Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Salbutamol is a selective β2-agonist providing short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction.
Ventolin Nebules are indicated for use in the routine management of chronic bronchospasm unresponsive to conventional therapy, and in the treatment of acute severe asthma.
Ventolin Nebules are indicated in adults, adolescents and children 4 to 11 years. For babies and children under 4 years of age see section 4.2.
Ventolin Nebules are for inhalation use only, to be breathed in through the mouth, under the direction of a physician, using a suitable nebuliser.
The solution should not be injected or swallowed.
2.5 mg to 5mg salbutamol up to four times a day. Up to 40 mg per day can be given under strict medical supervision in hospital.
Children aged 12 years and over: Dose as per adult population.
Children aged 4-11 years: 2.5 mg to 5 mg up to four times a day.
Other pharmaceutical forms may be more appropriate for administration in children under 4 years old.
Infants under 18 months old: Clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain. As transient hypoxia may occur supplemental oxygen therapy should be considered.
Ventolin Nebules are intended to be used undiluted. However, if prolonged delivery time (more than 10 minutes) is required, the solution may be diluted with sterile normal saline.
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 and lactic acidosis (see sections 4.4 and 4.8).
Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.
Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting beta-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting of overdose.
3 years if unopened.
3 months after removal from the foil overwrap, (see below).
Ventolin Nebules should be stored below 30°C. The Nebules should be protected from light after removal from the foil tray.
Low density polyethylene ampoules available in boxes of 20 in strips of 5.
The nebulised solution may be inhaled through a face mask, T-piece or via an endotracheal tube. Intermittent positive pressure ventilation (IPPV) 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 some nebulised drug will be released into the local environment. Ventolin Nebules should therefore be administered in a well-ventilated room, particularly in hospitals when several patients may be using nebulisers at the same time.
Dilution: Ventolin Nebules may be diluted with sterile normal saline. Solutions in nebulisers should be replaced daily.
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