SUMMARY CMI

Adenocor^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Adenocor?

Adenocor contains the active ingredient adenosine. Adenocor is used as an aid to doctors, to understand how your heart is working. Adenocor is a type of medicine used to treat a condition where the heart beats too rapidly.

For more information, see Section 1. Why am I using Adenocor? in the full CMI.

2. What should I know before I use Adenocor?

Do not use if you have ever had an allergic reaction to Adenocor or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Adenocor? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Adenocor and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Adenocor?

• Adenocor will only be given to you in hospital.
• Adenocor will be given to you as a rapid injection over a couple of seconds.

More instructions can be found in Section 4. How do I use Adenocor? in the full CMI.

5. What should I know while using Adenocor?

For more information, see Section 5. What should I know while using Adenocor? in the full CMI.

6. Are there any side effects?

There are a number of side effects associated with this medicine. It is important to be aware of them so that you can identify any symptoms if they occur (see the full CMI for more details).

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Adenocor^®

Active ingredient: adenosine

Consumer Medicine Information (CMI)

This leaflet provides important information about using Adenocor. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Adenocor.

Where to find information in this leaflet:

1. Why am I using Adenocor?
2. What should I know before I use Adenocor?
3. What if I am taking other medicines?
4. How do I use Adenocor?
5. What should I know while using Adenocor?
6. Are there any side effects?
7. Product details

1. Why am I using Adenocor?

Adenocor contains the active ingredient adenosine.

Adenocor is a type of medicine 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.

Adenocor is used as an aid to doctors, to understand how your heart is working.

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

Adenocor is only given in hospitals. It is given to you as an injection.

The effect of Adenocor only lasts for a couple of minutes.

Your doctor, however, may prescribe Adenocor for another purpose.

Ask your doctor if you have any questions about why it has been prescribed for you.

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

This medicine is not addictive.

2. What should I know before I use Adenocor?

Warnings

Do not receive Adenocor if you:

• are allergic to it or any of the ingredients listed at the end of this leaflet.
• have asthma or any other lung disease
• have recently had a heart transplant
• have some other problems with your heart or heart rhythm
• have severe low blood pressure

Tell your doctor if:

• you have allergies to any of the ingredients listed at the end of this leaflet
• you have allergies to any other medicines including:
  - theophylline or aminophylline
  - dipyridamole
  - carbamazepine
• you have allergies to any other substance, such as foods, preservatives or dyes

Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.

Tell your doctor if you eat or drink large amounts of food or drinks containing caffeine (e.g. coffee, tea, chocolate or cola).

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

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

• a history of heart problems including problems with your blood pressure
• a history of epilepsy or seizures
• asthma or any other lung disease

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or intend to become pregnant.

Like most medicines of this kind, Adenocor is not recommended to be used during pregnancy. Your doctor or pharmacist will discuss the risks and benefits of being given it if you are pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

It is not known whether Adenocor passes into breast milk. Your doctor or pharmacist will discuss the risks and benefits of being given it if you are breastfeeding or planning to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may be affected by Adenocor. These include:

• theophylline or aminophylline, medicines used to help relieve breathing problems
• dipyridamole, a medicine used for people who have had a stroke
• carbamazepine, a medicine used to treat epilepsy and seizures

These medicines may be affected by Adenocor or may affect how well it works. You may need to use
different amounts of your medicine, or take different medicines. Your doctor or pharmacist will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or to avoid while being given Adenocor.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Adenocor.

4. How do I use Adenocor?

How much is given

• The standard dose for this medicine is a series of injections
• Adults: One injection (3 mg). If the first injection does not slow down your heart rate within 1 or 2 minutes, one (6 mg) or two (12 mg) more doses may be given
• Children: There is not enough evidence to recommend the use of this medicine for children

How it is given

• Adenocor will only be given to you in hospital.
• Adenocor will be given to you as a rapid injection over a couple of seconds

When to receive it

• 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 receive too much

As Adenocor is given to you under the supervision of a doctor, it is very unlikely that you will receive too much.

However, if you experience any unexpected or worrying side effects after being given Adenocor and think you have been given too much, you should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26 in Australia or 0800 764 766 in New Zealand ), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

5. What should I know while using Adenocor?

Things you should not do

• 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.

