Bronchial spasm relaxants
= Additional active ingredients
PRESENTATION AND DOSSAGE
BOTTLE: 150 ml
Indicated for relief of bronchospasm in bronchial asthma of all types, chronic bronchitis and emphysema. Salbutamol is a selective beta-2-adrenoceptor agonist. At therapeutic doses it acts on the beta-2-adrenoceptors of bronchial muscle. It is suitable for the management and prevention of attacks in asthma. Bronchodilators should not be the only or 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 a high dose inhaled (e.g. >1mg/day) beclomethasone dipropionate) or oral corticosteroid therapy. Sudden worsening of symptoms may require increased costicosteroid dosage which should be administered under urgent medical supervision. SalbutamolSyrup is suitable for children and adults who prefer liquid drugs.
Patients with a history of hypersensitivity to any of its components. Although intravenous salbutamol and occasionally salbutamol tablets are used in the management of premature labour uncomplicated by conditions such as placenta praevia, ante-partum haemorrhage or toxaemia of pregnancy, salbutamol presentations should not be used for threatened abortion.
The management of asthma should normally follow a stepwise programme, and patient response should be monitored clinically and by lung function tests. Increasing use of short acting inhaled beta-2 agonists to control symptoms indicates deterioration of asthma control. Under these conditions the patient’s therapy plan should be reassessed. Sudden and progressive deterioration in asthma control is potentially life threatening and consideration should be given to starting or increasing corticosteroid therapy. In patients considered at risk, daily peak flow monitoring may be instituted. Potentially serious hypokalaemia may result from beta-2 agonist therapy mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations. Salbutamol should be administered cautiously to patients with thyrotoxicosis. In common with other beta-adrenoceptor agonists, salbutamol can induce reversible metabolic changes, for example increased blood sugar levels. The diabetic patient may be unable to compensate for this and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect. Patients should be warned that if either the usual relief is diminished or the usual duration of action reduced, they should not increase the dose or its frequency of administration, but should seek medical advice. Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from post-marketing data and published literature of myocardial ischaemia associated with salbutamol. Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.
Fine tremor of skeletal muscle, usually the hands. Feelings of tension, headaches. Muscle cramps, palpitations, Hypersensitivity reactions, including angioedema and urticaria, bronchospasm, hypotension. Cardiac arrhythmias.
Salbutamol and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together. Salbutamol is not contra-indicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).
The expected duration of action of a single dose of Salbutamol Syrup is 4 to 6 hours in most patients. As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice.
Populations: 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 glucocorticosteroid therapy should be considered.
Adults: The usual effective dose is 4mg (10ml of syrup) three or four times per day. If adequate bronchodilation is not obtained, each single dose may be gradually increased to as much as 8mg (20ml of syrup). Some patients obtain adequate relief with 5 ml of syrup (2 mg salbutamol) three or four times daily.
2-6 years: The minimum starting dose is 1mg as 2.5ml of syrup three times daily. This may be increased to 2mg as 5ml of the syrup three or four times daily.
6-12 years: The minimum starting dose is 2mg as 5ml syrupthree times daily. This may be increased to four times daily.
Over 12 years: The minimum starting dose is 2mg three times daily given as 5ml syrup. This may be increased to 4mg as 10ml of the syrup three or four times daily. Salbutamol is well tolerated by children so that if necessary, these doses may be cautiously increased to the maximum dose.
Special patient groups: In elderly patients or in those known to be usually sensitive to beta -adrenergic stimulant drugs, it is advisable to initiate treatment with the minimum starting dose of with 5ml of syrup (2 mg salbutamol ) three or four times per day.
The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events. Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored. Nausea, vomiting and hyperglycaemia have been reported, predominantly in children and when salbutamol overdose has been taken via the oral route.
Treatment: Consideration should be given to discontinuation of treatment and appropriate symptomatic therapy such as cardio-selective beta-blocking agents in patients presenting with cardiac symptoms (e.g. tachycardia, palpitations). Beta-blocking drugs should be used with caution in patients with a history of bronchospasm.
PREGNANCY & LACTATION
Pregnancy: Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Lactation: As salbutamol is probably secreted in breast milk its use in nursing mothers is not recommended unless the expected benefits outweigh any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate.
MANUFACTURER & DISTRIBUTER:
License Holder: GlaxoSmithKline Israel Ltd.