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NORADRENALINE (NOREPINEPHRINE) KABI is a brand name for Norepinephrine (also known as Noradrenaline). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Noradrenaline (Norepinephrine) Kabi 1 mg/ml concentrate for solution for infusion is indicated in adults for use as an emergency measure in the restoration of blood pressure in cases of acute hypotension.
Verbatim from this product's MHRA label. Tap a section to expand.
6, the final concentration of the infusion solution is 40 mg/litre noradrenaline base, which is equivalent to 80 mg/litre noradrenaline tartrate. Some clinicians may prefer to dilute to other concentrations. If dilutions other than 40 mg/l are used, check the infusion rate calculation carefully before starting treatment.
32 ml/min). 6 mg/hour noradrenaline tartrate). 4 mg/hour noradrenaline tartrate). 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 mm Hg) or to achieve an adequate mean arterial blood pressure (greater than 65 - 80 mm Hg – depending on the patient’s condition). 4 135 Duration of treatment and monitoring The noradrenaline infusion should be continued until adequate blood pressure and tissue perfusion are maintained without therapy.
The patient should be monitored carefully for the duration of noradrenaline therapy. Noradrenaline should only be administered by healthcare professionals who are familiar with its use and have appropriate facilities to adequately monitor the patient.
Withdrawal of therapy The noradrenaline infusion 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.
4). Paediatric population The safety and efficacy of noradrenaline in children and adolescents aged less than 18 years old has not yet been established. No data are available. Method of administration Route of administration For intravenous use only after dilution.
6. The infusion should be at a controlled rate using either a syringe pump or an infusion pump or a drip counter. Noradrenaline (Norepinephrine) Kabi 1 mg/ml concentrate for solution for infusion should be administered as a diluted solution and it should be administered via a central venous catheter.
4 “Extravasation”). A catheter tie-in technique should be avoided if possible, since the obstruction to blood flow around the tubing may cause stasis and increased local concentration of the drug.
Table 2 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 2 Adverse reactions reported with noradrenaline through spontaneous reporting System Organ Class Undesirable effect Psychiatric disorders Anxiety, insomnia, confusion, weakness, psychotic state Nervous system disorders Transient headache, tremor Eyes disorders Acute glaucoma (very frequent in patients anatomically predisposed with a closing of the iridocorneal angle).
4), peripheral ischaemia2 including gangrene of the extremities, plasma volume depletion with prolonged use Respiratory, thoracic and mediastinal disorders Dyspnoea, respiratory insufficiency or difficulty Gastrointestinal disorders Nausea, vomiting Skin and subcutaneous tissue disorders Paleness, scarification of the skin, bluish skin colour, hot flushes or skin redness, skin rash, hives or itching Renal and urinary tract disorders Retention of urine General disorders and administration site conditions Extravasation, necrosis at injection site 1 Bradycardia, probably as a reflex result of a rise in blood pressure 2 Ischaemia, due to potent vasoconstrictor action and tissue hypoxia Hypertension may occur, which may be associated with bradycardia as well as headache and peripheral ischemia, including gangrene of the extremities.
4): - severe peripheral and visceral vasoconstriction - decrease in renal blood flow - decrease in urine production - hypoxia - increase in lactate serum levels. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Do not use undiluted. 3). 8). 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.
, decreased renal perfusion) with diminution in blood flow and tissue perfusion with subsequent tissue hypoxia and lactic acidosis and possible ischaemic injury; gangrene of extremities has been rarely reported. When infusing noradrenaline, the blood pressure and rate of flow should be checked frequently to avoid hypertension, which may be associated with bradycardia as well as headache and peripheral ischemia, including rarely gangrene of the extremities.
Extravasation may cause local tissue necrosis (see section ‘Extravasation’ below). Particular caution should be observed in patients with coronary, mesenteric or peripheral vascular thrombosis because noradrenaline may increase the ischaemia 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.
Similar caution should be observed in patients with hypotension following myocardial infarction and in patients with angina, particularly Prinzmetal’s variant angina, diabetes, hypertension or hyperthyroidism. Caution is advised in patients with 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.
1. 4). - Do not use with cyclopropane and halothane anaesthetics as this may cause serious cardiac arrhythmias including ventricular fibrillation. 5.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Occurrence of heart rhythm disorders during the treatment must lead to a reduction in the dosage. 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 use of pressor amines with chloroform, enflurane or other halogenated anaesthetics may cause serious cardiac arrhythmias. 5). 3). 5). Special caution should be used for patients with liver failure, severe renal dysfunction, ischemic heart diseases and elevated intracranial pressure.
, hyperthyroid patients) may cause severe hypertension with violent headache, photophobia, stabbing retrosternal pain, pallor, intense sweating and vomiting. Hypertension may eventually lead to acute pulmonary edema, arrhythmia or cardiac arrest.
Care should be taken in diabetics as it increases the level of blood glucose (due to the glycogenolytic action in the liver and the inhibition of insulin release from the pancreas). Elderly patients 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 used by doctors familiar with the selective indications for its use. 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 rate of flow 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 rate of flow 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. The infusion of noradrenaline should be stopped gradually as sudden cessation may produce a catastrophic fall in blood pressure.
The vasopressor effect (resulting from the adrenergic action on the vessels) can be reduced by the concomitant administration of an alpha-blocking agent whereas the administration of a beta-blocking agent may result […]