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 a medicine called adenosine. This belongs to a group of medicines called 'coronary vasodilatators'. This medicine is for diagnostic use only. Adenosine is used before a test called "myocardial perfusion imaging" to look at your heart. During this test you are given a medicine called a "radiopharmaceutical". Adenosine works by opening up your heart's blood vessels and allowing blood to flow more freely. This allows the "radiopharmaceutical" medicine to get into your heart. The doctor can see your heart and assess your heart condition. This procedure is used if you are not capable of exercise or if an exercise stress test is not possible. 2. Before you are given Adenosine Do not have this medicine and tell your doctor if:
The following information is intended for healthcare professionals only: Posology and Method of Administration Adenosine 30 mg/10 ml solution for infusion is intended for use in hospitals with monitoring and cardio-respiratory resuscitation equipment available for immediate use if necessary. It should be administered following the same procedure as for exercise testing where facilities for cardiac monitoring and cardiorespiratory resuscitation are available. During administration of Adenosine 30 mg/10 ml solution for infusion continuous ECG control is necessary as life- threatening arrhythmia might occur. Heart rate and blood pressure should be monitored every minute. Posology Adults: 1. Adenosine 30 mg/10 ml solution for infusion should be administered undiluted as a continuous peripheral intravenous infusion at a dose of 140 μg/kg/min for six minutes using an infusion pump. Separate venous sites for Adenosine 30 mg/10 ml solution for infusion and radionuclide administration are recommended to avoid an adenosine bolus effect. 2. After three minutes of Adenosine 30 mg/10 ml solution for infusion, the radionuclide is injected to ensure sufficient time for peak coronary blood flow to occur. The optimal vasodilator protocol is achieved with six minutes of Adenosine 30 mg/10 ml solution for infusion. 3. To avoid an adenosine bolus effect, blood pressure should be measured in the arm opposite to the Adenosine 30 mg/10 ml solution for infusion.
You have any minor problem with your heart (first degree AtrioVentricular block or bundle branch block). These conditions may be temporarily aggravated when you are given Adenosine. 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 or nurse if you are taking or have recently taken 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 or nurse 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 or nurse. Adults (including the elderly)
The table below is given as a guide for adjustment of the infusion rate of undiluted Adenosine 30 mg/10 ml solution for infusion, in line with bodyweight (total dose 0.84 mg/kg). Patient Weight (kg) 45 – 49 50 – 54 55 – 59 60 – 64 65 – 69 70 – 74 75 – 79 80 – 84 85 – 89 90 – 94 95 – 99 100 – 104
Infusion Rate (ml/min) 2.1 2.3 2.6 2.8 3.0 3.3 3.5 3.8 4.0 4.2 4.4 4.7
Paediatric population: The safety and efficacy of adenosine in children aged 0-18 years old have not been established. Currently available data are described in section 5.1 but no recommendation on a posology can be made. Elderly: See dosage recommendations for adults. Incompatibilities Compatibility with other medicines is not known. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
the infusion is stopped. Sometimes you may need an injection of a medicine called aminophylline or theophylline to help with any side effects. If you have any further questions on the use of this medicine, ask your doctor or nurse.
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 immediately and they will decide if you should continue the infusion or not: The side effects normally settle within seconds or minutes after the infusion is finished but you should tell your doctor or nurse if any of them happen. Very common (affects more than 1 user in 10)
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.
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.
Shelf-Life Unopened: 24 Months Any portion of the vial not used at once should be discarded. Special Precautions for Storage Keep this medicine out of the sight and reach of children. Do not store above 25 °C. Do not refrigerate. Nature and Contents of Container Sulfur treated clear tubular Glass vial, Ph. Eur. Type-I with Teflon coated rubber closure and 10 ml fill volume. Packs of 5, 6, 10 and 25 vials. Not all pack sizes may be marketed. Special precautions for disposal Any unused medicinal product or waste material should be disposed of in accordance with local requirement.
