Consumer medicine information

Ventolin CFC-Free Inhaler (with counter)

Salbutamol

BRAND INFORMATION

Brand name

Ventolin CFC-free Inhaler with Counter

Active ingredient

Salbutamol

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ventolin CFC-Free Inhaler (with counter).

SUMMARY CMI

VENTOLIN CFC-FREE INHALER (with counter)

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 VENTOLIN INHALER?

VENTOLIN INHALER contains the active ingredient salbutamol sulfate. VENTOLIN INHALER, which you may know better as a 'puffer', helps you to breathe more easily.

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

2. What should I know before I use VENTOLIN INHALER?

Do not use if you have ever had an allergic reaction to salbutamol sulfate 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 VENTOLIN INHALER? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with VENTOLIN INHALER 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 VENTOLIN INHALER?

  • For adults, the usual dose is one or two puffs, as required, repeated four hourly.
  • For children, the usual dose is one puff, repeated four hourly. The dose may be increased to two puffs, repeated four hourly, if required.

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

5. What should I know while using VENTOLIN INHALER?

Things you should do
  • Remind any Healthcare Professional (HCP) you visit that you are using VENTOLIN INHALER.
  • Contact your doctor if you become concerned about any side effects.
  • Tell your doctor immediately, if you become or intend to become pregnant while using VENTOLIN INHALER and stop using it immediately.
  • Your doctor may tell you to take extra puffs of VENTOLIN INHALER if your wheezing or breathing suddenly gets worse. If you take extra puffs and do not get relief, tell your doctor immediately.
Things you should not do
  • 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.
  • Do not use VENTOLIN INHALER if the counter shows 000 or if the expiry date has passed.
Looking after your medicine
  • Store VENTOLIN INHALER below 30°C.
  • Clean VENTOLIN INHALER at least once a week.
  • Do not put the metal canister in water.
  • Do not put it in the refrigerator.
  • Do not expose to temperatures higher than 50°C.
  • Do not burn it or puncture it, even when it is empty.

For more information, see Section 5. What should I know while using VENTOLIN INHALER? 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, muscle cramps and nausea. Serious side effects include allergic reactions, irregular or fast heartbeat, 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 CFC-FREE INHALER (with counter)

Active ingredient: salbutamol sulfate 100 micrograms per inhalation

Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

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

1. Why am I using VENTOLIN INHALER?

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

VENTOLIN INHALER is 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 within a few minutes. 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 INHALER.

Ask your doctor if you have any questions about why you are using this medicine.

2. What should I know before I use VENTOLIN INHALER?

Warnings

When the dose counter reading approaches zero, contact your Healthcare Professional (HCP) to get a new inhaler.

Any puffs left in the device after the dose counter reads zero (000) are not enough to give you the right dose of salbutamol, so you cannot be sure you will receive any medicine after using 200 puffs.

Consider keeping a back-up inhaler.

Do not use VENTOLIN INHALER if:

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

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

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

Check with your doctor or pharmacist if you:

  • have any other medical conditions.
  • take any medicines for any other condition.
  • have had to stop taking this or any other asthma medicine for any reason.
  • are allergic to any medicine.
  • 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.

VENTOLIN INHALER is not usually recommended for use during pregnancy. Your doctor will weigh up the benefits to you against the potential risks to your baby when considering the use of VENTOLIN INHALER during your pregnancy.

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

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

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 INHALER and affect how it works or make it more likely that you will 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.
  • 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 INHALER.

4. How do I use VENTOLIN INHALER?

How much to use

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

VENTOLIN INHALER should be used as required rather than regularly.

If you are using VENTOLIN INHALER 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:

  • To relieve asthma symptoms/attack, the usual dose for adults is one or two inhalations repeated four hourly.
  • To prevent asthma symptoms/attack, the usual dose for adults is two puffs 10 to 15 minutes before exercise or exposure to a "trigger".
  • Your doctor may tell you to take extra puffs of VENTOLIN INHALER if your chest condition suddenly gets worse. If you take extra puffs and do not get relief, tell your doctor immediately.
  • Initial doses in the elderly may be lower than the recommended adult dose.

