Consumer medicine information

Butamol Nebuliser solution

Salbutamol

BRAND INFORMATION

Brand name

Butamol Nebuliser solution

Active ingredient

Salbutamol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Butamol Nebuliser solution.

What is in this leaflet

This leaflet answers some common questions about Butamol 2.5 and Butamol 5. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risk of you taking this medicine against the benefits it is expected to have for you.

Ask your doctor or pharmacist if you have any concerns about taking this medicine.

This medicine is only part of a general plan to help you manage your asthma, or other chest conditions. You should discuss this plan with your doctor.

Ask your doctor to check your treatment plan regularly.

Keep this leaflet with the medicine.

You may want to read it again.

What Butamol is used for

The name of your medicine is Butamol 2.5 or Butamol 5. The medicine in your Butamol 2.5 and Butamol 5 is delivered through a device called a nebuliser.

Butamol contain a medicine called Salbutamol, which belongs to a group of medicines called beta-2-agonists. These work rapidly to open up the air passages in your lungs. Salbutamol is inhaled into the lungs for the treatment of Asthma.

Asthma is a disease where the lining of the lungs become inflamed (red and swollen), making it difficult to breathe. This may be due to an allergy to house dust mites, smoke, air-borne pollution and other irritants. Salbutamol opens up the air passages in people suffering from asthma, bronchitis and other breathing problems.

It may also be used before exercise to keep your air passages open if you start to wheeze or have difficulty breathing each time you exert yourself.

Salbutamol inhalation may be used for the management of other conditions that are not mentioned above. Your doctor will be able to tell you about the specific condition for which you have been prescribed Butamol 2.5 or Butamol 5. This medicine is only available with a doctor’s prescription.

Before you use it

When you must not use it

Do not use Butamol if you have an allergy to:

  • Salbutamol or any other medicines used to treat breathing problems
  • any other beta-2-agonist medicine
  • any of the inactive ingredients mentioned at the end of this leaflet.

Check with your doctor if you are not sure whether any of these apply to you.

Before you start to use it

Tell your doctor if:

  1. you have allergies to:
    - any other medicines
    - any other substances, including foods, preservatives or dyes.
  2. you are pregnant, plan on becoming pregnant
  3. you are breastfeeding or plan to breastfeed
  4. you have or have had any medical conditions, especially the following:
    - thyroid problems
    - heart problems
    - high blood pressure
    - diabetes
    - glaucoma.

Taking other medicines

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

Some medicines and Salbutamol may interfere with each other.

These include medicines used for:

  • high blood pressure
  • heart problems
  • hay fever, cough and colds
  • weight reduction
  • depression or other mood disorders.

Your doctor will advise you about continuing to take other medicines while you are receiving Salbutamol.

How to use it

How much to use

The usual dose is 5 mg for an adult and 2.5 mg for a child over 4 years, given every four to six hours. Your doctor will decide what dose and how often you should use Butamol.

The dosage you will be given will depend on your condition, what it is being used for and other factors, such as your age, and whether or not other medicines are being given at the same time.

Follow all directions given to you by your doctor or pharmacist carefully.

How to use it

The content of Butamol is inhaled through a nebuliser according to the manufacturer's instructions. The nebuliser changes the solution into a fine mist and delivers the medicine to your lungs when you inhale the mist through the mask.

Step 1: Remove the strip of Butamol from the carton and tear one ampoule from the strip. Open only one foil pack at a time, and use all 5 ampoules before opening the next foil pack.

Step 2: Never use a ampoule that has previously been opened. The ampoule may be opened by carefully holding the ampoule upright and twisting the top off.

Step 3: The content of the ampoule should be squeezed out into the nebuliser bowl.

The nebuliser should be assembled and used as directed by your doctor. After using the nebuliser, discard any solution remaining in the nebuliser bowl.

Follow the manufacturer's instructions on how to clean your nebuliser.

IMPORTANT: Fresh solution must be used for each dose. After the full dose has been given, any solution remaining in the nebuliser must be thrown away. Nebulisers must be cleaned after use according to the manufacturer's instructions.

If you forget to use it

If you miss a dose, do not worry. Just take the next dose at the normal time or earlier if you become wheezy or feel tight in your chest.

If you use too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have used too much Butamol. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you use too much, you may feel shaky, tremble or have a fast heart beat. These symptoms are usually mild side effects of Butamol. However, if they are severe or do not go away, it may be that you have taken too much Butamol.

While you are using it

Things you must do

If you have an Asthma Action Plan developed by your doctor, follow it closely at all times.

If the usual dose of Butamol is not giving as much relief as before, or you need to use it more often, please contact your doctor so that your condition can be checked.

This is important to ensure your breathing problem is controlled.

Continue using for as long as your doctor tells you.

Tell your doctor if you become pregnant while using this medicine.

If you are about to start taking a new medicine, tell your doctor and pharmacist that you are using Butamol.

Tell all the doctors, dentists and pharmacists who are treating you that you are using Butamol.

Visit your doctor regularly to check on your condition.

Things you must not do

Do not stop using Butamol, or lower the dose, without checking with your doctor.

Do not take any other medicines for your breathing problems without checking with your doctor.

Do not use it to treat any other conditions unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Side effects

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

Like all other medicines, it can cause some side effects. If they occur, most are likely to be minor or temporary. However, some maybe serious and need medical attention.

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

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

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

  • a feeling of warmth
  • difficulty breathing or worsening of your breathing problems
  • swelling or severe rash
  • fast or irregular heart beat
  • pounding heart beat.

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

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

  • sore mouth, throat or tongue
  • dry mouth
  • coughing
  • headache
  • drowsiness
  • feeling anxious, nervous, restless or upset
  • difficulty sleeping
  • dizziness
  • sweating
  • trembling or shaking
  • aching or weak muscles
  • cramps
  • tingling or numbness in the hands or feet ('pins and needles')
  • unpleasant taste in your mouth
  • nausea or vomiting
  • diarrhoea
  • rash or itchy skin
  • sore or puffy eyes.

These are the more common side effects of salbutamol. Mostly these are mild and short lived. Other side effects no listed above may also occur in some patients. If you notice any other side effects, check with your doctor. Some side effects may only be seen by your doctor.

Tell your doctor if you notice anything that is making you feel unwell.

After using it

Storage

Once you have opened each foil pack you need to note down the date of opening the foil lid. Add 3 months to this date and write it down in the space provided on the foil pack. Do not use the ampoules left in the tray after this date.

Keep your medicine in a cool dry place where the temperature stays below 25°C. It must be protected from light.

Do not store in direct sunlight or heat.

Do not leave in the car on hot days.

Keep your medicine where children cannot reach them.

Do not use after the expiry date on the carton has passed.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines. Do not store Butamol or any other medicine in the bathroom or near a sink.

Disposal

If your doctor tells you to stop using Butamol, or your medicine has passed its expiry date, ask your pharmacist what to do with any ampoules that are left over.

Product description

What it looks like

Butamol comes in 2 strengths:

  • Butamol 2.5
  • Butamol 5.

Each pack of Butamol contains 30 plastic ampoules. Each ampoule contains 2.5 mL of clear, colourless liquid.

Ingredients

The active ingredient in Butamol is Salbutamol (as Salbutamol sulfate):

  • each Butamol 2.5 ampoule contains 2.5 mg of salbutamol in 2.5 mL of solution
  • each Butamol 5 ampoule contains 5 mg of salbutamol in 2.5 mL of solution.

Butamol ampoules also contain:

  • sodium chloride
  • water for injections
  • sulfuric acid.

Butamol is sterile and preservative free.

Supplier

Aspen Pharma Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia

Australian Registration Numbers:
Butamol 2.5 - Aust R 158051
Butamol 5 - Aust R 158052

This leaflet was prepared May 2012.

BRAND INFORMATION

Brand name

Butamol Nebuliser solution

Active ingredient

Salbutamol

Schedule

S4

 

Name of the medicine

Salbutamol sulfate.

Excipients

Sodium chloride and sulfuric acid.

Description

Chemical name: di[(RS)-2-(1,1-dimethyl)ethylamino-1- [4-hydroxy-3 -(hydroxymethyl)phenyl]ethanol] sulfate. Molecular formula: C13H21NO3)2,H2SO4. MW: 576.7. CAS: 51022-70-9. Salbutamol sulfate is a white or almost white odourless, crystalline powder with a slightly bitter taste. It is freely soluble in water, practically insoluble or very slightly soluble in ethanol (96 percent) and in methylene chloride. Salbutamol sulfate 1.2 mg is approximately equivalent to salbutamol 1 mg.

Pharmacology

Action.

