Consumer medicine information

Airomir Autohaler

Salbutamol

BRAND INFORMATION

Brand name

Airomir Autohaler and Inhaler

Active ingredient

Salbutamol

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Airomir Autohaler.

FULL CMI

Airomir® Autohaler® (airo-meer auto-hailer)

Active ingredient: Salbutamol sulfate (sal-bute-a-mol sull-fate)

Consumer Medicine Information (CMI)

This leaflet provides important information when using AIROMIR Autohaler. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions when using AIROMIR Autohaler.

Where to find information in this leaflet:

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

1. Why am I using AIROMIR?

AIROMIR contains the active ingredient salbutamol sulfate.

Salbutamol sulfate is a direct acting sympathomimetic agent belonging to the beta-agonist family of medicines. It opens up the airways to your lungs, thereby relieving wheezing and the feeling of tightness in your chest, helping you to breathe more easily.

Asthma causes the lining of your lungs to become inflamed (red and swollen), making breathing difficult. AIROMIR is designed to enable the medicine to be inhaled into the lungs to treat asthma and other conditions where breathing is difficult.

AIROMIR is known as a RELIEVER medicine.

AIROMIR may also help prevent wheezing and chest tightness when you exercise. That's why your doctor or pharmacist may advise you take one or two puffs before exercise.

AIROMIR is designed to be part of a general plan to help you manage your asthma. Every asthma patient is different. Ask your doctor or pharmacist for an ASTHMA MANAGEMENT PLAN that suits you and visit them regularly to check whether your plan needs to be changed.

2. What should I know before using AIROMIR?

Warnings

Do not use AIROMIR:

  • If you are allergic to salbutamol sulfate, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
    Some of the symptoms of an allergic reaction may include:
    - shortness of breath
    - wheezing or difficulty breathing
    - swelling of the face, lips, tongue, or other parts of the body
    - rash, itching or hives on the skin.
  • After the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

Check with your doctor or pharmacist if you:

  • Have allergies to any other medicines, foods, preservatives or dyes.
  • Have or have previously suffered from the following:
    - Heart, liver or kidney problems
    - Diabetes (high blood sugar)
    - High blood pressure
    - Problems with your thyroid gland
    - Hypoxia (reduced oxygen in the tissues).
  • Have any other medical conditions or take any medicines for any other condition.
  • Are unsure whether you should start using AIROMIR.

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

Do not use AIROMIR if you are pregnant or intend to become pregnant. AIROMIR should be avoided as it is probable that the active ingredient, salbutamol sulfate, can pass through the placenta, and may affect your developing baby if used during pregnancy.

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

3. What if I am taking other medicines?

Tell your doctor or pharmacist 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 AIROMIR and affect how it works.

These include:

Any medications for high blood pressure or angina

Theophylline or any steroids

Fluid tablets (diuretics).

These medicines may be affected by AIROMIR or may affect how well they work. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect AIROMIR.

4. How do I use AIROMIR?

How much to take:

Adults & Children

  • The usual dose is one or two puffs to relieve wheezing or before exercise.
  • Do not use more than 16 puffs per day unless your doctor or pharmacist has prescribed a specific dose for you.
  • Children should be supervised by a responsible adult when using AIROMIR.

Elderly

  • Follow the instructions as prescribed by your doctor.

When to use AIROMIR:

Carefully follow all directions given to you by your doctor or pharmacist. They may differ from the information contained in this leaflet.

How to use AIROMIR:

Even if you have been using another type of Autohaler read the instructions in this leaflet before you start. If you do not understand the instructions, ask your doctor or pharmacist for help.

Airomir Autohaler Instructions for Use:

If your AIROMIR Autohaler is new or you have not used it for two weeks, you must test fire it by releasing two puffs into the air away from your face.

STEP 1: Remove the Mouthpiece Cover and Shake:

Remove the mouthpiece cover by unclipping it from the back.

Check that the mouthpiece is clean before use.

Hold the autohaler unit upright between your thumb and index finger and shake well.

STEP 2: Hold Upright and Push Lever Up:

Push the lever up so that it stays up.

Keep holding the autohaler unit upright making sure your hand is not blocking the air vent at the bottom.

