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NORADRENALINE (NOREPINEPHRINE) 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) is indicated in adults for the emergency restoration of blood pressure in cases of acute hypotension.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Noradrenaline (Norepinephrine) should be diluted before use. When diluted, the final concentration of the infusion solution is usually 40 mg/l noradrenaline (norepinephrine) (equivalent to 80 mg/l noradrenaline (norepinephrine) tartrate).
If other dilutions are used check the calculation carefully before starting treatment. 6 for dilution instructions. 33 ml/min). 6 mg/h noradrenaline (norepinephrine) tartrate).
Titration of dose:
Once an infusion of noradrenaline (norepinephrine) has been established the dose should be titrated 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 to 80 mm Hg – depending on the patient’s condition).
Posology instructions:
The posology per patient’s weight is detailed in the tables hereafter. Two tables are available: - Table 1: posology expressed in Noradrenaline, - Table 2: posology expressed in Noradrenaline TARTRATE. 8 135 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 noradrenaline (norepinephrine) therapy.
Blood pressure control:
Measure blood pressure every two minutes at the beginning of the infusion until the desired blood pressure is obtained. Then every five minutes when desired the blood pressure is obtained, if the administration has to be continued. The infusion should be at a control rate and the patient should be monitored carefully for the duration of noradrenaline (norepinephrine) therapy.
Withdrawal of therapy The infusion must not be stopped suddenly but should be gradually withdrawn to avoid disastrous falls in blood pressure. 4).
Paediatric population:
The safety and efficacy of noradrenaline (norepinephrine) in children aged less than 18 years has not yet been established. No data are available. Patients with renal and hepatic impairment There is no experience of treatment in patients with renal- and hepatic impairment.
Table 3:
Tabulated summary of adverse reactions Very common: ≥1/10 ; Common : ≥1/100, <1/10 ; Uncommon: ≥1/1,000, <1/100 ; Rare: ≥1/10,000, <1/1,000; Very rare: <1/10,000; Not known: cannot be estimated from the available data System Organ Class (SOC) Adverse Reactions (Frequency: not known) Metabolism and nutrition disorders anorexia.
System Organ Class (SOC) Adverse Reactions (Frequency: not known) Psychiatric disorders anxiety, insomnia, confusion, psychotic state, weakness. Nervous system disorders headaches, tremor, lower vigilance, Eye disorders acute glaucoma; very frequent in patients anatomically predisposed with the 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 skin, members (peripheries) and the face, and gangrene of the extremities; cyanosis; hot flushes or skin redness.
Respiratory, thoracic and mediastinal disorders respiratory insufficiency or difficulty, dyspnoea Skin and subcutaneous tissue disorders Scarification of the skin, skin rash, hives or itching. Gastrointestinal disorders nauseas and vomiting.
Renal and urinary disorders retention of urine. General disorders and administration site conditions possibility of irritation and necrosis at the injection site. Additional information regarding the safety of Noradrenaline (Norepinephrine) The continuous administration of vasopressor to maintain blood pressure in absence of blood volume replacement may cause the following symptoms: - severe peripheral and visceral vasoconstriction - decrease in renal blood flow - decrease in urine production - tissue hypoxia - lactic acidosis.
Warning: - Do not use undiluted. - Noradrenaline (Norepinephrine) should be used only in conjunction with appropriate blood volume replacement. - When infusing noradrenaline (norepinephrine), the blood pressure and rate of flow should be checked frequently to avoid hypertension.
g. elevation of the extremity, splinting, warming of affected limb with ad hoc device, use of vasodilating agents) to prevent progression and minimize the risks associated with necrosis of the extremities. - Extravasation risk: The infusion site should be checked frequently for free flow.
Care should be taken to avoid extravasation that would cause a necrosis of the tissues surrounding the vein used for the injection. Because of the vasoconstriction of the vein wall with increased permeability, there might be some leakage of noradrenaline (norepinephrine) in the tissues surrounding the infused vein causing a blanching of the tissues which is not due to an obvious extravasation.
Hence if blanching occurs, consideration should be given to changing the infusion site to allow the effects of local vasoconstriction to subside.
Treatment of the ischemia due to extravasation:
During an extravascular leak of the product or an injection besides the vein, tissue destruction can appear resulting from the vasoconstrictive action of the drug on the blood vessels. The area should be infiltrated as quickly as possible with 10 to 15ml of physiological salt solution containing 5 to 10 mg of phentolamine mesilate, an adrenergic blocking agent.
For this purpose, it is necessary to use a syringe provided with a fine needle and to inject locally throughout the area, which is easily identified by its cold, hard and pallid appearance.
Precautions for use:
Caution and respect of the strict indication must be retained in case of: - Major left ventricular dysfunction associated with acute hypotension, a careful evaluation of patient’s blood pressure is needed. Supportive therapy should be initiated simultaneously with diagnostic evaluation.
1. - Hypotension due to blood volume deficit (Hypovolaemia). - 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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Method of administration For intravenous use only after dilution. 6. Noradrenaline (Norepinephrine) should be administered through central venous devices to minimize the risk of extravasation and subsequent tissue necrosis. The infusion should be at a controlled rate using either a syringe pump or an infusion pump or a drip counter.
In case of hypersensitivity or overdose, the following effects may appear more frequently: hypertension, photophobia, retrosternal pain, pharyngeal pain, pallor, intense sweating and vomiting. Prolonged administration of any potent vasopressor may result in plasma volume depletion which should be continuously corrected by appropriate water 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. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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Noradrenaline (Norepinephrine) should be reserved for patients with cardiogenic shock and refractory hypotension, in particular those without elevated systemic vascular resistance. - Particular caution should be observed in patients with coronary, mesenteric or peripheral vascular thrombosis because noradrenaline (norepinephrine) may increase the ischaemia and extend the area of infarction.
Similar caution should be observed in patients with hypotension following myocardial infarction and in patients with Prinzmetal's variant angina. - Occurrence of heart rhythm disorders during the treatment must lead to a reduction in the dosage.
- Caution is advised in patients with hyperthyroidism or diabetes mellitus. - The elderly may be especially sensitive to the effects of noradrenaline (norepinephrine) due to the greater frequency of hepatic, renal or cardiac function and concomitant disease or other drug therapy.
2). The vasopressor effect (resulting from the adrenergic action on the vessels) can be reduced by the concomitant administration of an α-blocking agent (phentolamine mesilate) whereas the administration of a ß-blocking agent (propranolol) may result in a reduction of the stimulating effect of the product on the heart and in an increase of the hypertensor effect (through reduction of arteriolar dilatation), resulting from ß1 adrenergic stimulation.
16 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.