Consumer medicine information

Ventolin Nebules

Salbutamol

BRAND INFORMATION

Brand name

Ventolin Nebules

Active ingredient

Salbutamol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ventolin Nebules.

SUMMARY CMI

VENTOLIN NEBULES

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 taking VENTOLIN NEBULES?

VENTOLIN NEBULES contains the active ingredient salbutamol sulfate. VENTOLIN NEBULES is used to help you to breathe more easily.

For more information, see Section 1. Why am I taking VENTOLIN NEBULES? in the full CMI.

2. What should I know before I take VENTOLIN NEBULES?

Do not take if you have ever had an allergic reaction to VENTOLIN NEBULES 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. Do not use in children under 18 months.

For more information, see Section 2. What should I know before I take VENTOLIN NEBULES? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with VENTOLIN NEBULES 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 take VENTOLIN NEBULES?

  • For adults, the usual dose is one 5 mg Nebule via nebuliser every 4-6 hours as necessary.
  • For children (aged 4-12 years), the usual dose is one 2.5 mg Nebule via nebuliser every 4-6 hours as necessary.

More instructions can be found in Section 4. How do I take VENTOLIN NEBULES? in the full CMI.

5. What should I know while taking VENTOLIN NEBULES?

Things you should do
  • Remind any Healthcare Professional (HCP) you visit that you are taking VENTOLIN NEBULES.
  • Contact your doctor if you become concerned about any side effects.
  • Tell your doctor immediately, if you become or intend to become pregnant while taking VENTOLIN NEBULES and stop using it immediately.
  • Tell your doctor if your breathing or wheezing gets worse straight after taking this medicine and stop taking it immediately.
Things you should not do
  • Do not stop taking this medicine suddenly or change the dosage without checking with your doctor.
  • Do not take any other medicines to help you breathe without checking with your doctor.
  • You should not give this medicine to anyone else, even if their symptoms seem similar to yours.
Looking after your medicine
  • Keep your Nebules in the pack until it is time to take them. Once the Nebules are removed from the foil overwrap, use within 3 months.
  • Store VENTOLIN NEBULES below 30°C away from moisture, heat, or sunlight.

For more information, see Section 5. What should I know while taking VENTOLIN NEBULES? in the full CMI.

6. Are there any side effects?

Less serious side effects include headache, tremor, feelings of anxiety, restlessness, or excitability, 'warm' feeling or flushing, restlessness in children, mouth or throat irritation and muscle cramps. Serious side effects include allergic reactions, irregular or fast heartbeat, increased blood flow to extremities, immediate breathing difficulties and wheezing, changes in blood potassium levels and lactic acidosis.

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

VENTOLIN NEBULES

Active ingredient(s): salbutamol sulfate 2.5 milligrams or 5 milligrams in 2.5 millilitres per nebule.


Consumer Medicine Information (CMI)

This leaflet provides important information about taking VENTOLIN NEBULES. You should also speak to your Healthcare Professional (HCP) if you would like further information or if you have any concerns or questions about taking VENTOLIN NEBULES.

Where to find information in this leaflet:

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

1. Why am I taking VENTOLIN NEBULES?

VENTOLIN NEBULES contains the active ingredient salbutamol sulfate. VENTOLIN NEBULES belong to a group of medicines called bronchodilators. Because VENTOLIN NEBULES gives fast relief from your chest symptoms, it is often called a 'reliever'.

VENTOLIN NEBULES are used for the relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease (COPD), and for relief against exercise-induced asthma and other stimuli known to induce bronchospasm.

Bronchodilators relax the muscles of the small air passages in the lungs. This helps to open the airways and makes it easier for air to get in and out of the lungs. When it is used regularly, it helps the small air passages to remain open.

There are other types of medicines that prevent wheezing or chest tightness. These medicines are called 'preventers' and must be used every day. Your doctor may tell you to use a 'preventer' in addition to VENTOLIN NEBULES.

VENTOLIN NEBULES are not the only form of VENTOLIN available. Your doctor will decide which form of VENTOLIN is right for you.

Your doctor may have prescribed VENTOLIN NEBULES for another reason.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

2. What should I know before I take VENTOLIN NEBULES?

Warnings

Do not take VENTOLIN NEBULES if:

  • you are allergic (hypersensitive) to salbutamol sulfate, or any of the ingredients listed at the end of this leaflet.
  • the expiry date printed on the pack has passed or if the packaging is torn or shows signs of tampering.

Do not use VENTOLIN NEBULES to stop a miscarriage or premature labour.

Always check the ingredients to make sure you can take this medicine.

Check with your doctor if you:

  • have any other medical conditions.
  • take any medicines for any other condition.
  • are allergic (hypersensitive) to foods, dyes, preservatives or any other medicines.
  • have had to stop taking this or any other asthma medicine for any reason.
  • have been diagnosed with, or are being treated for, a thyroid problem.
  • have been diagnosed with, or are being treated for, high blood pressure.
  • have been diagnosed with, or are being treated for, a heart problem.
  • have been diagnosed with, or are being treated for, a liver problem.
  • Have been diagnosed with, or are being treated for, a kidney problem.
  • have ever been told you have diabetes or high blood sugar.

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.

The ingredients of VENTOLIN NEBULES are known to cross the placenta during pregnancy. Your doctor can discuss with you the risks and benefits involved.

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

It is not known whether the ingredients of VENTOLIN NEBULES can pass into breast milk.

Children

Do not give this medicine to children under 18 months.

3. What if I am taking other medicines?

Tell your Healthcare Professional (HCP) 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 VENTOLIN NEBULES and affect how it works or make it more likely that you'll have side effects.

These medicines include:

  • xanthine derivatives (such as theophylline) or steroids to treat asthma
  • diuretics (also called water tablets), sometimes used to treat high blood pressure or a heart condition
  • nebulised anticholinergics
  • ephedrine or pseudoephedrine, to relieve a stuffy nose
  • beta-blockers, used to treat high blood pressure or a heart condition

Check with your Healthcare Professional (HCP) if you are not sure about what medicines, vitamins or supplements you are taking and if these affect VENTOLIN NEBULES.

4. How do I take VENTOLIN NEBULES?

How much to take

Always take VENTOLIN NEBULES exactly as your doctor has told you to. Check with your Healthcare Professional (HCP) if you are not sure.

  • Instructions provided by your HCP may differ from the information contained in this leaflet. The pharmacist's label will usually tell you how many VENTOLIN NEBULES should be taken.
  • If your condition suddenly gets worse, your doctor may tell you to increase your dose.

VENTOLIN NEBULES should be used as required rather than regularly.

If you are using VENTOLIN NEBULES more than twice a week to treat your asthma symptoms, not including preventive use before exercise or other triggers, this indicates poorly controlled asthma and may increase the risk of severe asthma attacks (worsening of asthma). You should contact your doctor as soon as possible to review your asthma treatment.

If you use your asthma anti-inflammatory medicine daily, e.g., "inhaled corticosteroid", it is important to continue using it regularly, even if you feel better.

Adults:

  • The dose for adults is one 5 mg Nebule via the nebuliser every 4-6 hours as necessary.
  • Initial doses in the elderly may be lower than the recommended adult dose.

Children (aged 4-12 years):

  • The dose for children (aged 4-12 years) is one 2.5 mg Nebule via the nebuliser every 4-6 hours as necessary.

When to take VENTOLIN NEBULES

  • Your doctor will decide how often and for how long you have to take VENTOLIN NEBULES.
  • The pharmacist's label will usually tell you how often to take VENTOLIN NEBULES.
  • VENTOLIN NEBULES should generally be taken every 4-6 hours as necessary.