STEP 3: Breathe Out and Position Mouthpiece:

Breathe out as far as you comfortably can and immediately close your lips around the mouthpiece.

STEP 4: Breathe In:

Breathe in slowly and deeply through the mouthpiece.

Do not stop breathing when you hear the 'click and whoosh' and feel the puff in your mouth. It is important to keep breathing in after the puff is released.

STEP 5: Hold Your Breath:

Hold your breath for 10 seconds and then breathe out slowly.

STEP 6: Push Lever Down:

After each puff return the lever to the down position whilst holding the autohaler unit upright.

If your doctor has prescribed more than one puff repeat steps 2 to 6.

Replace the mouthpiece cover after use.

Remember to push the lever up before each puff and gently back down afterwards, always holding the autohaler upright. This prepares the autohaler for your next dose. The lever should be left down between treatments and the mouthpiece replaced to keep your Autohaler clean.

How to Test Fire or Tell if Your Airomir Autohaler is Empty:

STEP 1: Remove the Mouthpiece Cover:

By unclipping it from the back and shake the Autohaler.

STEP 2: Hold the Autohaler Upright:

Point the mouthpiece away from you so that the puffs of medicine will go into the air.

STEP 3: Push the Lever Up:

So that it stays up.

STEP 4: Release a Puff:

By pushing the dose release slide (on the bottom of the autohaler unit) in the direction of the arrow.

STEP 5: To Release a Second Puff:

First return the lever to its down position, then repeat steps 2 and 3. Repeat until you have released four puffs altogether.

STEP 6: Always Push the Lever Back Down after Test Firing:

This prepares the AIROMIR Autohaler for your next dose.

If your AIROMIR Autohaler is empty you will not feel or hear a puff being discharged when you test fire.

Do not use the dose release slide to take your medicine.

Your AIROMIR Autohaler will automatically release a dose when you begin to breathe in from the mouthpiece.

AIROMIR Autohaler is designed for ease of use. To make it work you just breathe in through the mouthpiece. There is no need to press and breathe in at the same time.

A click and whoosh sound tells you that the Autohaler has automatically released the correct dose of medicine.

If Your Airomir Autohaler Doesn't Work Properly:

When your Autohaler is blocked, little or no medicine comes out when you press down on the metal canister. This may be due to one of the following reasons:

  • A dirty or clogged mouthpiece: Wash the mouthpiece as described in Step 1 and air dry thoroughly as described in Step 2 (for instructions see “Looking after your medicine” of this leaflet).
  • It may be empty. Check by shaking.
  • It may be put together incorrectly.

It is important that the canister in the correct position in your Autohaler. The narrow stem of the metal canister should be fitted into the small socket.

If the stem of the metal canister is not in the small socket, your autohaler will not work.

Do not take your Autohaler apart. Do not drop or hit your Autohaler because this may damage it.

If you take too much AIROMIR:

Taking too much of any asthma medication may be harmful. Potential unwanted side effects may include feeling tense ad shaky and experiencing an increase heart rate.

If you think that you have taken too much AIROMIR, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using AIROMIR?

Things you should do:

  • If you are about to start on any new medicines, remind any doctor, dentist or pharmacist you visit that you are using AIROMIR.
  • If you are going to have surgery, tell the surgeon or anaesthetist that you are using AIROMIR. It may affect other medicines used during surgery.
  • If you have an Asthma Management Plan, always follow it closely.
  • Continue using AIROMIR for as long as your doctor or pharmacist tells you. Visit your doctor regularly to check on your asthma condition.

Call your doctor straight away if you:

  • Become pregnant while using AIROMIR
  • Do not feel well while you are using AIROMIR
  • Feel that your usual dose of AIROMIR does not seem to be working or it is not lasting as long as before
  • Think your asthma is getting worse (ie: you suffer more frequent asthma attacks).

Things you should not do:

  • Do not use AIROMIR to treat any other conditions unless your doctor or pharmacist tells you to do so.
  • Do not give your medicine to anyone else to use, even if they have the same condition as you.
  • Do not use more puffs than the recommended dose unless your doctor or pharmacist tells you to.