β2-Adrenoreceptor agonist.
Salbutamol is a long acting, relatively selective β2-receptor stimulant. Administration by inhalation results in direct stimulation of β2-receptors in bronchial smooth muscle and hence bronchodilatation. This is thought to be due to stimulation of adenyl cyclase by salbutamol, resulting in increased levels of cyclic adenosine monophosphate (AMP) within cells. These are thought to inhibit the entry of calcium ions into the cells, thus inhibiting smooth muscle contraction. High levels of cyclic AMP in mast cells may also inhibit the release of histamine and slow reacting substance-A (SRS-A).
After administration of salbutamol, stimulation of both β1 and β2-receptors occurs because β2 selectivity is not absolute. This results in the β1 effect of cardiac stimulation, though not so much as with isoprenaline, and β2 effects of peripheral vasodilation and hypotension, skeletal muscle tremor and uterine muscle relaxation. Stimulation of β2-receptors can result in changes in serum levels of glucose, insulin and potassium.

Pharmacokinetics.

Absorption.

Following inhalation of salbutamol the onset of action is 5 to 15 minutes. Only 10 to 20% of the dose reaches the lungs, the remainder stays in the mouth, stomach or on the apparatus. Salbutamol reaching the lungs acts rapidly and directly on bronchial smooth muscle. Initially, the drug is undetectable in blood but after two to three hours, low concentrations are seen, due presumably to the portion of the dose which is swallowed and absorbed by the gut.

Distribution.

Salbutamol is not bound to plasma proteins.

Metabolism.

The major metabolite of salbutamol, recovered from urine, has been identified as the 4'-o-sulfate ester. This metabolite has negligible β stimulant activity. Salbutamol is not metabolised in the lung and the pattern of metabolism and excretion (as well as absorption) suggests that most aerosol is swallowed. The elimination half-life is between 2.7 and 5 hours.

Excretion.

Following inhalation of salbutamol, 77 to 97% of the dose is recovered in the urine after 48 hours, 45 to 60% as the 4'-o-sulfate ester and the rest as unchanged salbutamol. A small fraction is excreted in the faeces.

Indications

Relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease.
Acute prophylaxis against exercise induced asthma or in other situations known to induce bronchospasm.

Contraindications

Patients with a history of hypersensitivity to any of the listed ingredients in Description.

Precautions

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 β2-agonists to control symptoms indicates deterioration of asthma control. In this situation, 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. Daily peak flow monitoring may be instituted in patients considered at risk.
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 high dosages of some sympathomimetic amines may cause cardionecrotic effects. Based on this evidence, the possibility of the occurrence of myocardial lesions cannot be excluded subsequent to long-term treatment with these drugs.
Care should be taken with patients who are known to have received large doses of salbutamol or other sympathomimetic drugs, or who are suffering from hypertension, hyperthyroidism, myocardial insufficiency or diabetes mellitus.
Salbutamol should be administered cautiously to patients with thyrotoxicosis.
Excessive use may induce a nonresponsive state leading to a worsening of hypoxaemia.
Potentially serious hypokalaemia may result from β2-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 salbutamol injection.
Addition of other active substances to salbutamol cannot be recommended.

Use in pregnancy.

(Category A)
Salbutamol is known to cross the placental barrier in humans. Safety for use in pregnancy has not been demonstrated; therefore, the drug should not be used in pregnant women or those likely to become pregnant, unless the expected benefits outweigh any potential risk.
Oral administration of salbutamol to rats and rabbits during pregnancy showed no teratogenic effects in offspring.
Although intravenous salbutamol and occasionally salbutamol tablets are used in the management of uncomplicated labour, salbutamol presentations should not be used for threatened abortion during the first or second trimesters of pregnancy. Intravenous salbutamol is contraindicated in cases of antepartum 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.

Use in lactation.

It is not known whether salbutamol is excreted in breast milk nor whether it has a harmful effect on the newborn infant. Therefore, it is not recommended for breastfeeding mothers unless the expected benefits outweigh any potential risk.

Interactions

β-Adrenergic blocking drugs.

β-Adrenergic blocking drugs inhibit the bronchodilator action of salbutamol and other sympathomimetic bronchodilators. Such drugs should not be used in asthmatic patients as they may increase airway resistance.

β-Adrenergic stimulants or sympathomimetic amines.

