ADRENALINE

Acute anaphylaxis The intramuscular (IM) route is the route of choice for most individuals who have to be given adrenaline for the management of acute anaphylaxis, using the doses in table 1. 01 mg per kilogram of body weight (10 micrograms/kg).

5 mg (500 micrograms). For children, when the weight is not known, the table below, showing recommended doses according to age, can be advised: Table 1. 01 mL/kg If necessary, these doses may be repeated several times at 5 – 15 minutes intervals according to blood pressure, pulse and respiratory function.

A small volume syringe should be used. When the patient is severely ill and there is real doubt about adequacy of the circulation and absorption from the IM injection site, Adrenaline 1:1000 (1mg/mL) Solution for injection may be given by intravenous injection (IV).

4). In the case of intravenous adrenaline, the dose must be titrated using 50 microgram boluses according to response. e. a 1:10 mL dilution of the contents of the ampoule). Do not give the undiluted 1:1000 adrenaline solution IV. If repeated adrenaline doses are needed, an IV adrenaline infusion is recommended, with the rate titrated according to response in the presence of continued haemodynamic monitoring.

Cardiopulmonary resuscitation Adults 1 mg adrenaline by the intravenous or intraosseous route repeated every 3-5 minutes until return of spontaneous circulation. If injected through a peripheral line, it must be followed by flush of at least 20 mL of fluid and elevation of the extremity for 10– 20 seconds to facilitate delivery of the medicinal product to the central circulation.

Paediatric population The recommended intravenous or intraosseous dose of adrenaline in children is 10 micrograms/kg. e. a 1:10 mL dilution of the contents of the ampoule). Subsequent doses of adrenaline may be given every 3–5 min. The maximum single dose is 1 mg.

The side effects of adrenaline are related to the stimulation of both alpha- and beta- adrenergic receptors. The occurrence of undesirable effects depends on the sensitivity of the individual patient and the dose involved. Frequencies are defined using the following convention: very common ( ≥ 1/10), common ( ≥ 1/100 to < 1/10), uncommon ( ≥ 1/1000 to < 1/100), rare ( ≥ 1/10000 to < 1/1000), very rare (< 1/10000), not known (cannot be estimated from the available data).

System organ class Undesirable effects (Frequency unknown) Metabolism and nutrition disorders Hypokalaemia Metabolic acidosis Hyperglycaemia (even with low doses) Psychiatric disorders Psychotic states Anxiety Fear Confusional state Irritability Insomnia Nervous system disorders Headache Dizziness Tremor Restlessness Cardiac disorders Disturbances of cardiac rhythm and rate Palpitation Tachycardia Chest pain/ angina Potentially fatal ventricular arrhythmias Fibrillation Electrocardiogram T-wave amplitude decreased Vascular disorders Hypertension (with risk of cerebral haemorrhage) Coldness of limbs Respiratory, thoracic and mediastinal disorders Dyspnoea Pulmonary oedema Gastrointestinal disorders Dry mouth Decreased appetite Nausea Vomiting Hypersalivation Renal and urinary disorders Difficulty in micturition Urinary retention General disorders and administration site conditions Sweating Weakness In patients with Parkinsonian Syndrome, adrenaline increases rigidity and tremor.

Subarachnoid haemorrhage and hemiplegia have resulted from hypertension, even following subcutaneous administration of usual doses of adrenaline. 5). Pulmonary oedema may occur after excessive doses or in extreme sensitivity. Repeated injections of Adrenaline 1:1000 (1mg/mL) Solution for injection can cause necrosis as a result of vascular constriction at the injection site.

Tissue necrosis may also occur in the extremities, kidneys and liver. 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.

This product is for emergency use only and medical supervision of the patients is necessary after administration. The IM route is generally preferred in the initial treatment of anaphylaxis, the intravenous (IV) route is generally more appropriate in the Intensive Care Unit (ICU) or Emergency Department (ED) setting.

Adrenaline (epinephrine) injection 1:1000 (1 mg/mL) is not suitable for IV use. 1 mg/mL) injection is not available, adrenaline (epinephrine) injection 1:1000 must be diluted to 1:10000 before IV use. The IV route for injection of adrenaline must be used with extreme caution and is best reserved for specialists familiar with IV use of adrenaline.

g. ventricular fibrillation). Anginal pain maybe induced when coronary insufficiency is present. Adrenaline may increase intra-ocular pressure in patients with narrow angle glaucoma. Adrenaline may cause or exacerbate hyperglycaemia, blood glucose should be monitored, particularly in diabetic patients.

Repeated local administration may produce necrosis at the sites of injection. The best site for IM injection is the anterolateral aspect of the middle third of the thigh. The needle used for injection needs to be sufficiently long to ensure that the adrenaline is injected into muscle.

Intramuscular injections of Adrenaline 1:1000 (1mg/mL) Solution for injection into the buttocks should be avoided because of the risk of tissue necrosis. Prolonged administration may induce metabolic acidosis, renal necrosis and adrenaline-fastness or tachyphylaxis.

Adrenaline should be avoided or used with extreme caution in patients undergoing anaesthesia with halothane or other halogenated anaesthetics, in view of the risk of inducing ventricular fibrillation. Adrenaline should not be used with local anaesthesia of peripheral structures including digits, ear lobe.

Do not mix with other agents unless compatibility is known. 6). Accidental intravascular injection may result in cerebral haemorrhage due to the sudden rise in blood pressure. Monitor the patient as soon as possible (pulse, blood pressure, ECG, pulse oximetry) in order to assess the response to adrenaline.

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