NORADRENALINE (NOREPINEPHRINE)

5 mg/ml solution for infusion in pre-filled syringe is 500 mg/l noradrenaline base (1000 mg/liter noradrenaline tartrate). 15 micrograms/kg/min. 1 μg/kg/min of noradrenaline base according to the pressor effect observed. There is great individual variation in the dose required to attain and maintain normotension.

The aim should be to establish a low normal systolic blood pressure (100-120 mmHg) or to achieve an adequate mean arterial blood pressure (greater than 65-80 mm Hg – depending on the patient's condition). 4). Elderly Elderly are very sensitive to the effects of sympathomimetics.

4). Paediatric population The safety and efficacy of noradrenaline (norepinephrine) in children less than 18 years of age has not yet been established. No data are available. Duration of treatment and monitoring Noradrenaline (Norepinephrine) should be continued for as long as vasoactive drug support is indicated.

The patient should be monitored carefully for the duration of therapy. Blood pressure should be carefully monitored for the duration of therapy. Withdrawal of therapy The noradrenaline (norepinephrine) infusion should be gradually decreased since abrupt withdrawal can result in acute hypotension.

Route of administration For intravenous use. 5 mg/ml, solution for infusion in pre-filled syringe is already diluted and ready to use. It should be used with a suitable syringe driver pump capable of accurately and consistently delivering the minimum specified volume at a strictly controlled rate of infusion in line with the dose titration instructions specified in above table.

When programming the pump for the infusion, select “BD Plastipak®” as the syringe setting.

Psychiatric disorders - anxiety Nervous system disorders - headache, tremor Eye disorders - acute glaucoma (very frequent in patients anatomically predisposed with closing of the iridocorn angle) Cardiac disorders - tachycardia, bradycardia (probably as a reflex result of blood pressure rising), arrhythmias, palpitations, increase in the contractility of the cardiac muscle resulting from the ß adrenergic effect on the heart (inotrope and chronotrope), acute cardiac insufficiency, stress cardiomyopathy Vascular disorders - arterial hypertension and tissue hypoxia; ischemic injury due to potent vasoconstrictor action (may result in coldness and paleness of the limbs and the face) Respiratory, thoracic and mediastinal disorders - respiratory insufficiency or difficulty, dyspnea Gastrointestinal disorders - vomiting Renal and urinary disorders - retention of urine General disorders and administration site conditions - locally: possibility of irritation and necrosis at the injection site The continuous administration of vasopressor to maintain blood pressure in the absence of blood volume replacement may cause the following symptoms - severe peripheral and visceral vasoconstriction - decrease in renal blood flow - decrease in urine production - hypoxia - increase in lactate serum levels.

In case of hypersensitivity or overdose, the following effects may appear more frequently: hypertension, photophobia, retrosternal pain, pharyngeal pain, pallor, intense sweating and vomiting. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Warning Noradrenaline (Norepinephrine) is contraindicated in hypotensive patients in whom circulatory collapse is associated with hypovolaemia except as an emergency measure to maintain supply to the coronary and cerebral arteries until blood volume replacement therapy can be instituted.

Noradrenaline (Norepinephrine) solution is intended for infusion via a central venous catheter only. As such, the risk of extravasation and subsequent tissue necrosis is very limited. The infusion site should be checked frequently. However, if extravasation occurs, the infusion should be stopped immediately and the area should be infiltrated with phentolamine without delay, monitored closely for improvement and re-assessed for further treatment to reverse the ischemic effect.

Precautions for use In general, cautious evaluation is recommended in the following cases of hypotension and hypoperfusion, in which a reduction in the dose of noradrenaline (norepinephrine) may be required: - major left ventricular dysfunction associated with acute hypotension.

Supportive therapy should be initiated simultaneously with diagnostic evaluation. Noradrenaline (Norepinephrine) should be reserved for patients with cardiogenic shock and refractory hypotension, in particular those without elevated systemic vascular resistance.

- hypotensive patients diagnosed with coronary, mesenteric or peripheral vascular thrombosis, myocardial infarction or Prinzmetal's variant angina. Particular caution should be observed as noradrenaline (norepinephrine) may increase the associated ischaemia and extend the area of infarction.

- occurrence of heart rhythm disorders during noradrenaline (norepinephrine) therapy. Prolonged administration of any potent vasopressor may result in plasma volume depletion which should be continuously corrected by appropriate water and electrolyte replacement therapy.

If plasma volumes are not corrected, hypotension may recur when the noradrenaline (norepinephrine) infusion is discontinued, or blood pressure may be maintained with the risk of severe peripheral and visceral vasoconstriction with diminution in blood flow.

Pheochromocytoma Noradrenaline (Norepinephrine) should be used with caution in patients with pheochromocytoma, as it may increase the risk of noradrenaline (norepinephrine) effects on the heart. Angle-closure glaucoma Noradrenaline (Norepinephrine) should be used with caution in patients with angle-closure glaucoma.

Prostate adenoma Noradrenaline (Norepinephrine) should be used with caution in patients with prostate adenoma. Those patients may have an increased risk of urinary retention. Renal impairment and liver impairment There is no experience in treatment of hepatically or renally impaired patients.

Because the blood flow in organs such as the liver and the kidneys may decrease, caution should be preserved when using sympathomimetics in patients with hepatic - or renal impairment. Hyperthyroidism or diabetes mellitus Caution is advised in patients with hyperthyroidism or diabetes mellitus.

In cases where it is necessary to administer noradrenaline (norepinephrine) at the same time as total blood or plasma, the latter must be administered in a separate drip. 82 mmol (or 180 mg) sodium per pre-filled syringe, equivalent to 9% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

1.