MINITRAN

What it is

Minitran is a transdermal drug delivery system containing glyceryl trinitrate. The Minitran Transdermal Delivery System is designed to provide continuous controlled release of glyceryl trinitrate through intact skin to overcome the problems of the short half-life and extensive first-pass metabolism of glyceryl trinitrate. Minitran is available as thin, transparent oval patches in three strengths: Minitran 5 (6.7 cm²), Minitran 10 (13.3 cm²), and Minitran 15 (20.0 cm²).

Approved indications

— Prevention of chronic, stable angina pectoris due to coronary artery disease.

Dosing overview

The response to nitrates differs between individuals and the minimum effective dose should be prescribed in each case; treatment is started with one Minitran 5 patch per day, with upward dosage titration when necessary. To avoid the development of tolerance with continuous application, it is recommended that Minitran should be applied daily with a patch free interval of 8–12 hours (usually at night). The Minitran patch should be applied to a clean, dry, healthy area of skin on the upper arm or chest and should not be applied to the distal parts of the extremities. Subsequent patches should not be applied to the same area of skin until several days have elapsed.

Key safety warnings

Severe hypotension, particularly with upright posture, may occur with even small doses of glyceryl trinitrate, particularly in the elderly, and Minitran should therefore be used with caution in elderly patients who may be volume depleted, are on multiple medications, or who are already hypotensive. Do not use Minitran in patients who are taking phosphodiesterase inhibitors (such as sildenafil, tadalafil, or vardenafil) for erectile dysfunction or pulmonary hypertension because concomitant use may amplify the vasodilatory effects of Minitran resulting in severe hypotension. Do not use Minitran in patients who are taking the soluble guanylate cyclase stimulator riociguat, as concomitant use can cause hypotension. Minitran is not indicated for the treatment of acute angina attacks requiring rapid relief. As all nitrate vasodilators can induce withdrawal reactions, abrupt withdrawal of Minitran should be avoided and it is advisable to gradually reduce the dosage over a period of 4 to 6 weeks to prevent a potential withdrawal reaction.

Contraindications

Minitran is contraindicated in cases of known hypersensitivity to organic nitrates or to the stated excipients, severe anaemia, increased intra-ocular and intracranial pressure, marked arterial hypotension or shock, and acute myocardial insufficiency due to obstruction as in aortic or mitral stenosis or constrictive pericarditis. Minitran is contraindicated in patients taking phosphodiesterase inhibitors for erectile dysfunction or pulmonary hypertension. Minitran is contraindicated in patients taking riociguat.

PBS listing

Minitran 18 mg transdermal patch is listed on the PBS with 2 items, restriction type restricted, at an ex-manufacturer price of A$15.09.

Regulatory history

Minitran 5, Minitran 10, and Minitran 15 were first registered on the ARTG on 8 August 1995.