After being given Adenocor

• If you have any queries about any aspects of your medicine, or any questions regarding this leaflet, discuss them with your doctor, nurse or pharmacist.

Looking after your medicine

• Adenocor is stored in the pharmacy or on the ward.
• Adenocor is kept in a cool, dry place where the temperature stays below 25°C.
• Not to be refrigerated.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

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

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Adenocor.

It helps most people with heart problems, but it may have unwanted side effects in a few people.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems or to the Centre for Adverse Reactions Monitoring (CARM) within the New Zealand Pharmacovigilance Centre nzphvc.otago.ac.nz/reporting (New Zealand). By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What Adenocor contains

Do not take this medicine if you are allergic to any of these ingredients.

What Adenocor looks like

Adenocor is a clear colourless solution that comes in a glass vial with a rubber closure and aluminium cap.

Each box of Adenocor contains 6 vials.

AUST R 49439.

Who distributes Adenocor

Distributed in Australia by:

sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Email: [email protected]

Distributed in New Zealand by:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
P O Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
Email: [email protected]

This leaflet was prepared in August 2022.

adenocor-ccdsv9-cmiv7-23aug22

Published by MIMS October 2022

1 Name of Medicine

Adenosine.

2 Qualitative and Quantitative Composition

Each vial contains 6 mg of adenosine in 2 mL of a 0.9% w/v solution of sodium chloride in sterile water for injections.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Adenocor is a clear colourless sterile solution for intravenous injection (rapid bolus).

4 Clinical Particulars

4.1 Therapeutic Indications

Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White syndrome).

Diagnostic indications.

4.2 Dose and Method of Administration

Adenocor should be used only in hospitals, with monitoring and cardiorespiratory resuscitation equipment available for immediate use if necessary. 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, it should be administered either directly into a vein or into an IV line. If administered via an IV line it should be injected as proximally as possible, and followed by a rapid saline flush.
Adenocor should only be used when facilities exist for cardiac monitoring. Patients who develop high-level AV block at a particular dose should not be given further dosage increments.

Therapeutic dose.

Initial dose.

Second dose.

Third dose.

Diagnostic dose.

4.3 Contraindications

Adenocor is contraindicated in patients with:
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 physicians familiar with the product (see Section 4.2 Dose and Method of Administration) in a hospital setting with monitoring and cardio-respiratory 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 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. The use of Adenoscan infusion is contraindicated in patients receiving dipyridamole (see Adenoscan product information, see Section 4.3 Contraindications). If use of adenosine bolus injection (Adenocor) is judged to be essential, dipyridamole should be discontinued 24 hours beforehand or the dose of adenosine should be significantly reduced.
Adenocor (adenosine) should be given as a rapid intravenous bolus. Adenosine is ineffective in the management of SVT 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.

Atrial fibrillation.

Bradycardia.

Heart block and myocardial infarction.

Arrhythmias at time of conversion.

Post heart transplantation.

Bronchoconstriction.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Intravenous Adenocor (adenosine) has been effectively administered 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 fourfold increase in adenosine activity. The use of Adenoscan infusion is contraindicated in patients receiving dipyridamole (see Adenoscan product information, see Section 4.3 Contraindications). If the use of adenosine bolus injection (Adenocor) is judged to be essential, dipyridamole should be discontinued 24 hours beforehand, or the dose of Adenocor 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.

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 have been 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: ≥ 1/1000 (0.1%) and < 1/100 (1%), rare: ≥ 1/10,000 (0.01%) and < 1/1000 (0.1%), very rare: < 1/10,000 (0.01%), not known: (cannot be estimated from available data).

Cardiovascular system.

Respiratory system.

Central nervous system.

Gastrointestinal system.

Other.

Postmarketing experience.

Reporting suspected adverse effects.

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 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Other cardiac preparations, ATC code: C01EB10.

Mechanism of action.

Haemodynamics.

Clinical trials.

5.2 Pharmacokinetic Properties

Intravenously administered Adenocor (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 and renal failure.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

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

Store below 25°C. Do not refrigerate.

6.5 Nature and Contents of Container

Injection vials 6 mg/2 mL: 6s.
Clear glass vials.

6.6 Special Precautions for Disposal

Any portion of the vial not used at once should be discarded.
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Adenosine is designated chemically as 6-amino-9-β-D-ribofuranosyl-9-H-purine and has the following chemical structure:

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes