Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2017 Publisher: Rex Medical Ltd, 67L Elizabeth Knox Place, Panmure, AUCKLAND Ph (09) 574 6060 Fax (09) 574 6070
Salbutamol is a selective β2 adrenoceptor agonist. At therapeutic doses it acts on the β2 adrenoceptors of bronchial muscle, with little or no action on the heart. With its fast onset of action, it is particularly suitable for the management and prevention of attack in asthma.
Bronchodilators should not be the only or the main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited physical capacity, and PEF values below 60% predicted at baseline with greater than 30% variability, usually not returning entirely to normal after a bronchodilator. These patients will require high dose inhaled (e.g. >1mg/day beclomethasone dipropionate) or oral corticosteroid therapy. Sudden worsening of symptoms may require increased corticosteroid dosage which should be administered under urgent medical supervision.
Asthalin is indicated for use in the routine management of chronic bronchospasm – unresponsive to conventional therapy and in the treatment of acute severe asthma (status asthmaticus).
Salbutamol has a duration of action of 4 to 6 hours in most patients. Asthalin is intended to be used undiluted. However, if prolonged delivery time is desirable (more than 10 minutes) dilution using sterile normal saline for injection as a diluent may be required.
Asthalin is to be used with a nebuliser, under the direction of a physician. The solution must not be injected or swallowed.
Increasing use of β2 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 agent will be released in the local environment. Asthalin should therefore be administered in a well ventilated room, particularly in hospitals when several patients may be using nebulisers at the same time.
A suitable starting dose of salbutamol by wet inhalation is 2.5 milligrams. This may be increased to 5 milligrams. Treatment may be repeated four times daily. In adults higher dosing, up to 40 milligrams per day, can be given under strict medical supervision in hospital for the treatment of severe airways obstruction.
Clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain. As transient hypoxaemia may occur, supplemental oxygen therapy should be considered.
The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events (see Special Warnings and Special Precautions for Use and Undesirable Effects).
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.
Contact the National Poisons Centre on 0800 764 766 for advice on the management of an overdose.
Shelf life is 24 months (2 years) from manufacture.
Asthalin should be stored at a temperature below 25ºC and protected from light.
Asthalin 2.5mg/2.5 ml and 5.0 mg/2.5 ml are available in boxes containing 20 ampoules.
None known.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
