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.
Adenosine 3mg/ml Solution for Injection
⚠ 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 Adenosine 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 The name of your medicine is Adenosine Injection. The active ingredient in your medicine is adenosine. Adenosine belongs to a group of medicines called antiarrhythmics. Adenosine Injection works by slowing down electrical impulse between the upper and lower chambers of the heart. This slows the fast or uneven heartbeat called arrhythmias. Adenosine Injection is used:
- during a test. This helps doctors find out what type of arrhythmia (uneven heartbeat) you have
- to bring your heart back to normal if you have a type of arrhythmia called paroxysmal supraventricular tachycardia (PSVT) or Wolff Parkinson-White Syndrome (WPW). In children, Adenosine Injection bolus is used:
- To bring your child's heart beat back to normal if your child has a type of heart rhythm trouble called PSVT.
What you need to know before you take it
Adenosine Injection Do not take Adenosine Injection if you
- are allergic (hypersensitive) to adenosine or to any of the other ingredients in this medicine (see section 6. Further information) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
- have problems with your heart rhythm and do not have a pacemaker (second or third degree atrioventricular block, sick sinus syndrome)
- have very low blood pressure (severe hypotension)
- have asthma or any other severe breathing problem
- have a type of heart failure where your heart is not pumping out enough blood
- have been told you have 'Long QT syndrome'. This is a rare heart problem that can lead to a fast heartbeat and fainting. Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given Adenosine. Warnings and precautions Talk to your doctor, nurse, pharmacist before you have taken Adenosine if:
- low blood volume which is not corrected by medicines
- narrowing of your left main artery supplying blood to your heart (left main coronary stenosis)
- been told that you have a heart problem whereby the electrical impulses in parts of your heart take longer than normal to discharge and then recharge (prolonged QT interval)
- narrowing of the main arteries in the neck, so not enough blood is getting to the brain
- a heart disease which is caused by the narrowing of your heart valves (stenotic valvular heart disease)
- a left-right shunt in your heart, which means blood goes directly from the left side of your heart to the right side
- problems with a part of your nervous system called the autonomic nervous system
- inflammation of the membrane surrounding your heart (pericarditis) or a build-up of the INFORMATION FOR HEALTHCARE PROFESSIONALS Adenosine 3mg/ml Solution for Injection Please refer to the Summary of Product Characteristics (SmPC) for further details on this product. Qualitative and Quantitative Composition Each vial contains 6mg of adenosine per 2ml (3mg/ml). Contains sodium. For a full list of excipients, see Section 6.1. Pharmaceutical Form Solution for injection (Injection). A clear, colourless solution free from visible particles. Therapeutic indications 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 injection will not convert atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of AV conduction helps diagnosis of atrial activity.
Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client's brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
fluid around your heart (pericardial effusion)
- had severe heart failure
- had a heart attack or if you have had a heart transplant in the last year
- any minor problem with your heart (first degree atrioventricular block or a bundle branch block). These conditions may be temporarily aggravated when you are given Adenosine Injection
- an unusual heart rhythm, for example your heartbeat is very fast or uneven (atrial fibrillation or atrial flutter) and in particular if you have a condition where your heart has abnormal electrical activity ('accessory conduction pathway)'
- difficulty in breathing (bronchospasm)
- ever had fits or convulsions. If you get a very slow heartbeat (severe bradycardia), respiratory failure, a heart problem that can be fatal (asystole), severe chest pains (angina) or very low blood pressure (severe hypotension), then treatment with Adenosine should be stopped. If you are not sure if any of the above applies to you, talk to your doctor or nurse before being given Adenosine Injection. Talk to your doctor immediately if:
