD., India. Manufactured for: Torrent Pharma INC., Basking Ridge, NJ 07920. 8109641 Revised: April 2026 logo

Isosorbide mononitrate extended-release tablets are contraindicated in patients who have shown hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.

Amplification of the vasodilatory effects of isosorbide mononitrate 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 ISMN in patients with acute myocardial infarction or congestive heart failure have not been established; because the effects of isosorbide mononitrate are difficult to terminate rapidly, this drug is not recommended in these settings. If isosorbide mononitrate is used in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.

The table below shows the frequencies of the adverse events that occurred in >5% of the subjects in three placebo-controlled North American studies, in which patients in the active treatment arm received 30 mg, 60 mg, 120 mg, or 240 mg of isosorbide mononitrate extended-release tablets once daily. In parentheses, the same table shows the frequencies with which these adverse events were associated with the discontinuation of treatment. Overall, 8% of the patients who received 30 mg, 60 mg, 120 mg, or 240 mg of isosorbide mononitrate in the three placebo-controlled North American studies discontinued treatment because of adverse events. Most of these discontinued because of headache. Dizziness was rarely associated with withdrawal from these studies. …