MONODUR

What it is

MONODUR contains isosorbide mononitrate. The registered variants are a 60 mg modified release tablet and a 120 mg modified release tablet.

Approved indications

— Prophylactic treatment of angina pectoris.

Dosing overview

The standard dose is one tablet once daily, which may be increased to two tablets daily, both tablets taken at the same time. MONODUR should not be administered twice daily. The tablets should be swallowed whole with half a glass of fluid and should not be chewed or crushed.

Key safety warnings

There is a risk of developing tolerance to haemodynamic and antianginal effects if higher doses (more than 120 mg per day) and/or more frequent doses (such as twice daily) are administered. It is important that MONODUR is administered once a day to ensure intervals with low nitrate concentrations are achieved each day, reducing the risk of tolerance development. Severe hypotension, particularly with upright posture, may occur with even small doses of isosorbide mononitrate. Hypotension and lightheadedness on standing may be more frequent in patients who have consumed alcohol. Concomitant administration of isosorbide mononitrate and phosphodiesterase type 5 inhibitors can potentiate the vasodilatory effect of isosorbide mononitrate with the potential result of serious side effects such as syncope or myocardial infarction. MONODUR is not recommended for the management of acute attacks of angina pectoris. In the event of an acute attack, sublingual or buccal glyceryl trinitrate tablets should be used. Although no clear cut rebound phenomena were seen upon abrupt withdrawal of isosorbide mononitrate sustained release tablets, such withdrawal is not recommended because of the possibility of severe exacerbation of anginal symptoms.

Contraindications

Known hypersensitivity to nitrates or to any of the components in MONODUR. Shock (including cardiogenic shock), hypotension, obstructive hypertrophic cardiomyopathy and pericarditis, aortic stenosis, cardiac tamponade, mitral stenosis and severe anaemia. Phosphodiesterase type 5 inhibitors (such as sildenafil, tadalafil and vardenafil) are contraindicated and must not be given to patients already receiving isosorbide mononitrate therapy. Severe cerebrovascular insufficiency or hypotension are relative contraindications to the use of isosorbide mononitrate 60 mg sustained release tablets.

Regulatory history

MONODUR isosorbide mononitrate 60 mg modified release tablet was first listed on the ARTG on 7 July 1997. MONODUR isosorbide mononitrate 120 mg modified release tablet was first listed on the ARTG on 8 July 1998.