- You experience signs of stroke. This may present itself as a sudden numb or weak feeling in the face, arms, or legs. Other signs include feeling confused, problems with sight, walking, coordination or balance, problems in saying words or slurring of speech
- You experience signs of heart attack (myocardial infarction). Severe chest pain is the usual main symptom. The pain may also travel up into your jaw, and down your left arm, or down both arms. You may also sweat, feel sick, and feel faint. A small heart attack (myocardial infarction) occasionally happens without causing pain (a 'silent myocardial infarction'). It may be truly pain- free, or sometimes the pain is mild and you may think it is just heartburn or 'wind'. Children and adolescents In children with a heart rhythm trouble called 'Wolff-Parkinson- White (WPW) syndrome', Adenosine Injection may cause some unexpected severely abnormal heart rhythm. Other medicines and Adenosine Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following medicines can affect or be affected by treatment with Adenosine Injection:
- dipyridamole (a medicine used to thin the blood). Make sure you tell your doctor you are taking dipyridamole. Your doctor may decide you should not have Adenosine Injection or may tell you to stop taking dipyridamole 24 hours before you are given Adenosine Injection or may need to give you a lower dose
- aminophylline or theophylline (medicines used to help breathing) Your doctor may tell you to stop taking it 24 hours before you are given Adenosine Injection
- caffeine (sometimes found in headache medicines). Taking Adenosine Injection with food and drink Food and drink containing xanthines, for example tea, coffee, chocolate and cola, should be avoided for at least 12 hours before you are given Adenosine Injection. Pregnancy and breast-feeding Talk to your doctor or nurse before having this medicine if:
- You are pregnant, might become pregnant, or think that you may be pregnant. You should not be given Adenosine Injection unless clearly necessary
- You are breast-feeding. You should not be given Adenosine Injection. Ask your doctor or nurse for advice before taking any medicine. Important information about some of the ingredients of Adenosine Injection This medicinal product contains approximately 7mg sodium per vial (2ml) i.e. essentially 'sodium-free'.
How to take it
Adenosine Injection Adenosine Injection is a medicine for use in hospitals with resuscitation equipment available. Adenosine Injection will be given to you by a doctor or nurse as an injection. The injection will be into one of your veins. Your heart rate and blood pressure will be closely monitored.
Sensitisation of intra-cavitary electrophysiological investigations. Posology and Method of Administration 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. 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. Patients who develop high-level AV block at a particular dose should not be given further dosage increments. Posology Adults: 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.
Customer
Wockhardt UK Limited
Colours Used
Description
Adenosine injection leaflet
Black
Item Code
105565/7
Keyline (Non-Printing)
Profile
as supplied
Text Free Area (Non-Printing)
Size
148 x 460mm
Cirrus_Info_Box
Min.Point Size
Other
Market
UK
Language
English
Standard 235
Barcode Proof By
EBR
Proof No.
1
Date
28/06/2023
Body Text Fonts:
Myriad Pro
Body Text Ctd.
Actual Min Point Size
9pt/7.5pt
Adults (including the elderly) The first dose is 3mg given over 2 seconds. This is given as a rapid injection into your vein. If the first dose does not bring your heartbeat to normal then you will be given a second dose. The second dose will be 6mg given as a rapid injection. If the second dose does not bring your heart rate to normal then you will be given a third dose. The third dose is 12mg given as a rapid injection. You will not be given any more doses after the 12mg dose. Children and adolescents Your doctor will decide if this medicine is needed, how much should be given depending on your child's weight, and if several injections are needed.
