EPHEDRINE HYDROCHLORIDE

Posology Adults Slow intravenous injection of 3 to 6 mg (maximum 9 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 dose administered for 24 hours must not exceed 150 mg.

Paediatric population Ephedrine Hydrochloride 3 mg/ml solution for Injection in Prefilled Syringe 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.

Eldery 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. For intravenous use.

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 Blood and lymphatic system disorders: Not known: primary haemostasis modifications Immune system disorders: Not known: hypersensitivity Psychiatric disorders: Common: confusion, anxiety, depression Not known: psychotic states, fear Nervous system disorders: Common: nervousness, irritability, restlessness, weakness, insomnia, headache, sweating Not known: tremor, hypersalivation Eye disorders: Not known: episodes of angle-closure glaucoma Cardiac disorders: Common: palpitations, hypertension, tachycardia Rare: cardiac arrhythmia Not known: anginal pain, reflex bradycardia, cardiac arrest, hypotension Vascular disorders: Not known: cerebral haemorrhage Respiratory, thoracic and mediastinal disorders: Common: dyspnoea Not known: pulmonary oedema Gastrointestinal disorders: Common: nausea, vomiting Not known: reduced appetite Renal and urinary disorders: Rare: acute urinary retention Investigations: Not known: 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 also 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.

An increased risk of arrhythmia may also occur if ephedrine is given to patients receiving cardiac glycosides, quinidine, or tricyclic antidepressants. Many sympathomimetics interact with monoamine oxidase inhibitors, and should not be given to patients receiving such treatment or within 14 days of its termination.

It is advisable to avoid sympathomimetics when taking selective MAO inhibitors. 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.

Propranolol and other beta- adrenoceptor blocking agents antagonise the effects of beta2 adrenoceptor stimulants (beta2 agonists) such as salbutamol. 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 2 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 arrhythmia. Hypokalaemia may be enhanced by concomitant administration of aminophylline or other xanthines, corticosteroids, or by diuretic therapy.

1. • In combination with other indirect sympathomimetic agents such as phenylpropanolamine, phenylephrine, pseudoephedrine and methylphenidate. • In combination with alpha sympathomimetic agents. • In combination with non-selective MAO inhibitors or within 14 days of their withdrawal.