Consumer medicine information

Bricanyl Injection

Terbutaline sulfate

BRAND INFORMATION

Brand name

Bricanyl Injection

Active ingredient

Terbutaline sulfate

Schedule

SUMMARY CMI

BRICANYL^® INJECTION

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 BRICANYL INJECTION?

BRICANYL INJECTION contains the active ingredient terbutaline sulfate. BRICANYL INJECTION is used to open up the airways in people with asthma, bronchitis and other breathing problems so that they can breathe more easily.

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

2. What should I know before I use BRICANYL INJECTION?

Do not use if you have ever had an allergic reaction to BRICANYL INJECTION 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 BRICANYL INJECTION? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with BRICANYL INJECTION 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 BRICANYL INJECTION?

Your doctor or a specially trained nurse will give you the injection. It will be given just under the skin, and repeated when needed, up to every 6 hours.

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

5. What should I know while using BRICANYL INJECTION?

Things you should do	Remind any doctor, dentist or pharmacist you visit that you are using BRICANYL INJECTION. If you have an Asthma Action Plan agreed with your doctor or nurse, follow it closely at all times. See your doctor regularly to ensure that your asthma is not getting worse.
Things you should not do	Do not use BRICANYL INJECTION to treat any other complaints unless your doctor tells you to. Do not give BRICANYL INJECTION to anyone else, even if they have the same condition as you.
Looking after your medicine	BRICANYL INJECTION is usually stored in hospital or clinic where you receive treatment. Keep BRICANYL INJECTION protected from light in a cool dry place where the temperature stays below 25°C.

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

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. These include headache, nervousness, tremor (shaky hands), increased heart rate, palpitations, nausea (feeling sick), vomiting, diarrhoea, a bad taste in your mouth, sweating, muscle twitching or cramps, drowsiness, dizziness, agitation, restlessness, hyperactivity, disturbed sleep or skin rash. However, some side effects may need medical attention. These include severe allergic reactions such as shortness of breath, wheezing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on skin, chest pain, difficulty breathing or worsening of your breathing problem and fast or irregular heart beat. Serious side effects are rare.

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

BRICANYL^® INJECTION

Active ingredient: terbutaline sulfate

Consumer Medicine Information (CMI)

This leaflet provides important information about using BRICANYL INJECTION. 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 BRICANYL INJECTION.

Where to find information in this leaflet:

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

1. Why am I using BRICANYL INJECTION?

BRICANYL INJECTION contains the active ingredient terbutaline sulfate. Terbutaline is a bronchodilator and belongs to a group of medicines called beta-2-agonists.

BRICANYL INJECTION is used to open up the airways in people with asthma, bronchitis and other breathing problems so that they can breathe more easily. It can also be used before exercise to keep the airways open if you start to wheeze or have trouble breathing each time you exert yourself.

BRICANYL INJECTION is usually only given in hospital in cases of severe breathing difficulties.

2. What should I know before I use BRICANYL INJECTION?

Warnings

Do not use BRICANYL INJECTION if:

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

Check with your doctor if you:

have any allergies to any other medicines,foods, preservatives or dyes.
have any of the following medical conditions, as it may not be safe for you to use BRICANYL INJECTION:
- heart problems
- hypertension (high blood pressure)
- diabetes
- thyroid problems
take any medicines for any other condition

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

Check with your doctor if you are pregnant or intend to become pregnant.

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

Your doctor will advise you of the risks and benefits of using BRICANYL INJECTION during pregnancy and while breastfeeding.

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 interfere with BRICANYL INJECTION and affect how it works. You may need different amounts of your medicine or you may need to use a different medicine. Your doctor or pharmacist will advise you. These include:

medicines used to treat heart problems or high blood pressure
medicines for glaucoma, including eye drops
medicines to treat asthma, bronchitis or breathing problems
some types of anaesthetics
injectable corticosteroids (medicines such as dexamethasone or methylprednisolone, which reduce the activity of your immune system)

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

4. How do I use BRICANYL INJECTION?

How much to use

Your doctor or a specially trained nurse will give you the injection. It will be given just under the skin, and repeated when needed, up to every 6 hours.