How to take VENTOLIN NEBULES

  • VENTOLIN NEBULES must only be taken by inhalation from a nebuliser and must not be injected or swallowed.
  • VENTOLIN NEBULES is a plastic container that contains a liquid. The liquid is put into a machine called a nebuliser. The nebuliser produces a fine mist which you breathe in through a face mask or a mouthpiece. Make sure you know how to take it properly. If you have any problems ask your HCP.
  • Do not let the liquid, or the mist produced by the nebuliser get into your eyes. You can wear glasses or goggles to protect them.
  • Use your nebuliser in a well-ventilated room as some of the mist will be released into the air and may be breathed in by others.
  • Any solution remaining in the nebuliser should be discarded after use.

If you forget to take VENTOLIN NEBULES

VENTOLIN NEBULES should be taken as required. If you forget to take a dose, do not worry. Just take the next dose at the normal time or earlier if you become wheezy or feel tight in the chest.

Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting unwanted side effects.

  • If you are not sure what to do, ask your Healthcare Professional (HCP).
  • If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much VENTOLIN NEBULES (overdose)

If you think that you have used too much VENTOLIN NEBULES, you may need urgent medical attention. You may notice that your heart is beating faster than usual, you feel shaky or have a headache.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26 in Australia), 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.

5. What should I know while taking VENTOLIN NEBULES?

Things you should do

  • Remind any Healthcare Professional (HCP) you visit that you are taking VENTOLIN NEBULES, especially if you are about to be started on any new medicine.
  • If you are about to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
  • If you are about to have any blood tests, inform your HCP that you are taking this medicine.
  • Keep all of your doctor's appointments so that your progress can be checked.
  • If your asthma worsens (for example you have frequent symptoms or flare ups such as breathlessness, cough, wheezing, tight chest, night-time awakening or limited physical ability), you should tell your doctor who may start or increase a medicine to control your asthma such as an inhaled corticosteroid.

Call your doctor straight away if you:

  • become pregnant while taking this medicine.
  • feel that VENTOLIN NEBULES do not help your breathing as much as usual.
  • feel that the effect of VENTOLIN NEBULES does not last as long as usual.

Please see Section 6. Are there any side effects? for more instances in which you should contact your doctor.

Things you should not do

  • Do not stop using this medicine suddenly or change the dosage without medical advice.
  • Do not take VENTOLIN NEBULES to treat any other complaints unless your doctor tells you to.
  • VENTOLIN NEBULES is only for you. You should not give this medicine to anyone else, even if their symptoms seem similar to yours.

Driving or using machines

VENTOLIN NEBULES is not expected to have any effect on your ability to drive or use machines.

Action Plan

If you feel that VENTOLIN NEBULES are not having the same effect as before, this may be a sign that your chest condition is getting worse. Your doctor may decide to prescribe other forms of VENTOLIN, or another medicine, for you to use.

This medicine is only one part of a general plan to help you manage your asthma or other chest condition. You should discuss this plan with your doctor. Ask your doctor to check your treatment regularly.

Looking after your medicine

  • Store in the original pack until it is time to take your Nebules. If you take the Nebules out of the pack, they may not keep well.

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

Store VENTOLIN NEBULES in a cool dry place away from moisture, heat, or sunlight where the temperature stays below 30°C.

Do not store:

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

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.

When to discard your medicine

Once the Nebules are removed from the foil overwrap, use within 3 months. Do not use VENTOLIN NEBULES after 3 months.

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 or if the packaging is torn or shows signs of tampering

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.

Do not be alarmed by the following list of side effects. You may not experience any of them.

