Consumer medicine information

Bricanyl Turbuhaler

Terbutaline sulfate

BRAND INFORMATION

Brand name

Bricanyl Turbuhaler

Active ingredient

Terbutaline sulfate

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Bricanyl Turbuhaler.

SUMMARY CMI

BRICANYL® TURBUHALER®

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 Turbuhaler?

Bricanyl Turbuhaler contains the active ingredient terbutaline sulfate. Bricanyl Turbuhaler 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 Turbuhaler? in the full CMI.

2. What should I know before I use Bricanyl Turbuhaler?

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

Talk to your doctor or pharmacist 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 Turbuhaler? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Bricanyl Turbuhaler 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 Turbuhaler?

  • Bricanyl Turbuhaler should be inhaled into your lungs through the mouth.
  • Follow all directions given to you by your doctor or pharmacist.

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

5. What should I know while using Bricanyl Turbuhaler?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Bricanyl Turbuhaler.
  • If you have an Asthma Action Plan agreed with your doctor or nurse, follow it closely at all times.
  • If you find that the usual dose of Bricanyl Turbuhaler is not giving you as much relief as before, or you are needing to use it more often (three or more short acting beta-2 agonist (SABA) reliever inhalers in a year), please contact your doctor so that your condition can be checked.
  • See your doctor regularly to ensure that your asthma is not getting worse.
Things you should not do
  • Do not use Bricanyl Turbuhaler to treat any other complaints unless your doctor tells you to.
  • Do not give Bricanyl Turbuhaler to anyone else, even if they have the same condition as you.
Looking after your medicine
  • Keep your Turbuhaler in a cool dry place where the temperature stays below 30 degrees Celsius, with the cover firmly in place.
  • The Turbuhaler mouthpiece must be wiped with a clean dry tissue and must never get wet.

For more information, see Section 5. What should I know while using Bricanyl Turbuhaler? 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, nausea, vomiting, a bad taste in your mouth, sweating, muscle twitching or cramps, dizziness, agitation, restlessness, 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 or tongue, rash, itching or hives on skin, chest pain, difficulty breathing or worsening of your breathing problem. 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® TURBUHALER®

Active ingredient: terbutaline sulfate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Bricanyl Turbuhaler. 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 Turbuhaler.

Where to find information in this leaflet:

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

1. Why am I using Bricanyl Turbuhaler?

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

Bricanyl Turbuhaler 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 Turbuhaler is a reliever medicine and you should only use it when you need it.

2. What should I know before I use Bricanyl Turbuhaler?

Warnings

Do not use Bricanyl Turbuhaler if:

  • you are allergic to any medicine containing terbutaline, or lactose (inactive ingredient in the 120 inhalations Bricanyl Turbuhaler only), 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 or pharmacist if you:

  • have any allergies to any other medicines or foods.
  • have, or have had, any of the following medical conditions, as it may not be safe for you to take Bricanyl Turbuhaler:
    - thyroid problems
    - diabetes
    - heart problems
    - hypertension (high blood pressure)
  • are taking short acting beta-2 agonist (SABA) reliever (eg. Bricanyl Turbuhaler) alone for asthma without regular maintenance treatment. This may be associated with an increased risk of severe asthma attack.
  • have any other medical conditions.
  • have any questions about how you should be using your Bricanyl Turbuhaler.

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 or pharmacist if you are pregnant or intend to become pregnant.

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

Your doctor or pharmacist will discuss the possible risks and benefits of using Bricanyl Turbuhaler during pregnancy and while breastfeeding.

3. What if I am taking other medicines?

Some medicines may interfere with Bricanyl Turbuhaler and affect how it works. 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 type of anaesthetics

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

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 Turbuhaler.

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while using Bricanyl Turbuhaler.

4. How do I use Bricanyl Turbuhaler?

How to use your Bricanyl Turbuhaler

You should only use Bricanyl Turbuhaler when you need it to ease your breathing. Unless your doctor or pharmacist has told you to, you should not use Bricanyl Turbuhaler regularly.

Each pack of Bricanyl Turbuhaler contains an instruction for use leaflet that tells you the correct way to use it. Please read this carefully.

If you are not sure how to use the Turbuhaler, ask your doctor or pharmacist to show you how.

How much to take

Adult

The dose is one inhalation when needed up to every 4 to 6 hours. If you have severe breathing problems this may be increased to 3 inhalations.

You should not use more than 12 inhalations in any 24 hour period.

Children

Children are usually considered to be aged 12 years or less, but check with your doctor or pharmacist if you are at all worried about the dose that has been prescribed/recommended for your child.

