SUMMARY CMI

ISOPRENALINE HYDROCHLORIDE MEDSURGE

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 Isoprenaline Hydrochloride Medsurge?

Isoprenaline Hydrochloride Medsurge contains the active ingredient Isoprenaline hydrochloride. Isoprenaline hydrochloride is used to treat heart block and cardiac arrest. For more information, see Section 1. Why am I using Isoprenaline Hydrochloride Medsurge? in the full CMI.

2. What should I know before I use Isoprenaline Hydrochloride Medsurge?

Do not use if you have ever had an allergic reaction to Isoprenaline Hydrochloride Medsurge 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 Isoprenaline Hydrochloride Medsurge? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Isoprenaline Hydrochloride Medsurge 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 Isoprenaline Hydrochloride Medsurge?

• Your doctor will decide what dose of Isoprenaline Hydrochloride Medsurge you will receive. The dosage will depend on your condition.

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

5. What should I know while using Isoprenaline Hydrochloride Medsurge?

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

6. Are there any side effects?

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

Some unwanted effects may occur, 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.

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

ISOPRENALINE HYDROCHLORIDE MEDSURGE

Active ingredient(s): Isoprenaline hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Isoprenaline Hydrochloride Medsurge. 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 Isoprenaline Hydrochloride Medsurge.

Where to find information in this leaflet:

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

1. Why am I using Isoprenaline Hydrochloride Medsurge?

Isoprenaline Hydrochloride Medsurge contains the active ingredient Isoprenaline hydrochloride. Isoprenaline hydrochloride is used to treat heart block and cardiac arrest.

Isoprenaline Hydrochloride Medsurge is intended to be used in hospitals only.

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

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

Ask your doctor if you have any questions about why Isoprenaline Hydrochloride Medsurge has been prescribed for you.

Your doctor may have prescribed it for another reason.

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

2. What should I know before I use Isoprenaline Hydrochloride Medsurge?

Warnings

Do not use Isoprenaline Hydrochloride Medsurge if:

• You must not be given Isoprenaline Hydrochloride Medsurge if you are allergic to:
  - Any medicines 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 Isoprenaline Hydrochloride Medsurge 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 Isoprenaline Hydrochloride Medsurge.

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 and Isoprenaline hydrochloride 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 hydrochloride in combination with aminophylline, theophylline and intravenous corticosteroids

4. How do I use Isoprenaline Hydrochloride Medsurge?

How much to take/use

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

When to take/use Isoprenaline Hydrochloride Medsurge

Isoprenaline Hydrochloride Medsurge is used to treat heart block and cardiac arrest. Isoprenaline Hydrochloride Medsurge is intended to be used in hospitals only.

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

How to take Isoprenaline Hydrochloride Medsurge

Isoprenaline Hydrochloride Medsurge will normally be given to you as an injection under the skin, or into the vein, muscle or heart.

If you use too much Isoprenaline hydrochloride

As Isoprenaline hydrochloride 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 Isoprenaline hydrochloride, 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 Isoprenaline hydrochloride overdose include the side effects listed below in the ‘Side Effects’ section but are usually of a more severe nature.

5. What should I know while using Isoprenaline Hydrochloride Medsurge?

Things you should do

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

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 you should not do

Driving or using machines

Be careful driving or operating machinery until you know how Isoprenaline Hydrochloride Medsurge 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.

Drinking alcohol

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.

Isoprenaline Hydrochloride Medsurge will be stored in the pharmacy or on the ward. Store below 25°C, protected from light.

Do not store it:

• in the bathroom or near a sink, or
• in the car or on windowsills.

Keep it where young children cannot reach it.

When to discard your medicine

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.

Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given Isoprenaline Hydrochloride Medsurge.

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 Isoprenaline hydrochloride.

Less serious side effects

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.

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.

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 Isoprenaline Hydrochloride Medsurge contains

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

What Isoprenaline Hydrochloride Medsurge looks like

Solution for injection
Clear, colorless to slightly yellow colour solution. Practically free from any visible particles It is available as:

Isoprenaline Hydrochloride Medsurge 0.2 mg/1mL and 1.0 mg/5 mL solution for injection is filled into 1 mL and 5 mL clear glass ampoules with a blue band and a white OPC mark.

Pack sizes:
0.2 mg/1 mL – cartons containing 5 or 25 ampoules
1.0 mg/5 mL – cartons containing 10 ampoules

Australian Registration number:
0.2 mg/1 mL: AUST R 358313
1.0 mg/5 mL: AUST R 377578

Who distributes Isoprenaline Hydrochloride Medsurge

Medsurge Healthcare Pty Limited
Unit 2, 6-7 Gilda Court
MULGRAVE VICTORIA 3170
Tel: 1300 788 261
www.medsurge.com.au

This leaflet was prepared in February 2022.

Published by MIMS May 2022

1 Name of Medicine

Isoprenaline hydrochloride.

2 Qualitative and Quantitative Composition

Isoprenaline Hydrochloride Medsurge injection solution contains 0.2 mg (200 microgram) of isoprenaline hydrochloride in 1 mL (1:5000) and 1.0 mg of isoprenaline hydrochloride in 5 mL (1:5000).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for Injection.
Clear, colorless to slightly yellow colour solution. Practically free from any visible particles.

4 Clinical Particulars

4.1 Therapeutic Indications

Isoprenaline hydrochloride 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.

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.

4.3 Contraindications

Use of isoprenaline hydrochloride 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

Isoprenaline hydrochloride 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, isoprenaline hydrochloride 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, isoprenaline hydrochloride 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 isoprenaline hydrochloride 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 isoprenaline hydrochloride 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

Isoprenaline hydrochloride 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.
Isoprenaline hydrochloride 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 methyl xanthines (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 isoprenaline hydrochloride on the ability to drive and use machines. However, adverse effects of isoprenaline hydrochloride 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 isoprenaline hydrochloride are infrequent. The following effects, however, have been reported:

CNS.

Cardiovascular.

Other.

Reporting suspected adverse effects.

4.9 Overdose

The acute toxicity of isoprenaline hydrochloride 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 isoprenaline hydrochloride until the patient's condition stabilises. Blood pressure, pulse, respiration and ECG should be monitored.
Very cautious use of a non-selective 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 isoprenaline hydrochloride is dialysable.
The oral LD50 of isoprenaline hydrochloride 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 chloride, sodium citrate dihydrate, citric acid, sodium hydroxide, hydrochloric acid, 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

It is recommended that, to reduce microbiological contamination hazards, the diluted solutions should be prepared immediately prior to use and infusion commenced as soon as practicable after preparation of the mixture. Keep diluted solution at 25°C for not more than 24 hours. The diluted infusion solution should be used within 24 hours and any residue discarded.

6.5 Nature and Contents of Container

Isoprenaline Hydrochloride Medsurge 0.2 mg/1 mL and 1.0 mg/5 mL solution for injection is filled into 1 mL and 5 mL clear glass ampoules with a blue band and a white OPC mark.

Pack sizes.

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. It has the following structural formula:

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription only Medicine (S4).

Summary Table of Changes