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
Nervous system disorders:
  • headache
  • tremor (shakiness)
  • feelings of anxiety, restlessness or excitability
  • 'warm' feeling or flushing
  • restlessness in children
Respiratory, thoracic and mediastinal disorders:
  • mouth or throat irritation
Musculoskeletal and connective tissue disorders:
  • muscle cramps
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 reactions:
  • If you have any of the following symptoms after using VENTOLIN NEBULES, stop using this medicine and tell your doctor immediately.
  • Symptoms of an allergic reaction usually include some or all of the following:
    - shortness of breath
    - wheezing, coughing or difficulty breathing
    - swelling of the face, lips/mouth, tongue, or throat
    - rash, itching, redness, or hives on the skin
    - suddenly feeling weak or light headed (may lead to loss of consciousness)
Cardiovascular disorders:
  • irregular or fast heartbeat
  • increased blood flow to extremities
Immediate breathing difficulties and wheezing:
  • If your breathing or wheezing gets worse straight after using VENTOLIN NEBULES, stop using it immediately, and tell your doctor as soon as possible.
  • If available, use a quick-acting asthma medicine as soon as possible.
Metabolic and nutritional disorders:
  • Changes in blood potassium levels. This can only be detected when your doctor conducts tests over time to monitor your progress.
Lactic acidosis:
  • This often affects people who have severe kidney disease.
  • Symptoms of lactic acidosis include some or all of the following:
    - rapid breathing, shortness of breath even though there may be improvement in your wheezing
    - feeling cold
    - stomach pain, nausea and vomiting
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.

Tell your doctor 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 before you decide to stop taking any of your medicines.

7. Product details

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

What VENTOLIN NEBULES contains

Active ingredientSalbutamol sulfate
Other ingredientsSodium chloride
Sulfuric acid
Water
Potential allergensVENTOLIN NEBULES do not contain a preservative

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

What VENTOLIN NEBULES looks like

VENTOLIN NEBULES are plastic containers that contain a liquid.

VENTOLIN NEBULES are supplied in packs of 20, arranged as four individually foil overwrapped pouches containing five Nebules linked together.

VENTOLIN NEBULES 2.5 mg / 2.5 mL (AUST R 12533): each 2.5 mL Nebule (0.1%) contains 2.5 mg of salbutamol (as salbutamol sulfate).

VENTOLIN NEBULES 5 mg / 2.5 mL (AUST R 12534): each 2.5 mL Nebule (0.2%) contains 5 mg of salbutamol (as salbutamol sulfate).

Who distributes VENTOLIN NEBULES

GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street,
Abbotsford, Victoria, 3067
Phone: 1800 033 109
www.gsk.com.au

Trademarks are owned by or licensed to the GSK group of companies.

©2024 GSK group of companies or its licensor.

This leaflet was prepared in October 2024.

Version 7.0

Published by MIMS August 2025

BRAND INFORMATION

Brand name

Ventolin Nebules

Active ingredient

Salbutamol

Schedule

S4

 

1 Name of Medicine

Salbutamol sulfate.

2 Qualitative and Quantitative Composition

Nebuliser Solution.
2.5 mg: contain a concentration of salbutamol of 0.1% (1 mg salbutamol, as the sulfate, in 1 mL). Each nebule contains 2.5 mL of solution equivalent to 2.5 mg salbutamol.
5.0 mg: contain a concentration of salbutamol of 0.2% (2 mg salbutamol, as the sulfate, in 1 mL). Each nebule contains 2.5 mL of solution equivalent to 5.0 mg salbutamol.

List of excipients with known effect.

For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Inhalation.

4 Clinical Particulars

4.1 Therapeutic Indications

For the 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.

4.2 Dose and Method of Administration

Increasing use of beta-2 agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient's therapy plan may be required and concomitant glucocorticosteroid therapy should be considered (see Section 4.4 Special Warnings and Precautions for Use).
Ventolin Nebules are to be used under the direction of a physician. The solution must not be injected or ingested.
2.5 mg/2.5 mL and 5 mg/2.5 mL may be delivered from any efficient nebulising device.
Ventolin Nebules may be used to achieve bronchodilatation as part of an inhalation therapy regime or for patients requiring assisted ventilation.
There is a large safety margin between therapeutic effects and unpleasant side effects. Nevertheless, because of the possibility of uncontrolled dosage associated with continuous administration, intermittent administration of appropriate amounts of Ventolin Nebules is preferred.

