Consumer medicine information

Adenosine Viatris

Adenosine

BRAND INFORMATION

Brand name

Adenosine Viatris

Active ingredient

Adenosine

Schedule

What is in this leaflet

This leaflet answers some common questions about Adenosine Mylan.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking adenosine against the benefits expected for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What this medicine is used for

Adenosine Mylan is used to treat a condition called paroxysmal supraventricular tachycardia (including a condition called Wolff-Parkinson-White syndrome). This is when the heart beats too rapidly. If left untreated, this condition can be life threatening.

Adenosine can also be used as an aid to doctors to understand how your heart is working.

It works by slowing down the electrical impulses that control heart rhythm. This allows the heart rhythm to return to normal.

Adenosine is only given in hospitals. It is given to you as an injection. The effect of this medicine only lasts for a couple of minutes.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another use.

There is no evidence this medicine is addictive.

This medicine is available only with a doctor's prescription.

Before you are given it

When you must not take it

Do not take this medicine if you have an allergy to:

any medicine containing adenosine, the active ingredient
any of the ingredients listed at the end of this leaflet

Some of the symptoms of an allergic reaction may include

shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin

You must not be given this medicine if:

you have asthma
you have a heart disorder (e.g. heart block or sick sinus syndrome - unless you also have a pacemaker, long QT syndrome or heart failure)
you have severe low blood pressure.

Talk to your doctor if you are not sure whether you should be given this medicine.

Before you are given it

Tell your doctor if you have allergies to:

any other medicines, foods, preservatives or dyes.
theophylline or aminophylline
dipyridamole
carbamazepine

Tell your doctor if you have or have had any of the following medical conditions:

a lung disease, such as bronchitis or emphysema
any other type of heart condition
you have had a heart transplant within the last 12 months
a history of epilepsy or seizures
you eat or drink large amounts of food or drinks containing caffeine (e.g. coffee, tea, chocolate or cola)

These could affect how well adenosine works.

Tell your doctor if you are pregnant or breastfeeding. Your doctor will discuss the benefits and possible risks of using adenosine during pregnancy or breastfeeding.

If you have not told your doctor about any of the above, tell them before you start being given this medicine.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you get from your pharmacy, supermarket or health food shop.

Some medicines may interfere with adenosine. These include:

medicines used to help relieve breathing problems, such as theophylline or aminophylline
dipyridamole, a medicine used for people who have had a stroke
carbamazepine, a medicine used to treat epilepsy and seizures
caffeine-containing beverages and foods such as tea, coffee, chocolate or cola.

These medicines may be affected by adenosine or may affect how well it works.

Ask your doctor if you are not sure whether you should be given this medicine. Your doctor has more information on medicines to be careful with or avoid while using this medicine.

How it is given

Adenosine Mylan will be given to you in a hospital by a trained healthcare professional.

How much to be given

Your doctor will decide what dose of Adenosine Mylan you will receive. This depends on your condition. Usually you will only need one or several doses a few minutes apart.

Adults:

One injection (3mg). If the first injection does not slow down your heart rate within 1 or 2 minutes, one (6 mg) or two (12 mg) doses may be given.

Children:

There is not enough evidence to recommend the use of this medicine for children.

How it is given

Adenosine Mylan is given by injection either directly into a vein or via an intravenous (I.V.) line.

Do not eat or drink food or drinks containing caffeine (e.g. coffee, tea, chocolate or cola) for at least 12 hours before you receive your injection.

If you are given too much (overdose)

As this medicine is given to you under the supervision of your doctor, it is very unlikely that you will be given too much.

However, tell your doctor or nurse immediately if you think you have received too much of this medicine.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well during or after treatment with adenosine.

This medicine helps most people who are treated with it, but it may have unwanted side effects in some people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Ask your doctor to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

facial flushing
shortness of breath or urge to breathe deeply
a feeling of tightness across the chest
nausea
headache
light headedness or dizziness
discomfort in the throat, neck or jaw
a burning sensation

These are usually mild and should only last a short time.

Tell your doctor or nurse immediately if you notice any of the following:

irregular or slow heart beat
problems with your breathing

These may be serious side effects of adenosine. You may require medical attention. Serious side effects are uncommon.

