SALBUTAMOL

Posology Adults:

The usual effective dose is 4mg three or four times per day. If adequate bronchodilation is not obtained each single dose may be gradually increased to as much as 8mg. However, it has been established that some patients obtain adequate relief with 2mg three or four times daily.

In elderly patients or in those known to be unusually sensitive to beta-adrenergic stimulant drugs, it is advisable to initiate treatment with 2mg three or four times per day.

Children:

The following doses should be administered three or four times daily. 2-6 years: 1-2mg 6-12 years: 2mg Over 12 years: 2-4mg The product is not recommended for children under 2 years of age. The drug is well tolerated by children so that, if necessary, these doses may be cautiously increased.

Method of administration For oral use.

The frequencies of adverse reactions are ranked according to the following MedDRA convention: Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).

System organ class Common Uncommon Rare Very rare Not known Immune system disorders Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse Metabolism and nutrition disorders Hypokalaemia (with high doses) Hyperglycaemia Lactic acidosis Metabolic change Nervous system disorders Tremor Headache Dizziness Hyperactivity Sleep disturbances Cardiac disorders Cardiac arrhythmias* Tachycardia Palpitations Myocardial ischemia Peripheral vasodilation Respiratory, thoracic and mediastinal disorders Pulmonary oedema Gastrointestinal disorders Nausea Vomiting Musculoskeletal and connective tissue disorders Muscle cramps Akathisia Feeling of muscle tension * including atrial fibrillation, supraventricular tachycardia and extrasystoles.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 those patients. Patients should seek medical advice if treatment with salbutamol tablets becomes less effective.

The dosage or frequency of administration should only be increased on medical advice. Patients taking salbutamol tablets may also be receiving short-acting inhaled bronchodilators to relieve symptoms. The management of asthma should normally follow a stepwise programme, and patient response should be monitored clinically and by lung function tests.

Increasing use of bronchodilators in particular short-acting inhaled beta2- 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 they need more inhalations than usual.

g. higher doses of inhaled corticosteroids or a course of oral corticosteroid). Severe exacerbations of asthma must be treated in the normal way. Patients should be warned that if either the usual relief with salbutamol tablets is diminished or the usual duration of action reduced, they should not increase the dose or its frequency of administration, but should seek medical advice.

Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with salbutamol. 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. Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis. Potentially serious hypokalaemia may result from beta-2 agonist therapy mainly from parenteral and nebulized 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. It is recommended that serum potassium levels are monitored in such situations.

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. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose – galactose malabsorption should not take this medicine. Salbutamol tablets contain carmoisine (E122) which may cause allergic reactions.

This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

1. v. formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion.