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  • Nitroderm TTS
    / Novartis


    Active Ingredient
    Nitroglycerine 25 mg, 50 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Patch

    TTS 5: 10 X 25 mg

    full basket chart 1482 14052

    Patch

    TTS 10: 10 X 50 mg

    full basket chart 2515 14053

    Related information


    Dosage

    General rules: Nitroderm TTS is not intended for the immediate relief of acute attacks of angina pectoris; if these occur, rapid-acting nitrate preparations should be used. The response to nitrate preparations varies from patient to patient; the lowest effective dose should be prescribed. The application site should be changed regularly to prevent local irritation. Development of tolerance or attenuation of therapeutic effect commonly occurs with prolonged or frequent administration of long-acting nitrates, including Nitroderm TTS or other transdermal systems. A patch-off period of 8-12 hours, usually at night, every 24 hours is recommended to overcome tolerance. Clinical trials have shown that in most patients intermittent therapy is more effective than continuous administration. Continuous application of Nitroderm TTS may be appropriate for patients in whom long-term clinical responsiveness can be reliably assessed.
    Prophylaxis of angina pectoris: Treatment should be initiated with one Nitroderm TTS 5 daily. According to the clinical response the daily dose can then be titrated upwards to:
    – one Nitroderm TTS 10 (normal maintenance dose)
    – one Nitroderm TTS 10 plus one Nitroderm TTS 5
    – two Nitroderm TTS 10
    Special populations
    Use in the elderly: No specific information on use in the elderly is available; however, there is no evidence to suggest that the dosage needs to be adjusted in elderly patients.
    Use in children: Not enough is known about the effects of Nitroderm TTS in children, which means that it cannot be recommended for use in this age group.


    Indications

    Prophylaxis of angina pectoris.


    Contra-Indications

    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. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrite overdose, with elevation of the extremities and with central volume expansion. The onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute attack. Allergy to the adhesives used in nitroglycerin patches has also been reported, and it similarly constitutes a contraindication to the use of this product.


    Special Precautions

    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 Imagining), 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. A cardioverter/defibrillator should not be discharged through a paddle electrode that overlies a Nitroderm TTS patch. The arching that may be seen in this situation is harmless in itself, but it may be associated with local current concentration that can cause damage to the paddles and burns to the patient.
    Hypoxaemia: Caution should be exercised in patients with arterial hypoxemia (including G6PD deficiency induced forms) due to severe anemia, because in such patients the biotransformation of nitroglycerin is reduced. Similarly, caution is called for in patients with hypoxemia and ventilation/perfusion imbalance due to lung disease or ischemic 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 ischemia 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 additional anti-anginal therapy is desirable.
    Tolerance to sublingual nitroglycerin: As tolerance to nitroglycerin patches develops, the effect of sublingual nitroglycerin on exercise tolerance may be partially diminished.
    Driving and using machines: When driving or using machines, patients should be aware that Nitroderm TTS, especially at the start of treatment, may cause dizziness. In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence.
    Information for Patients: Daily headaches sometimes accompany treatment with nitroglycerin. In patients who get these headaches, the headaches may be a marker of the activity of the drug. Patients should resist the temptation to avoid headaches by altering the schedule of their treatment with nitroglycerin, since loss of headache may be associated with simultaneous loss of antianginal efficacy. Treatment with nitroglycerin may be associated with lightheadedness on standing, especially just after rising from a recumbent or seated position. This effect may be more frequent in patients who have also consumed alcohol. After normal use, there is enough residual nitroglycerin in discarded patches that they are a potential hazard to children and pets.
    For full details see prescribing information.


    Side Effects

    Very common: Nausea, vomiting, 
    Common:
    Headache.
    For full details see prescribing information.


    Drug interactions

    Interactions resulting in concomitant use contraindicated: Concomitant administration of Nitroderm TTS and  other vasodilators e.g PDE5 inhibitors such as sildenafil,  potentiates the blood-pressure-lowering effect of Nitroderm TTS.
    Interactions to be considered: 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 possibility that the ingestion of acetylsalicylic acid and non-steroidal anti-inflammatory drugs might diminish the therapeutic response to Nitroderm TTS cannot be excluded.


    Pregnancy and Lactation

    Pregnancy: Like any drug, Nitroderm TTS should be employed with caution during pregnancy, especially in the first 3 months.
    Breast-feeding: 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.


    Overdose

    Hemodynamic effects: The ill effects of nitroglycerin overdose are generally the results of nitroglycerin’s capacity to induce vasodilation, venous pooling, reduced cardiac output, and hypotension. These hemodynamic changes may have protean manifestations, including increased intracranial pressure, with any or all of persistent throbbing headache, confusion, and moderate fever; vertigo; palpitations; visual disturbances; nausea and vomiting (possibly with colic and even bloody diarrhea); syncope (especially in the upright posture); air hunger and dyspnea, later followed by reduced ventilatory effort; diaphoresis, with the skin either flushed or cold and clammy; heart block and bradycardia; paralysis; coma; seizures; and death. Methaemoglobinaemia has also been reported following accidental overdosage.
    Methemoglobinemia: Nitrate ions liberated during metabolism of nitroglycerin can oxidize hemoglobin into methemoglobin. Even in patients totally without cytochrome B5 reductase activity, however, and even assuming that the nitrate moieties of nitroglycerin are quantitatively applied to oxidation of hemoglobin, about 1mg/kg of nitroglycerin should be required before any of these patients manifests clinically significant (≥ 10%) methemogolobinemia. In patients with normal reductase function, significant production of methemoglobin should required even larger doses of nitroglycerin.
    For full details see prescribing information.


    Important notes

    Storage: Store below 25°C.


    Manufacturer
    Novartis Pharma Stein AG Switzerland
    Licence holder
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