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Therapeutic Category
- RESPIRATORY TRACT DRUGS
- Pharmaceutical Form : Solutions for Inhalation
- Composition : Each 2.5ml ampoule contains: 2.5mg or 5.0mg of salbutamol (as salbutamol sulphate).
- Active Substance : salbutamol
COMPOSITION
Each 2.5ml ampoule contains: 2.5mg or 5.0mg of salbutamol (as salbutamol sulphate).
PROPERTIES:
Salbutamol is a selective β2-agonist providing short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction.
At therapeutic doses it acts on the β2-adrenoceptors of bronchial muscle. With its fast onset of action, it is particularly suitable for the management and prevention of attack in asthma.
INDICATIONS
Salbutamol Nebuliser Solution is indicated in adults, adolescents and children aged 4 years and above.
Salbutamol Nebuliser Solution is indicated for use in the routine management of chronic bronchospasm unresponsive to conventional therapy and the treatment of acute severe asthma.
CONTRAINDICATIONS
Hypersensitivity to the active substance salbutamol or to the excipients.
Although some forms of salbutamol sulfate have been used in the management of premature labour, Salbutamol Nebuliser Solution should not be used for this purpose. Salbutamol Nebuliser Solution should not be used in threatened abortion.
WARNINGS:
Salbutamol Nebuliser Solution is for use with a nebuliser under the direction of a physician. The solution must not be injected or administered orally.
In patients with severe or unstable asthma, bronchodilators should not be the only or main treatment. Regular medical assessment is required including lung function testing, as they are at risk of severe attacks and even death.
Oral corticosteroid therapy and/or inhaled corticosteroids should be considered. Increasing use of bronchodilators to relieve symptoms indicates deterioration of asthma control.
In the following cases, salbutamol should only be used with caution and if strictly indicated:
– serious cardiac disorders, in particular recent myocardial infarction
– coronary heart disease, hypertrophic obstructive cardiomyopathy and tachyarrhythmia
– severe and untreated hypertension
– aneurysm
– hyperthyroidism
– diabetes which is difficult to control
– pheochromocytoma
UNDESIRABLE EFFECTS:
Immune system disorders
Very rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse
Metabolism and nutrition disorders
Rare: Hypokalaemia.
Unknown: Lactic acidosis
Nervous system disorders
Common: Tremor, headache.
Very rare: Hyperactivity.
Cardiac disorders
Common: Tachycardia.
Uncommon: Palpitations
Very rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles
Unknown: Myocardial ischaemia
Vascular disorders
Rare: Peripheral vasodilatation.
Respiratory, thoracic and mediastinal disorders
Very rare: Paradoxical bronchospasm.
Gastrointestinal disorders
Uncommon: Mouth and throat irritation.
Musculoskeletal and connective tissue disorders
Uncommon: Muscle cramps.
DOSAGE& ADMINISTRATON:
Adults
The usual starting dose is 2.5mg as a single dose. This may be increased to 5mg. Treatment may be repeated up to four times a day.
For the treatment of severe airways obstruction in adult hospitalised patients, higher doses up to 40mg per day can be given under strict medical supervision.
In domiciliary practice the benefits of increasing the dosage should be weighed against the risk that deterioration in the patient’s underlying condition may be masked. In this case a medical assessment should be considered and alternative therapy instituted where indicated.
Pediatric Population
Children aged 12 years and over: Dose as per adult population.
Children aged 4 to 11 years: 2.5mg to 5mg up to four times a day.
Other pharmaceutical forms may be more appropriate for administration in children under 4 years old.
Clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain. As transient hypoxaemia may occur, supplemental oxygen therapy should be considered.
Salbutamol Nebuliser Solution is designed to be used undiluted. However, if a prolonged delivery time is indicated (more than 10 minutes) then dilution with Sodium Chloride Solution (0.9%w/v) for Nebulisation or sterile sodium chloride injection (normal saline) may be required.
STORAGE CONDITIONS
Store below 25°C. Store in the original packaging.
Ampoules should be opened immediately before use and any solution remaining after use should be discarded
PACKAGING:
2.5 mL single dose polyethylene plastic ampoules packed in cartons to contain 5 ampoules
2.5 mL single dose polyethylene plastic ampoules packed in cartons to contain 25 ampoules