VENTOLIN RESPIRATOR SOLUTION 0.5% W/V [SIN02988P]
Active ingredients: VENTOLIN RESPIRATOR SOLUTION 0.5% W/V
Product Info
VENTOLIN RESPIRATOR SOLUTION 0.5% W/V
[SIN02988P]
Product information
Active Ingredient and Strength | SALBUTAMOL SULPHATE EQV SALBUTAMOL - 0.5% W/V |
Dosage Form | SOLUTION |
Manufacturer and Country | GLAXO WELLCOME OPERATIONS - UNITED KINGDOM |
Registration Number | SIN02988P |
Licence Holder | GLAXOSMITHKLINE PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | R03AC02 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
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).
Dosing
Dosage and Administration
Pharmaceutical form: Nebuliser solution/Respirator solution.
VENTOLIN Respirator solution is administered by the inhaled route only, to be breathed in through the mouth.
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 corticosteroid therapy should be considered (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice.
VENTOLIN Respirator Solution has a duration of action of 4 to 6 hours in most patients.
The solution must not be injected or swallowed.
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 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.
VENTOLIN Respirator Solution is to be used with a respirator or nebuliser, only under the direction of a physician.
Routine management of Chronic bronchospasm (unresponsive to conventional therapy) and Treatment of acute severe asthma (Status Asthmaticus)
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.
Contraindications
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.
