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    Active Ingredient
    Glyceryl Trinitrate 18.7 mg , 37.4 mg (releasing an average dose of 5 mg, 10 mg respectively)

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Transdermal Patch

    10 X 5 NT - 18.7 mg

    full basket chart 58578 4454

    Transdermal Patch

    10 X 10 NT - 37.4 mg

    full basket chart 58579 4453

    Related information


    Dosage

    Each patch of  Glyceryl trinitrate 18.7 mg., 37.4 mg. Releasing an average of 5 mg, 10 mg over 24 hrs.
    Dermal: Adults: Treatment should be initiated with one patch daily. If necessary the dosage may be increased to two patches. It is recommended that the patch is applied to healthy, undamaged, relatively crease free and hairless skin. The best places to apply the patches are the easily reached, fairly static areas at the front or side of the chest. However, the  patches may also be applied to the upper arm, thigh, abdomen or shoulder. Skin care products shouldnot be used before applying the patch. The replacement patch should be applied to a new area of skin. Allow several days to elapse before applying a fresh patch to thesame area of skin. Tolerance may occur during chronic nitrate therapy. Tolerance is likely to be avoided by allowing a patch-free period of 8-12 hours each day, usually at night. Additional anti-anginal therapy with drugs not containing nitro compounds should be considered for the nitrate-free interval if required. As with any nitrate therapy, treatment with these patches should not be stopped abruptly. If the patient is being changed to another type of treatment, the two should overlap.
    Older people: No specific information on use in the elderly is available, however there is no evidence to suggest that an alteration in dose is required.
    Paediatric population: The safety and efficacy of this patch in children has yet to be established.
    See prescribing information for full details.          


    Indications

    Prophylaxis of angina pectoris alone or in combination with other anti-anginal therapy.


    Contra-Indications

    Known hypersensitivity to nitrates or to the adhesives used in the patch Raised intracranial pressure including that caused by head trauma or cerebral haemorrhage. Acute circulatory failure associated with marked hypotension (shock). Myocardial insufficiency due to obstruction, as in aortic or mitral stenosis or constrictive pericarditis. Marked anaemia. Closed angle glaucoma. Severe Hypotensive conditions  (systolic blood pressure less than 90 mmHg). Severe hypovolemia. Hypertrophic obstructive cardiomyopathy. Aortic stenosis and mitral stenosis. Constrictive pericarditis. Cardiac tamponade. Concomitant use of phosphodiesterase type-5 inhibitors. Phosphodiesterase type 5 inhibitors (e.g. sildenafil, tadalafil, vardenafil) have been shown to potentiate the hypotensive effects of nitrates, and their co-administration with nitrates or nitric oxide donors is therefore contra-indicated. During nitrate therapy, the soluble guanylate cyclase stimulator riociguat must not be used.
    See prescribing information for full details.


    Special Precautions

    In cases of recent myocardial infarction or acute heart failure, treatment with the preparation 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.
    This patch should be used with caution in patients with: Severe hepatic or renal impairment. Hypothyroidism. Hypothermia.  Malnutrition. A recent history of myocardial infarction. Hypoxaemia or a ventilation/perfusion imbalance due to lung disease or ischaemic heart failure. Arterial Hypoxaemia due to severe anaemia (including G6PD deficiency induced forms), because in such patients the biotransformation of nitroglycerin is reduced. Alveolar hypoventilation a vasoconstriction occurs within the lung to shift perfusion from areas of alveolar hypoxia to better ventilated regions of the lung (Von Euler–Liljestrand mechanism). 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 entilation/perfusion imbalance, and a further decrease in the arterial partial pressure of oxygen.
    Methemoglobinemia: Following treatment with GTN, methemoglobinemia has been reported. Treatment of methaemoglobinemia with methylene blue is contraindicated in patients with glucose-6-phosphate deficiency or methemoglobin-reductase Deficiency. The patch is not indicated for use in acute angina attacks. In the event of an acute angina attack, sublingual treatment such as a spray or tablet should be used. As with all nitrate preparations withdrawal of long-term treatment should be gradual by replacement with decreasing doses of long acting oral nitrates. Also when transferring the patient on long-term therapy to another form of medication, nitroglycerin should be gradually withdrawn and overlapping treatment started.
    See prescribing information for full details.