β-Adrenergic stimulants or sympathomimentic amines, such as ephedrine, should not be given concomitantly. Salbutamol should not be given to patients who have already received large doses of sympathomimetics.

Antidepressants.

Salbutamol has been shown to produce possible interactions in animals with the following drugs: imipramine, chlordiazepoxide and chlorpromazine. The clinical significance of this is undetermined.

Anticholinergics-ipratropium.

A small number of cases of acute angle closure glaucoma have been reported in patients treated with a combination of nebulised salbutamol and ipratropium bromide. A combination of nebulised salbutamol with nebulised anticholinergics should, therefore, be used cautiously.

Cardiac glycosides.

Hypokalaemia produced by β2-agonists may result in an increased susceptibility to digitalis induced arrhythmias, although salbutamol intravenously and by mouth can also decrease serum concentrations of digoxin.

Corticosteroids.

Corticosteroids and β2-agonists may both produce falls in plasma potassium concentrations; these may be exacerbated by concomitant administration. The possibility of enhanced hypoglycaemic effects from such a combination should also be borne in mind.

Diuretics.

Hypokalaemia is known to be a possible side effect during treatment with β2-agonists, such as salbutamol, and this may be enhanced during concomitant diuretic therapy. In addition, the arrhythmogenic potential of this interaction may be important in patients with ischaemic heart disease.
Patients should receive adequate instruction in correct administration and be warned not to let the solution or mist enter the eye.

Adverse Effects

Adverse events are described according to the CIOMS classification: very common (≥ 10%); common (≥ 1%, < 10%); uncommon (≥ 0.1%, < 1%); rare (≥ 0.01%, < 0.1%); very rare (< 0.01%).

Very common.

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

Note.

The incidence and severity of particular side effects depends on the dosage and route of administration. Salbutamol does not cause difficulty in micturition because, unlike sympathomimetic drugs, e.g. ephedrine, therapeutic doses have no α-adrenergic receptor stimulant activity.
Potentially serious hypokalaemia may result from β2-agonist therapy.
As with other inhalation therapy, the potential for paradoxical bronchospasm should be kept in mind. If it occurs, the preparation should be discontinued immediately and alternative therapy instituted.
As with other β2-agonists, hyperactivity has been reported rarely in children. Overuse of salbutamol preparations may produce significant tachycardia, arrhythmias and hypotension.

Dosage and Administration

Increasing use of β2-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.
Butamol 2.5 and Butamol 5 are to be used under the direction of a doctor.
The solution must not be injected or ingested.
Butamol 2.5 and Butamol 5 may be delivered from any efficient nebulising device. Butamol 2.5 and Butamol 5 may be used to achieve bronchodilatation as part of an inhalational therapy regimen or for patients requiring assisted ventilation.
There is a large safety margin between therapeutic effects and unpleasant side effects. Nevertheless, because of the possibility of uncontrolled dosage associated with continuous administration, intermittent administration of appropriate amounts of Butamol 2.5 and Butamol 5 is preferred.

Children 4 to 12 years.

2.5 mg.

Adults.

5 mg.
This dosage may be repeated as necessary every four to six hours.

Important.

Fresh dilutions should be prepared for each inhalation and any solution remaining in the nebuliser after treatment should be discarded immediately. To avoid contamination, nebulising devices should be thoroughly cleaned after use, according to manufacturer's instructions.
Clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain. As transient hypoxaemia may occur, supplemental oxygen therapy should be considered.

Use in the elderly.

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

Impaired hepatic function.

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

Impaired renal function.

About 60 to 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.

Overdosage

In general, β-blocking drugs should be used with caution as they may cause bronchospasm in sensitive individuals. Hypokalaemia may occur following overdosage with salbutamol. Serum potassium levels should be monitored. The signs of overdosage are significant tachycardia and/or significant muscle tremor.

Treatment.

The specific antidote for overdosage with salbutamol is a cardioselective β-blocking agent given by intravenous injection.
Contact the Poisons Information Centre on 131 126 (Australia) for advice on the management of overdosage.

Presentation

Nebuliser solution (clear, sterile isotonic aqueous solution, preservative free), 2.5 mg/2.5 mL, 5 mg/2.5 mL: 30's (single dose ampoule).

Storage

Shelf life: 3 years when stored below 25°C. Store protected from light. Once removed from the foil overwrap, ampoules have a shelf life of 3 months when stored below 25°C.

Poison Schedule

S4.