Driving or using machines:

Be careful before you drive or use any machines or tools until you know how AIROMIR affects you.

Drinking alcohol:

Tell your doctor if you drink alcohol.

Looking after your medicine:

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

Care and Cleaning:

Keeping the plastic mouthpiece clean is very important to prevent the Autohaler from becoming dirty and clogged.

Your Autohaler should be cleaned at least once a week as follows:

STEP 1: Wash mouthpiece under warm running water

Remove the canister and put aside in a safe place. Never immerse the canister in water.

Wash the mouthpiece through the top and bottom with warm running water for 30 seconds.

Wash the mouthpiece cover as well.

STEP 2: Shake off excess water and air dry

To dry, shake off excess water and leave the mouthpiece and cover in a safe place to air dry thoroughly, such as overnight.

When the mouthpiece is dry, replace the canister and the mouthpiece cover.

If you need to use your Autohaler before it is completely dry, shake off excess water, replace the canister and remove most of the water remaining in the mouthpiece by test spraying twice into the air away from your face. Then take your dose as prescribed. After use, wash the Autohaler again and air dry thoroughly as recommended above.

NOTE: a blockage from a build-up of medication is more likely to occur if the mouthpiece is not allowed to air-dry thoroughly.

Storage:

Store below 30°C and protect from heat.

Store the AIROMIR Autohaler with the mouthpiece cover attached to protect your medicine.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

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

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine:

Do not puncture the container or throw it into the fire even when it is empty as the canister may explode.

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.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious common side effects

Less serious side effectsWhat to do
  • Headache
  • Minor irritation to your mouth and throat
  • Fine shaking in the hands
  • Dizziness
  • Light headedness
  • Feeling tense
  • Nausea
  • Leg cramps
  • Itching and irritation.
Speak to your doctor or pharmacists if you have any of these less serious common side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • Chest pain
  • Heart palpitations (when your heart beats faster and harder than normal)
  • Lowering of the potassium level in your blood.
Call your doctor or pharmacist 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 AIROMIR contains:

Active ingredient
(main ingredient)		Salbutamol sulfate
Other ingredients
(inactive ingredients)		Ethanol
Oleic acid
Norflurane
Potential allergensEthanol

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

What AIROMIR looks like:

AIROMIR AUTOHALER is homogenous creamy-white to greyish-white coloured suspension supplied in a metal canister sealed inside a plastic autohaler unit. At the bottom of the autohaler unit is a mouthpiece with a plastic cover. At the top of the autohaler unit is a lever. Available in pack sizes of 200 doses.

Australian registration number: AUST R 67257

Who distributes AIROMIR:

Australia

iNova Pharmaceuticals (Australia) Pty Limited
Level 10, 12 Help Street
Chatswood NSW 2067
Tel: 1800 630 056

This leaflet was prepared in December 2023.

Published by MIMS February 2024

BRAND INFORMATION

Brand name

Airomir Autohaler and Inhaler

Active ingredient

Salbutamol

Schedule

S3

 

1 Name of Medicine

Salbutamol sulfate.

2 Qualitative and Quantitative Composition

Airomir contains microcrystalline salbutamol sulfate suspended in norflurane (1,1,1,2-tetrafluoroethane), a non-CFC propellant which does not deplete ozone from the atmosphere. Each metered dose delivers an amount of salbutamol sulfate equivalent to 100 microgram of salbutamol. Airomir also contains oleic acid and ethanol. Excipients with known effects: alcohol (ethanol) 21% v/v.
Airomir Autohaler is a breath actuated inhaler which automatically releases the dose of medication during inhalation through the mouthpiece and overcomes the need for patients to coordinate actuation with inspiration. Airomir Inhaler is a conventional press and breathe metered dose inhaler. There are no differences in formulation between the Autohaler and Inhaler products.

3 Pharmaceutical Form

Airomir Autohaler is a metered dose inhalation aerosol. Each unit delivers salbutamol sulfate equivalent to salbutamol 100 microgram per metered dose.
Airomir Inhaler is a metered dose inhalation aerosol. Each unit delivers salbutamol sulfate equivalent to salbutamol 100 microgram per metered dose.

4 Clinical Particulars

4.1 Therapeutic Indications

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.
The Autohaler device is of value in patients who are unable to achieve coordination using metered dose inhalers. No advantage over other metered dose inhalers is claimed for patients who do not have difficulty with coordination.

4.2 Dose and Method of Administration

Airomir is therapeutically equivalent to CFC salbutamol pressurised inhalers. Patients can be switched from CFC salbutamol pressurised inhaler to Airomir, at the same dosage, without loss of therapeutic effect.

Adults.

1 to 2 inhalations every four hours as necessary to obtain relief of bronchospasm. If previously effective doses do not provide relief, other treatment should be instituted promptly.

Children.

As for adults.

Elderly.

Dosage should at first be lower than for younger adults but may be increased gradually to the usual adult level if necessary.

Impaired hepatic or renal function.

Since salbutamol is extensively metabolised in the liver, any liver function impairment may necessitate a reduction in dosage. Similarly, impairment in renal function may also require a dosage reduction since a large proportion of inhaled salbutamol is excreted in the urine.

Note.

An increase in the use of salbutamol required to control asthma symptoms may indicate deterioration in the patient's asthma. If so, a reassessment of the patient's treatment regimen may be required. Should inhalation therapy fail to relieve asthma symptoms, other treatments should be implemented immediately in order to avoid a potential medical emergency.
Patients who are unable to successfully coordinate actuation of their metered dose inhaler with inhalation (including virtually all children) will benefit from substituting their conventional press and breathe metered dose inhaler with the Autohaler, or using a spacer device.
Where a spacer is considered necessary the AeroChamberPlus has been shown to be compatible with Airomir Inhaler. Use of an AeroChamberPlus spacer with Airomir Inhaler reduces the amount of drug deposited in the oropharynx without affecting drug deposition in the lungs. A change in the make of spacer or a change in the formulation of the drug used may be associated with alterations in the amount of drug delivered to the lungs, the clinical significance of which is uncertain. In these situations the patient should be monitored for any loss of asthma control. For instructions on the proper use of spacers, see Section 4.4 Special Warnings and Precautions for Use, Instructions for prescribers.

4.3 Contraindications

Known hypersensitivity to salbutamol sulfate or other sympathomimetics, or to any other ingredients.

4.4 Special Warnings and Precautions for Use

The results of animal experiments indicate that high dosages of some sympathomimetic agents may cause cardionecrosis. In view of this evidence, the possibility of cardiac lesions occurring in humans cannot be excluded. The administration of Airomir by inhalation results in low salbutamol plasma concentrations so the risk of this effect is correspondingly reduced.
Airomir contains norflurane, a non-CFC propellant. In animal studies, norflurane has been shown to have no significant pharmacological effects, except at very high exposure concentrations when necrosis and a relatively weak cardiac sensitising effect were found. The potency of the cardiac sensitisation of norflurane was less than that of trichlorofluoromethane (CFC-11). Large doses of CFC propellants have been reported in animals to produce cardiac arrhythmias and sensitise their hearts to adrenaline induced arrhythmias. Data in humans are limited. Inhalations of the maximum recommended dose of Airomir produce low concentrations of propellant in the plasma.
Excessive use of Airomir is potentially hazardous, both from the propellant as well as from the possibility of overdosage with the active medication. Patients should therefore be warned not to exceed the recommended dose. Additionally, overuse of inhaled salbutamol may cause a worsening of hypoxaemia.
Use with caution in the following circumstances.

Cardiac disease.

When Airomir is used at the recommended doses, the blood concentrations of salbutamol are usually too low to produce a significant systemic effect. However, prescribers should be aware of the possibility of the unwanted stimulation of cardiac adrenergic receptors, and care should be taken in patients with hypertension, coronary artery disease and myocardial insufficiency.

Cardiac arrhythmias.

Salbutamol may predispose to the occurrence of cardiac arrhythmias or may exacerbate existing arrhythmias. This effect may be due to a direct chronotropic effect and to the reduction of serum potassium. Care should be taken when using salbutamol in patients who have arrhythmias or who are receiving drugs such as digitalis or diuretics which do not spare potassium. Caution should also be taken when using salbutamol with anaesthetic agents which sensitise the myocardium to sympathomimetic agents.

