EPHEDRINE HYDROCHLORIDE

Posology Adults Slow intravenous injection of 5 mg (maximum 10 mg), repeated as needed every 3-4 min to a maximum of 30 mg. A lack of efficacy after 30 mg should lead to reconsideration of the choice of the therapeutic agent. The total dose administered over 24 hours must not exceed 150 mg.

Paediatric population Ephedrine is generally not recommended for use in children due to insufficient data on efficacy, safety and dosage recommendations. • Children under 12 years The safety and efficacy of ephedrine in paediatric patients under 12 years have not been established.

No data are available. • Children over 12 years The posology and method of administration is the same as for adults. Patients with renal or hepatic impairment There are no dose adjustment recommended for patients with renal or hepatic impairment.

Elderly As for adults. Method of Administration Ephedrine must be used solely by or under the supervision of the anaesthetist as an injection via intravenous route. 6). For intravenous use.

Very common: ≥1/10; Common: ≥1/100 to <1/10 ; Uncommon: ≥1/1,000 to <1/100 ; Rare: ≥1/10,000 to <1/1,000; Very rare: <1/10,000; Not known: cannot be estimated from the available data FrequencySystem Organ Class Very commo n Common Uncommo n Rare Not known Blood and lymphatic system disorders primary haemostasis modifications Imune system disorders hypersensitivi ty Psychiatric disorders confusion, anxiety, depression psychotic states, fear Nervous system disorders nervousness , irritability, restlessness, weakness, insomnia, headache, sweating tremor, hypersalivatio n Eye disorders episodes of angle-closure glaucoma Cardiac disorders palpitations, hypertensio n, tachycardia cardiac arrhythmia s anginal pain, reflex bradycardia, cardiac arrest, hypotension Vascular disorders cerebral haemorrhage Respiratory, thoracic and mediastinal disorders dyspnoea pulmonary oedema Gastrointestin al disorders nausea, vomiting reduced appetite Renal and urinary disorders: acute urinary retention Investigations hypokalaemia, changes in blood glucose levels 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Warnings Ephedrine should be used with caution in patients who may be particularly susceptible to their effects, particularly those with hyperthyroidism. Great care is needed in patients with cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia, occlusive vascular disorders including arteriosclerosis, hypertension, or aneurysms.

Anginal pain may be precipitated in patients with angina pectoris. Care is also required when ephedrine is given to patients with diabetes mellitus, closed-angle glaucoma or prostatic hypertrophy. Ephedrine should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane, or other halogenated anaesthetics, as they may induce ventricular fibrillation.

5). Many sympathomimetics interact with monoamine oxidase inhibitors and should not be given to patients receiving such treatment or within 14 days of its termination. 5). Ephedrine increases blood pressure and therefore special care is advisable in patients receiving antihypertensive therapy.

Interactions of ephedrine with alpha- and beta- blocking drugs may be complex. 5). Adverse metabolic effects of high doses of beta2 agonists may be exacerbated by concomitant administration of high doses of corticosteroids; patients should therefore be monitored carefully when the two forms of therapy are used together although this precaution is not so applicable to inhaled corticotherapy.

Hypokalaemia associated with high doses of beta2 agonists may result in increased susceptibility to digitalis- induced cardiac arrhythmias. 5). Precautions for use Ephedrine should be used with caution in patients with a history of cardiac disease.

Athletes should be informed that this preparation contains an active substance which might give a positive reaction in anti-doping tests. Check that the solution is clear and contains no visible particles before infusion. 12% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

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