This information is intended for use by health professionals
|Transiderm Nitro 5:||Nitroglycerin on lactose 250mg equivalent to nitroglycerin 25mg.|
|Transiderm Nitro 10:||Nitroglycerin on lactose 500mg equivalent to nitroglycerin 50mg.|
Adults:Angina: Treatment should be initiated with one Transiderm Nitro 5 patch daily. If a higher dosage is required a Transiderm Nitro 10 patch may be substituted. The dosage may be increased to a maximum of two Transiderm Nitro 10 patches daily in resistant cases. Transiderm Nitro may be given either continuously, or intermittently with a patch off period of 8-12 hours, usually at night, during each 24 hour period. Development of tolerance or attenuation of therapeutic effect commonly occurs with prolonged or frequent administration of all long-acting nitrates. Recent evidence suggests that intermittent therapy with Transiderm Nitro may reduce the incidence of tolerance.Prior to the use of intermittent therapy, the clinical benefits to the patients should be weighed against the risks of angina in the patch-free interval. In patients considered to be at risk, concomitant anti-anginal therapy should be implemented (see Precautions).It is recommended that the patch is applied to the lateral chest wall. The replacement patch should be applied to a new area of skin. Allow several days to elapse before applying a fresh patch to the same area of skin. If acute attacks of angina pectoris occur, rapidly acting nitrates may be required.Transiderm Nitro ® 5 only: Phlebitis and extravasation: One Transiderm Nitro 5 patch is to be applied distal to the site of intravenous cannulation at the time of venepuncture. The patch should be removed after 3-4 days and a new replacement patch applied to a different area of skin. Treatment with Transiderm Nitro should be discontinued once intravenous therapy has stopped.
Use in the elderlyNo specific information on use in the elderly is available; however no evidence exists to suggest that an alteration in dosage is required.
Use in childrenThere is insufficient knowledge of the effects of Transiderm Nitro in children and therefore recommendations for its use cannot be made.
WarningsAs 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when transferring the patient on long-term therapy to another form of medication, nitroglycerin should be gradually withdrawn and overlapping treatment started.The Transiderm Nitro patch contains an aluminium layer.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.
HypoxaemiaCaution 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 (EulerLiljestrand 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 cardiomyopathyNitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
Increased anginaThe 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 nitroglycerinIf 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 phlebitisThe infusion site should be examined regularly. If phlebitis develops, it should be treated accordingly.
Women of child-bearing potentialThere is no data supporting any special recommendations in women of child-bearing potential.
PregnancyLike any drug, Transiderm Nitro should be employed with caution during pregnancy, especially in the first 3 months.
LactationThere 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.
FertilityThere is no data available on the effect of Transiderm Nitro on fertility in humans.
|Nervous System Disorders:|
|Rare:||Orthostatic hypotension, flushing|
|Very Common:||Nausea, vomiting|
|Skin and subcutaneous tissue disorders:|
|General disorders and administration site conditions:|
|Uncommon:||Application site erythema, pruritus, burning, irritation.|
|Rare:||Heart rate increase|
Reporting of suspected adverse reactionsReporting 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.
SignsHigh doses of nitroglycerin may lead to severe hypotension and reflex tachycardia or to collapse and syncope. Methaemoglobinaemia has also been reported following accidental overdosage.
ManagementThe nitrate effect of Transiderm Nitro 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.
ATC code: C01DA02Nitroglycerin relaxes smooth muscle. It acts chiefly on systemic veins and large coronary arteries, with more predominant effects on the former. In angina pectoris the fundamental mechanism of action of nitroglycerin is based on an increase in venous capacitance leading to a decreased return of blood to the heart. Owing to this, preload and hence filling volume diminishes, resulting in a decreased myocardial oxygen requirement at rest and especially during exercise.In the coronary arterial circulation nitroglycerin dilates extramural conductance and small resistance vessels. It appears to cause redistribution of coronary blood flow to the ischaemic subendocardium by selectively dilating large epicardial vessels and also relaxes vasospasm.Nitroglycerin dilates the arteriolar vascular bed, as a result of which afterload and left ventricular systolic wall tension decrease, leading to a reduction in myocardial oxygen consumption.
MutagenicityStandard mutagenicity tests provided contradictory results in vitro. Cell culture and in vivo studies revealed no evidence of mutagenic activity of nitroglycerin, and therefore its use is considered devoid of genotoxic potential at exposures relevant to man.
CarcinogenicityDietary studies in rodents led to the conclusion that nitroglycerin has no carcinogenic effects relevant for the therapeutic dose range in man.
Reproduction toxicityAnimal teratology studies have not been conducted with nitroglycerin transdermal systems. Conventional reproduction studies involving the oral, intravenous, intraperitoneal and dermal (as ointment) administration routes of nitroglycerin have been performed in rats and rabbits. Nitroglycerin showed no teratogenic potential in these animals.
|Transiderm Nitro ® 5 only:||28 or 30 sealed patches in each cardboard container.|
|Transiderm Nitro ® 10 only:||28 sealed patches in each cardboard container.|