If you forget to use BRICANYL INJECTION

BRICANYL INJECTION will be given to you when required so you will not 'miss' a dose.

If you use too much BRICANYL INJECTION

If you think that you have used too much BRICANYL INJECTION, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

If you take too much BRICANYL INJECTION, you may experience shaky hands (tremor), headaches, feel sick (nausea), anxious, tense, restless, excited and be unable to sleep, muscle twitching or cramps, or fast or irregular heartbeats.

5. What should I know while using BRICANYL INJECTION?

Things you should do

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you have an Asthma Action Plan that you have agreed with your doctor or nurse, follow it closely at all times.

See your doctor regularly to ensure that your asthma is not getting worse.

If you are about to be started on a new medicine, tell your doctor or pharmacist that you are using BRICANYL INJECTION.

If you become pregnant while using BRICANYL INJECTION, tell your doctor or pharmacist.

Remind any doctor, dentist or pharmacist you visit that you are using BRICANYL INJECTION.

Things you should not do

Do not use BRICANYL INJECTION to treat any other complaints unless your doctor tells you to.
Do not give BRICANYL INJECTION to anyone else, even if they have the same condition as you.

Looking after your medicine

BRICANYL INJECTION is usually stored in hospital or clinic where you receive treatment.

Follow the instructions in the carton on how to take care of your medicine properly.

Keep BRICANYL INJECTION protected from light in a cool dry place where the temperature stays below 25°C.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

in the bathroom or near a sink, or
in the car or on window sills.

Keep it where young children cannot reach it.

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?

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.

Less serious side effects

Less serious side effects	What to do
headache tremor (shaky hands) nervousness increased heart rate or palpitations nausea (feeling sick), vomiting or diarrhoea a bad taste in your mouth sweating, muscle twitching or cramps drowsiness or dizziness agitation, restlessness, hyperactivity, or disturbed sleep skin rash	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

Allergic Reaction:

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

Others:

fast or irregular heart beat
chest pain
difficulty breathing or worsening of your breathing problem

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.
You may need urgent medical attention. Serious side effects are rare.

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. 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 BRICANYL INJECTION contains

Active ingredient (main ingredient)	terbutaline sulfate
Other ingredients (inactive ingredients)	sodium chloride hydrochloric acid (for pH adjustment) water for injections

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

What BRICANYL INJECTION looks like

BRICANYL INJECTION is clear, colourless solution injection in glass ampoules.

BRICANYL INJECTION is available in 1 mL ampoules in boxes of 5 (Aust R 12068).

Who distributes BRICANYL INJECTION

AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone:- 1800 805 342

This leaflet was prepared in SEP 2024.

BRICANYL is a registered trade mark of the AstraZeneca group of companies.

VV-RIM-04911098 v3

Published by MIMS November 2024

BRAND INFORMATION

Brand name

Bricanyl Injection

Active ingredient

Terbutaline sulfate

Schedule

1 Name of Medicine

Terbutaline sulfate.

2 Qualitative and Quantitative Composition

Bricanyl Injection solution for injection contains 0.5 mg/mL of terbutaline sulfate with sodium chloride, hydrochloric acid (for pH adjustment) and water for injections as the inactive ingredients.

3 Pharmaceutical Form

Clear, colourless solution for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

For relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease, and for acute prophylaxis against exercise induced asthma or in other situations known to induce bronchospasm.
Bricanyl Injection solution is recommended for acute use only.

4.2 Dose and Method of Administration

Adults and children over 12 years.

0.5 mL. Repeat as required up to every 6 hours.

Hepatic impairment.

Hepatic failure has not been shown to influence the metabolism of terbutaline. However, caution should be exercised in patients with impaired liver function.

Renal impairment.

As terbutaline sulfate is largely excreted in urine, caution should be exercised in patients with renal impairment.
Bricanyl Injection is for subcutaneous use only. Solutions should not be used if discoloured.