Children:

  • To relieve asthma symptoms/attack, the usual dose for children is one inhalation, as required, repeated four hourly, or as directed by their Healthcare Professional (HCP). The dose may be increased to two inhalations if required.
  • To prevent asthma symptoms/attack, the usual dose for children is one inhalation 10 to 15 minutes before exercise or exposure to a "trigger". The dose may be increased to two inhalations if required.

How to use VENTOLIN INHALER

  • If VENTOLIN INHALER is new and you have not used it before, release four puffs into the air until the counter reads 200 to make sure that it works.
  • If you have not used it for 5 days or more, or, if you drop the inhaler, you should shake it well, point the mouthpiece away from you and release two puffs into the air before use to make sure that it works.
  • Each time the inhaler is activated, the number on the counter will count down by one. In some cases, dropping the inhaler may cause the counter to count down.
  • When the dose counter reads 000, contact your Healthcare Professional (HCP) to get a new inhaler. Any puffs left in the device after the dose counter reads zero (000) are not enough to give you the right dose of the medicine.

Using your inhaler:

Follow the instructions on how to use VENTOLIN INHALER in the leaflet provided in the carton.

  1. Remove the mouthpiece cover by gently squeezing the sides of the cover.
  2. Check inside and outside of the inhaler including the mouthpiece for the presence of loose objects.
  3. Shake the inhaler well to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed.
  4. Hold the inhaler upright between fingers and thumb with your thumb on the base, below the mouthpiece.
  5. Breathe out as far as is comfortable and then place the mouthpiece in your mouth between your teeth and close your lips around it but do not bite it.
  6. Just after starting to breathe in through your mouth, press down on top of the inhaler to release salbutamol while still breathing in steadily and deeply.
  7. While holding your breath, take the inhaler from your mouth and take your finger from the top of the inhaler. Continue holding your breath for as long as is comfortable.
  8. If you are to take further puffs, keep the inhaler upright and wait about half a minute before repeating steps 3 to 7.
  9. Replace the mouthpiece cover by firmly pushing and snapping the cap into position.

How to clean VENTOLIN INHALER

VENTOLIN INHALER should be cleaned at least once a week. You may not see any medicine build-up on the inhaler, but it is important to keep it clean so medicine build-up will not block the spray.

  1. Remove the metal canister with dose counter from the plastic casing (actuator) of the inhaler and remove the mouthpiece cover.
  2. Rinse the actuator thoroughly under warm running water.
  3. Turn the actuator upside down and rinse again through the mouthpiece thoroughly under warm running water.
  4. Shake off as much water from the actuator as you can. Look into the mouthpiece to make sure any medicine build-up has been completely washed away. If there is any build-up, repeat Step 2 and Step 3.
  5. Dry the actuator thoroughly inside and out (such as overnight).
  6. Replace the metal canister and the mouthpiece cover.

DO NOT put the metal canister in water.

If you forget to use VENTOLIN INHALER

VENTOLIN INHALER should be used 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 use too much VENTOLIN INHALER (overdose)

If you think that you have used too much of VENTOLIN INHALER, 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 using VENTOLIN INHALER?

Things you should do

  • Remind any Healthcare Professional (HCP) you visit that you are using VENTOLIN INHALER, especially if you are about to be started on any new medicine.
  • Keep all of your doctor's appointments so that your progress can be checked.
  • Visit your Healthcare Professional (HCP) regularly to check that you are using VENTOLIN INHALER in the right way. If you are not breathing the medicine in correctly, the medicine may not be helping you as much as it could.
  • Talk to your Healthcare Professional (HCP) if you find it difficult to breathe in and press VENTOLIN INHALER at the same time. It may be better for you to use something called a spacer device with VENTOLIN INHALER. Your doctor or pharmacist will explain what this is and how to use it.
  • If you change the make of spacer you use this may alter the amount of drug delivered to the lungs. You should let your doctor know if your asthma symptoms worsen.
  • If your asthma worsens (for example you have frequent symptoms or flare ups such as breathlessness, cough, wheezing, tight chest, nighttime 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 using this medicine.
  • feel that your breathing suddenly becomes more difficult just after you have used VENTOLIN INHALER.
  • feel that VENTOLIN INHALER does not help your breathing as much as usual.
  • feel that the effect of VENTOLIN INHALER does not last as long as usual or lasts less than 3 hours.
  • need more puffs of VENTOLIN INHALER to get relief.

