Source: Health Products Regulatory Authority (IE) Revision Year: 2017 Publisher: Rottapharm Ltd, Damastown Industrial Park, Mulhuddart, Dublin 15
As with other nitrate preparations, when transferring the patient on long-term therapy to another form of medication, glyceryl trinitrate should be gradually withdrawn and overlapping treatment started.
DERMATRANS patch must be removed before applying magnetic or electrical fields to the body during procedures such as MRI (Magnetic Resonance Imaging), cardioversion or DC defibrillation, or diathermy treatment.
In cases of recent myocardial infarction or acute heart failure, treatment with DERMATRANS should be carried out cautiously under strict medical surveillance and/or haemodynamic monitoring.
Removal of the patch should be considered as part of the management of patients who develop significant hypotension.
DERMATRANS is not a treatment for acute anginal attacks requiring rapid relief, unstable angina and myocardial infarction.
The patch should be removed if collapse or shock occurs.
It may be advisable to titrate the dose gradually upwards until the optimal effect is achieved: if too high a starting dose is used severe headache or hypotension may occur in some patients. These unwanted effects are less likely to occur when transferring from intravenous nitrates to the transdermal form.
Cross tolerance with other nitrates may occur.
The use of products for topical application, especially if prolonged, may give rise to sensitisation phenomena, in which case treatment should be suspended, and suitable therapeutic measures adopted.
Paradoxical bradycardia and increased angina may occur in patients with glyceryl trinitrate-induced hypotension. DERMATRANS should be used with extreme caution in patients predisposed to closed angle glaucoma.
Caution should be exercised in patients with arterial hypoxaemia due to severe anaemia (including G6PD deficiency induced forms), because in such patients the biotransformation of glyceryl trinitrate is reduced. Similarly, caution is called for in patients with hypoxaemia and ventilation/perfusion imbalance due to lung disease or ischaemic heart failure. In Patients with alveolar hypoventilation a vasoconstriction occurs within the lung to shift perfusion from areas of alveolar hypoxia to better ventilated regions of the lung (Euler–Liljestrand mechanism). Patients with angina pectoris, myocardial infarction, or cerebral ischaemia frequently suffer from abnormalities of the small airways (especially alveolar hypoxia). Under these circumstances vasoconstriction occurs within the lung to shift perfusion from areas of alveolar hypoxia to better ventilated regions of the lung. As a potent vasodilator, glyceryl trinitrate could reverse this protective vasoconstriction and thus result in increased perfusion of poorly ventilated areas, worsening of the ventilation/perfusion imbalance, and a further decrease in the arterial partial pressure of oxygen.
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
The possibility of increased frequency of angina during patch-off periods should be considered. In such cases the use of additional anti-anginal therapy is desirable.
As tolerance to glyceryl trinitrate patches develops, the effect of sublingual glyceryl trinitrate on exercise tolerance may be partially diminished.
Concomitant administration of DERMATRANS and other vasodilators (e.g PDE5 inhibitors such as sildenafil) potentiates the blood-pressure-lowering effect of DERMATRANS.
The use of DERMATRANS with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see section 4.3) since concomitant use can cause hypotension.
Concomitant treatment with calcium antagonists, ACE inhibitors, beta-blockers, diuretics, antihypertensives, tricyclic antidepressants, neuroleptics and major tranquillisers may potentiate the bloodpressure-lowering effect of DERMATRANS, as may alcohol.
Concurrent administration of DERMATRANS with dihydroergotamine may increase the bioavailability of dihydroergotamine. This warrants special attention in patients with coronary artery disease, because dihydroergotamine antagonizes the effect of glyceryl trinitrate and may lead to coronary vasoconstriction.
Non-steroidal anti-inflammatory drugs except acetyl salicylic acid may diminish the therapeutic response to DERMATRANS.
Concurrent administration of DERMATRANS with amifostine and acetyl salicylic acid may potentiate the blood pressure lowering effects of DERMATRANS.
Like any drug, DERMATRANS should not be prescribed during pregnancy, especially in the first 3 months, unless there are compelling reasons for doing so. The benefits for the mother must be weighed against the risk for the child
There is limited information on the excretion of the active substance in human or animal breast milk. A risk to the suckling child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from DERMATRANS therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
There are no data available on the effect of DERMATRANS on fertility in humans.
DERMATRANS, especially at the start of treatment or dose adjustments, may impair the reactions or might rarely cause orthostatic hypotension and dizziness (as well as exceptionally syncope after overdosing). Patients experiencing these effects should refrain from driving or using machines.
Adverse drug reactions are listed by MedDRA System-Organ Class (SOC). Within each System-Organ Class the adverse drug reactions are ranked by frequency, with the most frequent first. Within each frequency grouping, adverse drug reactions are ranked in order of decreasing seriousness.
The following adverse drug reactions have been derived from post-marketing experience via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorized as not known.
| Organ system class | Very common (1/10) | Common (1/100 to <1/10) | Uncommon (1/1,000 to <1/100) | Rare (1/10,000 to <1/1,000) | Very rare (<1/10,000) |
|---|---|---|---|---|---|
| Nervous system disorders | Headache1 | Dizziness Syncope | |||
| Cardiac disorders | Tachycardia2 | ||||
| Vascular disorders | Orthostatic hypotension Flushing2 | ||||
| Gastrointestinal disorders | Nausea Vomiting | ||||
| Skin and subcutaneous tissue disorders | Dermatitis contact | ||||
| General disorders and administration site conditions | Application site erythema Pruritus Burning Irritation3 | ||||
| Investigations | Heart rate increase |
1 Like other nitrate preparations, DERMATRANS commonly causes dose-dependent headaches due to cerebral vasodilatation. These often regress after a few days despite the maintenance of therapy. If headaches persist during intermittent therapy, they should be treated with mild analgesics. Unresponsive headaches are an indication for reducing the dosage of glyceryl trinitrate or discontinuing treatment.
2 A slight reflex-induced increase in heart rate can be avoided by resorting, if necessary, to combined treatment with a betablocker.
3 Upon removal of the patch, any slight reddening of the skin will usually disappear within a few hours. The application site should be changed regularly to prevent local irritation.
Cardiac disorders: palpitation.
Skin and subcutaneous tissue disorders: rash generalized
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
Not applicable.
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