EPHEDRINE HYDROCHLORIDE

Posology Adults and children over 12 years and Elderly Slow intravenous injection of a solution containing ephedrine hydrochloride 3mg/ml, 3-6mg (maximum of 9mg) repeated every 3-4 minutes to a maximum of 30mg. Paediatrics Children under 12 years Not recommended 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, giddiness, 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 arrhythmias Not known: angina 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.

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.

Angina 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 arrhythmias may also occur if Ephedrine is given to patients receiving cardiac glycosides, quinidine, or tricyclic antidepressants. 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 arrhythmias. Hypokalaemia may be enhanced by concomitant administration of aminophylline or other xanthines, corticosteroids, or by diuretic therapy.

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. 6 mg of sodium per syringe: to be taken into consideration for patients on a controlled sodium diet.

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 Monoamine Oxidase Inhibitors (MAOI) or within 14 days of their withdrawal.