If any of the following happen, stop receiving this medicine and tell your doctor immediately:

swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
rash, itching or hives on the skin.

These are very serious side effects. If you have them, you may have had a serious allergic reaction to adenosine. You may need urgent medical attention.

Tell your doctor if you notice anything that is making you feel unwell, even if you think the problems are not connected with this medicine and are not referred to in this leaflet.

Other side effects not listed above may also occur in some people.

Do not be alarmed by this list of side effects. You may not experience any of them.

Product description

What it looks like

Adenosine Mylan comes in a clear, colourless, sterile solution in a glass vial.

Available in packs of 6 x 2mL.

Storage

Do not refrigerate.

Store below 25°C.

It will be stored in the pharmacy or on the ward.

Ingredients

Active ingredient:

Each vial contains 6 mg adenosine per 2 mL.

Inactive ingredients:

sodium chloride
water for injections

Adenosine Mylan does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

Alphapharm Pty Ltd
Level 1, 30 The Bond
30 - 34 Hickson Road
Millers Point, NSW 2000
www.mylan.com.au

AUST R 152014

This leaflet was prepared in December 2017

Published by MIMS March 2023

BRAND INFORMATION

Brand name

Adenosine Viatris

Active ingredient

Adenosine

Schedule

1 Name of Medicine

Adenosine.

2 Qualitative and Quantitative Composition

Adenosine Viatris is a sterile solution for intravenous injection (rapid bolus), available in clear glass vials and pre-filled syringes.
Each vial or pre-filled syringe contains 6 mg adenosine in 2 mL solution.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
Clear colourless solution free from visible particles.

4 Clinical Particulars

4.1 Therapeutic Indications

Therapeutic indications.

Adenosine Viatris is indicated for the rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White syndrome).

Diagnostic indications.

Adenosine Viatris is indicated as an aid to diagnosis of broad or narrow QRS complex supraventricular tachycardias. Although adenosine is not effective in converting atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of AV conduction helps diagnosis of atrial activity. In this respect adenosine should be used as an adjunct to, but not a replacement for, clinical and ECG observations. It should be used only when, despite all diagnostic attempts, doubt still persists.
Adenosine Viatris can also be used for improved diagnostic sensitivity of intracavity electrophysiological investigations.

4.2 Dose and Method of Administration

Adenosine Viatris should be used only in hospitals with monitoring and cardiorespiratory resuscitation equipment available for immediate use. It should be administered by rapid intravenous 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 administered into an IV line it should be injected as proximally as possible, and followed by a rapid saline flush.
Adenosine Viatris 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.
Adenosine Viatris is for use in one patient only. Discard any remaining contents.

Therapeutic dose.

Adults.

Initial dose.

3 mg given as a rapid intravenous bolus (over 2 seconds).

Second dose.

If the first dose does not result in the elimination of the supraventricular tachycardia within 1 or 2 minutes, 6 mg should be given, also as a rapid intravenous bolus.

Third dose.

If the second dose does not result in the elimination of the supraventricular tachycardia within 1 or 2 minutes, 12 mg should be given, also as a rapid intravenous bolus.
Children. No controlled paediatric study has been undertaken. Published uncontrolled studies show similar effects of adenosine in adults and children, effective doses for children were between 0.0375 mg/kg and 0.25 mg/kg.
Elderly. See dosage recommendations for adults.

Diagnostic dose.

The above ascending dosage schedule should be employed until sufficient diagnostic information has been obtained.

4.3 Contraindications

Adenosine Viatris is contraindicated in patients suffering from:
known hypersensitivity to adenosine;
sick sinus syndrome, second or third degree AV block (except in patients with a functioning artificial pacemaker);
chronic obstructive lung disease (such as asthma);
long QT syndrome;
severe hypotension;
decompensated states of heart failure.

4.4 Special Warnings and Precautions for Use

Adenosine is intended for use by doctors familiar with the product (see Section 4.2 Dose and Method of Administration) in a hospital setting with monitoring and cardiorespiratory resuscitation equipment available for immediate use if necessary.
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.
In patients with a history of convulsions/ seizures, the administration of adenosine should be carefully monitored.
As dipyridamole is a known inhibitor of adenosine uptake, it may potentiate the action of adenosine administration. If the use of adenosine bolus injection (Adenosine Viatris) is judged to be essential, dipyridamole should be discontinued 24 hours beforehand, or the dose of adenosine should be significantly reduced.
Adenosine should be given as a rapid intravenous bolus injection. Adenosine is ineffective in the management of supraventricular tachycardias when given as an infusion, rather than a bolus. This is most probably due to the different effect on sinus rate and atrioventricular nodal conduction.

