Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ephedrine Hydrochloride 3 mg/ml Solution for Injection in Pre-filled Syringe
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ephedrine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
This medicine is used for the management of low blood pressure induced by anaesthesia. 2.
What you need to know before you take it
Ephedrine Injection
Do not use Ephedrine Injection if:
- you are allergic to ephedrine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
- you are taking another indirect sympathomimetic agent such as phenylpropanolamine, phenylephrine, pseudoephedrine (medicines used to relieve blocked nose) or methylphenidate (medicine used to treat "attention deficit hyperactivity disorder (ADHD)"),
- you are taking an alpha sympathomimetic agent (medicines used to treat low blood pressure),
- you are taking or have taken in the last 14 days a non-selective monoamine oxidase inhibitor (medicines used to treat depression). Warnings and precautions Talk to your doctor before using Ephedrine Injection if:
- you are a diabetic;
- you suffer from heart disease or any other heart condition, including angina;
- you suffer from weakness in a blood vessel wall leading to a bulge developing (aneurysm);
- you have a high blood pressure;
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you have a narrowing and/or blockage of blood vessels (occlusive vascular disorders) you have an overactive thyroid gland (hyperthyroidism); you know or suspect that you suffer from glaucoma (increased pressure in your eyes) or prostatic hypertrophy (enlarged prostate gland); you are about to have an operation which requires that you are given an anaesthetic; you are currently taking or have taken within the last 14 days any monoamine oxidase inhibitor medicine used to treat depression.
Other medicines and Ephedrine Injection Tell your doctor if you are using, have recently used or might use any other medicines. This is especially important for the following medicines:
- methylphenidate, used to treat "attention deficit hyperactivity disorder (ADHD)";
- indirect stimulators of the sympathetic nervous system such as phenylpropanolamine or pseudoephedrine (medicines used in nasal decongestant), phenylephrine (a medicine used to treat hypotension);
- direct stimulators of alpha receptors of the sympathetic nervous system (oral and/or nasal use) that are used to treat hypotension or nasal congestion, among others;
- medicines used to treat depression;
- Ergot alkaloids, a type of medicines used as vasoconstrictors (narrowing blood vessels) or for their dopaminergic action (increasing the dopamine-related activity in the brain).
- linezolid, used to treat infections;
- guanethidine and related medicines, used to treat high blood pressure;
- sibutramine, a medicine used as an appetite suppressant;
- anaesthetics that are inhaled such as halothane;
- medicines used to treat asthma such as theophylline;
- corticosteroids, a type of medicines used to relieve swelling in a variety of different conditions;
- medicines for epilepsy;
- doxapram, a medicine used to treat breathing problems;
- oxytocin, a medicine used during labour;
- reserpine and methyldopa and related medicines, used to treat high blood pressure Pregnancy and breast-feeding Ephedrine should be avoided or used with caution, and only if necessary, during pregnancy. Depending on your condition, and following your doctor recommendation, breast-feeding could be suspended for several days following ephedrine administration. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before being given this medicine. Laboratory Testing This medicinal product contains an active ingredient that can induce positive results in antidoping controls. Ephedrine Injection contains sodium This medicine contains 33.9 mg sodium (main component of cooking/table salt) in each 10 ml pre-filled syringe. This is equivalent to 1.7% of the recommended maximum daily dietary intake of sodium for an adult.
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3.
How to take it
Your doctor or nurse will administer Ephedrine Injection to you into a vein (intravenous). Your doctor will decide the correct dosage for you and when and how the injection should be administered. The recommended doses are: Adults and elderly You will be given a slow injection of 3 to 6 mg (maximum 9 mg) into a vein, repeated, if necessary, every 3-4 minutes to a maximum of 30 mg. The total dose must be lower than 150 mg/24 hours. Use in children and adolescents
Children under 12 years
Ephedrine Hydrochloride 3 mg/ml solution for Injection in Prefilled Syringe is not recommended for use in children under 12 years old due to insufficient data on efficacy, safety and dosage recommendations.
Children over 12 years
The posology and method of administration is the same as for adults.
