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.
Isoprenaline Macure 0.2mg/ml concentrate for solution for infusion
⚠ 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 Isoprenaline 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
Isoprenaline Macure 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 Macure is used for the 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 StokesAdams syndrome). 2.
What you need to know before you take it
e Isoprenaline Macure
Do not use Isoprenaline Macure 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 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 using Isoprenaline Macure: • 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. 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 Macure 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 Macure 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. • 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 Macure may not be administered under chloroform, cyclopropane or halothane anaesthetics or any other halogen anaesthetic. Pregnancy and breast-feeding If you are pregnant, this medicine may only be used if the doctor considers it absolutely necessary. The administration of Isoprenaline Macure during the breast-feeding period is not recommended. 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. Isoprenaline Macure contains sodium This medicine contains 16 mg sodium (main component of cooking/table salt) in each ampoule. This is equivalent to 0.8 % of the recommended maximum daily dietary intake of sodium for an adult. 3.
How to take it
Isoprenaline Macure
This medicine will be administered to you by intravenous 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 Macure while closely monitoring your heart rate. If you use more Isoprenaline Macure than you should The symptoms of overdose are nausea, headaches, extra heart beats and heart rate acceleration. If you use more Isoprenaline Macure than you should, contact your doctor or nurse immediately. If necessary, a plasma or complete blood transfusion may be performed.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Not known (may affect an unknown number of people): • 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 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
Isoprenaline Macure
Keep this medicine out of the sight and reach of children. Store and transport refrigerated (2 °C – 8 °C). Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. 6.
Contents of the pack and other information
What Isoprenaline Macure contains The active substance is isoprenaline hydrochloride. 1 ml contains 0.2 mg isoprenaline hydrochloride equivalent to 0.17 mg isoprenaline. The other ingredients are sodium chloride, EDTA, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide (for pH adjustment) and hydrochloric acid (for pH adjustment) What Isoprenaline Macure looks like and contents of the pack Isoprenaline Macure is a clear and colourless or pale yellow concentrate for solution for infusion in an ampoule containing 5 ml. Packages of 5 ampoules. Marketing Authorisation Holder Macure Pharma ApS Hejrevej 39 2400 Copenhagen NV Denmark
Manufacturer s.a.l.f. Laboratorio Farmacologico S.p.A. Via Giuseppe Mazzini 9 24069 Cenate Sotto Italy This leaflet was last revised in 12/2020 Detailed information on this medicine is available on the website of Medicines and Healthcare products Regulatory Agency: https://www.gov.uk/government/organisations/medicines-and-healthcare-productsregulatory-agency —————————————————————————————————————————-The following information is intended for healthcare professionals only: For intravenous use. Dilute 10 ml (2 ampoules à 5 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 Macure 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 Macure 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. 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 at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Frequently asked questions about Isoprenaline Macure 0.2mg/ml concentrate for solution for infusion
How do I take Isoprenaline Macure 0.2mg/ml concentrate for solution for infusion?
Isoprenaline Macure 0.2mg/ml concentrate for solution for infusion comes as infusion containing 0.2mg/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 Isoprenaline Macure 0.2mg/ml concentrate for solution for infusion?
The active substance in Isoprenaline Macure 0.2mg/ml concentrate for solution for infusion is isoprenaline hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Isoprenaline Macure 0.2mg/ml concentrate for solution for infusion, 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 Isoprenaline Macure 0.2mg/ml concentrate for solution for infusion 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: isoprenaline 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 permanent bradycardia due to atrio-ventricular block pending or in the case of contraindication of a pacemaker.
Treatment of Adams-Stokes syndrome.
4.2. Posology and method of administration
Posology
Isoprenaline Macure 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.
Concomitant use with adrenaline:
Do not inject Isoprenaline Macure 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 (see sections 4.3 and 4.5).
Method of administration
Intravenous use.
Dilute 10 ml (2 ampoules à 5 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 (see section 6.6). This gives a concentration of 4 microgram/ml isoprenaline solution of infusion.
