Summary of Product Characteristics Updated 18-Jul-2018 | Mylan
Minitran 15 mg/ 24 h, transdermal patch
Minitran 15 has a surface area of 20 sq cm and contains 54 mg of glyceryl trinitrate. The average amount delivered in 24 hours is 15 mg.
For the full list of excipients, see section 6.1
Adhesive transdermal patch.
Minitran 15 is indicated for:
Prophylaxis of angina pectoris either alone or in combination with other anti-anginal therapy.
Prophylaxis of angina pectoris
The response to nitrates differs between individuals, and the minimum effective dose should be prescribed in each case. It is therefore recommended that treatment is started with one Minitran 5 patch per day, with upward dosage titration when necessary. Application can either be for a continuous period of 24 hours or intermittently, incorporating a patch free interval (usually at night). Attenuation of effect has occurred in some patients being treated with sustained release nitrate preparations. On the basis of current clinical studies it is recommended that in such cases Minitran should be applied daily with a patch free interval of 8 - 12 hours.
No specific information on use in the elderly is available, but there is no evidence to suggest that an alteration in dose is required.
The safety and efficacy of Minitran in children has yet to be established, and therefore recommendations for its use cannot be made.
Method of administration
Each Minitran patch is contained in a sealed sachet. The adhesive layer is covered by a protective film, which should be removed before application. The Minitran patch should be applied to a clean, dry healthy area of skin on the torso or the arms.
Subsequent patches should not be applied to the same area of skin until several days have elapsed. The Minitran patch adheres easily to the skin, and also stays in place whilst bathing or during physical exercise.
Minitran is contraindicated for patients with:
▪ Known hypersensitivity to glyceryl trinitrate, and related organic nitrates or any excipient of Minitran.
▪ Acute circulatory failure associated with marked hypotension (shock).
▪ Conditions associated with elevated intracranial and intra-ocular pressure.
▪ Myocardial insufficiency due to obstruction, as in aortic or mitral stenosis or constrictive pericarditis.
▪ Concomitant use of Minitran and phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil (Viagra®) is contraindicated, because PDE5 inhibitors may amplify the vasodilatory effects of Minitran resulting in severe hypotension.
▪ Severe anaemia
▪ Severe hypotension (systolic blood pressure less than 90 mmHg).
During therapy with nitrates or nitric oxide donors, the soluble guanylate cyclase stimulator riociguat must not be used (see section 4.5).
Minitran is not indicated for the treatment of acute angina attacks requiring rapid relief. Minitran should be used only under strict medical supervision in recent myocardial infarction or acute congestive cardiac insufficiency. Minitran should be used with caution in patients with hypoxaemia or ventilation perfusion imbalance.
The appearance of cross-tolerance with other nitrates is possible.
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.
Minitran does not contain any metal components, and therefore it is not considered necessary to remove the patch prior to diathermy.
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 (including G6PD deficiency induced forms), because in such patients the biotransformation of glyeryl 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, glyeryl 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 concomitant anti-anginal therapy is desirable.
Tolerance to sublingual glyceryl trinitrate
As tolerance to glyceryl trinitrate patches develops, the effect of sublingual glyceryl trinitrate on exercise tolerance may be partially diminished.
Use for maintenance of venous patency at peripheral infusion sites
The infusion site should be examined regularly. If phlebitis develops, it should be treated accordingly
Interactions resulting in a concomitant use contraindicated
Concomitant administration of Minitran and other vasodilators (e.g. PDE5 inhibitors such as sildenafil [Viagra®]), potentiates the blood-pressure-lowering effect of Minitran.
The use of Minitran with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see section 4.3) since concomitant use can cause hypotension.
Interactions to be considered
Concomitant treatment with calcium antagonists, ACE inhibitors, beta-blockers, diuretics, antihypertensives, tricyclic antidepressants, neuroleptics and major tranquillisers may potentiate the blood-pressure-lowering effect of Minitran, as may alcohol.
Concurrent administration of Minitran 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.
The non-steroidal anti-inflammatory drugs except acetyl salicylic acid may diminish the therapeutic response of Minitran.
Concurrent administration of Minitran with amifostine and acetyl salicylic acid may potentiate the blood pressure lowering effects of Minitran.
There is no data available on the effect of Minitran on fertility in humans.
As with all drugs Minitran should not be prescribed during pregnancy, particularly during the first trimester, unless there are compelling reasons for doing so. 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 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 Minitran therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Minitran, 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.
Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories:
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)
Not known (The adverse drug reactions have been derived from post-marketing experience with Minitran 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)
Nervous system disorders
Very rare: Dizziness
Not known: Syncope
Not known: Palpitation, fainting
Rare: Orthostatic hypotension, flushing2
Very common: Nausea, vomiting
Skin and subcutaneous tissue disorders
Uncommon: Dermatitis contact
Not known: Rash generalized
General disorders and administration site conditions
Uncommon: Application site erythema, pruritus, burning, irritation3
Rare: Heart rate increase
1 Like other nitrate preparations, Minitran 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 beta-blocker.
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.
Reporting of suspected adverse reactionsReporting 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
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 Minitran 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.
Pharmacotherapeutic group: Vasodilators used in cardiac diseases, organic nitrates
ATC Code: C01DA02
Mechanism of action
Nitroglycerin, the active constituent of Minitran is a dilator of smooth muscle, producing relaxation by an unknown mechanism. It has no direct effects on the inotropic or chronotropic state of the heart. It affects cardiac output only as a consequence of its effect on venous capacitance and arteriolar resistance vessels. These effects on preload and afterload reduce myocardial oxygen consumption and are primarily responsible for the mechanism by which nitroglycerin relieves the symptoms of angina pectoris. The drug's principal side effects (headache, flushing, dizziness, postural hypotension and tachycardia) are also a result of its smooth muscle relaxing effects.
When Minitran is applied to the skin, nitroglycerin is absorbed continuously through the skin into the systemic circulation and thus reaches the target organs (heart, vascular system) before deactivation by the liver. Minitran gives continuous release of nitroglycerin over 24 hours maintaining constant plasma levels. Nitroglycerin is metabolised by hydrolysis to dinitrates and the mononitrate.
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One Side Silicone Coated Polyester Film
Minitran must be stored at room temperature (below 25°C) under exclusion of light and moisture.
Each patch is individually packed in a heat sealed foil sachet. Cartons contain 30 patches.
The patch is covered by a protective polyester film, which is detached and discarded before use.
Mylan Products Ltd
28 February 1999/ 7 December 2005
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