Patients with kidney or liver disease: There are no dose adjustment recommended for patients with kidney or liver disease. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The most serious side effects that will require immediate medical attention from your doctor are:
- abnormal heart rhythm;
- palpitations, high blood pressure, fast heartbeat;
- pain over the heart, slow heartbeat, low blood pressure;
- heart failure (cardiac arrest),
- bleeding in the brain;
- build up of a fluid within the lungs (pulmonary oedema).
- increased pressure in the eye (glaucoma);
- difficulty in passing urine.
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Other side effects that you may experience while taking this medicine are listed below. Common (may affect up to 1 in 10 people): confusion, feeling worried, depression; nervousness, irritability, restlessness, weakness, sleeping problems, headache, sweating; shortness of breath; nausea, vomiting.
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Not known (frequency cannot be estimated from the available data):
- affects blood clotting;
- allergy;
- change in your personality or the way you feel or think, fear;
- tremor, excessive saliva production;
- reduced appetite;
- a decrease in blood potassium levels, changes in blood glucose levels; Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Ephedrine Injection
Keep this medicine out of the sight and reach of children. You should not be given this medicine if it has passed the expiry date shown on the carton and syringe label. Your doctor or nurse will check this. Store the blister in the outer carton in order to protect from light. Any unused product or waste material should be thrown away in accordance with local requirements. 6.
Contents of the pack and other information
What Ephedrine Injection contains
- The active ingredient is ephedrine hydrochloride. Each ml of solution for injection contains 3 mg ephedrine hydrochloride. Each 10 ml prefilled syringe contains 30 mg ephedrine hydrochloride.
- The other ingredients are sodium chloride, citric acid monohydrate, sodium citrate and water for injections and may contain hydrochloric acid or sodium hydroxide (for pH adjustments).
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What Ephedrine Injection looks like and contents of the pack Ephedrine Injection is a clear and colourless liquid. It is supplied in a 10 ml polypropylene prefilled syringe with a polypropylene tip cap and tamper proof seal, individually packaged in a transparent blister pack. The prefilled syringes are available in boxes of 1, 5, 10, 12 and 20 syringes. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: LABORATOIRE AGUETTANT 1, rue Alexander Fleming 69007 LYON France Manufacturer: LABORATOIRE AGUETTANT 1, rue Alexander Fleming 69007 LYON France or LABORATOIRE AGUETTANT Lieu-dit "Chantecaille" 07340 CHAMPAGNE France This leaflet was last revised in 12/2022. Detailed information on this medicine is available on the MHRA website.
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The following information is intended for medical or healthcare professionals only: This is an extract from the Summary of Product Characteristics to assist in the administration of Ephedrine Injection. When determining appropriateness of use in a particular patient, the prescriber should be familiar with the Summary of Product Characteristics of the product.
Drug name: Ephedrine Hydrochloride 3 mg/ml Solution for injection in Pre-filled Syringe Safety information For intravenous injection Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Administration: The pre-filled syringe contains a ready-to-use solution for injection containing 3 mg ephedrine hydrochloride in each ml of solution. Adult 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. Overdose: In the event of overdose, the occurrence of nausea, vomiting, fever, paranoid psychosis, ventricular and supraventricular arrhythmias, hypertension, respiratory depression, convulsions and coma is observed. The lethal dose in humans is approximately 2 g corresponding to blood concentrations of approximately 3.5 to 20 mg/I. Management The management of ephedrine overdose with this product may require intensive supportive treatment. Slow intravenous injection of labetalol 50-200 mg may be given with electrocardiograph monitoring for the treatment of supraventricular tachycardia. Marked 6
hypokalaemia (< 2.8 mmol.l-1) due to compartmental shift of potassium predisposes to cardiac arrhythmia 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. Instructions for use Please prepare the syringe carefully as follows. The pre-filled syringe is for single patient only. Discard syringe after use. DO NOT REUSE. The content of un-opened and un-damaged blister is sterile, and must not be opened until use. The product should be inspected visually for particles and discoloration prior to administration. Only clear colourless solution free from particles or precipitates should be used. The product should not be used if the tamper evident seal on syringe is broken. The external surface of syringe is sterile until blister is opened. 1) Withdraw the pre-filled syringe from the sterile blister. 2 2) Push on the plunger to free the bung.
