EPHEDRINE HYDROCHLORIDE Tablet Ref.[7877] Active ingredients: Ephedrine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, United Kingdom

Contraindications

Ischaemic heart disease.

Hypertension.

Thyrotoxicosis.

Prostatic hypertrophy.

Ephedrine has positive inotropic and chronotropic effects on the heart and its use should be avoided in patients with ischaemic heart disease.

Ephedrine increases blood pressure in man. Over the counter acquisition of sympathomimetics should always be considered in hypertensive patients whose blood pressure control has suddenly deteriorated.

Patients with hyperthyroidism may be susceptible to the effects of ephedrine. Ephedrine may precipitate acute urinary retention in patients with prostatic hypertrophy.

Special warnings and precautions for use

Ephedrine should be given with care to patients with hyperthyroidism, diabetes mellitus, angle-closure glaucoma and renal impairment.

Ephedrine has potentially life threatening effects in its acute cardiovascular and central stimulant effects.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Interaction with other medicinal products and other forms of interaction

Other adrenoceptor stimulants

Concurrent use of ephedrine with theophylline may result in increased nausea, nervousness, and insomnia.

Anaesthetics

There may be an increased risk of arrhythmias when used with volatile liquid anaesthetics.

Antidepressants

Ephedrine should not be given to patients who are being treated with monoamine oxidase inhibitors as they may cause hypertensive crisis with marked headache, severe hypertension and subarachnoid haemorrhage. Noradrenaline is displaced by ephedrine with the release of large amounts of catecholamine. The interaction may occur up to two weeks after stopping MAOI therapy. There may be an increased risk of arrhythmias when ephedrine is used with tricyclic antidepressants.

Antihypertensives

Loss of blood pressure control has been detected in hypertensive patients undergoing concurrent therapy with ephedrine and adrenergic neurone blocking drugs and may also occur with other antihypertensives.

Antimigraine drugs

Enhanced vasoconstriction and pressor effects with ergotamine or methysergide; concurrent use of ergotamine not recommended (risk of gangrene).

Cardiac glycosides

Increased risk of arrhythmias in patients receiving ephedrine and cardiac glycosides.

Corticosteroids

Ephedrine has been shown to increase the clearance and prolong the half-life of dexamethasone in asthmatic patients.

Oxytocin

Increased risk of vasoconstrictor or pressor effects in patients receiving oxytocin and ephedrine.

Urinary acidifiers/alkalinisers

Effects of ephedrine may be reduced by acidification and increased by alkalinization of the urine.

Pregnancy and lactation

The use of ephedrine in pregnancy should be avoided as ephedrine crossed the placenta and this has been associated with an increase in foetal heart rate and beat to beat variability. Ephedrine is excreted in breast milk and therefore its use during lactation should be avoided. Irritability and disturbed sleep patterns have been reported in breast fed infants.

Effects on ability to drive and use machines

Not applicable.

Undesirable effects

The most common side-effects of ephedrine are tachycardia, anxiety, nausea, restlessness and insomnia. Tremor, dry mouth, impaired circulation to the extremities, hypertension, headache and cardiac arrhythmias may occur. Tolerance with dependence has been reported with prolonged administration.

Myocardial infarction has occurred very rarely in patients taking ephedrine or pseudoephedrine.

Ephedrine may act as stimulant in children with nocturnal enuresis and cause sleeplessness. It may have sedative effects in some children.

The elderly are more sensitive to the cardiovascular effects of ephedrine.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

Incompatibilities

None known.

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