Salbutamol
Ventolin Tablet 2 mg
Ventolin Syrup
Presentation
Ventolin Tablet: White tablets each containing Salbutamol BP 2 mg as sulphate.
Ventolin Syrup: Salbutamol BP 2 mg as sulphate in each 5 ml of a fruit-flavoured, sugar-free syrup, which is devoid of artificial colouring agents.
Uses
Salbutamol BP is a beta-adrenergic stimulant which has a highly selective action on the receptors in bronchial muscle, and in therapeutic dosage, little or no action on the cardiac receptor.
Ventolin Tablet and Ventolin Syrup are indicated for the relief of bronchospasm in bronchial asthma of all types, chronic bronchitis and emphysema. Ventolin Syrup is suitable oral therapy for children or for those adults who prefer liquid medicines.
Because of their selective action on the bronchi and their lack of effects on the cardiovascular system. Ventolin oral preparations are suitable for treating bronchospasm in patients with coexisting heart disease or hypertension.
Dosage and Administration
Posology and method of administration
Salbutamol has aduration of action of 4 to 6 hours in most patients. 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.
As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice.
Adults: The usual effective dose is 4 milligrams Salbutamol (two tablets 2 mg or 10 ml 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 20 ml of syrup (8 milligram Salbutamol).
However, it has been established that some patients obtain adequate relief with 2 mg three or four time daily. In elderly patients or in those known to be unusually sensitive to beta-adrenergic stimulant drugs, it is advisable to initiate treatment with 2 mg three or four times per day.
Children: The following doses should be administered three or four times daily:
2 to 6 years : 1 to 2 mg as 2.5 to 5 ml of syrup or ½ to 1 tablet 2 mg.
6 to 12 years : 2 mg as 5 ml of syrup or 2 mg as 1 tablet 2 mg.
Over 12 years : 2 to 4 mg as 5 ml to 10 ml of syrup or 2 to 4 mg as 1 to 2 tablet 2 mg.
The drug is well tolerated by children so that, if necessary, these doses may be cautiously increased.
Contra-Indications
Ventolin oral preparations and beta-blocking drugs, such as propranolol, should not usually be prescribed together.
Ventolin oral preparations are contra-indicated in patients with a history of hypersensitivity to any of their components.
Precautions
Special warning and special precaution for use
The management of asthma should normally follow a stepwise programme, and patient's 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. 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.
Salbutamol should be administered cautiously to patients with thyrotoxicosis. Potentially serious hypokalaemia may result from beta-2 agonists 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.
As maternal pulmonary oedema has been reported during or following treatment of premature labour with beta-2 agonists, careful attention should be given to fluid balance and cardio-respiratory function monitored.
Interaction with other medicaments and other forms of interaction
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)
Pregnancy and Lactation
Unnecessary administration of drugs during the first trimester of pregnancy is undesirable. 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. Salbutamol has been in widespread use for many years in human beings; this includes its well established use in the management of premature labour. However, as with the majority of drugs, there is little published evidence of its safety in the early stages of human pregnancy, but in animal studies there was evidence of some harmful effects on the foetus.
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,
Side Effects
Ventolin oral preparations may cause a fine tremor of skeletal muscle, usually the hands are most obviously affected. This effect is dose related and is common to all beta-adrenergic stimulants. A few patients experience a feeling of tension; this is also due to the effects on skeletal muscle and not to direct CNS stimulation. Occasionally headaches have been reported.
In patients who are unusually sensitive to beta-adrenergic stimulants, peripheral vasodilatation and a compensatory small increase in heart rate may occur. Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely. There have been very rare reports of transient muscle cramps. Potentially serious hypokalaemia may result from beta-2 agonist therapy. As with other beta-2 agonists hyperactivity has been reported rarely in children.
Overdosage
The preferred antidote for overdosage with Salbutamol is a cardioselective beta-blocking agent.
However, beta-blocking drugs should be used with caution in patients with a history of bronchospasm.
Pharmaceutical Precautions
Storage : Ventolin Syrup and Ventolin Tablet 2 mg should be stored at a temperature not exceeding 30°C. Ventolin Syrup should be protected from light.
Dilution: Ventolin Syrup does not contain sugars. Ventolin Syrup may be diluted with Purified Water BP. The resulting mixture should be protected from light and used within 28 days. A 50% v/v dilution of Ventolin Syrup has been shown to be adequately preserved against microbial contamination. However, to avoid the possibility of introducing excessive microbial contamination, the Purified Water used for dilution should be recently prepared or alternatively it should be boiled and cooled immediately before use. Dilution of Ventolin Syrup with Syrup BP or Sorbitol solution is not recommended as this may result in precipitations of the cellulose thickening agent. Admixture of Ventolin Syrup with other liquid preparations is not recommended.
Legal Category
On medical prescription only.
Further Information
The syrup preparation does not contain sugars, so it is unlikely to predispose to dental caries with long term use.
Ventolin does not cause difficulty in micturition because, unlike sympathomimetic drugs such as ephedrine, it does not stimulate alpha-adrenoceptors.
Package Quantities and Registration Number
Ventolin Tablets 2 mg are supplied in cartons of 3 alufoil blisters of 10 tablets, Reg. No. DKL9232000610A1
Ventolin Syrup is supplied in bottles of 100 ml, Reg. No. DKL9232000537Al.
HARUS DENGAN RESEP DOKTER
Manufactured by
PT. Glaxo Wellcome Indonesia
Jakarta, lndonesia
™Ventolin is a trade mark of the GlaxoSmithKline group of companies
ICT #08, Rl01193 for Tablets
ICT #09, R050494 for Syrup
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