Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Isuprel™.

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

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Isuprel™ against the benefits they expect it will have for you.

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

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

What Isuprel™ is used for

Isuprel™ is used to treat heart block and cardiac arrest. Isuprel™ is intended to be used in hospitals only.

It belongs to a group of medicines called synthetic sympathomimetic amines.

Isuprel™ helps improve the efficiency with which your heart pumps blood around your body. Isuprel™ works by strengthening your heart muscles and increasing the heartbeat rate.

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 reason.

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

Before you are given Isuprel™

When you must not be given it

You must not be given Isuprel™ if you have an allergy to:

• any medicine containing isoprenaline
• 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 Isuprel™ if you have any of the following:

• fast heart rate
• fast, slow or irregular heart beat caused by digitalis toxicity
• medicines used to treat unusual heart beat, such as inotropic therapy
• recently suffered a heart attack
• a feeling of tightness, pressure or heaviness in the chest

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

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

• asthma
• diabetes
• hyperthyroidism
• other heart conditions

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you start taking Isuprel™.

Taking other medicines

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

Some medicines and Isuprel™ may interfere with each other. These include:

• combined use of adrenaline and digitalis, medicines used to stimulate the heart
• inhalational anaesthetics such as halothane and cyclopropane
• medicines used to treat certain mental and emotional conditions such as chlorpromazine or monoamine oxidase inhibitors
• slow injection of isoprenaline in combination with aminophylline, theophylline and intravenous corticosteroids.

These medicines may be affected by Isuprel™ or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take Isuprel™

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

How much is given

Your doctor will decide what dose you will receive. The dosage will depend on your condition.

How it is given

Isuprel™ will normally be given to you as an injection under the skin, or into the vein, muscle or heart.

If you take too much (overdose)

As Isuprel™ is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any severe side effects after being given Isuprel™, tell your doctor immediately or go to Accident and Emergency at the nearest hospital. You may need urgent medical attention.

In case of overdose, immediately contact the Poisons Information Centre for advice (telephone 13 11 26 in Australia).

Symptoms of Isuprel™ overdose include the side effects listed below in the ‘Side Effects’ section, but are usually of a more severe nature.

While you are using Isuprel™

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Isuprel™.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Keep all of your doctor’s appointments so that your progress can be checked.

Things to be careful of

Be careful driving or operating machinery until you know how Isuprel™ affects you. This medicine may cause dizziness and light-headedness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Be careful when drinking alcohol while you are taking this medicine. If you drink alcohol, dizziness or light-headedness may be worse.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you being given Isuprel™. This medicine helps most people with heart block and cardiac arrest, but it may have unwanted side effects in a few 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.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Some unwanted effects may occur when being treated with Isuprel™. These include:

• nervousness
• headache, dizziness or light-headedness
• restlessness
• palpitations, sweating
• mild tremors, weakness
• hot flashed, flushing of the skin
• fast heart beat
• ringing in the ears (tinnitus)
• nausea and vomiting

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

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

After using Isuprel™

Storage

Isuprel™ will be stored in the pharmacy or on the ward. The ampoule is stored below 25°C. It should be protected from light.

Product description

What it looks like

Isuprel™ is a clear, colourless solution. It is available as 1mL ampoules in packs of 25 and 5mL ampoules in packs of 10.

Ingredients

Isuprel™ contains 0.2 mg of isoprenaline hydrochloride as the active ingredient.

It also contains:

• disodium edetate
• sodium citrate dihydrate
• citric acid
• sodium chloride
• water for injections
• hydrochloride acid or sodium hydroxide used to adjust pH

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

Isuprel™ is supplied by:

Australian Sponsor:

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free number: 1800 675 229
www.pfizer.com.au

New Zealand Sponsor:

Pfizer New Zealand Limited
PO Box 3998
Auckland, New Zealand
Toll Free number: 0800 736 363

Isuprel™ is available in the following strengths:

• 0.2 mg / 1 mL ampoules AUST R 198887
• 1 mg/ 5 mL ampoules AUST R 198888

This leaflet was prepared in October 2019

Published by MIMS December 2019

1 Name of Medicine

Isoprenaline hydrochloride.

2 Qualitative and Quantitative Composition

Each milliliter of the sterile 1:5000 solution contains 200 microgram of isoprenaline.
The sterile 1:5000 solution can be administered by the intravenous, intramuscular, subcutaneous or intracardiac routes.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Concentrated solution for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Isuprel is indicated:
for mild or transient episodes of heart block that do not require electric shock or pacemaker therapy;
for serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation) (see Section 4.3 Contraindications);
for use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, are available (see Section 4.3 Contraindications);
for bronchospasm occurring during anaesthesia.
As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolaemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure and cardiogenic shock. (See Section 4.4 Special Warnings and Precautions for Use.)

4.2 Dose and Method of Administration

Dosage.

Adults.

Recommended dosage for adults with shock and hypoperfusion states.

Recommended dosage for adults with heart block, Adams-Stokes attacks and cardiac arrest.

Recommended dosage for adults with bronchospasm occurring during anaesthesia.

Children.

4.3 Contraindications

Use of Isuprel is contraindicated in patients with tachyarrhythmias; tachycardia or heart block caused by digitalis intoxication; ventricular arrhythmias which require inotropic therapy; recent myocardial infarction; angina pectoris; hypersensitivity to isoprenaline.