- Your child will be closely monitored, including recording of his/her heart's electrical activity using an ECG (electrocardiogram) machine
- It will be given as an injection into your child's vein by a doctor or nurse. If you have more Adenosine Injection than you should This medicine is given to you by your doctor or nurse. It is unlikely that you will be given too much. You doctor will carefully work out how much Adenosine Injection you should be given. If you have more of this medicine than you should, the following effects may happen:
- very low blood pressure (severe hypotension)
- slow heartbeat (bradycardia)
- a heart problem (asystole). Your doctor will be monitoring your heart throughout the procedure. The length of time Adenosine stays in the blood is very short. Any side effects of too much Adenosine Injection would quickly stop when the injection is stopped. You may be given an injection of a medicine called theophylline to help with any side effects. If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, Adenosine Injection can cause side effects, although not everybody gets them. The following side effects may be experienced when taking Adenosine Injection. If any of the 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 person in 10)
- a slow heartbeat (bradycardia)
- skipped heartbeats or extra heartbeats
- a heart problem called an atrioventricular block where the heart starts to beat slowly
- severe heart problems which can be fatal (asystole) or uneven heartbeat
- shortness of breath or the urge to breathe deeply (dyspnoea)
- reddening of the skin with a feeling of heat (flushing)
- chest pain or pressure on the chest. Common (affects less than 1 person in 10)
- headache
- paraesthesia
- dizziness, light-headedness
- feeling nervous
- nausea (feeling sick)
- unusual skin feelings, such as burning. Uncommon (affects less than 1 person in 100)
- feeling pressure in your head or a weighed down feeling your arms
- blurred vision
- metallic taste in your mouth
- being aware of your heartbeat or feeling it 'racing' (palpitations)
- sweating
- discomfort in the leg, arm or back
- feeling of general discomfort, weakness or pain
- breathing more quickly or more deeply than normal (hyperventilation). Very rare side effects (affects less than 1 person in every 10,000)
- severe bradycardia (very slow heartbeat)
- very slow, fast or uneven heartbeats
- severe breathlessness or problems in breathing
- redness, pain or swelling at the site of injection
- feeling uncomfortable during the injection
- worsening of high blood pressure that affects the brain (intracranial hypertension).
How to store it
Adenosine Injection This medicine will be kept by your doctor or nurse in a safe place where children cannot see or reach it. 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. Store below 25°C. Do not refrigerate. The product should be used immediately after opening. Any portion of the vial not used at once should be disposed of. Do not use if any particles or discolouration are noticed in the solution. If the appearance of the vial has changed the vial must be thrown away. Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will dispose of any unused medicine. These measures will help protect the environment.
Contents of the pack and other information
What Adenosine 3mg/ml (6mg in 2ml) Solution for Injection contains The active ingredient is adenosine. Each 2ml vial contains 6mg of adenosine. The other ingredients are sodium chloride and water for injections. What Adenosine 3mg/ml (6mg in 2ml) Solution for Injection looks like and the contents of the pack Adenosine is a clear, colourless solution for injection. Adenosine 3mg/ml (6mg in 2ml) Solution for Injection is available in packs of 6 single use glass vials. Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham LL13 9UF, UK Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham LL13 9UF, UK Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only). Please be ready to give the following information: Product name Reference number PL 29831/0457 Adenosine 3mg/ml (6mg in 2ml) Solution for Injection This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in 06/2023
105565/7 Incompatibilities In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Shelf Life Unopened: 36 months. The product should be used immediately after opening. Special precautions for storage Store below 25°C. Do not refrigerate. Nature and contents of container Clear, neutral type I glass vials (2ml) sealed with chlorobutyl rubber closures. Packs of 6 vials packed in a PVC tray in a cardboard carton. Special precautions for disposal Do not use if any particles or discolouration are noticed in the solution. Any unused product or waste material should be disposed of in accordance with local requirements. Marketing Authorisation Holder Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK Marketing Authorisation Number PL 29831/0457 Date of Revision of Text 06/2023
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: 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: Rapid intravenous injection only. Pharmaceutical Particulars List of Excipients Sodium chloride Water for injections
Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client's brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
Frequency not known:
- anaphylactic reaction (including angioedema and skin reactions such as urticaria and rash)
- loss of consciousness or fainting
- vomiting (feeling sick)
- convulsions
- low blood pressure
- your heart does not work properly to circulate blood around your body (cardiac arrest). This can be fatal
- a severe heart problem, where the heart stops pumping blood around the body (asystole). This can be fatal
- your lungs do not work properly to provide enough oxygen to your blood
- stopping breathing (respiratory arrest)
- spasm of the artery in the heart which may lead to a heart attack. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. 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 the 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
105565/7
Customer
Wockhardt UK Limited
Colours Used
Description
Adenosine injection leaflet
Black
Item Code
105565/7
Keyline (Non-Printing)
Profile
as supplied
Text Free Area (Non-Printing)
Size
148 x 460mm
Cirrus_Info_Box
Min.Point Size
Other
Market
UK
Language
English
Standard 235
Barcode Proof By
EBR
Proof No.
1
Date
28/06/2023
Body Text Fonts:
Myriad Pro
Body Text Ctd.
Actual Min Point Size
9pt/7.5pt
Frequently asked questions about Adenosine 3mg/ml Solution for Injection
How do I take Adenosine 3mg/ml Solution for Injection?
Adenosine 3mg/ml Solution for Injection 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.
What is the active substance in Adenosine 3mg/ml Solution for Injection?
The active substance in Adenosine 3mg/ml Solution for Injection is adenosine.
Are there equivalent medicines to Adenosine 3mg/ml Solution for Injection?
Medicines with the same active substance, strength and form include: Adenosine 3mg/ml Solution for Injection (Focus). They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Adenosine 3mg/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.
Can I get Adenosine 3mg/ml Solution for Injection 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: adenosine
- 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
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 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.
4.2. Posology and method of administration
Adenosine is intended for hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use.
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.
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.
Patients who develop high-level AV block at a particular dose should not be given further dosage increments.
Posology
Adults:
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).
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.
4.3. Contraindications
Adenosine injection is contraindicated for patients presenting:
- Known hypersensitivity to adenosine or to any of the excipients.
- 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.
4.4. Special warnings and precautions for use
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 injection 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. There have been reports of cerebrovascular accident/transient ischemic attack, secondary to the haemodynamic effects of adenosine.
There have been reports of myocardial infarction shortly after use of Adenosine. .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- 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 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 injection. It is therefore suggested that adenosine injection should not be administered to patients receiving dipyridamole; if use of Adenosine Injection is essential, dipyridamole should be stopped 24 hours before hand, or the dose of Adenosine Injection should be greatly reduced. (see Section 4.5).
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 injection should be used with caution in patients with a prolonged QT interval, whether this is drug induced or of metabolic origin. Adenosine 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 injection contains approximately 7mg sodium per injection vial (2ml) i.e. essentially 'sodium-free'.
Paediatric population
Adenosine 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.
4.5. Interaction with other medicinal products and other forms of interaction
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 injection should not be administered to patients receiving dipyridamole; if use of adenosine injection is essential, dipyridamole should be stopped 24 hours before hand, or the dose of adenosine should be greatly reduced (see section 4.4).
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 injection.
Adenosine may interact with drugs tending to impair cardiac conduction.
4.6. Fertility, pregnancy and lactation
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.
Breast Feeding:
It is unknown whether adenosine metabolites are excreted in human milk
Adenosine Injection should not be used during breast-feeding.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Undesirable effects
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).
Adverse events are ranked under the heading of the frequency:
Very common (>1/10), Common (≥1/100, <1/10), Uncommon (≥1/1,000, <1/100), Rare (≥1/10,000, <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from available data).
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: 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
Not known: hypotension (sometimes severe) (see section 4.4)
Nervous system disorders:
Common: headache, dizziness, light-headedness, paraesthesia
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
Psychiatric disorders:
Common: nervousness
General disorders and administration site conditions:
Very common: chest pain or pressure, feeling of thoracic constriction/oppression
Common: burning sensation
Uncommon: sweating, discomfort in the leg, arm or back, feeling of general discomfort, weakness/pain
Very rare: injection site reactions
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
Overdose 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.
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Ask anything about Adenosine 3mg/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.