NORADRENALINE (NOREPINEPHRINE) Solution for infusion Ref.[7928] Active ingredients: Noradrenaline

Warning

Noradrenaline 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 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

Noradrenaline 0.08 mg/ml, solution for infusion should not be used for initiating vasopressor treatment.

In general, cautious evaluation is recommended in the following cases of hypotension and hypoperfusion, in which a reduction in the dose of noradrenaline may be required:

• Major left ventricular dysfunction associated with acute hypotension. Supportive therapy should be initiated simultaneously with diagnostic evaluation. Noradrenaline 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 may increase the associated ischaemia and extend the area of infarction.
• Occurrence of heart rhythm disorders during noradrenaline therapy.

Caution is advised in patients with hyperthyroidism or diabetes mellitus.

In cases where it is necessary to administer Noradrenaline at the same time as total blood or plasma, the latter must be administered in a separate drip.

This medicinal product contains sodium. To be taken into consideration by patients on a controlled sodium diet, see section 2.

Inadvisable combinations

Volatile halogen anaesthetics: severe ventricular arrhythmia (increase in cardiac excitability).

Imipramine antidepressants: paroxysmal hypertension with the possibility of arrhythmia (inhibition of the entry of sympathomimetics into sympathetic fibres).

Serotoninergic-adrenergic antidepressants: paroxysmal hypertension with the possibility of arrhythmia (inhibition of the entry of sympathomimetics into sympathetic fibres).

Combinations requiring precautions for use

Non-selective MAO inhibitors: increase in the pressor action of the sympathomimetic which is usually moderate. Should only be used under close medical supervision.

Selective MAO-A inhibitors, Linezolid and Methylene Blue: by extrapolation from non-selective MAO inhibitors, risk of increase in the pressor action. Should only be used under close medical supervision.

Pregnancy

Because of its indications, noradrenaline may be administered if necessary during pregnancy.

However, pharmacodynamics properties of the substance have to be considered. Noradrenaline may impair placental perfusion and induce fetal bradycardia. It may also exert a contractile effect on the pregnant uterus and lead to fetal asphyxia in late pregnancy.

Lactation

No information is available on the use of noradrenaline in lactation.

Not relevant.

Psychiatric disorders: Anxiety.

Nervous system disorders: Headache, tremor.

Eyes disorders: Acute glaucoma (very frequent in patients anatomically predisposed with closing of the iridocorneal angle).

Cardiac disorders: Tachycardia, bradycardia (probably as a reflex result of blood pressure rising), arrhythmia, 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 members 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.

This medicinal product must not be mixed with other medicinal products.