Children should be 5 years or older before they use the Turbuhaler.

The dose is one inhalation when needed every 4 to 6 hours. If your child has severe breathing problems this may be increased to 2 inhalations.

A child should not take more than 8 inhalations in any 24 hour period.

If you use too much Bricanyl Turbuhaler

If you think that you have used too much Bricanyl Turbuhaler, 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 Turbuhaler you may experience shaky hands (tremor), headache, feel sick (nausea), anxious, tense, restless, excited and be unable to sleep, muscle twitching or cramps, fast or irregular heartbeats, dizziness or drowsiness.

5. What should I know while using Bricanyl Turbuhaler?

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.

If you are also prescribed regular maintenance medication for asthma, you should continue to using it even if you do not need to use your Bricanyl Turbuhaler.

If you find that the usual dose of Bricanyl Turbuhaler is not giving you as much relief as before, or you are needing to use it more often (three or more SABA reliever inhalers in a year), please contact your doctor so that your condition can be checked.

This is important to ensure your breathing problem is controlled properly.

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

It is recommended that you rinse your mouth out with water after each use if possible. Do not swallow the water.

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

If you become pregnant while using Bricanyl Turbuhaler, tell your doctor or pharmacist.

Call your doctor straight away if:

  • your asthma symptoms (breathlessness, wheezing or tight chest) are getting worse or if you are too breathless to speak, eat or sleep.

Remind any doctor, dentist or pharmacist you visit that you are using Bricanyl Turbuhaler.

Things you should not do

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

Looking after your medicine

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

Storage

Keep your Turbuhaler in a cool dry place where the temperature stays below 30 degrees Celsius, with the cover firmly in place.

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.

Cleaning

The Turbuhaler mouthpiece must be wiped with a clean dry tissue and must never get wet.

Full instructions on the right way to use and clean Bricanyl Turbuhaler are inside each pack.

Getting rid of any unwanted medicine

Since some medicine may remain inside your Bricanyl Turbuhaler you should always return it to your pharmacist for disposal including:

  • when you have taken all your doses and the red mark is at the bottom of the dose indicator window (see instructions in the pack), or
  • it is damaged or past its expiry date, or
  • your doctor/pharmacist have told you to stop using it.

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 effectsWhat 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 effectsWhat 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 available over-the-counter without a doctor's prescription.

What Bricanyl Turbuhaler contains

Active ingredient
(main ingredient)		terbutaline sulfate
Other ingredients
(inactive ingredients)		Lactose monohydrate
Potential allergensLactose monohydrate

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

What Bricanyl Turbuhaler looks like

Bricanyl Turbuhaler is a plastic inhaler containing the medicine as a dry powder.

Each Bricanyl Turbuhaler contains 120 inhalations of the medicine. [AUST R 315075]

Who distributes Bricanyl Turbuhaler

AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113

Telephone:- 1800 805 342

This leaflet was prepared on 24 April 2023

Bricanyl and Turbuhaler are registered trade marks of the AstraZeneca group of companies.

© AstraZeneca, 2023

Doc ID-001914903 v7

Published by MIMS June 2023

BRAND INFORMATION

Brand name

Bricanyl Turbuhaler

Active ingredient

Terbutaline sulfate

Schedule

S3

 

1 Name of Medicine

Terbutaline sulfate.

2 Qualitative and Quantitative Composition

Bricanyl Turbuhaler delivers (ex-mouthpiece) 400 microgram of terbutaline sulfate per inhalation (delivered dose):

M3 Turbuhaler version.

Labelled as the delivered dose 400 microgram terbutaline sulfate per inhalation (corresponding to 500 microgram metered dose). It is free from propellant, lubricant, preservative or carrier substances but contains the excipient, lactose monohydrate.

Excipient(s) with known effect.

Lactose monohydrate (M3 Turbuhaler). For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for inhalation.

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 Turbuhaler is intended for short-term management of bronchospasm.

4.2 Dose and Method of Administration

Inhaled bronchodilators should be used as required rather than regularly.
Dosage should be individualised. If long-term use of terbutaline is proposed, particularly if the patient is asked to take terbutaline in conjunction with other medications, objective pulmonary function testing (for example, by peak flow meter or spirometer) may be useful as part of assessment of the efficacy or treatment.

Adults and children over 12 years.

1 inhalation as required up to every 4 to 6 hours. In severe cases the single dose may be increased to 3 inhalations. The total daily dose should not exceed 12 inhalations per 24 hours.

Paediatric.

1 inhalation as required up to every 4 to 6 hours. In severe cases the single dose may be increased to 2 inhalations. The total daily dose should not exceed 8 inhalations per 24 hours.

