Nitrolingual Spray

/ Megapharm

Unless otherwise prescribed, 1 – 3 actuations of Nitrolingual Spray (equivalent to 0.4 – 1.2mg glyceryl trinitrate) are administered at the start of an angina pectoris attack or immediately prior to exertion known to precipitate an angina pectoris attack, depending on the degree of severity.
In acute left heart failure and acute myocardial infarction, 1 – 3 actuations of Nitrolingual Spray (equivalent to 0.4 – 1.2 mg glyceryl trinitrate) are given, depending on the degree of severity, whilst monitoring circulatory conditions (systolic blood pressure above 100 mmHg).
In the absence of a response, treatment with the same dose can be repeated after 10 minutes. In prophylactic use prior to coronary angiography, 1 – 2 actuations of Nitrolingual Spray are given (equivalent to 0.4 mg – 0.8 mg glyceryl trinitrate).
Adjuvant anti-anginal therapy with medicinal products not containing nitrate compounds should be considered for the nitrate-free interval. Actuations are sprayed (not inhaled) into the oral cavity (preferably under the tongue) at
intervals of approximately 30 seconds, whilst holding the breath. To use, remove the protective cap by pulling it straight up and off. To familiarise themselves with the handling of Nitrolingual Spray and for complete filling of the dosing chamber for initial use, patients should firstly prime the valve and spray the contents into the air (fully depress the spray head swiftly and then release). This may also be required if the spray has not been used for prolonged periods. The spray is now ready for use. Do not shake the spray before use. Whilst spraying, hold the bottle upright with the spray head pointing upwards. The spray head opening should be placed as near to the mouth as possible. As the opening can be easily felt with the finger, it also acts as a reliable aid for guiding the spray during night-time administration.
For full details see prescribing information.

Treatment and prophylaxis of angina pectoris.

Nitrolingual Spray must not be used in the following cases:
– hypersensitivity to glyceryl trinitrate, other nitrate compounds or to any of the
excipients,
– acute circulatory failure (shock, circulatory collapse),
– cardiogenic shock, unless a sufficiently high left-ventricular end-diastolic pressure is ensured by intra-aortic counterpulsation or positive inotropic medications,
– marked hypotension (systolic blood pressure less than 90 mmHg),
– intake of phosphodiesterase inhibitors for the treatment of erectile dysfunction or pulmonary arterial hypertension, as these can considerably potentiate the antihypertensive effect of Nitrolingual Spray. Thus, in patients with coronary heart disease, please note the restrictions on the use of such medications.
Similarly, Nitrolingual Spray may not be used if patients have taken phosphodiesterase inhibitors for the treatment of erectile dysfunction or pulmonary arterial hypertension, even if acute symptoms of angina pectoris develop.

Glyceryl trinitrate may only be used with caution in the following cases:
– hypertrophic obstructive cardiomyopathy, constrictive pericarditis and pericardial tamponade,
– low filling pressures, e.g. in acute cardiac infarction, impaired left ventricular function (left heart failure). A fall in blood pressure below 90 mmHg systolic should be avoided,
– aortic and/or mitral stenosis,
– susceptibility to orthostatic circulatory dysregulation, – disorders associated with increased intracranial pressure (an increase in pressure has hitherto been observed only with high-dose IV administration of glyceryl trinitrate.

Nervous system disorders Very common: Headache (“nitrate-induced headache”) may occur at the start of treatment which, based on experience, mostly subsides after a few days with continued intake.
Vascular disorders Common: During initial use, as well as after a dose increase, a fall in blood pressure and/or orthostatic hypotension are observed, which may be accompanied by a reflex increase in pulse rate, light-headedness, as well as feelings of dizziness and weakness. Uncommon: Marked hypotension may occur with exacerbation of angina pectoris symptoms.
Uncommon: States of collapse occur, with bradyarrhythmias and syncope (common).
Immune system disorders Uncommonly hypersensitivity reactions have been observed.
Skin and subcutaneous tissue disorders Uncommon: Transient reddening of the skin (flush) and allergic cutaneous reactions have been observed.
Uncommonly allergic dermatitis may occur. Very rare exfoliative dermatitis may occur.
Gastrointestinal disorders Uncommon: Nausea and vomiting may occur. The frequency of occurrence of swollen tongue cannot be estimated from the available data.
General disorders and administration site conditions There have been reports of tolerance development and the occurrence of cross tolerance with other nitrate compounds. To prevent any attenuation or loss of effect, high continuous dosages should be avoided.
For full details see prescribing information

The following interactions of this medicinal product must be taken into consideration: Concomitant intake of other vasodilators, antihypertensives, ACE inhibitors, beta-receptor blockers, calcium antagonists, diuretics, neuroleptics or tricyclic antidepressants, alcohol and sapropterin can potentiate the antihypertensive effect of Nitrolingual Spray.
If phosphodiesterase inhibitors are taken in addition to existing nitrate therapy (e.g. together with Nitrolingual Spray) for the treatment of erectile dysfunction or pulmonary arterial hypertension, the antihypertensive effect may be greatly potentiated. Patients with coronary heart disease may therefore not take phosphodiesterase inhibitors for the treatment of erectile dysfunction or pulmonary arterial hypertension. With concomitant use of dihydroergotamine, Nitrolingual Spray may lead to an increase in DHE levels and thus potentiate its hypertensive effect. With concomitant use of heparin and Nitrolingual Spray, the effect of heparin is attenuated. The heparin dose must be adjusted accordingly under close monitoring of coagulation parameters. Upon discontinuation of glyceryl trinitrate, a reduction in the heparin dose may be required, as coagulation may be significantly reduced (massive rise in PTT). In patients pretreated with organic nitrate compounds, e.g. isosorbide dinitrate, isosorbide-5- mononitrate, a higher dosage of glyceryl trinitrate may be required to achieve the desired haemodynamic effect.
For full details see prescribing information

As a special precaution during pregnancy and lactation, glyceryl trinitrate should be used only after careful consideration of the benefits and risks. There is no adequate experience in humans, particularly for the first trimester of pregnancy.

Symptoms of an overdose: A fall in blood pressure may occur, with orthostatic dysregulation, reflex tachycardia and headache, feelings of weakness, dizziness, light-headedness, flush, nausea, vomiting and diarrhoea. At high doses (more than 20 mg/kg body weight) methaemoglobin formation, cyanosis, dyspnoea and tachypnoea are likely as a result of the nitrite ion formed during GTN degradation. At very high doses, there may be an increase in intracranial pressure with cerebral symptoms. In cases of chronic overdose, increased methaemoglobin levels have been measured, the clinical relevance of which is the subject of debate.
Measures to treat an overdose: As well as general measures, such as gastric lavage and supine positioning of the patient with the legs raised, vital parameters must be monitored under intensive care conditions andm corrected where necessary. Volume replacement should be administered in the event of marked hypotension and/or shock; norepinephrine and/or dopamine can be infused in exceptional cases as circulation therapy. Administration of epinephrine and related substances is contraindicated.
For full details see prescribing information.