VENTOLIN should be administered cautiously to patients with thyrotoxicosis.
Evohaler/Respirator Solution/Nebule/Infusion: 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 short-acting inhaled bronchodilators, in particular beta2-agonists to relieve symptoms indicates deterioration of asthma control. Under these conditions, 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. In patients considered at risk, daily peak flow monitoring may be instituted.
Syrup/Evohaler/Respirator Solution/Nebule: Potentially serious hypokalaemia may result from beta2-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 by hypoxia. It is recommended that serum potassium levels are monitored in such situations.
Syrup/Respirator Solution/Nebule/Infusion: In common with other beta-adrenoceptor agonists, VENTOLIN can induce reversible metabolic changes, for example increased blood glucose levels. The diabetic patient may be unable to compensate for this and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.
Syrup/Respirator Solution/Nebule: Patients should be warned that if either the usual relief 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. 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.
Respirator Solution/Nebule: VENTOLIN must only be used by inhalation, to be breathed in through the mouth, and must not be injected or swallowed.
VENTOLIN should be used with caution in patients known to have received large doses of other sympathomimetic drugs.
A small number of cases of acute angle closure glaucoma have been reported in patients treated with a combination of nebulised VENTOLIN and ipratropium bromide. A combination of nebulised VENTOLIN 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.
Respirator Solution/Nebule/Infusion: Lactic acidosis has been reported very rarely in association with high therapeutic doses of intravenous and nebulised short-acting beta-agonist therapy, mainly in patients being Lactic acidosis has been reported very rarely 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 Adverse Reaction). 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.
Evohaler/Respirator Solution/Nebule: As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator, if immediately available. VENTOLIN should be discontinued, and if necessary a different fast-acting bronchodilator instituted for ongoing use.
Syrup: 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 Ventolin syrup becomes less effective.
The dosage or frequency of administration should only be increased on medical advice.
Patients taking Ventolin syrup may also be receiving short-acting inhaled bronchodilators to relieve symptoms.
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.
In this situation patients should be reassessed and consideration given to the need for increased anti-inflammatory therapy (eg. Higher doses of inhaled corticosteroids or a course of oral corticosteroid). Severe exacerbations of asthma must be treated in the normal way.
Ventolin Syrup contains 5.6 mg sodium in each 5 ml of syrup. This should be taken into consideration by patients on a controlled sodium diet. Ventolin syrup is sugar free.
Evohaler: In the event of a previously effective dose of inhaled VENTOLIN failing to give relief for at least three hours, the patient should be advised to seek medical advice in order that any necessary additional steps may be taken.
The patient's inhaler technique should be checked to make sure that the aerosol actuation is synchronised with inspiration of breath for optimum delivery of the drug to the lungs.
Infusion: The use of VENTOLIN parenteral preparations in the treatment of severe bronchospasm or status asthmaticus does not obviate the requirement for glucocorticoid steroid therapy as appropriate.
When practicable, administration of oxygen concurrently with parenteral VENTOLIN is recommended, particularly when it is given by intravenous infusion to hypoxic patients.
Diabetic patients and those concurrently receiving corticosteroids should be monitored frequently during intravenous infusion of VENTOLIN so that remedial steps (e.g. an increase in insulin dosage) can be taken to counter any metabolic change occurring. For these patients, VENTOLIN Solution for Intravenous Infusion should be diluted with Sodium Chloride Injection BP, rather than Sodium Chloride and Dextrose Injection BP.
Obstetric use only: In the treatment of premature labour, before VENTOLIN parenteral preparations are given to any patient with known or suspected heart disease, an adequate assessment of the patient's cardiovascular status should be made by a physician experienced in cardiology.
Tocolysis with VENTOLIN parenteral preparations is not recommended when membranes have ruptured or the cervix has dilated beyond 4 cm.
Tocolysis: Serious adverse reactions including death have been reported after administration of terbutaline/salbutamol to women in labor. In the mother, these include increased heart rate, transient hyperglycaemia, hypokalaemia, cardiac arrhythmias, pulmonary oedema and myocardial ischemia. Increased fetal heart rate and neonatal hypoglycaemia may occur as a result of maternal administration.
As maternal pulmonary oedema and myocardial ischaemia have been reported during or following treatment of premature labour with beta2-agonists, careful attention should be given to fluid balance and cardio-respiratory function, including ECG should be monitored. If signs of pulmonary oedema or myocardial ischaemia develop, discontinuation of treatment should be considered (see Dosage & Administration and Adverse Reactions).
In the treatment of premature labour by intravenous infusion of VENTOLIN increases in maternal heart rate of the order 20 to 50 beats per minute usually accompany the infusion. The maternal pulse rate should be monitored and not normally allowed to exceed a sustained rate of 120 beats per minute. The effect of infusion on foetal rate is less marked but increases of up to 20 beats per minute may occur.
Cautious use of salbutamol injections is required in pregnant patients when it is given for relief of bronchospasm so as to avoid interference with uterine contractibility.
Maternal blood pressure may fall slightly during the infusion; the effect being greater on diastolic than on systolic pressure. Falls in diastolic pressure are usually within the range of 10 to 20 mmHg.
Effects on the Ability to Drive and Use Machines: None known/reported.