Special patient populations.

Renal impairment.

As terbutaline sulfate is largely excreted in urine, caution should be exercised in patients with renal impairment.

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.

Use in paediatric patients.

Bricanyl Turbuhaler is suitable for use by children since it is breath activated and does not require coordination of dose release and inhalation as with use of aerosol inhalers.

Method of administration.

For detailed instructions, see the Turbuhaler instructions leaflet provided in each pack of Bricanyl Turbuhaler. Patients should be instructed on how to administer the product correctly and advised to read the instruction leaflet carefully.

4.3 Contraindications

Hypersensitivity to sympathomimetic amines or any other ingredient in the product (see Section 6.1 List of Excipients).

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.
Patients who are prescribed regular maintenance treatment for asthma should be advised to continue taking their maintenance treatment medication even when symptoms decrease and they do not require Bricanyl Turbuhaler.
If a previously effective dosage regimen no longer gives the same symptomatic relief, the patient should seek medical advice as soon as possible as this could be a sign of worsening of the underlying condition and warrants a reassessment of the therapy.
Increasing use of short acting β2-agonists (SABA) to control symptoms indicates deterioration of asthma control. Sudden and progressive deterioration in control of asthma or COPD is potentially life threatening and consideration should be given to the need for starting or increasing therapy with corticosteroids.

Over-reliance of SABA reliever in patients with asthma.

Irrespective of asthma severity, having uncontrolled asthma is an important risk factor for exacerbations. Dispensing of three or more SABA inhalers in a year is associated with an increased risk of severe exacerbations and mortality. The risk increases with the number of inhalers dispensed.
In mild asthma patients, there is an increased risk of severe exacerbations associated with over-reliance on SABA monotherapy.

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 post-marketing 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.

Acute asthma.

If patients with an acute attack of asthma fail to respond to a dry powder inhaler of β2-agonist they should be advised to follow their personal asthma action plan. Failure to respond to β2-agonists in general can be due to various reasons related to drug administration or the disease itself. Particularly in children 5 years or younger, and exceptionally in other cases, inspiratory flow through a dry powder inhaler may not be sufficient for optimal drug delivery. If a non-response occurs, medical help should be sought while a β2-agonist treatment is continued. In such a situation, and if available, a nebuliser or pressurised metered dose inhaler with spacer should be used.

Lactose.

Bricanyl Turbuhaler (M3 version) contains lactose monohydrate (approximately 400 microgram/inhalation delivered dose) which may contain small amounts of milk protein residues. This amount does not normally cause problems in lactose intolerant people. In patients with hypersensitivity to milk protein, these small amounts may cause allergic reactions.

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.

See Section 4.2 Dose and Method of Administration.

Paediatric use.

See Section 4.2 Dose and Method of Administration.

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.

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. However, adverse effects of terbutaline sulfate include dizziness and drowsiness which could affect the ability to drive or use machines (see Section 4.8 Adverse Effects (Undesirable Effects)).

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. An initial dose-titration will often reduce side effects. 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.

See Table 1.

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). In rare cases, through unknown mechanisms, drugs for inhalation may cause bronchospasm.

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).
There is a potential for progressive accumulation of dry powder in the mouthpiece of the Bricanyl Turbuhaler that could be released if dropped (for example, from a table) towards the end of inhaler life. To minimize unnecessary systemic exposure to terbutaline, the patients should be advised to, when possible, rinse their mouth after each use.

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 lactacidosis (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 cardio-selective 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.

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 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.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

The drug is absorbed unchanged from the respiratory tract.

Metabolism.

The presence of the two phenolic hydroxyl groups in the meta positions confers resistance to metabolism by the enzyme catechol-o-methyl transferase. Metabolism of terbutaline sulfate which is ingested orally or swallowed following inhalation is principally by conjugation in the gastrointestinal mucosa.

Excretion.

The drug is excreted mainly unchanged in the urine. Practically all of an administered dose of terbutaline is eliminated after 72 hours.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lactose monohydrate (Bricanyl Turbuhaler M3 version). 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 30°C. Replace cap firmly after use.

6.5 Nature and Contents of Container

Bricanyl Turbuhaler is a breath activated multiple dose dry powder inhaler available as single inhaler packs:

M3 Turbuhaler (AUST R 315075).

120 inhalations.

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.

Terbutaline sulfate, 2-(tert-butylamino)-1-(3,5-dihydroxyphenyl) ethanol sulfate, a sympathomimetic bronchodilator with a degree of selective β2-stimulant activity on the respiratory system.

CAS number.

23031-32-5.

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist Only Medicine.

Summary Table of Changes