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

Things you should not do

  • VENTOLIN INHALER is only for you. You should not give this medicine to anyone else, even if their symptoms seem similar to yours.
  • Do not use VENTOLIN INHALER if the counter shows 000 or if the expiry date has passed. When the counter shows 000 you must dispose of VENTOLIN INHALER.
  • Never try to alter the numbers on the counter or detach the counter from the metal canister. The counter cannot be reset and is permanently attached to the canister.
  • Do not use VENTOLIN INHALER to treat any other complaints unless your doctor tells you to.

Driving or using machines

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

Action Plan

If you feel that VENTOLIN INHALER is not having the same effect as before, this may be a sign that your chest condition is getting worse. Your doctor may decide to add another medicine to your treatment.

Looking after your medicine

  • Straight after use, replace the mouthpiece cover firmly and click it into position.

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

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

Do not store:

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

If VENTOLIN INHALER becomes very cold, it may not work properly. To warm it, pull out the metal canister from its plastic holder and warm it in your hand for a few minutes. Do not warm the canister in any other way. Push the canister firmly back into its holder before using.

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.

WARNING: The metal canister is pressurised. Do not expose to temperatures higher than 50°C. Do not burn it or puncture it, even when it is empty.

When to discard your medicine

You will find an expiry (or use by) date on the label of the metal canister. Do not use VENTOLIN INHALER after this date.

You can recycle the plastic casing and cap of VENTOLIN INHALER with other plastic items.

The plastic casing (actuator) is manufactured from polypropylene.

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 or pharmacist 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 INHALER, 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 INHALER, stop using it immediately, and tell your doctor 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 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 VENTOLIN INHALER contains

Active ingredientSalbutamol sulfate
Other ingredientsHFA-134a, a propellant
Potential allergensVENTOLIN INHALER contains no other additives

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

Each puff contains 100 micrograms of salbutamol (as sulfate). There are 200 puffs in each VENTOLIN INHALER.

What VENTOLIN INHALER looks like

VENTOLIN INHALER (AUST R 317221) consists of a plastic casing which contains a small metal canister. The casing has a mouthpiece which is covered by a cap.

The canister has a counter attached to show how many puffs of medicine you have left. The number of puffs left will show through a window in the back of the plastic casing. Each time the canister is pressed, a puff of the medicine is released and the counter will count down by one.

Who distributes VENTOLIN INHALER

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.

© 2025 GSK group of companies or its licensor.

This leaflet was prepared in July 2025.

Version 6.0

Published by MIMS August 2025

BRAND INFORMATION

Brand name

Ventolin CFC-free Inhaler with Counter

Active ingredient

Salbutamol

Schedule

S3

 

1 Name of Medicine

Salbutamol sulfate BP.

2 Qualitative and Quantitative Composition

Ventolin Inhaler is a pressurised metered dose inhaler which delivers 100 microgram of salbutamol (as sulfate) per actuation.

3 Pharmaceutical Form

Pressurised inhalation.

Ventolin inhaler (without dose counter).

Suspension contained in an aluminium alloy can, sealed with a metering valve. The canister is fitted with a plastic actuator incorporating an atomising nozzle and fitted with a mouthpiece cover.

Ventolin inhaler (with dose counter).

Suspension contained in an aluminium alloy can, sealed with a metering valve. The canister has a counter attached to it and is fitted with a plastic actuator incorporating an atomising nozzle and fitted with a mouthpiece cover.

4 Clinical Particulars

4.1 Therapeutic Indications

Ventolin Inhaler is indicated for the relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease, and for acute prophylaxis against exercise-induced asthma and other stimuli known to induce bronchospasm.

4.2 Dose and Method of Administration

Ventolin Inhaler is administered by the inhaled route only, to be breathed in through the mouth.
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).
As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice.

Adults and children.

If required, one or two inhalations, repeated four-hourly. The bronchodilator effect of each administration of Ventolin Inhaler lasts for at least four hours and more frequent use should be unnecessary. The patient can readily recognise any reduction in the length of action and should be instructed to consult a doctor if the effect of a previously adequate dose lasts for less than three hours.
For detailed instructions on how to use Ventolin Inhaler refer to the patient information leaflet.

Note 1.

Failure to obtain relief from the Inhaler may be a medical emergency. Other appropriate treatment must be instituted without delay.

Note 2.

