VIPRANOP

This presentation is suitable for perioperative setting, the concentration is not adapted to critical care setting. Posology This medicinal product should not be diluted before use: it is supplied ready to use and must not be mixed with other medicines.

It is suitable for injection or continuous infusion through a peripheral venous line. The patient should be monitored carefully for the duration of noradrenaline therapy. Noradrenaline should only be administered by healthcare professionals who are experienced with its use and have appropriate facilities to adequately monitor the patient.

1 μg/kg/min of noradrenaline tartrate). An initial intravenous bolus of 5 μg to 10 μg of noradrenaline (10 μg to 20 μg noradrenaline tartrate) may be administered before the start of the infusion, following spinal anesthesia, or the induction of general anesthesia.

Titration of dose Once an infusion of noradrenaline has been established the dose can be increased or decreased at the discretion of the attending physician to maintain an adequate target blood pressure during the peri-operative period.

The dose should be adjusted according to age, weight and clinical condition of the patient. Intravenous bolus of 5 μg to 10 μg noradrenaline (10 μg to 20 μg noradrenaline tartrate) can be administered if the blood pressure needs to be increased rapidly.

4 Duration of treatment and monitoring Noradrenaline should be continued throughout the peri-operative period as long as considered necessary to maintain adequate blood pressure and tissue perfusion. Withdrawal of therapy Infusions should be reduced gradually, avoiding abrupt withdrawal which can result in acute hypotension.

Hepatic/renal impairment There is no experience in treatment of hepatically or renally impaired patients. Elderly patients In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range as to reflect the greater frequency of decreased hepatic, renal or cardiac function and concomitant disease or other drug therapy.

Paediatric population This medicinal product is indicated for adults only. The safety and efficacy of noradrenaline in children aged less than 18 years old has not yet been established. No data are available. Method of administration For intravenous use.

This medicinal product is a ready to use solution for single use only, which should not be diluted before use. It can be administered as a continuous infusion or bolus injection through a peripheral venous line. The infusion can be administered at a controlled rate using either a syringe pump or an infusion pump or a drip counter.

Site of infusion This medicinal product should be infused through a peripheral or a central venous catheter.

Table 1 lists adverse reactions that have been experienced following treatment with noradrenaline. This data has largely been collected from spontaneous reporting, and due to the problems in calculating reporting frequencies from spontaneous reporting, the frequency of the listed adverse reactions is not known (cannot be estimated from the available data).

The adverse reactions are reported in decreasing order of frequency within each system order class (SOC).

Table 1:

Adverse reactions reported with noradrenaline through spontaneous reporting System Organ Class (SOC) Adverse Reactions Psychiatric disorders Anxiety, insomnia. Nervous system disorders Transient headache, tremor, dizziness. Eye disorders Acute glaucoma.

Cardiac disorders Bradycardia1, arrythmia, electrocardiogram change, tachycardia, cardiogenic shock, stress cardiomyopathy. Vascular disorders Hypertension, peripheral ischaemia2 including gangrene of the extremities, plasma volume depletion with prolonged use.

Respiratory, thoracic and mediastinal disorders Dyspnea. Gastrointestinal disorders Nausea and vomiting. Renal and urinary disorders Retention of urine. General disorders and administration site conditions Extravasation, injection site necrosis 1 Bradycardia, probably as a reflex result of a rise in blood pressure.

2 Ischaemia, due to potent vasoconstrictor action and tissue hypoxia. , hyperthyroid patients) may cause severe hypertension with violent headache, photophobia, stabbing retrosternal pain, pallor, fever, intense sweating and vomiting.

Hypertension may eventually lead to acute pulmonary oedema, arrhythmia or cardiac arrest. Reporting of suspected adverse reactions 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.

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This medicinal product can be used as injection/infusion through a peripheral venous catheter. The infusion should be at a controlled rate using either a syringe pump, an infusion pump or a drip counter. This presentation is suitable for perioperative setting, the concentration is not adapted to critical care setting.

Noradrenaline should be used only in conjunction with appropriate blood volume replacement. If noradrenaline is continuously administered to maintain blood pressure in the absence of blood volume replacement, the following may occur: severe peripheral and visceral vasoconstriction, decreased renal perfusion and urine output, poor systemic blood flow despite “normal” blood pressure, tissue hypoxia and lactic acidosis.

g. if given simultaneously, use Y-tubing and individual containers). Prolonged administration of any potent vasopressor may result in plasma volume depletion which should be continuously corrected by appropriate fluid and electrolyte replacement therapy.

g. decreased renal perfusion) with diminution in blood flow and tissue perfusion with subsequent tissue hypoxia and lactic acidosis and possible ischemic injury; gangrene of extremities has been rarely reported. Particular caution should be observed in patients with coronary, mesenteric or peripheral vascular thrombosis because noradrenaline may increase the ischemia and extend the area of infarction, unless in the opinion of the attending physician, the administration of noradrenaline is necessary as a life-saving procedure.

Special caution should be used for patients with liver failure, severe renal dysfunction, ischemic heart diseases and elevated intracranial pressure. 8). The elderly may be especially sensitive to the effects of noradrenaline due to the greater frequency of hepatic, renal or cardiac dysfunction and concomitant disease or other drug therapy.

2). Noradrenaline should only be administered by healthcare professionals who are familiar with its use and have appropriate facilities to adequately monitor the patient. Where indicated, appropriate replacement therapy of blood or fluid together with adoption of the supine position with elevation of the legs, must be instituted and maintained prior to and/or during therapy with this product.

When infusing noradrenaline, the blood pressure and flow rate should be checked frequently to avoid hypertension. Therefore, it is desirable to record the blood pressure every two minutes from the time the administration started until the desired blood pressure is obtained and then every five minutes thereafter, if the administration is to be continued.

The flow rate must be watched constantly and the patient should never be left unattended while receiving noradrenaline. Hypertension may eventually lead to acute pulmonary oedema, arrhythmia or cardiac arrest. Cardiac arrhythmias may arise when noradrenaline is used in conjunction with cardiac sensitizing agents and may be more likely in patients with hypoxia or hypercarbia.

The infusion of noradrenaline should be stopped gradually as sudden cessation may produce a catastrophic fall in blood pressure. 2 – Site of infusion). Extravasation The infusion site should be checked frequently for free flow. Care should be taken to avoid extravasation of noradrenaline into the tissues, as local necrosis might ensue due to the vasoconstrictive action of the drug.

Blanching along the course of the infused vein, sometimes without obvious extravasation, has been attributed to vasa vasorum constriction with increased permeability of the vein wall, permitting some leakage. On rare occasions this may progress to superficial slough, particularly during infusion into leg veins in elderly patients or in those suffering from obliterative vascular disease.

If blanching occurs, consideration should be given to changing the infusion site at intervals to allow the effects of local vasoconstriction to subside. IMPORTANT- Antidote for extravasation ischaemia To prevent sloughing and necrosis in areas in which extravasation has taken place, the area should be infiltrated as soon as possible with 10 ml to 15 ml of saline solution containing from 5 mg to 10 mg of phentolamine, an adrenergic blocking agent.

A syringe with a fine hypodermic needle should be used with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard and pallid appearance. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours.

Phentolamine should be given as soon as possible after the extravasation is noted and noradrenaline infusion should be stopped. 6 % of the WHO recommended maximum daily intake of 2 g sodium for an adult. 9 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

1. Do not use with cyclopropane, halothane anaesthetics. 5.