SUMMARY CMI

Cipla Isoprenaline

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 Cipla Isoprenaline?

Cipla Isoprenaline contains the active ingredient isoprenaline. Cipla Isoprenaline is used to treat heart block and cardiac arrest. Cipla Isoprenaline is intended to be used in hospitals only.

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

2. What should I know before I use Cipla Isoprenaline?

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

3. What if I am taking other medicines?

Some medicines may interfere with Cipla Isoprenaline 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 Cipla Isoprenaline?

• Your doctor will decide what dose you will receive. The dosage will depend on your condition.
• Cipla Isoprenaline will normally be given to you as an injection under the skin, or into the vein, muscle or heart.
• Follow all directions given to you by your doctor or pharmacist carefully.

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

5. What should I know while using Cipla Isoprenaline?

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

6. Are there any side effects?

You may experience side effects such as 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 and 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

Cipla Isoprenaline

Active ingredient(s): Isoprenaline

Consumer Medicine Information (CMI)

This leaflet provides important information about using Cipla Isoprenaline. 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 Cipla Isoprenaline.

Where to find information in this leaflet:

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

1. Why am I using Cipla Isoprenaline?

Cipla Isoprenaline contains the active ingredient isoprenaline. It belongs to a group of medicines called synthetic sympathomimetic amines. Cipla Isoprenaline helps improve the efficiency with which your heart pumps blood around your body. Cipla Isoprenaline works by strengthening your heart muscles and increasing the heartbeat rate.

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

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.

2. What should I know before I use Cipla Isoprenaline?

Warnings

Do not use Cipla Isoprenaline if:

• you are allergic to isoprenaline, any medicine containing isoprenaline or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.

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 Cipla Isoprenaline 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

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

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?

Pregnancy and breastfeeding

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.

3. What if I am 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 Cipla Isoprenaline 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 Cipla Isoprenaline 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.

4. How do I use Cipla Isoprenaline?

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

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

If you take too much Cipla Isoprenaline

As Cipla Isoprenaline 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 Cipla Isoprenaline, 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 Cipla Isoprenaline 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 Cipla Isoprenaline?

Things you should do

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

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.

Driving or using machines

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

Looking after your medicine

• Cipla Isoprenaline will be stored in the pharmacy or on the ward. The ampoule is stored below 25°C. It should be protected from light. Keep in original outer carton.
• From a microbiological point of view, the product should be used immediately. To reduce microbiological hazard, use as soon as practicable after dilution. If storage is necessary, hold at 25°C for not more than 8 hours. The diluted infusion solution should be used within 8 hours and any residue discarded.

When to discard your medicine

Product is for single use in one patient only. Discard any residue.

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.

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.

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

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

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 Cipla Isoprenaline. 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.

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 Cipla Isoprenaline contains

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

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

What Cipla Isoprenaline looks like

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

Australian Registration Number

0.2 mg/1 mL ampoules
AUST R 356387

1.0 mg/5 mL ampoules
AUST R 379570

Who distributes Cipla Isoprenaline

Cipla Australia Pty Ltd
Level 1, 132-136 Albert Road,
South Melbourne, VIC 3205.
[email protected]
Toll Free number: 1800 569 074

This leaflet was prepared in January 2022.

Published by MIMS July 2022

1 Name of Medicine

Isoprenaline hydrochloride.

2 Qualitative and Quantitative Composition

Cipla Isoprenaline solution for injection 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.
Cipla Isoprenaline is clear colourless to practically colourless solution and with no visible particles.
Cipla Isoprenaline should be inspected visually (in diffused light) for particulate matter and discolouration prior to administration. Such solutions should not be used.

4 Clinical Particulars

4.1 Therapeutic Indications

Cipla Isoprenaline 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.

Method of administration.

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 or to any of the excipients listed in Section 6.1 List of Excipients.

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

Citric acid, disodium edetate, hydrochloric acid or sodium hydroxide used to adjust pH, sodium chloride, sodium citrate dihydrate, 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. Protect from light. Keep in original outer carton.
It is recommended that, in order 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

Cipla Isoprenaline 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 ring at the bulb.

Pack sizes.

6.6 Special Precautions for Disposal

Product is for single use in one patient only. Discard any residue.
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.
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 (Schedule 4).

Summary Table of Changes