Source: Health Products Regulatory Authority (IE) Revision Year: 2017 Publisher: Rottapharm Ltd, Damastown Industrial Park, Mulhuddart, Dublin 15
Preventive treatment of angina pectoris either alone or in combination with other anti-anginal therapy.
Different strengths of DERMATRANS are available.
Treatment is usually initiated with one DERMATRANS 5 mg/24 h applied to the skin once daily. DERMATRANS 5 mg/24 h delivers 0.2 mg/h of glyceryl trinitrate. The dose should be adjusted individually during the treatment to achieve optimum therapeutic effect.
The maximum daily dose for DERMATRANS should be 15 mg glyceryl trinitrate.
DERMATRANS is administered intermittently, with a daily nitrate-free interval, in order to avoid the development of nitrate tolerance. This free interval should correspond for the patient to a period with no attacks. The timing of administration of concomitant anti-anginal agents (beta-blockers and/or calcium antagonists) should be established in order to provide a therapeutic cover during the nitrate-free interval.
The nitrate-free interval must last at least 8 hours.
The development of nitrate tolerance is a well established event during the preventive treatment of angina. An adequate prescription with a nitrate-free interval guarantees the therapeutic efficacy of nitrates.
Patients experiencing nocturnal angina may benefit from overnight treatment with a nitrate-free interval during the day. In these patients, an additional antianginal therapy may be needed during the day.
Patients with severe angina may also need an additional antianginal therapy during nitrate-free intervals.
No dose adjustment is recommended in elderly patients since no studies have been performed in these subjects.
Since no studies have been performed in patients with impaired renal and/or liver function, no dose recommendations can be given.
DERMATRANS is not recommended in children and adolescents below the age of 18 years.
Each DERMATRANS transdermal patch is contained in a sealed sachet. The adhesive layer is covered by a protective film, which has to be be removed before application. The DERMATRANS transdermal patch adheres easily to the skin, and also stays in place whilst bathing or during physical exercise.
It is recommended to apply DERMATRANS transdermal patches to the skin of the chest, or outer upper arm, free of redness or irritation and to rotate the sites of application. Subsequent transdermal patches should not be applied to the same area of skin until several days have elapsed.
Suitable area may be shaved if necessary. Areas that form folds or are subjected to friction during movement should be avoided.
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 DERMATRANS 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.
Three years.
Do not store above 25°C. Store in the original package.
Immediate packaging:
The adhesive side of the patch is covered by a square both side aluminised and siliconised protective liner that is removed before use; each patch is sealed in a sachet consisting of Surlyn, heat sealable material, aluminium foil, polyethylene and paper.
Secondary packaging:
Cardboard box.
Each cardboard box contains 15 or 30 patches.
Not all pack sizes may be marketed.
Tear open the sachet at the indentation (do not use scissors to avoid damaging the patch) and remove the patch. The patch must be used immediately after opening the sachet.
Hold the patch between the thumb and index finger at the corner of the pull-off-tag. Detach the protective liner with the other hand and discard it.
Do not touch the adhesive side of the patch. Apply the patch to the skin holding between the thumb and index finger the part still covered by the protective liner. Detach the remaining part of the protective liner and press firmly for about 10 seconds on the whole surface of the patch. Pass a finger along the edges to assure good adhesion.
Hands should be washed before and after applying DERMATRANS.
After use, the patch should be folded with the adhesive part inside and discarded.
Any unused product or waste material should be disposed of in accordance with local requirements.
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