Hypokalaemia.

Potentially serious hypokalaemia may result from β2-agonist therapy mainly from parenteral and nebulised administration. This effect may be potentiated in patients with hypoxia or those treated concomitantly with theophylline, steroids or diuretics. Caution should be taken in these patients.

Diabetes mellitus.

When given by inhalation at recommended doses, salbutamol should have little or no hyperglycaemic effect; however, care should be taken initially in using salbutamol in diabetics.

Hyperthyroidism.

Salbutamol should be used with caution in patients with thyrotoxicosis.

Lactic acidosis.

Lactic acidosis has been reported very rarely in association with high therapeutic doses of intravenous and nebulised short-acting β-agonist therapy, mainly in patients 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 β-agonist treatment. It is therefore recommended that patients are monitored for the development of elevated serum lactate and consequent metabolic acidosis in this setting.

Instructions for prescribers.

Asthma management should be adjusted according to individual need based on lung function and clinical monitoring. Increasing use of β2-agonist may be a sign of worsening asthma. Under these conditions a reassessment of the patients' therapy plan may be required and concomitant glucocorticosteroid therapy should be considered. This is important since poor asthma control can result in potential life threatening situations and increased use of β2-agonists may cause deterioration of asthma control.
Patients should be informed of the importance of correct inhaler technique (either breath actuated inhaler or conventional inhaler). To ensure correct use of Airomir Autohaler and Inhaler, refer patients to the patient instruction leaflet accompanying each unit. If necessary, correct technique should be demonstrated to patients, particularly first time users and those with poor coordination.
It is advisable to check the patient's compliance and inhaler technique before increasing the dose. Patients should be advised to seek medical advice when the bronchodilator effect is reduced and not to increase the dose over that prescribed. Patients should be warned that excessive use of inhaled salbutamol may result in significant adverse effects and/or loss of asthma control. Patients should also be advised not to use other asthma medications at the same time as Airomir unless on medical advice.
If using a spacer, the patient should be instructed to breathe in and out several times after each release into the spacer. Any delay should be kept to a minimum.
Because of electrostatic charge, leading to adherence of drug particles to the wall of the spacer, spacers should be washed in warm water with kitchen detergent and left to drain dry (without rinsing) before initial use and at least monthly thereafter. A cloth should not be used to dry the spacer, as this can produce more static electricity.

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 blockers specifically antagonise the action of salbutamol and other sympathomimetics on the airways. Use of these drugs is also generally contraindicated in asthma because they tend to increase airways resistance.
Concomitant use of theophylline (and other xanthine derivatives), steroids and diuretics may potentiate salbutamol induced hypokalaemia in acute severe asthma. In those circumstances and in other situations (such as hypoxia) likely to potentiate salbutamol induced hypokalaemia, serum potassium levels should be monitored.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B1)
There is no experience of Airomir in pregnant women. An inhalation reproductive study with Airomir Inhaler in rats did not exhibit any teratogenic effects. Salbutamol does however cross the placenta. In some rodent studies, large doses of salbutamol have been shown to be teratogenic although the relevance of these findings to humans is unknown. Safe use in pregnancy has not been established, therefore Airomir should not be used during pregnancy unless the benefits outweigh the potential risk.
 There is no experience of Airomir in lactating women. It is unknown whether salbutamol is excreted in breast milk. Airomir should, therefore, not be used in women who are breastfeeding, unless the benefits of therapy outweigh the potential 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)

The adverse effects of salbutamol sulfate are generally extensions of its sympathomimetic actions. Their rates of occurrence are dependent on route of administration as well as dose.

Clinical trial data.

In a 12 week double blind, double dummy study which compared Airomir, CFC salbutamol pressurised inhaler and a placebo (norflurane) inhaler in 565 asthmatic patients, the adverse events reported as probably or possibly related to study treatment, given as 2 puffs four times daily for 12 weeks, and with an incidence of 1% or greater are presented in Table 1. A dash represents an incidence of less than 1%.

Postmarketing data.