It is important that the patient be instructed in the proper use of the pressurised aerosol.

Note 3.

Instruct the patient to wash the plastic actuator with warm water and let it air-dry completely at least once a week, to prevent build-up of medicine in the plastic actuator and ensure proper dosing.

Geriatric.

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 metabolized 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 program, 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. In the event of a previously effective dose of inhaled salbutamol now failing to give relief for a duration of three hours following administration, the patient should be advised to promptly seek medical advice.
Failing to respond to treatment with salbutamol may signal a need for urgent medical advice or treatment.
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.
Ventolin Inhaler contains a hydrofluoroalkane (norflurane) propellant. In animal studies, norflurane has been shown to have no significant pharmacological effects, except at very high exposure concentrations when narcosis and a relatively weak sensitisation to the arrhythmogenic effects of catecholamines were found. The potency of the cardiac sensitisation was less than that of trichloromethane (CFC-11).
Salbutamol should be administered cautiously to patients with thyrotoxicosis.
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.
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.

For Ventolin Inhaler (without dose counter).

The inhaler contains enough salbutamol for 200 actuations (puffs) only. After 200 actuations (puffs), the inhaler can continue to spray but without the prescribed dose of salbutamol. Methods such as shaking, weighing, or submerging inhalers are not accurate for determining that an inhaler is empty of the prescribed dose of salbutamol. Maintaining a record of the number of actuations (puffs) administered to the patient should be considered, towards avoiding inadvertent use of an empty inhaler. Keeping a back-up inhaler could be considered. If the patient has more than one inhaler, it is recommended to keep track of each inhaler separately. For more instructions, please see the patient information leaflet.

For Ventolin Inhaler (with dose counter).

When the dose counter reads zero (000) the patient must always replace the inhaler as any actuations (puffs) left in the device are not enough to give the patient the prescribed dose. Patients should plan in advance for replacements (such as contacting their healthcare professional (HCP)) when the dose counter reading approaches zero. For more instructions, please see the patient information leaflet.

Spacer devices.

Most patients will benefit from the consistent use of a spacer device with their metered dose inhaler (MDI or 'puffer'), particularly those with poor inhaler technique. Use of a spacer will also decrease the amount of drug deposited in the mouth and back of the throat, and therefore reduce the incidence of local side effects, such as 'thrush' and a hoarse voice.
In those people using a spacer, a change in formulation of the drug used, or a change in the make of spacer may be associated with alterations in the amount of drug delivered to the lungs. The clinical significance of these alterations is uncertain. However, in these situations, the person should be monitored for any loss of asthma control.
If using a spacer, the patient should be instructed to actuate the inhaler into the spacer and then slowly breathe in as far as possible. Hold your breath for as long as comfortable, before breathing out slowly. This should be repeated for each actuation of the drug into the spacer. Any delays between actuation and inhalation should be kept to a minimum.
Static on the walls of the spacer may cause variability in drug delivery. Patients should be instructed to wash the spacer in warm water and detergent and allow it to air dry without rinsing or drying with a cloth. This should be performed before initial use of the spacer and at least monthly thereafter.

Use in the elderly.

See Section 4.2 Dose and Method of Administration, Geriatric for dosage requirements.

Paediatric use.

There are no special precautions for use in children.

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. Salbutamol and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together.
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.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There is no information on the effects of salbutamol on human fertility. Reproductive studies in rats revealed no evidence of impaired 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 benefit outweighs any potential risk.
Oral administration of salbutamol to rats and rabbits during pregnancy showed no teratogenic effects in offspring, but evidence of retardation of fetal development was recorded in an inhalational teratology study in rabbits at an estimated dose of 149 microgram/kg/day.
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 contraindicated 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.
 As salbutamol is probably secreted in breast milk, its use in nursing mothers is not recommended unless the expected benefit to the mother is greater than any possible risk to the infant.

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, 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.
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. Tachycardia may occur in some patients.
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.
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.
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.
In treating overdosage with Ventolin Inhaler, it is to be remembered that forty 100 microgram puffs of the inhaler contain as much salbutamol as one 4 mg Ventolin tablet.
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.

Pharmacodynamics.

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.