4.4 Special Warnings and Precautions for Use

Isuprel infusions may produce an increase in myocardial work and oxygen consumption. These effects may be detrimental to myocardial metabolism and functioning in patients in cardiogenic shock secondary to coronary artery occlusion and myocardial infarction.
In a few patients, presumably with organic disease of the A-V node and its branches, Isuprel has been reported, paradoxically, to precipitate Adams-Stokes seizures during normal sinus rhythm or transient heart block.
Adequate filling of the intravascular compartment by suitable volume expanders is of primary importance in most cases of shock, and should precede the administration of isoprenaline. In patients with normal cardiac function, determination of central venous pressure is a reliable guide during volume replacement. If evidence of hypoperfusion persists after adequate volume replacement, Isuprel may be given.
In addition to the routine monitoring of systemic blood pressure, heart rate, urine flow, and electrocardiograph, the response to therapy should also be monitored by frequent determinations of the central venous pressure and blood gases. Patients in shock should be closely observed during Isuprel administration. If the heart rate exceeds 110 beats per minute, it may be advisable to decrease the infusion rate or temporarily discontinue the infusion. Determinations of cardiac output and circulation time may also be helpful. Doses of Isuprel sufficient to increase the heart rate to more than 130 beats per minute may induce ventricular arrhythmia. If the cardiac rate increases sharply, patients with angina pectoris may experience anginal pain until the cardiac rate decreases.
If ventricular hyperexcitability (extrasystoles, polymorphic extrasystoles or sustained ventricular tachycardia) should occur, the dosage should be reduced and the electrocardiogram monitored.
Appropriate measures should be taken to ensure adequate ventilation. Careful attention should be paid to acid/ base balance and to the correction of electrolyte disturbances.
In cases of shock associated with bacteraemia, suitable antimicrobial therapy is, of course, imperative.
There are case reports of occasional fatal cardiac dysrhythmia and myocardial necrosis at autopsy as a result of intravenous isoprenaline. ECG changes and serum CPK-MB level elevation consistent with transient myocardial ischaemia and abnormal echocardiographic findings suggestive of myocardial dysfunction have been documented with the use of intravenous isoprenaline hydrochloride infusion for the treatment of severe asthma exacerbations in children. Care should be taken to ensure that oxygen is always administered during isoprenaline infusions in patients with asthma. Heart rate, blood pressure, arrhythmias and evidence of myocardial ischaemia by ECG should be monitored. Arterial blood gases should also be monitored carefully and PaO₂ maintained above 60 torr. Where the ECG suggests myocardial ischaemia, cardiac enzymes including cardiac specific CPK-MB isoenzyme levels should be determined.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Isuprel should not be given simultaneously with adrenaline or digitalis because both drugs are direct cardiac stimulants and their combined effects may induce serious arrhythmias. The drugs may, however, be administered alternately, provided a proper interval has elapsed between doses.
Isuprel should be used with caution, if at all, when potent inhalational anaesthetics such as halothane and cyclopropane are employed, because of their potential to sensitise the myocardium to the effects of sympathomimetic amines.
Isoprenaline should not be used with chlorpromazine or monoamine oxidase inhibitors since the effects of isoprenaline may be magnified.
Caution should be maintained when using continuous intravenous isoprenaline hydrochloride infusions in conjunction with intravenous methylxanthines (aminophylline, theophylline) and intravenous corticosteroids. The use of isoprenaline hydrochloride with aminophylline and corticosteroids may be additive in cardiotoxic properties and can lead to myocardial necrosis and death. Severe cardiac symptoms of sympathetic overactivation, i.e. hypertension, tachycardia, arrhythmias, seizures, myocardial ischaemia, and fatal myocardial necrosis, have been reported.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

No specific studies have been conducted to assess the direct effect of Isuprel on the ability to drive and use machines. However, adverse effects of Isuprel include dizziness which could affect the ability to drive or use machines. See Section 4.8 Adverse Effects (Undesirable Effects).

4.8 Adverse Effects (Undesirable Effects)

Serious effects to Isuprel are infrequent. The following effects, however, have been reported.

CNS.

Cardiovascular.

Other.

Reporting suspected adverse effects.

4.9 Overdose

The acute toxicity of Isuprel in animals is much less than that of adrenaline. Excessive doses in animals or humans can cause a striking drop in blood pressure, and repeated large doses in animals may result in cardiac enlargement and focal myocarditis.
In cases of accidental overdosage, as evidenced mainly by tachycardia or other arrhythmias, palpitations, angina, hypotension or hypertension, reduce rate of administration or discontinue Isuprel until the patient's condition stabilises. Blood pressure, pulse, respiration and ECG should be monitored.
Very cautious use of a nonselective beta-receptor antagonist should be considered if symptoms are very severe, but close monitoring of airway function would be essential.
It is not known whether Isuprel is dialysable.
The oral LD₅₀ of Isuprel in mice is 3,850 mg/kg ± 1,190 mg/kg of pure drug in solution.
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.

Clinical trials.

5.2 Pharmacokinetic Properties

The half-life of isoprenaline hydrochloride is brief, lasting only a few minutes following intravenous administration and up to 2 hours after subcutaneous administration. Isoprenaline is metabolised by catechol-ortho-methyl transferase, primarily in the liver. The major metabolite after intravenous administration is 3-O-methylisoprenaline, which is reported to have weak beta-adrenergic blocking activity, and its conjugates. The metabolites are excreted through the kidneys.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Disodium edetate, sodium citrate dihydrate, citric acid, sodium chloride, water for injections, hydrochloric acid or sodium hydroxide used to adjust pH.

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. Protect from light.

6.5 Nature and Contents of Container

Injection 200 microgram/1 mL ampoules: 25's; 1000 microgram/5 mL ampoules: 10's.

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

Isoprenaline hydrochloride is 3,4-dihydroxy-alpha-[(isopropylamino) methyl] benzyl alcohol hydrochloride, a synthetic sympathomimetic amine that is structurally related to adrenaline but acts almost exclusively on beta-adrenergic receptors.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes