1. Name of the medicinal product
2. Qualitative and quantitative composition
Each 5 ml contains 2 mg Salbutamol (as Salbutamol Sulfate BP).
Excipient with known effect:
For the full list of excipients, see section 6.1
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
Ventolin syrup is indicated in adults, adolescents and children aged 2 to 12 years.
Salbutamol is a selective beta-2 adrenoceptor agonist providing short-acting (4-6 hour) bronchodilation in reversible airways obstruction. Ventolin syrup can be used in the management of asthma, bronchospasm and/or reversible airways obstruction.
Relief of bronchospasm in bronchial asthma of all types.
Ventolin syrup is suitable oral therapy for children and adults who are unable to use an inhaler device.
4.2 Posology and method of administration
Route of administration: oral
The minimum starting dose is 2mg three times a day given as 5ml syrup. The usual effective dose is 4mg (10ml syrup) three or four times a day, which may be increased to a maximum of 8mg (20ml syrup) three or four times a day if adequate bronchodilation is not obtained.
In elderly patients or in those known to be unusually sensitive to beta-adrenergic stimulant drugs, it is advisable to initiate treatment with the minimum starting dose.
2 - 6 years: the minimum starting dose is 1mg as 2.5ml of syrup three times daily. This may be increased to 2mg as 5ml of syrup three or four times daily.
6 - 12 years: the minimum starting dose is 2mg as 5ml syrup three times daily. This may be increased to four times daily.
Over 12 years: the minimum starting dose is 2mg three times daily given as 5ml syrup. This may be increased to 4mg as 10ml syrup three or four times daily.
Ventolin is well tolerated by children so that, if necessary, these doses may be cautiously increased to the maximum dose.
For lower doses the syrup may be diluted with freshly prepared purified water BP.
Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Non-i.v. formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion.
4.4 Special warnings and precautions for use
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.
Patients should be warned that if either the usual relief with Ventolin oral preparations 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.