In a 3 month postmarketing surveillance study, 5,402 patients receiving CFC salbutamol pressurised inhaler were switched to Airomir. The reported adverse reactions which were considered to be probably or possibly related to treatment are presented below by body system in the following frequency categories: very common ≥ 10%, common ≥ 1% and < 10%, uncommon ≥ 0.1% and < 1%, rare ≥ 0.01% and < 0.1%, very rare < 0.01%.

Central, peripheral nervous system disorders.

Uncommon: headache, tremor, dizziness; rare: paraesthesia, leg cramps, dysphonia.

Respiratory system disorders.

Uncommon: pharyngitis, bronchospasm, increased asthma symptoms, coughing; rare: dyspnoea, acute asthma episode, upper respiratory tract infection, tracheitis, bronchitis, rhinitis.

Gastrointestinal system disorders.

Uncommon: nausea; rare: dry mouth, vomiting, stomatitis, abdominal pain, dyspepsia, tongue discolouration, anorexia.

Body as a whole, general disorders.

Uncommon: chest pain; rare: inadequate response, decreased therapeutic response, rigors, malaise, fever, oedema.

Heart rate and rhythm disorders.

Uncommon: palpitation.

Application site disorders.

Rare: inhalation site sensation, inhalation taste sensation, cough, increased asthma symptom, application site reaction, dysphonia.

Musculoskeletal disorders.

Rare: myalgia, arthralgia.

Skin and appendages disorders.

Rare: pruritus, rash, skin disorder.

Psychiatric disorders.

Rare: nervousness, depression, paroniria, agitation, emotional lability (mood swing), abnormal thinking, euphoria.

Resistance mechanism disorders.

Rare: infection.

Myo/ endo/ pericardial and valve disorders.

Rare: angina pectoris.

Platelet, bleeding and clotting disorders.

Rare: epistaxis.

Reproductive disorders (female).

Rare: breast pain.

Autonomic nervous system disorders.

Rare: flushing, saliva altered.

Special senses, other disorders.

Rare: taste perversion.
Lactic acidosis has been reported very rarely in patients receiving intravenous and nebulised salbutamol therapy for the treatment of acute asthma exacerbation.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

Symptoms.

The symptoms of overdosage are the same as the adverse effects of salbutamol, the most significant being tachycardia and/or muscle tremor. With the metered dose inhalers some toxicity may be due to the aerosol propellant.
Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting β-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is persistence or worsening of tachypnoea despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting of overdose.

Treatment.

Monitor biochemical abnormalities, particularly hypokalaemia. Hypokalaemia should be treated with potassium replacement if necessary.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Salbutamol is a direct acting sympathomimetic agent which mainly has β-adrenergic activity and a high degree of selectivity for β2-adrenoceptors. As a predominantly β2-adrenoceptor stimulant, salbutamol's bronchodilating action is relatively more prominent than its cardiac effects. Salbutamol is chemically related to adrenaline, noradrenaline and isoprenaline, but it has a longer duration of action than these compounds. This is possibly due to its resistance to catechol-O-methyl transferase (COMT), an inactivating enzyme which occurs in association with sympathetic receptors.
The β-sympathetic agonists act primarily through activation of adenylate cyclase which catalyses the conversion of adenosine triphosphate (ATP) to cyclic adenosine monophosphate (cAMP). Cyclic AMP mediates the effects of the β-agonists on sympathetic receptors. Increased cAMP concentrations also inhibit release of mediators of immediate hypersensitivity from mast cells, as well as relaxing bronchial smooth muscle. Stimulation of β2-receptors causes relaxation of the smooth muscle of the bronchi, uterus and blood vessels, decreases the duration of skeletal muscle contraction and increases glycolysis and glycogenolysis.
Airomir contains the sulfate salt of salbutamol, which has been shown to be clinically equivalent to salbutamol base when administered in equivalent doses by metered dose inhaler.

Clinical trials.

