Selective b2 -agonists (beta- agonists, beta-adrenoceptor stimulants).

Salbutamol

200mcg or 400mcg Salbutamol (as Sulphate) per blister.

Unit dose of powder in multidose presentation pack for inhalation use

Salbutamol is a selective ?2 adrenoceptor agonist. At therapeutic doses it acts on the ?2 adrenoceptors of bronchial muscle. With its fast onset of action, it is particularly suitable for the relief of acute asthma symptoms and the prevention of exercise induced asthma. Salbutamol provides short-acting (4-6 hour) bronchodilation with fast onset (within 5 minutes) in reversible airways obstruction. Ventodisks should be used to relieve symptoms when they occur and to prevent them in those circumstances recognised by the patient to precipitate an asthma attack (e.g. before exercise or unavoidable allergen exposure). Ventodisks are particularly valuable as relief medication in mild, moderate or severe asthma, provided that reliance on it does not delay the introduction and use of regular inhaled corticosteroid therapy.

Route of Administration

Ventodisks are for administration by the inhaled route only using a ventolin diskhaler.

Adults

For the relief of acute asthma symptoms 200 micrograms or 400 micrograms may be taken administered as a single dose.

The maximum dose is 400 micrograms four times daily.

To prevent allergen- or exercise-induced symptoms, 400 micrograms should be taken 10-15 minutes before exertion.

The recommended dose for relief of acute bronchospasm or before allergen exposure or exercise is 200 micrograms. The maximum daily dose is 200 micrograms four times a day.

The normal adult dose is applicable.

On-demand use of Ventodisks should not exceed four times daily. Reliance on such frequent supplementary use, or a sudden increase in dose, indicates deteriorating or poorly controlled asthma (see precautions).

Although intravenous salbutamol, and occasionally salbutamol tablets, are used in the management of premature labour, uncomplicated by conditions such as placenta praevia, ante-partum haemorrhage, or toxaemia of pregnancy, salbutamol preparations are not appropriate for managing premature labour. Salbutamol preparations should not be used for threatened abortion.

Ventodisks are contra-indicated in patients with a history of hypersensitivity to any of the components.

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 oral corticosteroid therapy and/or the maximum recommended dose of inhaled corticosteroid in these patients.

Increasing use of bronchodilators in particular β₂-agonists to relieve symptoms indicates deterioration of asthma control. If patients find that short acting relief bronchodilator treatment with ventodisks becomes less effective or they need more inhalations than usual, medical attention must be sought.

In this situation patient should be reassessed and consideration given to the need for increased anti-inflammatory therapy (e.g. higher doses of inhaled corticosteroids or a course of oral corticosteroids). Severe exacerbations of asthma must be treated in the normal way.

In the event of a previously effective dose of inhaled salbutamol failing to give relief lasting at least three hours, the patient should be advised to seek medical advice in order that any necessary additional treatment may be instituted.

As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice.

Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis.

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

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 hypoxia and by concomitant treatment with xanthine derivatives, steroids and diuretics. Serum potassium levels should be monitored in such situations.

None known

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (1/10), common (1/100 and <1/10), uncommon (1/1000 and <1/100), rare (1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports. Very common and common events were generally determined from clinical trial data. Rare and very rare events were generally determined from spontaneous data.

Immune system disorders

Very rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse

Metabolism and nutrition disorders

Rare: Hypokalaemia.

Potentially serious hypokalaemia may result from beta₂ agonist therapy.

Nervous system disorders

Common: Tremor, headache.

Very rare: Hyperactivity.

Cardiac disorders

Common: Tachycardia.

Uncommon: Palpitations.

Very rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.

Vascular disorders

Rare: Peripheral vasodilatation.

Respiratory, thoracic and mediastinal disorders

Very rare: Paradoxical bronchospasm.

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. Ventodisks should be discontinued immediately, the patient assessed, and, if necessary, alternative therapy instituted.

Gastrointestinal disorders

Uncommon: Mouth and throat irritation.

Musculoskeletal and connective tissue disorders

Uncommon: Muscle cramps.

Allen & Hanburys

(POM)

26 March 2009