4.3 Contraindications

Hypersensitivity to sympathomimetic amines or any other ingredient in the medicine.

4.4 Special Warnings and Precautions for Use

Treatment of asthma or COPD should be in accordance with current national treatment guidelines.
Patients with asthma should have a personal asthma action plan designed in association with their general practitioner. This plan should incorporate a stepwise treatment regimen which can be instituted if the patient's asthma improves or deteriorates.

Cardiovascular diseases and hyperthyroidism.

Caution is advised when terbutaline is administered to patients with thyrotoxicosis and to patients with hypertension, coronary artery disease, arrhythmias and tachyarrhythmia.
Cardiovascular effects may be seen with sympathomimetic drugs, including Bricanyl. There is some evidence from postmarketing data and published literature of rare occurrences of myocardial ischaemia associated with beta agonists. Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving Bricanyl, should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.

Arrhythmogenic potential.

β₂-stimulants have an arrhythmogenic potential which must be considered for each patient when receiving treatment for bronchospasm.

Diabetes.

Due to the blood glucose increasing effects of β₂-stimulants, extra blood glucose controls are initially recommended when diabetic patients are commenced on terbutaline.

Sensitivity to sympathomimetic amines.

Some patients may be unusually sensitive to β-adrenergic stimulants. Terbutaline should be used with caution when an increased susceptibility to sympathomimetic amines can be expected, for instance in other patients with hyperthyroidism not yet adequately controlled.

Hypokalaemia.

Potentially serious hypokalaemia may result from β₂-agonist therapy. Particular caution is recommended in acute severe asthma as the associated risk may be augmented by hypoxia. The hypokalaemic effect may be potentiated by concomitant treatments (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). It is recommended that serum potassium levels are monitored in such situations.

Lactic acidosis.

Lactic acidosis has been reported in association with high therapeutic doses of parenteral short acting β-agonist therapy, mainly in patients being treated for an acute asthma exacerbation (see Section 4.8 Adverse Effects (Undesirable Effects); Section 4.9 Overdose). In patients not adequately responding to acute therapy with Bricanyl Injection, consideration should be given to the presence of lactic acidosis as a possible contributing factor to ongoing respiratory symptoms.

Cardionecrosis.

Animal studies suggest that cardionecrotic lesions may occur with high doses of some sympathomimetic amines. On this evidence, it is not possible to exclude myocardial lesions as a possible hazard resulting from long-term treatment.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Other sympathomimetic amines.

Care is recommended if it is proposed to administer terbutaline in concomitant therapy with other sympathomimetic amines as excess sympathetic stimulation may occur.

β-adrenergic blocking drugs.

β-adrenergic blocking drugs, including eye drops, may inhibit the bronchodilating effect of sympathomimetic bronchodilators and may increase airways resistance in asthmatic patients.

Halogenated anaesthetics.

Halothane anaesthesia should be avoided during β₂-agonists treatment, since it increases the risk of cardiac arrhythmias. Other halogenated anaesthetics should be used cautiously together with β₂-agonists.

Potassium depleting agents and hypokalaemia.

Owing to the hypokalaemic effect of β-agonists, concurrent administration with Bricanyl of serum potassium depleting agents known to exacerbate the risk of hypokalaemia (such as diuretics, methyl xanthines and corticosteroids) should be administered cautiously after careful evaluation of the benefits and risks with special regard to the increased risk of cardiac arrhythmias arising as a result of hypokalaemia (see Section 4.4 Special Warnings and Precautions for Use, Hypokalaemia). Hypokalaemia also predisposes to digoxin toxicity.

Systemic corticosteroids.

The combination of intravenous β-agonists and systemic corticosteroids is known to increase blood glucose and can deplete serum potassium.
In addition, the risk of pulmonary oedema is heightened when intravenous β-agonists are used in combination with corticosteroids and intravenous fluids.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Although no adverse effects in pregnant women or their foetuses have been reported, care with Bricanyl, as with all other drugs, is recommended during the first 3 months of pregnancy.
Although terbutaline is secreted into breast milk, and milk concentrations are approximately those in maternal plasma, two individual case studies indicate that the infant is likely to receive 0.2-0.7% of the maternal dose (0.4 and 0.7 microgram/kg/day respectively), depending (for example) on the time of feeding in relation to administration of the drug. In the 4 infants studied this did not result in any signs of β-adrenoceptor stimulation.
Transient hypoglycaemia has been reported in newborn preterm infants after maternal β₂-agonist treatment.