In a 12 week randomised, double blind, double dummy, active and placebo controlled study, 565 adult patients with asthma were evaluated for the bronchodilator efficacy of Airomir (193 patients) in comparison to a CFC salbutamol pressurised inhaler (186 patients). Serial FEV1 (Forced Expiratory Volume) measurements demonstrated that two inhalations of Airomir produced significantly greater improvement in pulmonary function than placebo and produced outcomes which were clinically comparable to a CFC salbutamol pressurised inhaler. The mean time to onset of a 15% increase in FEV1 was 6 minutes and the mean time to peak effect was 50 minutes. The mean duration of effect as measured by a 15% increase in FEV1 was 3 hours. No statistically significant or clinically meaningful differences were seen in the safety parameters, including the overall adverse event rates, heart rate, blood pressure, serum potassium or ECG interval changes between Airomir and CFC salbutamol pressurised inhaler.
In a 4 week randomised, open label, parallel study, 63 children with asthma were evaluated for the bronchodilator efficacy of Airomir (33 patients) in comparison to a CFC salbutamol pressurised inhaler (30 patients). Serial FEV1 measurements demonstrated that two inhalations of Airomir produced a clinically comparable bronchodilator effect compared to a CFC salbutamol pressurised inhaler. Analysis of all safety parameters revealed that Airomir has a similar safety profile to CFC salbutamol pressurised inhaler.
In the 12 month studies, there were 337 adult patients assigned to Airomir and 132 to CFC salbutamol pressurised inhaler (2 puffs twice daily and prn). There were no significant differences between Airomir and CFC salbutamol pressurised inhaler treatment groups for total reported adverse events, clinically meaningful changes in laboratory tests or physical examinations (changes in pulse rate, blood pressure, serum potassium and ECG intervals). Baseline lung function, assessed as the FEV1 obtained at visits prior to dosing did not change in either group over the one year treatment periods. No significant differences in bronchodilator efficacy were found between Airomir and CFC salbutamol pressurised inhaler throughout the studies.
Forty eight asthmatic patients (adults) completed 16 puffs cumulative dose, crossover studies comparing Airomir to CFC salbutamol pressurised inhaler. The efficacy equivalence between Airomir and CFC salbutamol pressurised inhaler was confirmed by the comparable FEV1 responses, while equivalence in safety was confirmed by comparable falls in serum potassium, changes in vital signs (heart rate, blood pressure) and ECG intervals.

5.2 Pharmacokinetic Properties

When Airomir is inhaled at the recommended doses salbutamol is delivered topically to the lung such that its effects are apparent within minutes. Because of the small amount of drug administered and due to its gradual absorption from bronchi, plasma levels of salbutamol are extremely low after oral inhalation. Salbutamol is not metabolised in the lung.
Swallowed salbutamol is readily absorbed from the gastrointestinal tract and undergoes extensive presystemic metabolism by conjugation to a 4'-O-sulfate ester in the gastrointestinal tract and the liver. Its systemic bioavailability is about 50%.
Salbutamol and its metabolites are rapidly excreted in the urine and faeces. About 80% of a single dose is recovered in urine within 24 hours. Following oral inhalation, unchanged salbutamol accounts for approximately 30% of the excreted dose in the urine. The elimination half-life of salbutamol is about 3-6 hours. Salbutamol is not significantly bound in plasma. The elimination of salbutamol may be altered by changes to hepatic or renal function; consequently dosage reduction may be required in patients with hepatic or renal impairment.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

There are no reasons to consider norflurane as a potential mutagen, clastogen or carcinogen judging from in vitro and in vivo studies which include long-term administration by inhalation in rodents.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Airomir should be stored below 30°C, away from direct heat or sunlight. As the canister is pressurised, no attempt should be made to puncture it or dispose of it by burning.

6.5 Nature and Contents of Container

Airomir Autohaler and Airomir Inhaler* are each available in pack sizes of 100* and 200 doses. Each unit is supplied with an actuator.
* Not currently marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.


(RS)-2-tert-butylamino- 1-(4-hydroxy- 3-hydroxymethylphenyl) ethanol sulfate.
Salbutamol sulfate is a white or almost white powder. It is soluble in water but is only slightly soluble in alcohol, chloroform and ether. 1.2 mg of salbutamol sulfate is equivalent to 1.0 mg of salbutamol base.
Molecular formula is C13H21NO3.½H2SO4.

CAS number.

51022-70-9.

7 Medicine Schedule (Poisons Standard)

(S3) Pharmacist Only Medicine.

Summary Table of Changes