Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: hameln pharmaceuticals ltd, Nexus, Gloucester Business Park, Gloucester, GL3 4AG, United Kingdom
Ephedrine Hydrochloride 30 mg/ml Solution for Injection should not be used in case of:
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.
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 betaadrenoceptor 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.
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 administration.
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.
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 hypertension.
Tricyclic 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 perioperative hypertensive crisis and serious ventricular arrhythmias.
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 hypertension.
Oxytocin: Hypertension with vasoconstrictor sympathomimetics.
Hypotensive agents: Reserpine and methyldopa may reduce the vasopressor action of ephedrine.
Studies in animals have shown a teratogenic effect.
Clinical data from epidemiological studies on a limited number of women appear to indicate no particular effects of ephedrine with respect to malformation.
Isolated cases of maternal hypertension have been described after abuse or prolonged use of vasoconstrictor amines.
Ephedrine crosses the placenta and this has been associated with an increase in fetal heart rate and beat-to-beat variability.
Therefore, ephedrine should be avoided or used with caution, and only if necessary, during pregnancy.
Ephedrine is excreted in breast milk. Irritability and disturbed sleep patterns have been reported in breast-fed infants.
There is evidence that ephedrine is eliminated within 21 to 42 hours after administration, therefore a decision needs to be made on whether to avoid ephedrine therapy or lactation should be suspended for 2 days following its administration taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
No data available.
Not relevant.
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
Not known: primary hemostasis modifications
Not known: hypersensitivity
Common: confusion, anxiety, depression
Not known: psychotic states, fear
Common: nervousness, irritability, restlessness, weakness, insomnia, headache, sweating
Not known: tremor, hypersalivation
Not known: episodes of angle-closure glaucoma
Common: palpitations, hypertension, tachycardia
Rare: cardiac arrhythmias
Not known: angina pain, reflex bradycardia, cardiac arrest, hypotension
Not known: cerebral haemorrhage
Common: dyspnoea
Not known: pulmonary oedema
Common: nausea, vomiting
Not known: reduced appetite
Rare: acute urinary retention
Not known: hypokalaemia, changes in blood glucose levels
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
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