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Isosorbide mononitrate

Ismn Genericon, Monoket Retard · ATC code C01DA14

Also known as: Isosorbidmononitrat, İzosorbid mononitrat · Brand names: Ismn Genericon, Monoket Retard, Elantan Long, Is, Ismn, Ismo, Angitan, Isorat, Monodur, Monoket

Key facts
Active substance
Isosorbide mononitrate
Drug class
Vasodilator agent
ATC code
C01DA14
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Isosorbide mononitrate is, per the US prescribing information, an organic nitrate for the prevention and treatment of angina pectoris due to coronary artery disease; it does not act fast enough to abort an acute attack.

What it is used for

  • Prevention and treatment of angina pectoris due to coronary artery disease.
  • Not useful for aborting an acute anginal episode, as the onset of action is not rapid enough.

Dosing

  • 20 mg twice daily with the doses seven hours apart (e.g. first dose on awakening, second 7 hours later); this asymmetric regimen provides a daily nitrate-free interval to minimize tolerance.
  • A starting dose of 5 mg may suit persons of particularly small stature, increased to at least 10 mg by the second or third day.
  • No dose adjustment for elderly patients or altered hepatic or renal function.
  • Doses above 20 mg twice a day have not been adequately studied.

Contraindications

  • Allergy to isosorbide mononitrate.
  • Concomitant phosphodiesterase inhibitors such as sildenafil, tadalafil or vardenafil (severe hypotension, syncope, myocardial ischemia).
  • Concomitant riociguat, a soluble guanylate cyclase stimulator (hypotension).

Important warnings

  • Severe hypotension, particularly upright, may occur even with small doses; caution in volume depletion or existing hypotension; paradoxical bradycardia and increased angina possible.
  • Not recommended in acute myocardial infarction or congestive heart failure because its effects are difficult to terminate rapidly.
  • May aggravate angina caused by hypertrophic cardiomyopathy.
  • Chest pain, myocardial infarction and sudden death have occurred during temporary withdrawal of nitrates.
  • Headaches are a marker of drug activity; patients should not alter the dosing schedule to avoid them.

Side effects

  • Most frequent: headache (35% at 20 mg), decreasing after the first few days.
  • Others: dizziness, nausea, fatigue, light-headedness on standing (more frequent with alcohol).

Interactions

  • Phosphodiesterase inhibitors and riociguat: contraindicated.
  • Other vasodilators, alcohol in particular, have additive effects.
  • Calcium channel blockers: marked symptomatic orthostatic hypotension reported; dose adjustments may be needed.

Pregnancy and breastfeeding

  • Animal studies showed no harm to the fetus; there are no adequate studies in pregnant women.
  • It is not known whether it is excreted in human milk; use caution in nursing women.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • Ismn GenericonGenericon Pharma Gesellschaft M.B.H. · 1 register entry
  • Monoket RetardMerus Labs Luxco Ii S.À R.L. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Elantan LongYinglian Health Pharmaceutical Gmbh · 1 register entry
  • IsRatiopharm Gmbh · 2 register entries
  • IsmnAbz-Pharma Gmbh, Stadapharm Gmbh · 2 register entries
  • IsmoEsteve Pharmaceuticals Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • AngitanNOBEL İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • IsoratBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • MonodurSANOFİ SAĞLIK ÜRÜNLERİ LTD. ŞTİ. · 1 register entry
  • MonoketADEKA İLAÇ SAN. VE TİC. A.Ş. · 6 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 24 more European countries
Bulgaria
Oликард, Изосорб, Неосорбид
Croatia
Ismn Genericon, Isocard, Olicard Retard
Cyprus
Monorem
Czechia
Mono Mack Depot, Monosan, Monotab, Sorbimon
Denmark
Farmidur, Fem-Mono Retard, Imdur, Isomex
Estonia
Imdur, Isomonit, Monosan
Finland
Isangina, Ormox
Greece
Dilavase, G-Dil, Monosordil
Hungary
Mono Mack Depot, Olicard
Iceland
Fem-Mono Retard, Imdur
Ireland
Elantan, Imdur, Isomel Sr, Isomonit Retard, Sormon
Italy
Elan, Isosorbide Mononitrato Eg, Monoket
Latvia
Imdur, Ismn Stada, Isomonit, Monosan
Lithuania
Imdur, Ismn Stada, Isomonit
Malta
Imdur, Monorem R
Netherlands
Isosorbide-5-Mononitraat, Isosorbide Mononitraat Retard Rph, Isosorbide Mononitraat Retard Viatris, Mono-Cedocard Retard
Norway
Isomex, Monoket Od
Poland
Effox Long, Mononit, Olicard Retard
Portugal
Ismo, Monoket, Mononitrato De Isossorbido Mylan, Monopront
Romania
Mononitron Ep, Olicard Retard
Slovakia
Mono Mack Depot, Monosan, Olicard Retard, Sorbimon
Slovenia
Monosan, Olicard
Spain
Coronur, Dolak Retard, Mononitrato De Isosorbida Normon, Uniket
Sweden
Imdur, Isomex, Monoket Od

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Sources

  1. U.S. Food and Drug Administration. isosorbide mononitrate (OMNIVIUM PHARMACEUTICALS LLC.) – Prescribing Information, 2025-08-06. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cdf01e14-778b-4b3f-8372-1c18f266fb98
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC C01DA.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.