Adults and children.

Children 4 to 12 years.

2.5 mg.

Adults.

5.0 mg.
This dosage may be repeated as necessary every 4-6 hours. Any solution remaining in the nebuliser after completion of therapy should be discarded.
Clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain. As transient hypoxaemia may occur, supplemental oxygen therapy should be considered.

Elderly.

Initial doses of salbutamol in the elderly should be lower than the recommended adult dosage. The dose may then be gradually increased if sufficient bronchodilatation is not achieved.

In impaired liver function.

As about 60% of orally administered salbutamol (this includes not only tablet and syrup preparations but also approximately 90% of an inhaled dose) is metabolised to an inactive form, impairment of liver function may result in accumulation of unchanged salbutamol.

In impaired renal function.

About 60-70% of salbutamol administered by inhalation or intravenous injection is excreted in urine unchanged. Impairment of renal function may therefore require a reduction in dosage to prevent exaggerated or prolonged effects.

4.3 Contraindications

Hypersensitivity to any of the ingredients.
Non-i.v. formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion.

4.4 Special Warnings and Precautions for Use

The management of asthma should normally follow a stepwise programme, and patient response should be monitored clinically and by lung function tests. Increasing use of short-acting inhaled beta-2 agonists to control symptoms indicates deterioration of asthma control. Under these conditions, the patient's therapy plan should be reassessed as soon as possible by a physician. Patients who are taking salbutamol more than twice a week on an "as needed" basis, not counting prophylactic use prior to a known trigger, may be at risk for overuse of salbutamol. A reassessment of the patient's therapy plan may be required.
Overuse of short-acting beta agonists may mask the progression of the underlying disease which could contribute to deteriorating asthma control, leading to an increased risk of severe asthma exacerbations and possibly mortality.
Sudden and progressive deterioration in asthma control is potentially life-threatening and consideration should be given to starting or increasing corticosteroid therapy. In patients considered at risk, daily peak flow monitoring may be instituted.
Patients who are prescribed regular asthma anti-inflammatory therapy (e.g. inhaled corticosteroids) should be advised to continue taking their anti-inflammatory medication even when symptoms improve, and they no longer require salbutamol.
Patients should be warned that if either the usual relief is diminished or the usual duration of action reduced, they should seek medical advice at the earliest opportunity after increasing the dose.
Animal studies suggest that cardionecrotic effects may occur with high dosages of some sympathomimetic amines. On this evidence the possibility of the occurrence of myocardial lesions cannot be excluded subsequent to long term treatment with these drugs.
Care should be taken with patients who are known to have received large doses of salbutamol or other sympathomimetic drugs, or who are suffering from hypertension, hyperthyroidism, myocardial insufficiency, or diabetes mellitus.
Salbutamol should be administered cautiously to patients with thyrotoxicosis.
In common with other beta-adrenoceptor agonists, salbutamol can induce reversible metabolic changes, for example increased blood sugar levels. The diabetic patient may be unable to compensate for this and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.
Excessive use may induce a non-responsive state leading to a worsening of hypoxaemia.
Potentially serious hypokalaemia may result from beta-2-agonist therapy mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and hypoxia. It is recommended that serum potassium levels are monitored in such situations.
The possibility of cardiac arrhythmias arising as a consequence of salbutamol induced hypokalaemia should be borne in mind, especially in digitalised patients, following the administration of Ventolin Injection.
Addition of other active substances to Ventolin Nebules cannot be recommended.
As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator, if immediately available. The specific salbutamol presentation should be discontinued, and if necessary a different fast-acting bronchodilator instituted for ongoing use.
Lactic acidosis has been reported very rarely in association with high therapeutic doses of intravenous and nebulised short-acting beta-agonist therapy, mainly in patients being treated for an acute asthma exacerbation (see Section 4.8 Adverse Effects (Undesirable Effects)). Increase in lactate levels may lead to dyspnoea and compensatory hyperventilation, which could be misinterpreted as a sign of asthma treatment failure and lead to inappropriate intensification of short-acting beta-agonist treatment. It is therefore recommended that patients are monitored for the development of elevated serum lactate and consequent metabolic acidosis in this setting.