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)

Most of the side effects are characteristic of sympathomimetic amines. The incidence and severity of particular side effects depends on the dose and rate of administration. At recommended therapeutic doses, the frequency of side effects is minimal.

More common reactions.

More commonly observed side effects include tremor and headache. Commonly observed side effects include nervousness, tachycardia, palpitations, tonic muscle cramps and hypokalaemia.

Less common reactions.

Cardiovascular.

Ectopic beats.

Gastrointestinal.

Nausea, vomiting, bad taste, diarrhoea.

General.

Sweating.

Musculoskeletal.

Muscle twitching, cramps.

Nervous system.

Drowsiness, dizziness, sleep disturbance, behavioural disturbances (such as agitation, hyperactivity, restlessness).

Dermatological.

Rash, urticaria, exanthema.
Rare cases of lactic acidosis have been reported with high therapeutic doses of Bricanyl Injection.

Serious or life threatening reactions.

Cardiac arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia and extrasystoles) and myocardial ischaemia have been rarely reported.
Overdose of terbutaline preparations may produce significant tachycardia, arrhythmia and hypotension (see Section 4.9 Overdose).

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

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

Possible symptoms and signs.

Too frequent administration, as with other sympathomimetic agents, may cause nausea, headaches, changes in blood pressure, anxiety, tension, restlessness, insomnia, tremor, excitement, tonic muscle cramps, palpitations, tachycardia and cardiac arrhythmias. The symptoms and signs are those characteristic of excessive sympathetic stimulation.

Laboratory findings.

Hyperglycaemia and lactic acidosis (see Section 4.4 Special Warnings and Precautions for Use) sometimes occur. β₂-agonists may cause hypokalaemia as a result of redistribution of potassium.

Treatment.

The specific antidote for accidental overdosage with terbutaline sulfate is a cardioselective β-adrenergic blocking drug such as metoprolol (5-10 mg by slow intravenous injection, repeated if necessary after 5 minutes). β-blockers should be used with care because of the possibility of inducing bronchospasm in sensitive individuals.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Terbutaline sulfate - a sympathomimetic bronchodilator with a degree of selective β2-stimulant activity on the respiratory system.
The tertiary butyl group attached to the terminal nitrogen of the terbutaline molecule is thought to confer selective stimulation of the pulmonary β₂-receptors and only relatively minor stimulation of cardiac β₁-receptors. The presence of the two phenolic hydroxyl groups in the meta positions confers resistance to metabolism by the enzyme catechol-o-methyl transferase. The potent bronchospasmolytic effect is rapid in onset and reaches a maximum about 30 minutes after subcutaneous injection, 1 hour after aerosol and 2-3 hours after oral administration. The duration of action is between 4 and 5 hours. In addition to its bronchospasmolytic effect, terbutaline has also been shown to improve mucociliary clearance. Metabolism of terbutaline sulfate which is ingested orally or swallowed following inhalation is principally by conjugation in the gastrointestinal mucosa. The drug is absorbed unchanged from the respiratory tract and is excreted mainly as such in the urine. Practically all of an administered dose of terbutaline is eliminated after 72 hours.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

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. Solutions containing terbutaline are sensitive to excessive heat and light.

6.5 Nature and Contents of Container

0.5 mg/mL of 5 x 1 mL glass ampoules.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Chemical name: 2-(tert-butylamino)-1-(3,5-dihydroxyphenyl) ethanol sulfate.
Molecular formula: (C₁₂H₁₉NO₃)₂.H₂SO₄.

CAS number.

23031-32-5.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

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Bricanyl Injection

Terbutaline sulfate

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