Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Minitran 5 is indicated for:
The response to nitrates differs between individuals, and the minimum effective dose should be prescribed in each case. It is therefore recommended that treatment is started with one Minitran 5 patch per day, with upward dosage titration when necessary. Application can either be for a continuous period of 24 hours or intermittently, incorporating a patch free interval (usually at night). Attenuation of effect has occurred in some patients being treated with sustained release nitrate preparations. On the basis of current clinical studies it is recommended that in such cases Minitran should be applied daily with a patch free interval of 8-12 hours.
One Minitran 5 patch is applied distal and close to the site of intravenous cannulation at the time of venepuncture. The patch should be changed daily. Treatment with Minitran 5 should be discontinued when intravenous therapy is stopped.
No specific information on use in the elderly is available, but there is no evidence to suggest that an alteration in dose is required.
The safety and efficacy of Minitran in children has yet to be established, and therefore recommendations for its use cannot be made.
Each Minitran patch is contained in a sealed sachet. The adhesive layer is covered by a protective film, which should be removed before application. The Minitran patch should be applied to a clean, dry healthy area of skin on the torso or the arms.
Subsequent patches should not be applied to the same area of skin until several days have elapsed. The Minitran patch adheres easily to the skin, and also stays in place whilst bathing or during physical exercise.
High doses of glyceryl trinitrate may lead to severe hypotension and reflex tachycardia or to collapse and syncope. Methaemoglobinaemia has also been reported following accidental overdosage.
The nitrate effect of Minitran can be rapidly terminated simply by removing the system(s).
Hypotension or collapse can be treated by elevation or, if necessary, compression bandaging of the patient’s legs.
Shelf life: 3 years.
Minitran must be stored at room temperature (below 25°C) under exclusion of light and moisture.
Each patch is individually packed in a heat sealed foil sachet. Cartons contain 30 patches.
The patch is covered by a protective polyester film, which is detached and discarded before use.
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