TRANSIDERM NITRO Transdermal patch Ref.[27764] Active ingredients: Glyceryl trinitrate

Warnings

As with other nitrate preparations, when transferring the patient on long-term therapy to another form of medication, nitroglycerin should be gradually withdrawn and overlapping treatment started.

The Transiderm Nitro patch contains an aluminium layer. Therefore the patch must be removed before applying magnetic or electrical fields to the body during procedures such as MRI (Magnetic Resonance Imaging), cardioversion, DC defibrillation or diathermy treatment.

In cases of recent myocardial infarction or acute heart failure, treatment with Transiderm Nitro 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.

Precautions

Hypoxaemia

Caution should be exercised in patients with arterial hypoxaemia (including G6PD deficiency induced forms) due to severe anaemia because, in such patients the biotransformation of nitroglycerin is reduced. Similarly, caution is called for in patients with hypoxaemia and a 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, nitroglycerin 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.

Hypertrophic cardiomyopathy

Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.

Increased angina

The possibility of increased frequency of angina during patch-off periods should be considered. In such cases, the use of concomitant anti-anginal therapy is desirable.

Tolerance to sublingual nitroglycerin

If tolerance to nitroglycerin patches develops, the effects of sublingual nitroglycerin on exercise tolerance may be partially diminished.

Transiderm Nitro 5 only: Use of Transiderm Nitro in the prevention of phlebitis

The infusion site should be examined regularly. If phlebitis develops, it should be treated accordingly.

Concomitant administration of Transiderm Nitro and other vasodilators e.g PDE5 inhibitors such as sildenafil potentiates the blood pressure lowering effects of Transiderm Nitro.

Concomitant treatment with calcium antagonists, ACE inhibitors, beta-blockers, diuretics, antihypertensives, tricyclic antidepressants and major tranquillisers may potentiate the blood pressure-lowering effect of Transiderm Nitro, as may alcohol.

Concurrent administration of Transiderm Nitro with dihydroergotamine may increase the bioavailability of dihydroergotamine. This warrants special attention in patients with coronary artery disease, because dihydroergotamine antagonises the effect of nitroglycerin and may lead to coronary vasoconstriction.

The non-steroidal anti-inflammatory drugs except acetyl salicylic acid may diminish the therapeutic response of Transiderm Nitro.

Concurrent administration of Transiderm Nitro with amifostine and acetyl salicylic acid may potentiate the blood pressure lowering effects of Transiderm Nitro.

Women of child-bearing potential

There is no data supporting any special recommendations in women of child-bearing potential.

Pregnancy

Like any drug, Transiderm Nitro should be employed with caution during pregnancy, especially in the first 3 months.

Lactation

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 Transiderm Nitro therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

There is no data available on the effect of Transiderm Nitro on fertility in humans.

Transiderm Nitro, 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 ranked in descending order of frequency, as follows: Very common (≥ 1/10); common (≥ 1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥ 1/10,000, <1/1000); very rare (<1/10,000), including isolated reports. Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

Table 1:

Like other nitrate preparations, Transiderm Nitro 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 nitroglycerin or discontinuing treatment.

A slight reflex-induced increase in heart rate can be avoided by resorting, if necessary, to combined treatment with a beta-blocker.

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.

The following adverse drug reactions have been derived from post-marketing experience with Transiderm Nitro 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.

• Cardiac disorders: palpitation.
• Skin and subcutaneous tissue disorders: rash generalized.

Reporting of suspected adverse reactions

Reporting 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

None.