Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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 Adenosine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Adenosine 3mg/ml Solution for Injection (called Adenosine Solution for Injection throughout the rest of this leaflet) belongs to a group of medicines called antiarrhythmics. Antiarrhythmics are used to treat an irregular heartbeat (arrhythmias). Adenosine Solution for Injection is used during hospital tests to help doctors or nurses determine what type of irregular heartbeat you have. It works by slowing down electrical impulses in your heart, in turn, slowing down either a fast or irregular heartbeat. In children, Adenosine Solution for Injection is used to bring your child's heartbeat back to normal if your child has a type of heart rhythm problem called 'paroxysmal supraventricular tachycardia' (PSVT). You will usually be in hospital when you receive this medicine.
Adenosine Solution for Injection Do not have Adenosine Solution for Injection
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Where possible, do not drink or eat products containing caffeine, such as tea, coffee, chocolate, or cola, for at least 12 hours before you are given Adenosine Solution for Injection.
Pregnancy and breast-feeding
Adenosine Solution for Injection You will usually be in hospital when you are given Adenosine Solution for Injection. You will be given it by a doctor or nurse, as an injection, into your vein. Your heart and blood pressure will be closely monitored. Adults and the elderly
an extreme lowering in blood pressure; • a lowering in heart rate; a heart problem.
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Adenosine stays in the blood for a very short period of time. Therefore, any side effects would soon subside once the injection has been stopped. You may be given a medicine called aminophylline or theophylline to help with any side effects experienced. 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. If you experience any of the following side effects after you have been given your medicine, tell your doctor or nurse immediately. If you are not in hospital, you MUST GO straight away. • Severe allergic reaction which may include a red and lumpy skin rash, difficulty breathing, swelling of face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away. • Severe chest pain. • An extreme lowering in heart rate. • An extreme lowering in blood pressure. • Respiratory failure. Very common side effects (may affect more than 1 in 10 people): • slow beating of your heart • chest pain or pressure on the chest • flushing (sudden reddening of the skin accompanied by the feeling of heat) • shortness of breath or the urge to take a deep breath • skipped heartbeats or extra heartbeats • a delayed, slow and irregular heartbeat
Common side effects (may affect up to 1 in 10 people): • headache • nausea (feeling sick) • dizziness or feeling light headed • apprehension (feeling nervous) • burning sensation of the skin Uncommon side effects (may affect up to 1 in 100 people): • feeling pressure in your head • blurred vision • metallic taste in your mouth • feeling of general discomfort, weakness or pain
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• • • •
sweating hyperventilation (breathing more quickly or more deeply than normal) palpitations (the awareness of an increased, irregular heartbeat) increased heart rate or arrhythmia
Very rare side effects (may affect up to 1 in 10,000 people): • intracranial hypertension (increased high blood pressure around the brain) • fast, slow or uneven heartbeat • difficulty breathing Other side effects which may occur: • fainting or loss of consciousness • convulsions (fits) • vomiting (being sick) • cardiac arrest (a sudden loss of heart function) • asystole (a severe and fatal heart problem) Very rare effects which may occur at the site of injection (affecting up to 1 in 10,000 people): • redness • itching • pain • abscesses • swelling • swollen and painful veins Not known: frequency cannot be estimated from the available data • spasm of the artery in the heart which may lead to a heart attack. You will be observed by medical staff at all times, whilst being given Adenosine Solution for Injection, to monitor the effects on your heart. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: . By reporting side effects you can help provide more information on the safety of this medicine.
Adenosine Solution for Injection This medicine will be stored, by your doctor, nurse or pharmacist, out of the sight and reach of children.
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This medicine should not be used after the expiry date stated on the carton and vial label. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. This product is for single use only. Once your doctor or nurse has opened the vial, it should be used immediately. Any remaining Adenosine Solution for Injection must be thrown away by the doctor or nurse.
What Adenosine Solution for Injection contains
Manufacturer Vianex S.A., Plant A, 12km National Road Athinon-Lamias, Metamorfosi Attiki, 14451, Greece. For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided below. This medicinal product is authorised in the Member States of the EEA under the following names: United Kingdom: Adenosine 3mg/ml Solution for Injection Greece: ADENORYTHM® 3mg/ml Ενέσιμο διάλυμα
This leaflet was last revised in 02/2026. Other sources of information
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For any information about this medicinal product, please contact Focus Pharmaceuticals Limited Medical Information by phone at +44 (0) 208 588 9131 or by email to [email protected]
<————————————————————————————————————–> Technical Leaflet intended for healthcare professionals only ADENOSINE 3MG/ML SOLUTION FOR INJECTION
GENERAL INFORMATION Adenosine 3mg/ml Solution for Injection is for single use only. Any portion of the vial, not used at once, should be discarded.
