What it is and what it is used for

for

Isoprenaline contains the active substance isoprenaline, which has a stimulating effect on a certain part of the nervous system (sympathomimetic). Isoprenaline leads to, among other things, increased heart rate, increased heart contractility and dilatation of blood vessels, which decreases blood pressure. Isoprenaline is used for the short-term treatment of:

• slow heart rate in patients awaiting the insertion of a pacemaker or when this is contraindicated.
• sudden fainting with loss of consciousness caused by a slowing of heart rate (called Adams-Stokes syndrome). 2.

What you need to know before you take it

Isoprenaline

Isoprenaline must not be given if you are allergic to isoprenaline hydrochloride or any of the other ingredients of this medicine (listed in section 6). if you are also taking adrenaline, a medicine used in intensive care to treat cardiac arrest (when the heart suddenly stops beating). if you suffer from a faster-than-usual heart rhythm. if your heart is stressed (atrial or ventricular hyperexcitability). if you have taken too much of a type of medicine called cardiac glycoside, such as digoxin (digitalis), a medicine to treat heart arrythmia and heart failure. if you suffer from a heart attack (myocardial infarction). if you suffer from chest pain (angina pectoris) and irregular heartbeat (ventricular arrhythmia) that requires treatment. Warnings and precautions Talk to your doctor or nurse before you are given Isoprenaline:

• if you have heart problems.
• if you suffer from diabetes.
• if you are taking digoxin (digitalis) (another medicine affecting the heart).
• if you have an overactive thyroid gland. This medicine is to be avoided in cases of uncontrolled hyperthyroidism.
• if you suffer from convulsive disorders (epilepsy). 2

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if you have ever had a reaction to a medicine affecting the heart and circulation (belonging to the sympathomimetic amine group). during your treatment with this medicine, you will be monitored by ECG and your dose may be adjusted. if you are being treated for decreased blood volume in the body (shock), Isoprenaline can only be used after your blood volume has been restored. be particularly careful in cases of doses high enough to reach a heart rate of above 130 beats/minute.

Other medicines and Isoprenaline Tell your doctor if you are using, have recently used or might use any other medicines. This is particularly important if you are taking any of the following medicines:

• other cardiac or central nervous system stimulants (medicines for heart or brain).
• adrenaline (a medicine used in intensive care to treat cardiac arrest).
• digitalis (another medicine affecting the heart).
• monoamine oxidase inhibitors (MAOIs), a class of medicines used to treat depression.
• antidepressants (such as imipramine).
• sulphates, such as salicylamide (painkiller).
• entacapone (a class of medicine used for Parkinson's disease).
• doxapram (a class of medicine used in intensive care to increase respiratory rate).
• ergotamine (a class of medicines used to treat acute migraine attacks).
• sympathomimetic vasoconstrictors (such as oxytocin). Isoprenaline may not be administered under chloroform, cyclopropane or halothane anaesthetics or any other halogen anaesthetic. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. If you are pregnant, this medicine may only be used if the doctor considers it absolutely necessary. The administration of Isoprenaline during the breast-feeding period is not recommended. Isoprenaline contains sodium. This medicine contains approx. 16.5 mg sodium (main component of cooking/table salt) in each 5 ml of sterile solution. This is equivalent to approx. 0.8 % of the recommended maximum daily dietary intake of sodium for an adult. 3.

How to take it

This medicine will be administered to you by intravenous (into a vein) infusion by a specialist doctor. The doctor will decide the best suitable dose for you. The medicine will be diluted in a physiological saline or isotonic glucose solution. The doctor will carefully increase the dose of Isoprenaline while closely monitoring your heart rate. Isoprenaline is not meant to be used routinely. If you are given more Isoprenaline than you should The symptoms of overdose are nausea, headaches, extra heart beats and heart rate acceleration. If you think you were given more Isoprenaline than you should, contact your doctor or nurse immediately.

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If necessary, a plasma or complete blood transfusion may be performed. If you have any further questions on the use of this medicine, ask your doctor or nurse. 4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Not known (frequency cannot be estimated from the available data):

• heart rate acceleration,
• cardiac rhythm disorders,
• nausea,
• chest pains,
• low blood pressure,
• high blood pressure,
• headaches,
• restlessness,
• tremors,
• dizziness,
• a feeling of weakness and sweating. Reporting of side effects If you get any side effects, talk to your doctor 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 at 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

Isoprenaline

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the outer carton and ampoule labels after "EXP". The expiry date refers to the last day of that month. Store below 30 °C. Store in the original package in order to protect from light. From a microbiological point of view, diluted solutions should be used immediately. If not used immediately, in-use storage times and conditions prior to use of the diluted solution are the responsibility of the user and would normally not be longer than 24 hours. 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 Isoprenaline contains The active substance is isoprenaline hydrochloride. Each ampoule with 5 ml of Isoprenaline contains 1 mg isoprenaline hydrochloride, equivalent to 0.853 mg of isoprenaline.

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The other ingredients are disodium edetate (E386), sodium chloride, sodium citrate (E331), citric acid (E330), hydrochloric acid, concentrated (E507) (for pH adjustment), water for injection.

What Isoprenaline looks like and contents of the pack Isoprenaline Hydrochloride 1 mg/5 ml concentrate for solution for infusion is a clear, colourless solution, practically free from visible particles. It is supplied in clear colourless type I glass ampoules with a white fracture crack, containing 5 ml. Packages of 5 ampoules. Marketing Authorisation Holder Synchrony Pharma Limited, 3 Bunhill Row London EC1Y 8YZ, United Kingdom Manufacturer Cooper Pharmaceuticals S.A. Aristovoulou 64, Athens, 11853, Greece This leaflet was last revised in February/2025 ———————————————————————————————————————–The following information is intended for healthcare professionals only: Isoprenaline must only be administered by physicians trained in anaesthesia, cardiology or intensive care, in an appropriately monitored or critical care setting. Circulatory and respiratory functions should be closely monitored. Isoprenaline should not be used routinely. For intravenous use. Dilute 10 ml of concentrate for solution for infusion (= 2.0 mg) in 500 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection or glucose 50 mg/ml (5 %) solution for injection. This gives a concentration of 4 microgram/ml isoprenaline solution of infusion. Isoprenaline should be carefully titrated under close monitoring to the lowest possible dose that obtains a heart rate of 50-60 beats per minute. The recommended start dose is 0.01 microgram/kg/minute. The dose can be increased in increments of 0.01 microgram/kg/minute until a maximal dose of 0.15 microgram/kg/minute. The rate of infusion should be adjusted based on the heart rate of the patient. National and international recommendations and guidelines on the appropriate use of isoprenaline should be followed. Do not inject Isoprenaline at the same time as adrenaline in any circumstances. However, if the administration of the two medicinal products is necessary, they can be given alternately every 4 hours. 5

After dilution with sodium chloride 9 mg/ml (0.9 %) solution for injection or glucose 50 mg/ml (5 %) solution for injection, the chemical and physical in-use stability has been demonstrated for 48 h at 25 °C and 2 °C – 8 °C. From a microbiological point of view, diluted solutions should be used immediately. If not used immediately, in-use storage times and conditions prior to use of the diluted solution are the responsibility of the user and would normally not be longer than 24 hours.

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