Product Description

1 Therapeutic indications

Salbutamol Aerosol are indicated in adults, adolescents and children aged 4 to 11 years. For babies and children under 4 years of age, see Section 4.2.

Salbutamol is a selective β2-agonist providing short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction.

Salbutamol Aerosol solutions are indicated for use in the routine management of chronic bronchospasm unresponsive to conventional therapy, and in the treatment of acute severe asthma.

4.2 Posology and method of administration

Posology

Adults (including the elderly):

2.5 mg to 5 mg salbutamol up to four times a day. Up to 40 mg per day can be given under strict medical supervision in hospital.

Paediatric Population

Children aged 12 years and over: Dose as per adult population.

Children aged 4-11 years: 2.5 mg to 5 mg up to four times a day.

Other pharmaceutical forms may be more appropriate for administration in children under 4 years old.

Infants under 18 months old:

Clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain. As transient hypoxia may occur supplemental oxygen therapy should be considered.

Salbutamol Aerosols solutions are intended to be used undiluted. However, if prolonged delivery time (more than 10 minutes) is required, the solution may be diluted with sterile normal saline.

Method of administration

Salbutamol Aerosol solutions are for inhalation use only, to be breathed in through the mouth, under the direction of a physician, using a suitable Aerosol.

The solution should not be injected or swallowed.

4.3 Contraindications

Hypersensitivity to salbutamol or to any of the excipients listed in section 6.1.

Non-IV formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion.

4.4 Special warnings and precautions for use

Salbutamol Aerosol solution must only be used by inhalation, to be breathed in through the mouth, and must not be injected or swallowed.

Potentially serious hypokalaemia has been reported in patients taking β-2-agonist therapy. Particular caution is advised in patients with acute severe asthma as hypokalaemia may be potentiated in hypoxic patients and those treated with xanthine derivatives, steroids, diuretics. In these groups of patients serum potassium levels should be monitored.

Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment, including lung-function testing, as patients are at risk of severe attacks and even death. Physicians should consider using the maximum recommended dose of inhaled corticosteroid and/or oral corticosteroid therapy in these patients.

Patients receiving treatment at home should seek medical advice if treatment with salbutamol Aerosol solution becomes less effective. The dosage or frequency of administration should only be increased on medical advice.

Patients being treated with salbutamol Aerosol solution may also be receiving other dosage forms of short-acting inhaled bronchodilators to relieve symptoms. Increasing use of bronchodilators, in particular short-acting inhaled β2- agonists to relieve symptoms indicates deterioration of asthma control. The patient should be instructed to seek medical advice if short-acting relief bronchodilator treatment becomes less effective or more inhalations than usual are required. In this situation patients should be assessed and consideration given to the need for increased anti-inflammatory therapy (e.g. higher doses of inhaled corticosteroid or a course of oral corticosteroid).

Severe exacerbations of asthma must be treated in the normal way.

Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis.

Salbutamol Aerosol solutions should be used with care in patients known to have received large doses of other sympathomimetic medicinal products.

Cardiovascular effects may be seen with sympathomimetic medicinal products, including salbutamol. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with salbutamol. Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.

In common with other β- adrenoceptor agonists, salbutamol can induce reversible metabolic changes such as increased blood glucose levels. Diabetic patients may be unable to compensate for the increase in blood glucose and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.

Lactic acidosis has been reported in association with high therapeutic doses of intravenous and nebulised short-acting beta-agonist therapy, mainly in patients being treated for an acute asthma exacerbation (see Section 4.8). Increase in lactate levels may lead to dyspnoea and compensatory hyperventilation, which could be misinterpreted as a sign of asthma treatment failure and lead to inappropriate intensification of short-acting beta-agonist treatment. It is therefore recommended that patients are monitored for the development of elevated serum lactate and consequent metabolic acidosis in this setting.

A small number of cases of acute angle-closure glaucoma have been reported in patients treated with a combination of nebulised salbutamol and ipratropium bromide. A combination of nebulised salbutamol with nebulised anticholinergics should therefore be used cautiously. Patients should receive adequate instruction in correct administration and be warned not to let the solution or mist enter the eye.

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator. Salbutamol Aerosol solutions should be discontinued, and if necessary a different fast-acting bronchodilator instituted for on-going use.

4.5 Interaction with other medicinal products and other forms of interaction

Salbutamol and non-selective β-blocking medicinal products such as propranolol, should not usually be prescribed together.

4.6 Fertility, pregnancy and lactation

Pregnancy

Administration of medicinal products during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.

As with the majority of medicinal products, there is little published evidence of the safety of salbutamol in the early stages of human pregnancy, but in animal studies there was evidence of some harmful effects on the fetus at very high dose levels.

Breast-feeding

As salbutamol is probably secreted in breast milk, its use in nursing mothers requires careful consideration. It is not known whether salbutamol has a harmful effect on the neonate, and so its use should be restricted to situations where it is felt that the expected benefit to the mother is likely to outweigh any potential risk to the neonate.

Fertility

There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in animals (see section 5.3).

4.7 Effects on ability to drive and use machines

None reported.

4.8 Undesirable effects

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Very common and common events were generally determined from clinical trial data. Rare, very rare and unknown events were generally determined from spontaneous data.