Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom
Salbutamol nebuliser solutions are indicated in adults, adolescents and children aged 4 to 11 years. For babies and children under 4 years of age, see Section 4.2.
Salbutamol is a selective β2-agonist providing short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction.
Salbutamol nebuliser solutions are indicated for use in the routine management of chronic bronchospasm unresponsive to conventional therapy, and in the treatment of acute severe asthma.
2.5 mg to 5 mg 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.
Salbutamol nebulisers solutions 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.
Salbutamol nebuliser solutions 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.
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.
Shelf life:
2 years unopened.
3 months after opening the foil over-wrap.
Store in the original package.
The ampoules should be protected from light after removal from the foil over-wrap.
Plastic polyethylene ampoules in strips of 5 ampoules, with a protective foil over-wrap. Available in boxes containing 20 ampoules.
Nebulisers should be used in a well ventilated room as it is usual for some nebulised drug to be released into the local environment.
Dilution: May be diluted with sterile sodium chloride solution, (normal saline) if required.
For instructions on the use of this product refer to the Patient Information Leaflet.
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