3 3) Twist off the end cap to break the seals.
4 4) Check that the syringe seal has been completely removed. If not, replace the cap and twist again.
5 5)
Expel the air by gently pushing the plunger.
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6) Connect the syringe to the IV access. Push the plunger slowly to inject the required volume. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Storage and Shelf life: Do not use this product after the expiry date which is stated on the carton and syringe label. The expiry date refers to the last day of that month. After opening: the product must be used immediately. Store the blister in the outer carton in order to protect from light.
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Frequently asked questions about Ephedrine Hydrochloride 3 mg/ml Solution for Injection in Pre-filled Syringe
How do I take Ephedrine Hydrochloride 3 mg/ml Solution for Injection in Pre-filled Syringe?
Ephedrine Hydrochloride 3 mg/ml Solution for Injection in Pre-filled Syringe comes as injection containing 3mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Ephedrine Hydrochloride 3 mg/ml Solution for Injection in Pre-filled Syringe?
The active substance in Ephedrine Hydrochloride 3 mg/ml Solution for Injection in Pre-filled Syringe is ephedrine hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ephedrine Hydrochloride 3 mg/ml Solution for Injection in Pre-filled Syringe, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ephedrine Hydrochloride 3 mg/ml Solution for Injection in Pre-filled Syringe without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: ephedrine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment of hypotension from spinal, epidural, and general anaesthesia.
4.2. Posology and method of administration
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.
4.3. Contraindications
Ephedrine should not be used in case of:
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• 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.
4.4. Special warnings and precautions for use
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.
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.
This medicinal product contains sodium:
This medicinal product contains 33.9 mg sodium per 10 ml pre-filled syringe, equivalent to 1.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
4.5. Interaction with other medicinal products and other forms of interaction
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 hypertension
Tricyclic antidepressants (e.g. imipramine)
Paroxysmal hypertension with possibility of arrhythmia (inhibition of adrenaline or noradrenaline entry in sympathetic fibres).
Noradrenergic-serotoninergic antidepressants (minalcipran, venlafaxine)
Paroxysmal hypertension with possibility of arrhythmia (inhibition of adrenaline or noradrenaline entry in sympathetic fibres).
Guanethidine and related products
Substantial increase in blood pressure (hyperreactivity 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.
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 hypertension.
Oxytocin: hypertension with vasoconstrictor sympathomimetics.
Hypotensive agents: reserpine and methyldopa may reduce the vasopressor action of ephedrine.
4.6. Fertility, pregnancy and lactation
Pregnancy
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 foetal heart rate and beat-to-beat variability.
Therefore, ephedrine should be avoided or used with caution, and only if necessary, during pregnancy.
Breast-feeding
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.
Fertility
No data available.
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme:
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
In the event of overdose, the occurrence of nausea, vomiting, fever, paranoid psychosis, ventricular and supraventricular arrhythmia, hypertension, respiratory depression, convulsions and coma is observed.
The lethal dose in humans is approximately 2 g corresponding to blood concentrations of approximately 3.5 to 20 mg/l.
Management
The management 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 (<2.8mmol.l-1) due to compartmental shift of potassium predisposes to cardiac arrhythmia 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.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- EFEDRINA ZENTIVA 50 mg/ml (vezi R03CA02) prescriptionEPHEDRINI HYDROCHLORIDUM · injection / infusion
- EFEDRINA ZENTIVA 50 mg/ml (vezi C01CA26) prescriptionEPHEDRINI HYDROCHLORIDUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- Ephedrinum hydrochloricum WZFEphedrini hydrochloridum · injection / infusion
- Ephedrinum Hydrochloricum AguettantEphedrini hydrochloridum · injection / infusion
- Ephedrine KabiEphedrini hydrochloridum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Ephedrine Hydrochloride 3 mg/ml Solution for Injection in Pre-filled Syringe. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.