Salbutamol, delivered from a pressurised metered-dose inhaler using propellants 11 and 12 (Ventolin Inhaler P11/12), has been used for over 20 years in clinical practice and has been demonstrated to be safe and effective in the treatment of reversible obstructive airways disease. The following section describes clinical studies conducted to assess the therapeutic equivalence of salbutamol reformulated using a non-chlorofluorocarbon propellant (Ventolin Inhaler/ GR106642X) with the established product.
A clinical program was devised that included paediatric and adult patients, smokers and patients aged over 65 years. A total of 1,064 patients were randomised and received study medication in six clinical studies. Of these, 586 received Ventolin Inhaler/ GR106642X (approx. 81 patient-years) and 572 received Ventolin Inhaler P11/12 (approx. 79 patient-years). All studies compared Ventolin Inhaler/ GR106642X against Ventolin Inhaler P11/12.
Three single dose crossover studies, two bronchial provocation studies with histamine and a dose-ranging bronchodilatation study in adults demonstrated the efficacy of salbutamol formulated with GR106642X. Another bronchial provocation study demonstrated efficacy in paediatric patients.
Two randomised, double-blind, parallel group multiple dosing studies were also conducted in adults. In a four week '100 microgram prn' dosing study (n = 423), patients with mild to moderate reversible airways obstruction demonstrated equivalent usage of inhaled salbutamol (daily median usage of 4 actuations/day) in both treatment groups. In a twelve-week 200 microgram qds dosing study (n = 547), patients with moderate reversible airways obstruction recorded no change in heart rate (as a measure of tolerability) following the treatment period, and no detrimental effect was seen as a result of 'switching' from Ventolin Inhaler P11/12 to Ventolin Inhaler/ GR106642X.
These studies in both adult and paediatric patients showed that Ventolin Inhaler/ GR106642X at the same dose is clinically equivalent to, and is as well tolerated as, Ventolin Inhaler P11/12. There was no evidence to suggest any possible interactions between salbutamol and GR106642X. There were no reports of hypokalaemia or paradoxical bronchospasm in the clinical programme. No new or unexpected adverse events were highlighted when compared to Ventolin Inhaler P11/12.

5.2 Pharmacokinetic Properties

Following inhalation, salbutamol acts topically on 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 and carcinogenicity.

Salbutamol sulfate caused a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium in a 2-year study in the rat at oral doses of 2, 10 and 50 mg/kg. In another study this effect was blocked by the co-administration of propranolol. These findings are a drug class effect and are thought not to be relevant to the clinical use of the drug. An 18-month study in mice and a lifetime study in hamsters revealed no evidence of tumorigenicity. Studies with salbutamol revealed no evidence of mutagenesis.

6 Pharmaceutical Particulars

6.1 List of Excipients

Non-chlorofluorocarbon propellant 1,1,1,2-tetrafluoroethane (GR106642X or HFA-134a or norflurane).

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

Replace the mouthpiece cover firmly and snap it into position.
Ventolin Inhaler should be stored below 30°C. Protect from frost and direct sunlight. As with most inhaled medications in pressurised canisters, the therapeutic effect of this medication may decrease when the canister is cold.
Pressurised container. Do not expose to temperatures higher than 50°C.

6.5 Nature and Contents of Container

Ventolin Inhaler comprises a suspension of salbutamol sulfate in the propellant HFA-134a. The suspension is contained in an aluminium alloy can, sealed with a metering valve. Each canister is fitted with a plastic actuator incorporating an atomising nozzle and fitted with a mouthpiece cover.
Each canister contains at least 200 actuations.
Ventolin Inhaler is available with or without a counter (see Section 3 Pharmaceutical Form). The counter shows how many actuations of medicine are left. The number is visible through a window in the back of the plastic actuator.
Not all container types may be distributed in Australia.

6.6 Special Precautions for Disposal

The canister should not be punctured, broken or burnt even when apparently empty.
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical name: di[(RS)-2-(1,1-dimethylethyl) amino-1-(4-hydroxy-3-hydroxymethylphenyl) ethanol] sulfate.
Molecular formula: C26H44N2O10S.

Chemical structure.


CAS number.

51022-70-9.

Description.

Salbutamol sulfate is a white or almost white crystalline powder, freely soluble in water, practically insoluble or very slightly soluble in ethanol (96 per cent) and in methylene chloride.

7 Medicine Schedule (Poisons Standard)

Schedule 3 - Pharmacist Only Medicine.

Summary Table of Changes