Consumer medicine information

Ventolin CFC-Free Inhaler

Salbutamol

BRAND INFORMATION

Brand name

Ventolin CFC-free Inhaler

Active ingredient

Salbutamol

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ventolin CFC-Free Inhaler.

What is in this leaflet?

Read this leaflet carefully before you use your medicine.

This leaflet does not have the complete information about your medicine. If you have any questions about your medicine, you should ask your doctor or pharmacist (also known as a chemist).

All medicines have some risks. Sometimes new risks are found even when a medicine has been used for many years.

If there is anything you do not understand, ask your doctor or pharmacist. If you want more information, ask your doctor or pharmacist.

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.

Keep this leaflet with the medicine.

You may need to read it again.

What is the name of my medicine?

The name of your medicine is VENTOLIN Inhaler. You may know it better as a 'puffer'.

What is my VENTOLIN puffer used for?

Your VENTOLIN puffer helps you to breathe more easily. When your chest is tight or when you are wheezing, VENTOLIN opens up the breathing tubes in your lungs. Your medicine is known as a bronchodilator. Because your VENTOLIN puffer gives fast relief from your chest symptoms, it is often called a 'reliever puffer'.

Some people start wheezing or their chest starts to feel tight when they exercise. This is called exercise-induced asthma. If you have exercise-induced asthma, your doctor may tell you to take one or two puffs of your VENTOLIN puffer before you exercise. This can help to prevent the symptoms of exercise-induced asthma.

Before you take your VENTOLIN puffer

Do not take:

  • if you have ever had an allergic reaction to salbutamol sulfate or any of the ingredients listed toward the end of this leaflet
  • to stop a miscarriage or premature labour
  • if the expiry date (EXP) printed on the pack has passed
  • if the packaging is torn or shows signs of tampering.

Tell your doctor if:

You must tell your doctor:

  • the names of any other medicines you are already taking, including those from the pharmacy and supermarket
  • if you have had to stop taking this or any other asthma medicine
  • if you are allergic to any medicine
  • if you are having treatment for a thyroid problem
  • if you are having treatment for high blood pressure
  • if you have, or have had, a heart problem
  • if you have, or have had, a liver problem
  • if you have, or have had, a kidney problem
  • if you have sugar diabetes
  • if you are breastfeeding, pregnant or trying to become pregnant.

How do I use my VENTOLIN puffer?

You will find the instructions on how to use your VENTOLIN puffer on the back of this leaflet. Follow the instructions carefully.

If your VENTOLIN Inhaler is new and you have not used it before, or if you have not used it for 5 days or more, you should shake it well, point the mouthpiece away from you and activate two puffs into the air before use.

How much to take

The pharmacist's label will usually tell you how many puffs to take and how often to use your VENTOLIN puffer. If you are not sure, ask your doctor or pharmacist.

Adults and Children: one or two puffs, repeated four-hourly as required.

Initial doses in the elderly may be lower than the recommended adult dose.

Your doctor may tell you to take extra puffs of your VENTOLIN puffer if your chest condition suddenly gets worse. If you take extra puffs and do not get relief, tell your doctor immediately.

You should visit your doctor or pharmacist regularly to check that you are using your VENTOLIN puffer 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.

If you find it difficult to breathe in and press your VENTOLIN puffer at the same time, talk to your doctor or pharmacist. It may be better for you to use something called a spacer device with your VENTOLIN puffer. 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 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.

Your VENTOLIN Inhaler should be cleaned at least once a week. To do so:

  1. Remove the metal canister from the plastic casing of the inhaler and remove the mouth piece cover
  2. Rinse the actuator thoroughly under warm running water
  3. Dry the actuator thoroughly inside and out
  4. Replace the metal canister and the mouth piece cover.

DO NOT put the metal canister in water.

While you are taking your VENTOLIN puffer

IMPORTANT: If your breathing suddenly becomes more difficult just after you have used your VENTOLIN puffer, tell your doctor immediately.

Tell your doctor as soon as possible if:

  • your VENTOLIN puffer does not help your breathing as much as usual
  • the effect of your VENTOLIN puffer does not last as long as usual, or lasts less than 3 hours
  • you need more puffs of your VENTOLIN puffer to get relief.

These may be signs that your chest condition is getting worse.

Your doctor may decide to add another medicine to your treatment if your VENTOLIN puffer is not having the same effect as before.

Things you must not do

Your VENTOLIN puffer is only for you. You should not give this medicine to anyone else, even if their symptoms seem similar to yours.

What are the side effects?

Like all other medicines, your VENTOLIN puffer may cause some side effects. Most of the side effects will be minor and temporary, but some may be serious. Your doctor or pharmacist will be able to answer any questions you may have.

If you have any of the following side effects, tell your doctor or pharmacist but do not stop using your VENTOLIN puffer.

If you have an allergic reaction, for example, skin rash, angioedema (sudden swelling under the skin), or a faint or dizzy feeling, you should stop using your VENTOLIN puffer and tell your doctor or pharmacist immediately.

Common side-effects:

  • headache
  • nausea
  • shaky or tense feeling
  • irregular or fast heart beat
  • 'warm' feeling
  • mouth or throat irritation.

Rare side-effects:

  • muscle cramps
  • restlessness in children.

In a few people, the medicine in VENTOLIN puffer may decrease blood potassium levels. Your doctor may do tests to check this.

If you have any other problems after using your VENTOLIN puffer, tell your doctor or pharmacist.

What if I take too many puffs of my VENTOLIN puffer?

You should not take more than the number of puffs that you have been told. If you accidentally take more than recommended, you may notice that your heart is beating faster than usual, and that you feel shaky. You may also have a headache. You should contact your nearest hospital or doctor without delay.

How do I store my VENTOLIN puffer?

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

Keep your VENTOLIN puffer in a place where children cannot reach it.

Keep your VENTOLIN puffer away from frost. Do not put it in the refrigerator.

Keep your VENTOLIN puffer away from bright sunlight.

Keep your VENTOLIN puffer away from heat (store below 30°C). Do not leave it in the car on hot days.

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

WARNING: The metal can is pressurised. Do not burn it or puncture it, even when it is empty.

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

Are there different types of asthma puffers?

Yes. VENTOLIN Inhaler is called a 'reliever' puffer. There are other types of puffers that prevent wheezing or chest tightness. These puffers are called 'preventer' puffers and must be used every day. Your doctor may tell you to use a 'preventer' puffer in addition to your VENTOLIN puffer.

Is there anything else I should know about my VENTOLIN puffer?

You can recycle the plastic holder and cap of your VENTOLIN puffer with other plastic things.

If you have any other questions, ask your doctor or pharmacist.

Product Description

Ingredients

The medicine in your VENTOLIN puffer is called salbutamol sulfate. Each puff contains 100 micrograms of salbutamol (as sulfate). There are 200 puffs in each VENTOLIN puffer.

Your VENTOLIN puffer also contains HFA-134a, a propellant. It has no other additives.

Supplier

Your VENTOLIN puffer is supplied by:

GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford Victoria 3067

VENTOLIN Inhaler (CFC-free) 100 micrograms per metered dose salbutamol, as sulfate (AUST R 62695)

This leaflet was prepared on 26 June 2017.

Version 7.0

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

© 2017 GSK group of companies or its licensor.

BRAND INFORMATION

Brand name

Ventolin CFC-free Inhaler

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 micrograms 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.
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.

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. 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 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.
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.

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 micrograms/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 β2-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 micrograms 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 micrograms 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.

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