THERAPEUTIC INDICATIONS Adenosine 3mg/ml Solution for Injection is indicated in adults and children aged 0 to 18 years. Adults Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory by-pass tracts (Wolff-Parkinson-White Syndrome). Diagnostic Indications Aid to diagnosis of broad or narrow complex supraventricular tachycardias. Although Adenosine 3mg/ml Solution for Injection will not convert atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of AV conduction helps diagnosis of atrial activity. Sensitisation of intra-cavitary electrophysiological investigations. Paediatric population Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardia in children aged 0 to 18 years.
POSOLOGY AND METHOD OF ADMINISTRATION Adenosine 3mg/ml Solution for Injection is intended for hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use, if necessary. Method of administration It should be administered by rapid IV bolus injection according to the ascending dosage schedule below. To be certain the solution reaches the systemic circulation, administer either directly into a vein or into an IV line. If given into an IV line, it should be injected as proximally as possible and followed by a rapid saline flush.
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Adenosine 3mg/ml Solution for Injection should only be used when facilities exist for cardiac monitoring. Patients who develop high-level AV block at a particular dose should not be given further dosage increments.
Therapeutic dose Adult: Initial dose: 3mg given as a rapid intravenous bolus (over 2 seconds). Second dose: If the first dose does not result in elimination of the supraventricular tachycardia within 1 to 2 minutes, 6mg should be given also as a rapid intravenous bolus. Third dose: If the second dose does not result in elimination of the supraventricular tachycardia within 1 to 2 minutes, 12mg should be given also as a rapid intravenous bolus. Additional or higher doses are not recommended. Paediatric population During administration of Adenosine 3mg/ml Solution for Injection, cardio-respiratory resuscitation equipment must be available for immediate use if necessary. Adenosine 3mg/ml Solution for Injection is intended for use continuous monitoring and ECG recording during administration. The dosing recommended for the treatment of paroxysmal supraventricular tachycardia in the paediatric population is:
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STORAGE AND DISPOSAL OF ADENOSINE 3MG/ML SOLUTION FOR INJECTION This medicinal product does not require any special storage conditions. The product should be inspected visually for particulate matter and colouration prior to administration. Where the visual appearance of the product may have changed, the vial should be discarded. Dispose of any remaining solution after a single use. Any unused product or waste material should be disposed of in accordance with local requirements. Shelf life: Unopened: 3 years Once opened, the product should be used immediately.
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Adenosine 3mg/ml Solution for Injection (Focus) 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.
The active substance in Adenosine 3mg/ml Solution for Injection (Focus) is adenosine.
Medicines with the same active substance, strength and form include: Adenosine 3mg/ml Solution for Injection. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Adenosine 3mg/ml Solution for Injection (Focus), as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory by-pass tracts (Wolff-Parkinson-White Syndrome).
Adenosine 3mg/ml Solution for Injection is indicated in adults and children aged 0 to 18 years.
Diagnostic Indications
Aid to diagnosis of broad or narrow complex supraventricular tachycardias. Although Adenosine 3mg/ml Solution for Injection will not convert atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of AV conduction helps diagnosis of atrial activity.
Sensitisation of intra-cavitary electrophysiological investigations.
Paediatric population
Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardia in children aged 0 to 18 years.
Adenosine 3mg/ml Solution for Injection is intended for hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use, if necessary.
Method of administration
It should be administered by rapid IV bolus injection according to the ascending dosage schedule below. To be certain the solution reaches the systemic circulation, administer either directly into a vein or into an IV line. If given into an IV line, it should be injected as proximally as possible and followed by a rapid saline flush.
Adenosine 3mg/ml Solution for Injection should only be used when facilities exist for cardiac monitoring. Patients who develop high-level AV block at a particular dose should not be given further dosage increments.
Therapeutic dose
Adult:
Initial dose: 3mg given as a rapid intravenous bolus (over 2 seconds).
Second dose: If the first dose does not result in elimination of the supraventricular tachycardia within 1 to 2 minutes, 6mg should be given also as a rapid intravenous bolus.
Third dose: If the second dose does not result in elimination of the supraventricular tachycardia within 1 to 2 minutes, 12mg should be given also as a rapid intravenous bolus.
Additional or higher doses are not recommended.
Paediatric population
During administration of Adenosine 3mg/ml Solution for Injection, cardio-respiratory resuscitation equipment must be available for immediate use if necessary. Adenosine 3mg/ml Solution for Injection is intended for use with continuous monitoring and ECG recording during administration.
The dosing recommended for the treatment of paroxysmal supraventricular tachycardia in the paediatric population is:
- first bolus of 0.1mg/kg body weight (maximum dose of 6mg)
- increments of 0.1mg/kg body weight as needed to achieve termination of supraventricular tachycardia (maximum dose of 12mg).
Elderly
See dosage recommendations for adults.
Diagnostic dose
The above ascending dosage schedule should be employed until sufficient diagnostic information has been obtained.
Method of administration
Adults and the elderly: Rapid intravenous injection only.
Paediatrics: Adenosine 3mg/ml Solution for Injection should be administered by rapid intravenous (IV) bolus injection into a vein or into an IV line. If given into an IV line, it should be injected through as proximally as possible and followed by a rapid saline flush. If administered through a peripheral vein, a large bore cannula should be used.
Adenosine 3mg/ml Solution for Injection is contraindicated for patients presenting:
− Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
− Sick sinus syndrome, second or third degree Atrio-Ventricular block (except in patients with a functioning artificial pacemaker)
− Chronic obstructive lung disease with evidence of bronchospasm (e.g. asthma bronchiale)
− Long QT syndrome
− Severe hypotension
- Decompensated states of heart failure
Special warnings:
Due to the possibility of transient cardiac arrhythmias arising during conversion of the supraventricular tachycardia to normal sinus rhythm, administration should be carried out in a hospital setting with monitoring and cardio-respiratory resuscitation equipment available for immediate use, if necessary. During administration, continuous ECG monitoring is necessary as life-threatening arrhythmia might occur (see section 4.2).
Because it has the potential to cause significant hypotension, adenosine should be used with caution in patients with left main coronary stenosis, uncorrected hypovolemia, stenotic valvular heart disease, left to right shunt, pericarditis or pericardial effusion, autonomic dysfunction or stenotic carotid artery disease with cerebrovascular insufficiency.
Adenosine should be used with caution in patients with recent myocardial infarction, severe heart failure, or in patients with minor conduction defects (first degree A-V block, bundle branch block) that could be transiently aggravated during infusion. Adenosine should be used with caution in patients with atrial fibrillation or flutter and especially in those with an accessory by-pass tract since particularly the latter may develop increased conduction down the anomalous pathway.
Rare cases of severe bradycardia have been reported. Some occurred in early post heart transplant patients; in the other cases, occult sino-atrial disease was present. The occurrence of severe bradycardia should be taken as a warning of underlying disease and could potentially favour the occurrence of torsades de pointes, especially in patients with prolonged QT intervals.
In patients with recent heart transplantation (less than 1 year) an increased sensitivity of the heart to adenosine has been observed.
Since neither the kidney nor the liver are involved in the degradation of exogenous adenosine, Adenosine 3mg/ml Solution for Injection's efficacy should be unaffected by hepatic or renal insufficiency.
As dipyridamole is a known inhibitor of adenosine uptake, it may potentiate the action of Adenosine 3mg/ml Solution for Injection. It is therefore suggested that Adenosine 3mg/ml Solution for Injection should not be administered to patients receiving dipyridamole; if use of Adenosine 3mg/ml Solution for Injection is essential, dipyridamole should be stopped 24 hours before hand, or the dose of Adenosine 3mg/ml Solution for Injection should be greatly reduced (see Section 4.5 Interactions with other Medicaments and other forms of Interaction).
Precautions:
The occurrence of angina, severe bradycardia, severe hypotension, respiratory failure (potentially fatal), or asystole/cardiac arrest (potentially fatal), should lead to immediate discontinuation of administration.
Adenosine may trigger convulsions in patients who are susceptible to convulsions. In patients with history of convulsions/seizures, the administration of adenosine should be carefully monitored.
Because of the possible risk of torsades de pointes, Adenosine 3mg/ml Solution for Injection should be used with caution in patients with a prolonged QT interval, whether this is drug induced or of metabolic origin. Adenosine 3mg/ml Solution for Injection is contraindicated in patients with Long QT syndrome (see section 4.3).
Adenosine may precipitate or aggravate bronchospasm (see sections 4.3 and 4.8).
Adenosine 3mg/ml Solution for Injection contains 9mg of sodium chloride per 1ml of solution (corresponding to 3.54mg (0.15mmol) of sodium per 1ml of solution). To be taken into consideration by patients on a controlled sodium diet.
