Consumer medicine information

Bricanyl Injection

Terbutaline sulfate

BRAND INFORMATION

Brand name

Bricanyl Injection

Active ingredient

Terbutaline sulfate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

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

What is in this leaflet

This leaflet answers some common questions asked about Bricanyl Injection. It does not contain all the information that is known about Bricanyl Injection.

It does not take the place of talking to your doctor or pharmacist.

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

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

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

What Bricanyl Injection is used for

Bricanyl Injection contains 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.

Ask your doctor if you have any questions about why Bricanyl Injection has been prescribed for you. Your doctor may prescribe it for another reason.

Bricanyl Injection is not addictive.

Bricanyl Injection is available only with a doctor's prescription.

Before you use Bricanyl Injection

When you must not use it

Do not use Bricanyl Injection if you have an allergy to:

  • any medicine containing terbutaline
  • any of the ingredients listed at the end of this leaflet

Some of the symptoms of an allergic reaction may include:

  • 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

Do not use Bricanyl Injection after the expiry date (EXP) 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 using this medicine, talk to your doctor or pharmacist.

Before you start to use it

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

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

  • heart problems
  • hypertension (high blood pressure)
  • diabetes
  • thyroid problems

It may not be safe for you to take Bricanyl Injection if you have any of these conditions.

Tell your doctor if you are pregnant or plan to become pregnant, or breastfeeding. Your doctor will advise you of the risks and benefits of using Bricanyl Injection during pregnancy and while breastfeeding.

If you have not told your doctor about any of the above, tell them before you are given Bricanyl Injection.

Taking other medicines

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

Some medicines and Bricanyl Injection may interfere with each other.

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)

These medicines may be affected by Bricanyl Injection, or may affect how well 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.

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

How Bricanyl Injection is given

How much to take

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 it

Bricanyl injection will be given to you when required so you will not 'miss' a dose.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (131 126), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Bricanyl Injection. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

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.

While you are using Bricanyl Injection

Things you must 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, follow it closely at all times.

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

Tell any other doctors, dentists and pharmacists who are treating you that you are using Bricanyl Injection.

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.

Things you must 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.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Bricanyl Injection.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

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

Tell your doctor if you notice any of the following and they worry you:

  • 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

These side effects are usually mild.

Tell your doctor or pharmacist immediately if you notice any of the following:

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

These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may occur in some patients.

After using Bricanyl Injection

Storage

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

Do not store Bricanyl or any other medicine in the bathroom or near a sink.

Do not leave it in the car on hot days or on window sills. Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using Bricanyl Injection, or it has passed its expiry date, ask your pharmacist what to do with any Bricanyl Injection you have left over.

Product description

Bricanyl Injection contains 0.5 mg/mL of terbutaline sulfate and the following inactive ingredients:

  • sodium chloride
  • hydrochloric acid (for pH adjustment)
  • water for Injections

Bricanyl injection is available in 1 mL ampoules in boxes of 5.

Supplier

AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
Macquarie Park, NSW, 2113
Telephone: 1800 805 342

This leaflet was prepared 3 August 2017

Australian Registration Number:

AUST R 12068

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

© AstraZeneca, 2017

Doc ID-003669481 v1

Published by MIMS October 2017

BRAND INFORMATION

Brand name

Bricanyl Injection

Active ingredient

Terbutaline sulfate

Schedule

S4

 

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).

Summary Table of Changes