Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
SOLUTION
**Dosage and Administration** _VENTOLIN_ has a duration of action of 4 to 6 hours in most patients. _VENTOLIN_ Respirator Solution is to be used with a respirator or nebuliser, only under the direction of a physician. The solution must not be injected, or swallowed. Increasing use of beta-2 agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient's therapy plan may be required and concomitant glucocorticosteroid therapy should be considered. Delivery of the aerosol may be by facemask, 'T' piece or via an endotracheal tube. Intermittent positive pressure ventilation may be used but is rarely necessary. When there is a risk of anoxia through hypoventilation, oxygen should be added to the inspired air. As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice. As many nebulisers operate on a continuous flow basis, it is likely that nebulised drug will be released in the local environment. _VENTOLIN_ Respirator Solution should therefore be administered in a well-ventilated room, particularly in hospitals when several patients may be using nebulisers in the same space at the same time. **1\. By intermittent administration** Intermittent treatment may be repeated 4 times daily. • **Adults** _VENTOLIN_ Respirator Solution 0.5 to 1.0 ml (2.5 to 5.0 mg of salbutamol) should be diluted to a final volume of 2.0 or 2.5 ml using sterile normal saline as a diluent. The resulting solution is inhaled from a suitably driven nebuliser until aerosol generation ceases. Using a correctly matched nebuliser and driving source this should take about 10 minutes. _VENTOLIN_ Respirator Solution may be used undiluted for intermittent administration. For this, 2.0 ml of _VENTOLIN_ Respirator Solution (10.0 mg salbutamol) is placed in the nebuliser and the patient allowed to inhale the nebulised solution until bronchodilatation is achieved. This usually takes 3 to 5 minutes. Some adult patients may require higher doses of salbutamol, up to 10 mg, in which case nebulisation of the undiluted solution may continue until aerosol generation ceases. • **Children** The same mode of administration for intermittent administration is also applicable to children. The usual dosage for children under the age of 12 years is 0.5 ml (2.5 mg salbutamol) diluted to 2.0 or 2.5 ml using sterile normal saline as diluent. Some children may however require higher doses of salbutamol up to 5.0 mg. Clinical efficacy of nebulised _VENTOLIN_ in infants under 18 months is uncertain. As transient hypoxaemia may occur, supplemental oxygen therapy should be considered. **2\. By continuous administration** _VENTOLIN_ Respirator Solution is diluted using sterile normal saline to contain 50–100 mcg of salbutamol per ml, (1 to 2 ml solution made up to 100 ml with diluent). The diluted solution is administered as an aerosol by a suitably driven nebuliser. The usual rate of administration is 1 to 2 mg per hour.
RESPIRATORY (INHALATION)
Medical Information
**Indications** _VENTOLIN_ Respirator Solution is indicated for the treatment of severe acute asthma (status asthmaticus) and routine management of chronic bronchospasm (unresponsive to conventional therapy).
**Contraindications** _VENTOLIN_ Respirator Solution is contraindicated in patients with a history of hypersensitivity to any of its components. Non-i.v. formulations of _VENTOLIN_ must not be used to arrest uncomplicated premature labour or threatened abortion.
R03AC02
salbutamol
Manufacturer Information
GLAXOSMITHKLINE PTE LTD
GLAXO WELLCOME OPERATIONS
Active Ingredients
Documents
Package Inserts
Ventolin Respirator Solution PI.pdf
Approved: June 24, 2020