Active ingredient
- ephedrine hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
This information is intended for use by health professionals
Each ml of Solution for Injection contains 2.36 mg equivalent to 0.102 mmol of sodium.
Each 10 ml pre-filled syringe contains 23.6 mg equivalent to 1.02 mmol of sodium.
For a full list of excipients, see section 6.1.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 recommendedMethod of administrationEphedrine must be used solely by or under the supervision of the anaesthetist as an injection via intravenous route. For intravenous use.Contraindicated combinations:
Indirect sympathomimetic agents (phenylpropanolamine, pseudoephedrine, phenylephrine, methylphenidate)
Risk of vasoconstriction and/or of acute episodes of hypertension.Alpha sympathomimetics (oral and/or nasal route of administration)
Risk of vasoconstriction and/or episodes of hypertension.Non-selective MAO inhibitors
Paroxysmal hypertension, hyperthermia possibly fatal.Combinations not recommended:
Ergot alkaloids (dopaminergic action)
Risk of vasoconstriction and/or episodes of hypertension.Ergot alkaloids (vasoconstrictors)
Risk of vasoconstriction and/or episodes of hypertension.Selective MAO-A inhibitors (administered concomitantly or within the last 2 weeks)
Risk of vasoconstriction and/or episodes of hypertension.Linezolid
Risk of vasoconstriction and/or episodes of hypertensionTricyclic antidepressants (e.g. imipramine)
Paroxysmal hypertension with possibility of arrhythmias (inhibition of adrenaline or noradrenaline entry in sympathetic fibres).Noradrenergic-serotoninergic antidepressants (minalcipran, venlafaxine)
Paroxysmal hypertension with possibility of arrhythmias (inhibition of adrenaline or noradrenaline entry in sympathetic fibres).Guanethidine and related products
Substantial increase in blood pressure (hyper reactivity linked to the reduction in sympathetic tone and/or to the inhibition of adrenaline or noradrenaline entry in sympathetic fibres).If the combination cannot be avoided, use with caution lower doses of sympathomimetic agents.Sibutramine
Paroxysmal hypertension with possibility of arrhythmia (inhibition of adrenaline or noradrenaline entry in sympathetic fibres).Halogenated volatile anaesthetics
Risk of peri-operative hypertensive crisis and serious ventricular arrhythmias.Combinations requiring precautions for use:
Theophylline
Concomitant administration of ephedrine and theophylline may result in insomnia, nervousness and gastrointestinal complaints.Corticosteroids
Ephedrine has been shown to increase the clearance of dexamethasone.Antiepileptics: increased plasma concentration of phenytoin and possibly of phenobarbitone and primidone.Doxapram: risk of hypertensionOxytocin: hypertension with vasoconstrictor sympathomimeticsHypotensive agents: reserpine and methyldopa may reduce the vasopressor action of ephedrine.Blood and lymphatic system disorders:
Not known: primary haemostasis modificationsImmune system disorders:
Not known: hypersensitivityPsychiatric disorders:
Common: confusion, anxiety, depressionNot known: psychotic states, fear, giddiness,Nervous system disorders:
Common: nervousness, irritability, restlessness, weakness, insomnia, headache, sweatingNot known: tremor, hypersalivationEye disorders:
Not known: episodes of angle-closure glaucomaCardiac disorders:
Common: palpitations, hypertension, tachycardiaRare: cardiac arrhythmiasNot known: angina pain, reflex bradycardia, cardiac arrest, hypotensionVascular disorders:
Not known: cerebral haemorrhageRespiratory, thoracic and mediastinal disorders:
Common: dyspnoeaNot known: pulmonary oedemaGastrointestinal disorders:
Common: nausea, vomitingNot known: reduced appetiteRenal and urinary disorders:
Rare: acute urinary retentionInvestigations:Not known: hypokalaemia, changes in blood glucose levelsReporting 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: Website: www.mhra.gov.uk/yellowcard.
Symptoms
In the event of overdose, the occurrence of nausea, vomiting, fever, paranoid psychosis, ventricular and supraventricular arrhythmias, hypertension, respiratory depression, convulsions and coma are observed.The lethal dose in humans is approximately 2 g corresponding to blood concentrations of approximately 3.5 to 20 mg/l.Treatment
The treatment of ephedrine overdose with this product may require intensive supportive treatment. Slow intravenous injection of labetalol 50-200mg may be given with electrocardiograph monitoring for the treatment of supraventricular tachycardia. Marked hypokalaemia (<2.8 mmol.l-1) due to compartmental shift of potassium predisposes to cardiac arrhythymias and may be corrected by infusing potassium chloride in addition to propranolol and correcting respiratory alkalosis, when present.A benzodiazepine and/or a neuroleptic agent may be required to control CNS stimulant effects.For severe hypertension, parenteral antihypertensive options include intravenous nitrates, calcium channel blockers, sodium nitroprusside, labetalol or phentolamine. The choice of antihypertensive drug is dependent on availability, concomitant conditions and the clinical status of the patient.02/09/2016
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