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

Beta adrenergic blocking drugs inhibit the bronchodilator action of salbutamol and other sympathomimetic bronchodilators. However such drugs should not be used in asthmatic patients as they may increase airway resistance.
Care is recommended if it is proposed to administer salbutamol in concomitant therapy with other sympathomimetic amines as excess sympathetic stimulation may occur.
Animal studies have shown that large doses of salbutamol may interact with imipramine, chlordiazepoxide and chlorpromazine but any practical significance of these results in man remains to be established.
A small number of cases of acute angle closure glaucoma have been reported in patients treated with a combination of nebulised salbutamol and ipratropium bromide. A combination of nebulised salbutamol with nebulised anticholinergics should therefore be used cautiously. Patients should receive adequate instruction in correct administration and be warned not to let the solution or mist enter the eye.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There is no information on the effects of salbutamol on human fertility.
(Category A)
Salbutamol is known to cross the placental barrier in humans. Safety for use in pregnancy has not been demonstrated, therefore the drug should not be used in pregnant women, or those likely to become pregnant, unless the expected benefits outweigh any potential risk.
Oral administration of salbutamol to rats and rabbits during pregnancy showed no teratogenic effects in offspring.
During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb defects have been reported in the offspring of patients being treated with salbutamol.
Although intravenous salbutamol and occasionally salbutamol tablets are used in the management of uncomplicated premature labour, Ventolin presentations should not be used for threatened abortion during the first or second trimesters of pregnancy. Intravenous salbutamol is contra-indicated in cases of ante-partum haemorrhage because of the risk of further haemorrhage from an atonic uterus and there is the risk of the same problem arising inadvertently in asthmatics using salbutamol. Profuse uterine bleeding following spontaneous abortion has been reported after the use of salbutamol. Special care is required in pregnant diabetic women.
It is not known whether salbutamol is excreted in breast milk nor whether it has a harmful effect on the newborn. Therefore it is not recommended for nursing mothers unless the expected benefits outweigh any potential risk.

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)

A fine tremor of skeletal muscle has been reported in some patients when salbutamol is administered orally or by inhalation, and in about 20% of patients receiving Ventolin Injection; the hands being the most obviously affected with a few patients feeling tense. These effects are dose related and are caused by a direct action on skeletal muscle and not by direct CNS stimulation.
Increases in heart rate may occur in patients with normal heart rate after administration of Ventolin Nebules. These increases are dose dependent and are of the order of 9 beats/minute when 10 mg of salbutamol as 0.5% w/v solution is inhaled by adults over 3 minutes, 13 beats/minute when 20 mg of salbutamol as 0.1% w/v solution is inhaled by adults over 3 minutes. In patients with pre-existing sinus tachycardia, especially those in status asthmaticus, the heart rate tends to fall after the administration of Ventolin Nebules as the condition of the patient improves.
With higher doses than those recommended, or in patients who are unusually sensitive to beta-adrenergic stimulants, dilatation of some peripheral arterioles may occur leading to a small reduction in arterial pressure; a compensatory increase in cardiac output may then occur.
Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) have been reported. Peripheral vasodilation and a compensatory small increase in heart rate may occur in some patients. Tachycardia may occur in some patients.
Other reactions which may occur are headaches, nausea, palpitations and sensations of warmth. Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely. There have been very rare reports of muscle cramps. Mouth and throat irritation may occur with inhaled salbutamol.

Note.