Paediatric population
Adenosine 3mg/ml Solution for Injection may trigger atrial arrhythmias and thus might lead to ventricular acceleration in children with Wolff-Parkinson-White (WPW) syndrome (see section 5.1).
The efficacy of intraosseus administration has not been established.
Dipyridamole inhibits adenosine cellular uptake and metabolism, and potentiates the action of adenosine. In one study, dipyridamole was shown to produce a 4 fold increase in adenosine actions. Asystole has been reported following concomitant administration.
It is therefore suggested that Adenosine 3mg/ml Solution for Injection should not be administered to patients receiving dipyridamole; if use of Adenosine 3mg/ml Solution for Injection is essential, dipyridamole should be stopped 24 hours beforehand, or the dose of Adenosine 3mg/ml Solution for Injection should be greatly reduced. See Section 4.4 Special Warnings and Precautions for Use.
Aminophylline, theophylline and other xanthines are competitive adenosine antagonists and should be avoided for 24 hours prior to use of adenosine.
Food and drinks containing xanthines (tea, coffee, chocolate and cola) should be avoided for at least 12 hours prior to use of adenosine.
Adenosine 3mg/ml Solution for Injection may interact with drugs tending to impair cardiac conduction.
Pregnancy: There are no or limited amount of data from the use of adenosine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Adenosine is not recommended during pregnancy unless the physician considers the benefits to outweigh the potential risks.
Lactation: It is unknown whether adenosine metabolites are excreted in human milk. Adenosine 3mg/ml Solution for Injection should not be used during breast-feeding.
Not relevant.
Adverse events are ranked under the heading of the frequency:
Very common (>1/10), Common (>1/100, <1/10), Uncommon (>1/1000, <1/100), Rare (>1/10000, <1/1000), Very rare (<1/10000), Not known (cannot be estimated from available data).
These side effects are generally mild, of short duration (usually less than 1 minute) and well tolerated by the patient. However severe reactions can occur.
Methylxanthines, such as IV aminophylline or theophylline have been used to terminate persistent side effects (50-125 mg by slow intravenous injection).
Frequency
Applicable to Adenosine 6mg/2ml
Cardiac Disorders
Very common
- Bradycardia
- Sinus pause, skipped beats
- Atrial extrasystoles
- Atrio-Ventricular block
- Ventricular excitability disorders such as ventricular extrasystoles, non-sustained ventricular tachycardia
Uncommon
- Sinus tachycardia
- Palpitations
Very rare
- Atrial fibrillation
- Severe bradycardia not corrected by atropine and possibly requiring temporary pacing
- Ventricular excitability disorders
Including ventricular fibrillation and torsade de pointes (see section 4.4)
Not known
- Hypotension sometimes severe
- Asystole /Cardiac arrest, sometimes fatal especially in patients with underlying ischemic heart disease /cardiac disorder (see section 4.4)
- Arteriospasm coronary which may lead to myocardial infarction.
Nervous System disorders
Common
- Headache
- Dizziness, light-headedness
Uncommon
- Head pressure
Very rare
- Transient and spontaneously rapidly reversible worsening of intracranial hypertension
Not known
- Loss of consciousness / syncope
- Convulsions, especially in predisposed patients (see section 4.4)
Eye disorders
Uncommon
- Blurred vision
Respiratory, thoracic and mediastinal disorders
Very common
- Dyspnea (or the urge to take a deep breath)
Uncommon
- Hyperventilation
Very rare
- Bronchospasm (see section 4.4)
Not known
- Respiratory failure (see section 4.4)
- Apnea / Respiratory arrest,
Cases of Respiratory failure, bronchospasm, apnea, and respiratory arrest with fatal outcome have been reported.
Gastrointestinal disorders
Common
- Nausea
Uncommon
- Metallic taste
Not known
- Vomiting
Vascular disorders
Very common
- Flushing
General disorders and Administration Site conditions
Very common
- Chest pressure/pain, feeling of thoracic constriction/oppression
Common
- Burning sensation
Uncommon
- Sweating
- Feeling of general discomfort / weakness / pain
Very rare
- Injection site reactions
Psychiatric disorders
Common
- Apprehension
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.
Overdosage would cause severe hypotension, bradycardia or asystole. The half life of adenosine in blood is very short, and side effects (when they occur) would quickly resolve. Administration of IV aminophylline or theophylline may be needed. Pharmacokinetic evaluation indicates that methyl xanthines are competitive antagonists to adenosine, and that therapeutic concentrations of theophylline block its exogenous effects.
Ask anything about Adenosine 3mg/ml Solution for Injection (Focus). 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.
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