Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland LOCAL REPRESENTATIVE: Novartis Pharma Services Inc., Methonis Tower, 73 Archibishop Makarios III Avenue, 1070 Nicosia ...
Known hypersensitivity to nitroglycerin, and related organic nitrates or any excipient of NITRODERM TTS.
Acute circulatory failure associated with marked hypotension (shock).
Conditions associated with elevated intracranial pressure.
Myocardial insufficiency due to obstruction, as in aortic or mitral stenosis or constrictive pericarditis.
Concomitant use of NITRODERM TTS and phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil is contraindicated, because PDE5 inhibitors may amplify the vasodilatory effects of NITRODERM TTS resulting in severe hypotension.
Severe hypotension (systolic blood pressure less than 90 mmHg).
Severe hypovolemia
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when transferring the patient on long‑term therapy to another form of medication, nitroglycerin should be gradually withdrawn and overlapping treatment started.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 NITRODERM TTS patch contains an aluminium layer. Therefore NITRODERM TTS 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 NITRODERM TTS 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.
Caution should be exercised in patients with arterial hypoxaemia due to severe anaemia, because in such patients the biotransformation of nitroglycerin 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 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.
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 nitroglycerin patches develops, the effect of sublingual nitroglycerin on exercise tolerance may be partially diminished.
The infusion site should be examined regularly. If phlebitis develops, it should be treated accordingly.
Concomitant administration of NITRODERM TTS and other vasodilators e.g PDE5 inhibitors such as sildenafil potentiates the blood pressure lowering effects of NITRODERM TTS.
Concomitant treatment with calcium antagonists, ACE inhibitors, beta-blockers, diuretics, antihypertensives, tricyclic antidepressants and major tranquillisers may potentiate the blood pressure-lowering effect of NITRODERM TTS, as may alcohol.
Concurrent administration of NITRODERM TTS 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 NITRODERM TTS.
Concurrent administration of NITRODERM TTS with amifostine and acetyl salicylic acid may potentiate the blood pressure lowering effects of NITRODERM TTS.
Like any drug, NITRODERM TTS should be employed with caution during pregnancy, especially in the first 3 months.
Animal technology 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.
It is not known whether the active substance passes into the breast milk. The benefits for the mother must be weighed against the risks for the child.
There is no data supporting any special recommendations in women of child-bearing potential.
There is no data available on the effect of Nitroderm TTS on fertility in humans.
A three-generation reproduction study was performed in rats. In this study, the rats received dietary nitroglycerin at doses of up to 363 mg/kg/day in males and up to 434 mg/kg/day in females for six months prior to mating of the F0 generation, with treatment continuing through successive F1 and F2 generations. Control groups recieved diets free of nitroglycerin. Matings consisted of 10 males and 20 females from each group for the F0 generation. No specific effect on the fertility of the F0 generation was seen. There was no specific nitroglycerin induced teratogenic effects. Infertility noted in subsequent generations, however, was attributed to increased interstitial cell tissue and aspermatogenesis in the high-dose males. There were no effects on fertility, viability, growth or development of offspring at doses of up to approximately 38 mg/kg/day, which is greater than 100-fold the maximum daily human dose (two Nitroderm TTS 10). The latter was confirmed in an antraperitoneal fertility study in rats receiving nitroglycerin doses of up to 20mg/kg/day for 63 days.
NITRODERM TTS 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:
Common: Headache
Very rare: Dizziness
Rare: Tachycardia
Rare: Orthostatic hypotension, flushing
Very Common: Nausea, vomiting
Uncommon: Contact dermatitis
Uncommon: Application site erythema, pruritus, burning, irritation.
Rare: Heart rate increase
Like other nitrate preparations, NITRODERM TTS 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 NITRODERM TTS 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.
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 at Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Fax: +357 22608649, Website: www.moh.gov.cy/phs.
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