Ventolin Inhaler CFC Free

/ GSK

Adults (including the elderly): For the relief of acute asthma symptoms including bronchospasm, one inhalation (100 micrograms) may be administered as a single minimum starting dose. This may be increased to two inhalations if necessary. To prevent allergen- or exercise-induced symptoms, two inhalations should be taken 1015 minutes before challenge.
For chronic therapy, two inhalations up to four times a day.
Paediatric Population
Relief of acute bronchospasm
The usual dosage for children under the age of 12 years: one inhalation (100 micrograms). The dose may be increased to two inhalations if required.
Children aged 12 years and over: Dose as per adult population.
Prevention of allergen or exercise-induced bronchospasm
The usual dosage for children under the age of 12 years: one inhalation (100 micrograms) before challenge or exertion. The dose may be increased to two inhalations if required.
Children aged 12 years and over: Dose as per adult population.
Chronic therapy
The usual dosage for children under the age of 12 years: up to two inhalations 4 times daily.
Children aged 12 years and over: Dose as per adult population.
The spacer device may be used to facilitate administration to children under 5 years of age.
On-demand use of Ventolin Inhaler should not exceed 8 inhalations in any 24 hours. Reliance on such frequent supplementary use, or a sudden increase in dose, indicates poorly controlled or deteriorating asthma.
For full details see prescribing information.

Relief and prevention of symptoms of asthma.

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, inhaled salbutamol preparations are not appropriate for managing premature labour. Salbutamol preparations should not be used for threatened abortion. Ventolin Inhaler is contra-indicated in patients with a history of hypersensitivity to any of the components.

Patients inhaler technique should be checked to make sure that aerosol actuation is synchronised with inspiration of breath for optimum delivery of drug to the lungs. Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment, including lungfunction 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. The dosage or frequency of administration should only be increased on medical advice. If a previously effective dose of inhaled salbutamol fails to give relief lasting at least three hours, the patient should be advised to seek medical advice. Increasing use of bronchodilators, in particular short-acting inhaled 2-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 the patient should be assessed and consideration given to the need for increased antiinflammatory 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. 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. 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.
Salbutamol should be administered cautiously to patients with thyrotoxicosis. Potentially serious hypokalaemia may result from 2-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.

Paradoxical bronchospasm. Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely. Cardiac arrhythmias, potentially serious hypokalemia. Fine tremor of skeletal muscle, usually in the hands. Tachycardia, with or without peripheral vasodilatation, may rarely occur. Headaches, mouth and throat irritation, rare reports of muscle cramps.
For full details see prescribing information.

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

Studies in animals have shown reproductive toxicity. Safety in pregnant women has not been established. No controlled clinical trials with salbutamol have been conducted in pregnant women. Rare reports of various congenital anomalies following intrauterine exposure to salbutamol (including cleft palate, limb defects and cardiac disorders) have been received. Some of the mothers were taking multiple medications during their pregnancies. Ventolin Inhaler should not be used during pregnancy unless clearly necessary. 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.

The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events, including tachycardia, tremor, hyperactivity and metabolic effects including hypokalaemia.
Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.
Consideration should be given to discontinuation of treatment and appropriate symptomatic therapy such as cardio-selective beta-blocking agents in patients presenting with cardiac symptoms (e.g. tachycardia, palpitations). Beta-blocking drugs should be used with caution in patients with a history of bronchospasm.