1400008699
Very rare (affects less than 1 user in 10 000)
What Adenosine contains
Rare (affects less than 1 user in 1000)
Other side effects (frequency cannot be estimated from the available data)
Adenosine 30 mg/10 ml solution for infusion comes as infusion containing 30mg / 10ml. 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 30 mg/10 ml solution for infusion is adenosine.
Medicines with the same active substance, strength and form include: Adenosine 30mg/10ml Solution for Infusion, Adenosine 30mg/10ml Solution for Infusion. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Adenosine 30 mg/10 ml 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.
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.
Intravenous (IV) Adenosine 30 mg/10 ml solution for infusion is a coronary vasodilator for use in conjunction with radionuclide myocardial perfusion imaging in patients who cannot exercise adequately or for whom exercise is inappropriate
Adenosine 30 mg/10 ml solution for infusion is intended for use in hospitals with monitoring and cardio-respiratory resuscitation equipment available for immediate use if necessary.
It should be administered following the same procedure as for exercise testing where facilities for cardiac monitoring and cardio- respiratory resuscitation are available.
During administration of Adenosine 30 mg/10 ml solution for infusion continuous ECG control is necessary as life- threatening arrhythmia might occur. Heart rate and blood pressure should be monitored every minute.
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.
Adults:
1. Adenosine 30 mg/10 ml solution for infusion should be administered undiluted as a continuous peripheral intravenous infusion at a dose of 140 µg/kg/min for six minutes using an infusion pump. Separate venous sites for Adenosine 30 mg/10 ml solution for infusion and radionuclide administration are recommended to avoid an adenosine bolus effect.
2. After three minutes of Adenosine 30 mg/10 ml solution for infusion, the radionuclide is injected to ensure sufficient time for peak coronary blood flow to occur. The optimal vasodilator protocol is achieved with six minutes of Adenosine 30 mg/10 ml solution for infusion
3. To avoid an adenosine bolus effect, blood pressure should be measured in the arm opposite to the Adenosine 30 mg/10 ml solution for infusion.
The table below is given as a guide for adjustment of the infusion rate of undiluted Adenosine 30 mg/10 ml solution for infusion, in line with bodyweight (total dose 0.84 mg/kg).
Patient Weight (kg)
Infusion Rate (ml/min)
45 - 49
2.1
50 - 54
2.3
55 - 59
2.6
60 - 64
2.8
65 - 69
3.0
70 - 74
3.3
75 - 79
3.5
80 - 84
3.8
85 - 89
4.0
90 - 94
4.2
95 - 99
4.4
100 - 104
4.7
Paediatric population:
The safety and efficacy of adenosine in children aged 0-18 years old have not been established. Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Elderly:
See dosage recommendations for adults.
Adenosine 30 mg/10 ml solution for infusion is contra-indicated in patients suffering from:
- Hypersensitivity to the adenosine or to any of the excipients.
- Second or third degree atrioventricular (AV) block, sick sinus syndrome except in patients with a functioning artificial pacemaker
- Long QT syndrome
- Severe hypotension
- Unstable angina not successfully stabilised with medical therapy
- Decompensated states of heart failure
- Chronic obstructive lung disease with evidence of bronchospasm (e.g. asthma bronchiale)
- Concomitant use of dipyridamole (see section 4.5).
Adenosine is intended for use 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 30 mg/10 ml solution for infusion 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 30 mg/10 ml solution for infusion should be discontinued in any patient who develops persistent or symptomatic hypotension.
Adenosine 30 mg/10 ml solution for infusion should be used with caution in patients with recent myocardial infarction or severe heart failure. Adenosine 30 mg/10 ml solution for infusion should be used with caution in patients with minor conduction defects (first degree AV block, bundle branch block) that could be transiently aggravated during infusion.
Adenosine may trigger convulsions in patients who are susceptible to convulsions.
Adenosine 30 mg/10 ml solution for infusion 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 should lead to treatment discontinuation. Severe bradycardia would favour the occurrence of torsades de pointes, especially in patients with prolonged QT intervals. But to date, no case of torsades de pointes has been reported when adenosine is continuously infused.