4.3. Contraindications
Isoprenaline Macure is contraindicated in the case of:
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Concomitant use with adrenaline (see sections 4.2 and 4.5)
• Pre-existing ventricular arrythmias
• Tachyarrythmias
• Cardiac glycoside intoxication
• Myocardial infarction
• Angina pectoris
4.4. Special warnings and precautions for use
• The use of Isoprenaline Macure requires ECG monitoring and reduction of doses in the case of ventricular myocardial hyperexcitability (polymorphic extrasystoles, repetitive burst pacing or ventricular tachycardia).
• Isoprenaline Macure should be used with caution in hypovolemic patients.
• Caution when used in diabetic patients.
• Caution when used on patients under the effect of digitalis.
• In cases of hyperthyroidism, caution is recommended. Administration of the medicinal product should be avoided in cases of uncontrolled hyperthyroidism.
• Caution in cases of cardiovascular disorders, especially coronary insufficiency, arrhythmias and hypertension.
• Caution in cases of convulsive disorders.
• Caution when doses are sufficient to reach a heart rate greater than 130 beats per minute.
• Caution when using on patients who respond to sympathomimetic amines in an unusual manner.
Isoprenaline Macure contains 16 mg sodium per ampoule. This is equivalent to 0.8 % 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
Isoprenaline must not be administered at the same time as adrenaline but it may be used simultaneously with dopamine or phenylephrine. If the administration of isoprenaline and adrenaline together is necessary they can be given alternately every 4 hours (see sections 4.2 and 4.3).
Isoprenaline is contraindicated in cases of intoxication caused by digitalis.
Isoprenaline should not be used during anaesthesia with chloroform, cyclopropane, halothane or other halogenated anaesthetic agents because they may cause or worsen ventricular arrhythmia.
Isoprenaline should not be administered simultaneously with MAOIs.
Isoprenaline toxicity increases when administered at the same time as other cardiotonics or drugs stimulating the central nervous system (such as sympathomimetics, theophylline or thyroid hormone products).
Isoprenaline may worsen cardiovascular side effects of tricyclic antidepressants such as imipramine.
The simultaneous administration of isoprenaline and drugs combined with sulphates, such as salicylamide, may exacerbate the pharmacological effects of isoprenaline.
Administration of entacapone may enhance the effect of isoprenaline.
Doxapram and MAOIs may cause a risk of severe hypertension.
Isoprenaline Macure may increase the risk of ergotism, if given together with ergotamine.
Hypertension may occur because of the high vasopressor effect of sympathomimetic vasoconstrictors (e.g. oxytocin).
4.6. Fertility, pregnancy and lactation
Pregnancy
Isoprenaline has often been administered during pregnancy.
Animal tests have not shown any teratogenic effect. Over 30 years of clinical experience failed to reveal any teratogenic effects attributable to isoprenaline.
In any event, as with any medication administered to a pregnant woman, you need to carefully weigh the clinical benefits against the possible risks to the mother and child.
Breast-feeding
Administration of Isoprenaline Macure during breast-feeding is not recommended.
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
Serious adverse reactions to isoprenaline occur infrequently. Most adverse reactions subside rapidly when isoprenaline is discontinued or may abate while the drug is still in use. Isoprenaline has almost exclusively beta-agonist properties but also stimulates the CNS.
MedDRA frequency
Not known (cannot be estimated from the available data)
MedDRA-system organ class
Cardiac disorders
fast heartbeat
arrhythmia
precordial pain
Vascular disorders
low blood pressure
high blood pressure
Nervous system disorders
nervousness
shakiness
dizziness
headache
Gastrointestinal disorders
nausea
General disorders and administration site conditions
asthenia
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 at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms
Nausea, headache, sinus tachycardia, polymorphic extrasystoles, ventricular tachycardia.
Treatment
Simply discontinue isoprenaline hydrochloride infusion. The therapeutic activity will disappear after a few minutes given the speed of inactivation.
If necessary, plasma or whole blood will then be administered.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- ISOPRENALIN MACURE 0,2 mg/ml prescriptionISOPRENALINUM · injection / infusion
- ISOPRENALINE HYDROCHLORIDE MACURE 0,2 mg/ml prescriptionISOPRENALINUM · 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 →
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Ask anything about Isoprenaline Macure 0.2mg/ml concentrate for solution for infusion. 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.