    Side Effects

    Dizziness, drowsiness, reflex tachycardia, and a feeling of weakness.
    See prescribing information for full details.  


    Drug interactions

    Concomitant treatment with other vasodilators, calcium antagonists, ACE inhibitors, beta-blockers, diuretics, antihypertensives, tricyclic antidepressants and major tranquillisers, as well as the consumption of alcohol, may potentiate the hypotensive effect of the preparation. The blood pressure lowering effect of these patches will be increased if used  ogether with phosphodiesterase inhibitors (e.g. sildenafil) which are used for erectile dysfunction. This might lead to life threatening cardiovascular complications. Patients who are on nitrate therapy must not use  hosphodiesterase inhibitors (e.g. sildenafil). The use of GTN with riociguat, a soluble guanylate cyclase stimulator, is contraindicated since concomitant use can cause hypotension. If administered concurrently, these patches may increase the blood level of dihydroergotamine and lead to coronary vasoconstriction. The possibility that ingestion of non-steroidal antiinflammatory drugs except Acetyl Salicylic acid might diminish the therapeutic response to the patch cannot be excluded.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: Like any drug, this drug  should be employed with caution during pregnancy, especially in the first 3 months.
    Lactation: It is not known whether the active substance passes into the breast milk.
    See prescribing information for full details.            


    Overdose

    In view of the transdermal mode of delivery, an overdose of glyceryl trinitrate is unlikely to occur. However, in the unlikely event of an overdose, the symptoms could include the following: Fall in blood pressure ≤ 90 mmHg, Collapse or syncope, Paleness, Sweating, Weak pulse, Reflex Tachycardia, Flushing, Light-headedness on standing, Headache Weakness, Dizziness, Nausea, Vomiting. Methaemoglobinaemia has been reported in patients receiving other organic nitrates. During glyceryl trinitrate biotransformation nitrite ions are released, which may induce methaemoglobinaemia and cyanosis with subsequent tachypnoea, anxiety, loss of consciousness and cardiac arrest. It cannot be excluded that an overdose of glyceryl trinitrate may cause this adverse reaction. In very high doses the intracranial pressure may be increased. This might lead to cerebral symptoms.
    General procedure: Since these patches are applied to the skin, removing the patch immediately stops delivery of the drug. General procedures in the event of nitrate-related hypotension Patient should be kept horizontal with the head lowered and legs raised or, if necessary, compression bandaging of the patient’s legs. Supply oxygen. Expand plasma volume. For specific shock treatment admit patient to intensive care unit.
    Special procedure: Raising the blood pressure if the blood pressure is very low. Treatment of methaemoglobinaemia. Treatment with intravenous methylene blue Initially 1 to 2 mg/kg, not exceeding 4 mg/kg of a 1% solution over 5 minutes. Repeat dose in 60 minutes if there is no response. Administer oxygen (if necessary). Initiate artificial ventilation Treatment with methylene blue is contraindicated in patients with glucose 6phosphate dehydrogenase (G-6-PD) deficiency or methaemoglobin reductase deficiency. Where treatment with methylene blue is contraindicated or is not effective, exchange transfusion and or transfusion of packed red blood cells is recommended.
    Resuscitation measures: In case of signs of respiratory and circulatory arrest, initiate resuscitation measures immediately.


    Important notes

    Effects on ability to drive and use machines: Glyceryl trinitrate can cause postural hypotension and dizziness. Patients should not drive or operate machinery if they feel affected.             

      


    Manufacturer
    Aesica Pharmaceuticals GmbH , Monheim, Germany
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