Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Laboratoire Aguettant, 1 rue Alexander Fleming, 69007 LYON, FRANCE
Patients with known hypersensitivity to an excipient, where an alternative presentation of adrenaline or alternative vasopressor is available.
Adrenaline 1 mg/10 ml (1:10,000), solution for injection in pre-filled syringe is indicated for emergency treatment. Medical supervision is necessary after administration.
For intramuscular administration, a 1 mg/ml (1:1000) solution should be used.
In the treatment of anaphylaxis and in other patients with a spontaneous circulation, intravenous adrenaline can cause life-threatening hypertension, tachycardia, arrhythmias and myocardial ischaemia.
Intravenous adrenaline should only be used by those experienced in the use and titration of vasopressors in their normal clinical practice. Patients who are given IV adrenaline require continuous monitoring of ECG, pulse oximetry and frequent blood pressure measurements as a minimum.
The risk of toxicity is increased if the following conditions are pre-existing
Prolonged use of adrenaline can result in severe metabolic acidosis because of elevated blood concentrations of lactic acid.
Adrenaline may increase intra-ocular pressure in patients with narrow angle glaucoma.
Adrenaline should be used with caution in patients with prostatic hyperplasia with urinary retention.
Adrenaline may cause or exacerbate hyperglycaemia, blood glucose should be monitored, particularly in diabetic patients.
Adrenaline should be used with caution in elderly patients.
Adrenaline should not be used during the second stage of labour (See Section 4.6).
This medicinal product contains 35.4 mg sodium per syringe equivalent to 1.77% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
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).
Sympathomimetic agents: concomitant administration of other sympathomimetic agents may increase toxicity due to possible additive effects.
Non-selective MAO inhibitors: increased pressor action of adrenaline, usually moderate.
Selective MAO-A inhibitors, Linezolid (by extrapolation from non-selective MAO inhibitors): Risk of aggravation of pressor action.
Alpha-adrenergic blocking agents: Alpha-blockers antagonise the vasoconstriction and hypertension effects of adrenaline, increasing the risk of hypotension and tachycardia.
Beta-adrenergic blocking agents: Severe hypertension and reflex bradycardia may occur with non-cardioselective beta-blocking agents. Beta-blockers, especially non-cardioselective agents, also antagonise the cardiac and bronchodilator effects of adrenaline.
Insulin or oral hypoglycaemic agents: Adrenaline-induced hyperglycaemia may lead to loss of blood-sugar control in diabetic patients treated with insulin or oral hypoglycaemic agents.
Teratogenic effect has been demonstrated in animal experiments.
Adrenaline should only be used during pregnancy if the potential benefits outweigh the possible risks to the foetus. If used during pregnancy, adrenaline may cause anoxia to the foetus.
Adrenaline usually inhibits spontaneous or oxytocin induced contractions of the uterus and may delay the second stage of labour. In dosage sufficient to reduce uterine contractions, adrenaline may cause a prolonged period of uterine atony with haemorrhage. For this reason parenteral adrenaline should not be used during the second stage of labour.
Adrenaline is distributed into breast milk. Breast-feeding should be avoided by mothers receiving adrenaline.
No information available concerning impact of adrenaline on fertility.
Not applicable in normal conditions of use.
Frequency not known: hyperglycaemia, hypokalaemia, metabolic acidosis.
Frequency not known: anxiety, nervousness, fear, hallucinations.
Frequency not known: headache, tremors, dizziness, syncope.
Frequency not known: mydriasis.
Frequency not known: palpitations, tachycardia. Takotsubo cardiomyopathy (stress cardiomyopathy) may occur. In high dosage or for patients sensitive to adrenaline: cardiac dysrhythmia (sinus tachycardia, ventricular fibrillation/cardiac arrest), acute angina attacks, and risk of acute myocardial infarction.
Frequency not known: pallor, coldness of the extremities. In high dosage or for patients sensitive to adrenaline: hypertension (with risk of cerebral haemorrhage), vasoconstriction (for example cutaneous, in the extremities or kidneys).
Frequency not known: dyspnoea.
Frequency not known: nausea, vomiting.
Frequency not known: sweating, weakness
Repeated local injections may produce necrosis at sites of injection as a result of vascular constriction.
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 Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
In the absence of compatibility studies, this product must not be mixed with other medicinal products.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
