Patient leaflet - Ephedrine Hydrochloride 30 mg/ml concentrate for solution for injection
1. What Ephedrine Sterile concentrate is and what it is used for
This medicine is a concentrate for solution for injection in an ampoule used for the treatment of low blood pressure during general and local/regional anaesthesia, whether it be spinal or epidural in adults and adolescents (over 12 years). This product must be used solely by or under the supervision of the anaesthetist.
2. What you need to know before you are given Ephedrine Sterile concentrate
Do not use Ephedrine Sterile concentrate 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 Sterile concentrate if:
- you are a diabetic;
- you suffer from heart disease or any other heart condition, including angina (chest pain);
- you suffer from weakness in a blood vessel wall leading to a bulge developing (aneurysm);
- you have a high blood pressure;
- 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 Sterile concentrate
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 low blood pressure);
- direct stimulators of alpha receptors of the sympathetic nervous system (oral and/or nasal use) that are used to treat hypotension (low blood pressure) 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 anti-doping controls.
3. How Ephedrine Sterile concentrate is given
Your doctor or nurse will administer Ephedrine Sterile concentrate 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. This medicine should be diluted before use. For instructions on dilution of the product before administration, see section: “Information intended for healthcare professionals only” at the end of the leaflet.
Package leaflet: Information for the user
Ephedrine Hydrochloride 30 mg/ml Concentrate for solution for injection
ephedrine hydrochloride (Referred to as “Ephedrine Sterile concentrate” in this leaflet)
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Use in children and adolescents
Children under 12 years
This medicine 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.
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.
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 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 Ephedrine Sterile concentrate
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the ampoule. The expiry date refers to the last day of that month. Store below 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Ephedrine Sterile concentrate contains
- The active ingredient is ephedrine hydrochloride. Each 1 ml ampoule contains 30 mg ephedrine hydrochloride.
- The other ingredient is water for injections.
What Ephedrine Sterile concentrate looks like and contents of the pack
Ephedrine Sterile concentrate is a clear and colourless liquid. It is supplied in a 1 ml glass ampoule.
The glass ampoules are available in boxes of 10.
Marketing Authorisation Holder and Manufacturer
Laboratoire Aguettant
1, rue Alexander Fleming
69007 Lyon
France
This leaflet was last revised in 07/2026.
Information intended for healthcare professionals only:
This medicinal product must be used solely by or under the supervision of the anaesthetist as an injection via intravenous route.
The medicinal product should be diluted before use. Visually inspect the solution in the ampoules for particles and coloration prior to administration. Do not use if the solution is coloured or if contains particles.
For single use only.
How to open the one point cut ampoules:
The ampoule is already filed down into a valve point. The coloured mark makes it possible to position it. Grasp the ampoule with the coloured mark towards you.
The ampoule will open easily by placing your thumb on the coloured mark and by bending from the top towards the bottom as shown in the diagram.
Instructions for dilution:
Dilute the concentrate for solution for injection to final concentration of 3 mg/ml or 5 mg/ml, as appropriate. This medicinal product is compatible with 0.9% w/v sodium chloride solution, Ringer’s lactate solution and 5% w/v glucose solution.
Diluted solution:
Chemical and physical in-use stability has been demonstrated for 72 hours at 30°C and 2-8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
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.
Management
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.