Isosorbide mononitrate is a nitrate vasodilator indicated for the prevention and treatment of angina pectoris due to coronary artery disease. It is available as extended-release tablets and tablets for oral use. MedsAcross supplies Isosorbide mononitrate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Isosorbide Mononitrate Tablets are indicated for the prevention and treatment 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.
Source: US FDA prescribing information
The recommended regimen of Isosorbide Mononitrate Tablets is 20 mg twice daily, with the doses seven hours apart. A starting dose of 5 mg (½ tablet of the 10 mg dosing strength) might be appropriate for persons of particularly small stature but should be increased to at least 10 mg by the second or third day of therapy. Dosage adjustments are not necessary for elderly patients or patients with altered hepatic or renal function. As noted above ( Clinical Pharmacology ), multiple studies of organic nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. The asymmetric (2 doses, 7 hours apart) dosing regimen for Isosorbide Mononitrate Tablets provides a daily nitrate-free interval to minimize the development of tolerance.
Source: US FDA prescribing information
Isosorbide mononitrate is contraindicated in patients who are allergic to it. Do not use isosorbide mononitrate 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. Do not use isosorbide mononitrate in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.
Source: US FDA prescribing information
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 isosorbide mononitrate 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.
Source: US FDA prescribing information
Headache is the most frequent side effect and was the cause of 2% of all dropouts from controlled-clinical trials. Headache decreased in incidence after the first few days of therapy. The following table shows the frequency of adverse reactions observed in 1% or more of subjects in 6 placebo-controlled trials, conducted in the United States and abroad. The same table shows the frequency of withdrawal for these adverse reactions. In many cases the adverse reactions were of uncertain relation to drug treatment.
Source: US FDA prescribing information
Store at 20° - 30°C (68° - 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
5 presentations of Isosorbide mononitrate, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Isosorbide mononitrate 30 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Isosorbide mononitrate 60 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Isosorbide mononitrate 120 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Isosorbide mononitrate 20 mg tabletOralGeneric name | — | US FDA | Available on request |
| Isosorbide mononitrate 10 mg tabletOralGeneric name | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 30 December 1991 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Isosorbide mononitrate in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 5 presentations of Isosorbide mononitrate and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Isosorbide mononitrate on 30 December 1991, according to Drugs@FDA.
No listed presentation of Isosorbide mononitrate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Isosorbide mononitrate is classified under ATC code C01DA14 (Isosorbide mononitrate).
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