The occurrence of respiratory failure (potentially fatal), asystole/cardiac arrest (potentially fatal), angina, severe bradycardia or severe hypotension should also lead to treatment discontinuation.
In patients with recent heart transplantation (less than 1 year) an increased sensitivity of the heart to adenosine has been observed.
Adenosine may precipitate or aggravate bronchospasm (see sections 4.3 and 4.8).
Adenosine 30 mg/10 ml solution for infusion contains 9 mg sodium chloride per ml (corresponding to 3.542 mg sodium per ml).
To be taken into consideration by patients on a controlled sodium diet.
Dipyridamole inhibits adenosine cellular uptake and metabolism, and potentiates the action of Adenosine 30 mg/10 ml solution for infusion. In one study dipyridamole was shown to produce a 4 fold increase in adenosine actions. It is therefore suggested that Adenosine 30 mg/10 ml solution for infusion should not be administered to patients receiving dipyridamole; if use of Adenosine 30 mg/10 ml solution for infusion is essential, dipyridamole should be stopped 24 hours before hand, or the dose of Adenosine 30 mg/10 ml solution for infusion should be greatly reduced.
Aminophylline, theophylline and other xanthines are competitive adenosine antagonists and should be avoided for 24 hours prior to use of Adenosine 30 mg/10 ml solution for infusion.
Food and drinks containing xanthines (tea, coffee, chocolate and cola) should be avoided for at least 12 hours prior to use of Adenosine 30 mg/10 ml solution for infusion.
Adenosine 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 30 mg/10 ml solution for infusion should not be used during breast-feeding.
Not relevant.
Effects related to the known pharmacology of adenosine are frequent, but usually self-limiting and of short duration. Discontinuation of infusion may be necessary if the effect is intolerable.
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 (≥1/1000, <1/100), Rare (≥1/10000, <1/1000), Very rare (<1/10000), 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:
- common: hypotension, sometimes severe (see section 4.4), ST segment depression, sustained or non- sustained ventricular tachycardia, AV block (see section 4.4).
If sustained second or third degree AV block develops the infusion should be discontinued. If first degree AV block occurs, the patient should be observed carefully as a quarter of patients will progress to a higher degree of block.
- uncommon: bradycardia sometimes severe (see section 4.4)
- not known: asystole /Cardiac arrest (sometimes fatal, especially in patients with underlying ischemic heart disease/cardiac disorders, see section 4.4): sinus tachycardia, atrial fibrillation, ventricular fibrillation. Arteriospasm coronary which may lead to myocardial infarction
Nervous system disorders:
- very common: headache
- common: dizziness, light-headedness, paraesthesia,
- rare: tremor, drowsiness
- not known: loss of consciousness / syncope, convulsions, especially in predisposed patients (see section 4.4)
Eye disorders:
- rare: blurred vision
Ear and labyrinth disorders:
- rare: tinnitus
Respiratory, thoracic and mediastinal disorders:
- very common: dyspnea (or the urge to breathe deeply)
- rare: bronchospasm (see section 4.4), nasal congestion
- very rare: respiratory failure (see section4.4)
- not known: apnea/respiratoryarrest
Cases with fatal outcome of respiratory failure, of bronchospasm, and of apnea / respiratory arrest have been reported
Gastro-intestinal disorders:
- very common: abdominal discomfort
- common: dry mouth
- uncommon: metallic taste
- not known: nausea, vomiting
Renal and Urinary disorders:
- rare: urinary urgency
Vascular disorders:
- very common: flushing
General disorders and administration site conditions:
- very common: chest pain or pressure, feeling of thoracic constriction/oppression
- common: throat, neck and jaw discomfort
- uncommon: sweating, discomfort in the leg, arm or back, feeling of general discomfort, weakness/pain
- very rare: injection site reactions
Reproductive system and breast disorders:
- rare: nipple discomfort
Psychiatric disorders:
- uncommon: nervousness
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 of Adenosine 30 mg/10 ml solution for Infusion (when they occur) would quickly resolve when the infusion is discontinued. Administration of IV aminophylline or theophylline may be needed.
Ask anything about Adenosine 30 mg/10 ml 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.
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