The incidence and severity of particular side effects depends on the dosage and route of administration. Ventolin does not cause difficulty in micturition because, unlike sympathomimetic drugs such as ephedrine, therapeutic doses have no alpha-adrenergic receptor stimulant activity.
Potentially serious hypokalaemia may result from beta-2-agonist therapy.
Lactic acidosis has been reported very rarely in patients receiving intravenous and nebulised salbutamol therapy for the treatment of acute asthma exacerbation.
As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in wheezing after dosing (see Section 4.4 Special Warnings and Precautions for Use).
As with other beta-2 agonists hyperactivity has been reported rarely in children.

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

The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)). The signs of salbutamol overdosage are significant tachycardia and/or significant muscle tremor.
Hypokalaemia may occur following overdosage with salbutamol. Serum potassium levels should be monitored.
Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting beta-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting of overdose.
Consideration should be given to discontinuation of treatment and appropriate symptomatic treatment such as a cardio-selective beta-blocking agent given by intravenous injection in patients presenting with cardiac symptoms (e.g. tachycardia, palpitations). Beta-blocking drugs should be used with caution as they may cause bronchospasm in sensitive individuals.
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.

Salbutamol is a relatively selective beta-2-adrenoreceptor stimulant. It is more specific than both isoprenaline and orciprenaline for adrenergic beta-2 receptors.
After oral and parenteral administration, stimulation of the beta receptors in the body, both beta-1 and beta-2, occurs because (a) beta-2 selectivity is not absolute, and (b) higher concentrations of salbutamol occur in the regions of these receptors with these modes of administration. This results in the beta-1 effect of cardiac stimulation, though not so much as with isoprenaline, and beta-2 effects of peripheral vasodilatation and hypotension, skeletal muscle tremor and uterine muscle relaxation.
Metabolic effects such as hyperinsulinaemia and hyperglycaemia also may occur, although it is not known whether these effects are mediated by beta-1 or beta-2 receptors. The serum potassium levels have a tendency to fall.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Following inhalation, salbutamol acts topically in bronchial smooth muscle and initially the drug is undetectable in the blood. After 2 to 3 hours low concentrations are seen, due presumably to the portion of the dose which is swallowed and absorbed in the gut.
The elimination half-life of inhaled or oral salbutamol is between 2.7 and 5 hours. Salbutamol is not metabolized in the lung but is converted to the 4'-o-sulfate ester in the liver. Salbutamol is excreted in the urine as free drug and as the metabolite. After oral administration 58-78% of the dose is excreted in the urine in 24 hours, approximately 60% as metabolites. A small fraction is excreted in the faeces.
Impairment of liver or renal function may necessitate a reduction in dosage (see Section 4.2 Dose and Method of Administration).

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Ventolin Nebules contains the excipients sodium chloride, sulfuric acid and purified water.

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

Ventolin Nebules should be stored below 30°C. Store protected from light. Once removed from the foil overwrap Nebules have a shelf-life of 3 months when stored below 30°C and should be protected from light.

6.5 Nature and Contents of Container

Ventolin Nebules are plastic ampoules containing a sterile preservative-free, isotonic, aqueous solution of salbutamol sulfate equivalent to either 2.5 mg salbutamol in 2.5 mL or 5 mg salbutamol in 2.5 mL. The nebules are supplied in packs of 5 and 20. The 20 pack size is arranged as four individually foil overwrapped pouches containing five Nebules linked together.
Not all strengths or pack sizes may be distributed in Australia.

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

Salbutamol sulfate is a white or almost white odourless powder. It is soluble in 4 parts of water; slightly soluble in 95% alcohol, in chloroform and solvent ether.
Chemical name: 1-(4-hydroxy-3-hydroxymethylphenyl)-2-(t-butylamino) ethanol sulfate.
Molecular formula: (C13H21NO3)2H2SO4.
The molecular weight for salbutamol sulfate is 576.7.

Chemical structure.


CAS number.

51022-70-9.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes