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 contains the active ingredient called adenosine. This belongs to a group of medicines called 'antiarrhythmics'. Adenosine works by slowing down electrical impulses between the upper and lower chambers of the heart. This slows the fast or uneven heartbeats called 'arrhythmias'. Adenosine is used:
e Adenosine Do not have this medicine and tell your doctor if:
then treatment with Adenosine should be stopped. If you are below 18 years of age In children with a heart rhythm trouble called 'Wolff-ParkinsonWhite (WPW) syndrome', Adenosine bolus may cause some unexpected severely abnormal heart rhythm. If you are not sure if any of the above apply to you, talk to your doctor or nurse before being given Adenosine. Other medicines and Adenosine Please tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Adenosine can affect the way some other medicines work. Also some medicines can affect the way Adenosine works. In particular, check with your doctor, nurse or pharmacist if you are taking any of the following:
If you are not sure why you are being given Adenosine or have any questions about how much Adenosine is being given to you, speak to your doctor, nurse or pharmacist. Adults (including the elderly)
The following information is intended for healthcare professionals only: Posology and Method of Administration Adenosine 3 mg/ml solution for injection is intended for hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use. 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 3 mg/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. Posology 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 cardio-respiratory resuscitation equipment must be available for immediate use if necessary. Adenosine 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:
Like all medicines, Adenosine can cause side effects, although not everybody gets them. While you are being given Adenosine you may have some of the following side effects: If any of the following side effects get worse, tell your doctor or nurse and they may stop the injection: The side effects normally settle within seconds or minutes after the injection is finished but you should tell your doctor or nurse if any of them happen. Very common (affects more than 1 in 10 people)
Each ml of solution for injection contains 3 mg adenosine Each 2ml vial contains 6mg of adenosine.
Common (affects up to 1 in 10 people)
Other side effects
1400008700
Very rare (affects up to 1 in 10,000 people)
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report any side effects directly via the Yellow Card Scheme at : www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
Adenosine Keep this medicine out of the sight and reach of children Adenosine should not be used after the expiry date which is stated on the carton and on the label. The expiry date refers to the last day of that month. Do not store above 25 °C. Do not refrigerate. The product is for single use only and should be used straight away after opening. Any portion of the vial not used at once should be disposed of. Do not use this medicine if the solution contains particles or is discolored. 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.
What Adenosine contains
Adenosine 3 mg/ ml solution for injection comes as injection containing 3mg. 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 3 mg/ ml solution for injection is adenosine.
This leaflet reproduces the patient information leaflet approved for Adenosine 3 mg/ ml solution for injection, 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).
Paediatric population
Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardia in children aged 0 to 18 years.
Diagnostic Indications
Aid to diagnosis of broad or narrow complex supraventricular tachycardias. Although Adenosine 3 mg/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.
Adenosine 3 mg/ml solution for injection is intended for hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use.
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 3 mg/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.
Posology
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 cardio-respiratory resuscitation equipment must be available for immediate use if necessary.
Adenosine 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 0.1 mg/kg body weight (maximum dose of 6mg)
- increments of 0.1 mg/kg body weight as needed to achieve termination of supraventricular tachycardia (maximum dose of 12mg).
Method of administration
Adenosine 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.
Each vial is intended for single use. The solution should be examined visually for particulate matter and discoloration prior to administration. Only clear and colourless solution should be used.
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: Rapid intravenous injection only.
Adenosine 3 mg/ml solution for injection is contraindicated for patients presenting:
- known hypersensitivity to the adenosine or to any of the excipients listed in section 6.1.
- Sick sinus syndrome, second or third degree Atrio-Ventricular (AV) 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. (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 3 mg/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 3 mg/ml solution for injection. It is therefore suggested that Adenosine 3 mg/ml solution for injection should not be administered to patients receiving dipyridamole; if use of Adenosine 3 mg/ml solution for injection is essential, dipyridamole should be stopped 24 hours before hand, or the dose of Adenosine 3 mg/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 3 mg/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 3 mg/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 contains 9 mg sodium chloride per ml. (corresponding to 3.54 mg sodium per ml). To be taken into consideration by patients on a controlled sodium diet.
Paediatric population
Adenosine may trigger atrial arrhythmias and thus might lead to ventricular acceleration in children with Wolff-Parkinson-White (WPW) syndrome. Also see section 5.1.
The efficacy of intraosseous 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 3 mg/ml solution for injection should not be administered to patients receiving dipyridamole; if use of Adenosine 3 mg/ml solution for injection is essential, dipyridamole should be stopped 24 hours before hand, or the dose of Adenosine 3 mg/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 3 mg/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 3 mg/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
Side effects
Psychiatric disorders
Common
- Apprehension
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
Immune system disorders:
Not known:
- anaphylactic reaction (including angioedema and skin reactions such as urticaria and rash).
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.
Vascular disorders
Very common
- Flushing
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
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
Reporting of suspected adverse reactions
Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported via 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.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
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 →
Medicines sold in Poland with the same active substance: W Polsce znany jako
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 anything about Adenosine 3 mg/ ml solution for injection. 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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