Hypotension.

Because it has the potential to cause significant hypotension, adenosine should be used with caution in patients with left main coronary stenosis, uncorrected hypovolaemia, stenotic valvular heart disease, left to right shunt, pericarditis or pericardial effusion, autonomic dysfunction or stenotic carotid artery disease with cerebrovascular insufficiency.

Atrial fibrillation.

Adenosine should be used with caution in patients with atrial fibrillation or flutter and especially in those with an accessory bypass tract, since particularly the latter may develop increased conduction down the anomalous pathway.

Bradycardia.

Some cases of severe bradycardia have been reported. Some occurred in early post-heart transplant patients; in other cases occult sinoatrial 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.

Heart block and myocardial infarction.

Adenosine exerts its effect by decreasing conduction through the AV node and may produce a short lasting first, second or third degree heart block. In extreme cases, transient asystole may result (one case has been reported in a patient with atrial flutter who was receiving carbamazepine). Appropriate therapy should be instituted as needed. Patients who develop high level block on one dose of adenosine should not be given additional doses. Because of the very short half-life of adenosine, these effects are generally self-limiting.
Adenosine should be used with caution in patients with recent myocardial infarction, heart failure or in patients with minor conduction defects (first degree A-V block, bundle branch block) that could be transiently aggravated during infusion.

Arrhythmias at time of conversion.

At the time of conversion to normal sinus rhythm, a variety of new rhythms may appear on the electrocardiogram. They generally last only a few seconds without intervention and may take the form of premature ventricular contractions, premature atrial contractions, atrial fibrillation, sinus bradycardia, sinus tachycardia, skipped beats, sinus pause and varying degrees of AV nodal block. Such findings were seen in 55% of patients. The induced bradycardia predisposes the patient to ventricular excitability disorders including ventricular fibrillation and torsade de pointes.
Because of the possible risk of torsade de pointes, adenosine should be used with caution in patients with a prolonged QT interval.

Post heart transplantation.

In patients with recent heart transplantation (less than 1 year), an increased sensitivity of the heart to adenosine has been observed. Adenosine should be used with caution in such cases.

Bronchoconstriction.

Adenosine administered by inhalation has been reported to cause bronchoconstriction in asthmatic patients, presumably due to mast cell degranulation and histamine release. These effects have not been observed in normal subjects. Adenosine has been administered to a limited number of patients with asthma and mild to moderate exacerbation of their symptoms has been reported. Adenosine should not be used in patients with asthma (see Section 4.3 Contraindications).
Respiratory compromise has occurred during adenosine infusion in patients with obstructive pulmonary disease. Adenosine should be used with caution in patients with obstructive lung disease not associated with bronchoconstriction (e.g. emphysema, bronchitis, etc) and should be avoided in patients with bronchoconstriction or bronchospasm (e.g. asthma). Adenosine should be discontinued in any patient who develops severe respiratory difficulties.
Adenosine may precipitate or aggravate bronchospasm.

Use in the elderly.

No data available.

Paediatric use.

No data has been submitted from controlled studies in children.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Intravenous adenosine has been administered effectively in the presence of other cardioactive drugs, such as digitalis, quinidine, beta-adrenergic blocking agents, calcium channel blocking agents, and angiotensin converting enzyme inhibitors, without any change in the adverse reaction profile.
Adenosine may interact with drugs that tend to impair cardiac conduction. Aminophylline, theophylline and other xanthines are competitive adenosine antagonists and should be avoided for 24 hours prior to the administration of adenosine.
Food and drinks containing xanthines e.g. tea, coffee, chocolate and cola should be avoided for at least 12 hours prior to the administration of adenosine.
Nucleoside transport inhibitors such as dipyridamole inhibit adenosine cellular uptake and metabolism, and potentiate the action of adenosine. In one study dipyridamole was shown to produce a four-fold increase in adenosine activity. If the use of adenosine bolus injection (Adenosine Viatris) is judged to be essential, dipyridamole should be discontinued 24 hours beforehand, or the dose of adenosine should be significantly reduced.
Carbamazepine has been reported to increase the degree of heart block produced by other agents. As the primary effect of adenosine is to decrease conduction through the AV node, higher degrees of heart block may be produced in the presence of carbamazepine.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

In rats and mice, adenosine administered intraperitoneally once a day for 5 days at 50, 100 and 150 mg/kg caused decreased spermatogenesis and increased numbers of abnormal sperm.
(Category B2)
Animal reproductive studies have not been conducted with adenosine, nor have studies been performed on pregnant women. In the absence of evidence that adenosine does not cause foetal harm, adenosine should not be used during pregnancy unless the doctor considers the benefits outweigh the potential risks.
Studies have not been performed in lactating animals or women. Therefore, adenosine should not be used during lactation. If adenosine treatment is considered essential by the doctor, another form of infant feeding should be considered.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The following adverse reactions were reported with adenosine rapid intravenous bolus injection. These adverse reactions have been classified using standard terminology and are categorised by body system. They are listed in order of decreasing frequency according to the following definitions.
Very common: ≥ 1/10 (10%); common: ≥ 1/100 (1%) and < 1/10 (10%); uncommon: ≥ 1/1,000 (0.1%) and < 1/100 (1%); rare: ≥ 1/10,000 (0.01%) and < 1/1,000 (0.1%); very rare: < 1/10,000 (0.01%); not known: (cannot be estimated from available data).

Cardiovascular system.

Very common: bradycardia; sinus pause, skipped beats; atrial asystoles; A-V block; ventricular excitability disorders such as ventricular asystoles, non-sustained ventricular tachycardia.
Uncommon: sinus tachycardia; palpitations.
Very rare: atrial fibrillation; ventricular excitability including ventricular fibrillation and torsades de pointes; severe bradycardia not corrected by atropine and possibly requiring temporary pacing.
Not known: asystole/cardiac arrest, sometimes fatal especially in patients with underlying ischemic heart disease/cardiac disorder; MI/ST segment elevation especially in patients with pre-existing severe CAD; cerebrovascular accident/transient ischemic attack, secondary to the hemodynamic effects of adenosine including hypotension; arteriospasm coronary which may lead to myocardial infarction; hypotension sometimes severe.

Respiratory system.

Very common: dyspnoea (or the urge to breathe deeply).
Uncommon: hyperventilation.
Very rare: bronchospasm.
Not known: respiratory failure; apnoea/respiratory arrest.

Central nervous system.

Common: headache; dizziness; lightheadedness.
Uncommon: head pressure.
Very rare: transient and spontaneously rapid reversible worsening of intracranial hypertension.
Not known: loss of consciousness/syncope; convulsions especially in predisposed patients.

Gastrointestinal system.

Common: nausea.
Uncommon: metallic taste.
Not known: vomiting.

Other.

Very common: flushing; chest pressure/ pain; feeling of thoracic constriction/ oppression.
Common: apprehension; burning and sensation.
Uncommon: blurred vision; sweating; feeling of general discomfort/ weakness/ pain.
Very rare: injection site reactions.
Not known: anaphylactic reaction (including angioedema and skin reactions such as urticaria and rash).

Post-marketing experience.

In post market clinical experience, hypotension, sometimes severe, has been reported. There have been reports of cerebrovascular accident/ transient ischemic attack, secondary to the hemodynamic effects of adenosine, including hypotension. Cases of asystole/ cardiac arrest, sometimes fatal, especially in patients with underlying ischaemic heart disease/ cardiac disorder have been reported (see Section 4.4 Special Warnings and Precautions for Use).
Loss of consciousness/ syncope and convulsions especially in predisposed patients have been reported (see Section 4.4 Special Warnings and Precautions for Use).
Apnoea/ respiratory arrest and respiratory failure (see Section 4.4 Special Warnings and Precautions for Use) have been reported. Cases of fatal outcome of respiratory failure, of bronchospasm and of apnoea/ respiratory arrest have also been reported.
Cases of vomiting have been reported.
Other reports include tingling in the arms, numbness, pressure in groin and transient increase in blood pressure.
Myocardial infarction and ST segment elevation have been reported, especially in patients with pre-existing severe coronary artery disease.
Anaphylactic reactions, including angioedema and skin reactions such as urticaria and rash, have been reported.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

As the half-life of adenosine is very short (less than 10 seconds), adverse effects are generally rapidly self-limiting.
Treatment of any prolonged adverse effects should be individualised and be directed toward the specific symptoms. Methylxanthines, such as caffeine and theophylline, and aminophylline are competitive antagonists of adenosine. Intravenous aminophylline or theophylline may be needed.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Adenosine administered by rapid intravenous injection depresses conduction through the atrioventricular (AV) node.
This action can interrupt re-entry circuits involving the AV node and restore normal sinus rhythm in patients with paroxysmal supraventricular tachycardias and paroxysmal supraventricular tachycardias associated with Wolff-Parkinson-White syndrome. Once the circuit has been interrupted, the tachycardia stops and normal sinus rhythm is re-established.
By transiently slowing AV conduction, atrial activity is easier to evaluate from ECG recordings and therefore adenosine can aid the diagnosis of broad or narrow QRS complex tachycardias.
Adenosine may be useful during electrophysiological studies to determine the site of AV block or to determine, in some cases of pre-excitation, whether conduction is occurring by an accessory pathway or via the AV node.

Haemodynamics.

The intravenous bolus dose of 3 mg or 6 mg adenosine usually has no systemic haemodynamic effects. Rarely, significant hypotension and tachycardia have been observed. When larger doses are given by infusion, adenosine decreases blood pressure by decreasing peripheral resistance.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Intravenously administered adenosine is removed from the circulation very rapidly. Following an intravenous bolus, adenosine is taken up by erythrocytes and vascular endothelial cells. The half-life of intravenous adenosine is estimated to be less than 10 seconds. Adenosine enters the body pool and is primarily metabolised to inosine and adenosine monophosphate (AMP).

Hepatic or renal failure.

Hepatic and renal failure should have no effect on the activity of a bolus injection of adenosine. Since adenosine has a direct action, hepatic and renal functions are not required for the activity or metabolism of a bolus injection.

5.3 Preclinical Safety Data

Genotoxicity.

Adenosine tested negative for mutation in the Salmonella/Mammalian Microsome Assay. Adenosine, like other nucleosides at millimolar concentrations present for several doubling times of cells in culture, is known to produce a variety of chromosomal alterations.

Carcinogenicity.

Studies in animals have not been performed to evaluate the carcinogenic potential of adenosine.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Adenosine Viatris 6 mg/2 mL glass vials.

Store below 25°C.

Adenosine Viatris 6 mg/2 mL pre-filled syringes.

Store below 30°C. Protect from light.
Do not refrigerate as crystallisation may occur. If cystallisation has occurred, dissolve crystals by warming to room temperature. The solution should be clear at time of use. Any portion of the vial not used at once should be discarded.

6.5 Nature and Contents of Container

Adenosine Viatris 6 mg/2 mL glass vial.

Injection, solution.
Glass Type I clear vial with a bromobutyl rubber stopper and aluminium seal with flip-off cap. Pack size: 6 x 2 mL vials.

Adenosine Viatris 6 mg/2 mL pre-filled syringe.

Injection, solution.
Glass Type I clear pre-filled syringe with barrel with luer adaptor and tip cap, polystyrene plunger rod and plunger stopper. Pack size: 5 syringes.
Some strengths, pack sizes and/or pack types may not be marketed.

Australian register of therapeutic goods (ARTG).

AUST R 152014 - Adenosine Viatris adenosine 6 mg/2 mL solution for injection vial.
AUST R 152015 - Adenosine Viatris adenosine 6 mg/2 mL injection pre-filled syringe.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Adenosine is a white, crystalline powder slightly soluble in water, soluble in hot water, practically insoluble in alcohol and in methylene chloride.
The pH is between 4.5 and 7.5.

Chemical structure.

Chemical name: 9-β-D-ribofuranosyl-9H-purin-6-amine.
Molecular formula: C₁₀H₁₃N₅O₄.
Molecular weight: 267.2.

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