Ventolin Nebules

Ventolin Nebules Special Precautions

salbutamol

Manufacturer:

GlaxoSmithKline Indonesia
Full Prescribing Info
Special Precautions
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 beta2 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. VENTOLIN Nebules must only be used by inhalation, to be breathed in through the mouth, and must not be injected or swallowed. Patients receiving treatment at home with VENTOLIN Nebules must 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.
VENTOLIN Nebules should be used with caution in patients known to have received large doses of other sympathomimetic drugs. VENTOLIN should be administered cautiously to patients with thyrotoxicosis. A small number of cases of acute angle closure glaucoma have been reported in patients treated with a combination of nebulised VENTOLIN and ipratropium bromide. A combination of nebulised VENTOLIN with nebulised anticholinergics should therefore be used cautiously. Patients should receive adequate instruction in correct administration and be warned not to let the solution or mist enters the eye. Potentially serious hypokalaemia may result from beta2 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.
As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator, if immediately available. VENTOLIN nebules should be discontinued, and if necessary a different fast-acting bronchodilator instituted for ongoing use. In common with other beta-adrenoceptor agonists, VENTOLIN 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.
Lactic acidosis has been reported very rarely in association with high therapeutic doses of intravenous and nebulised short-acting beta-agonist therapy, mainly in patients being treated for an acute asthma exacerbation (see Side Effects). Increase in lactate levels may lead to dyspnoea and compensatory hyperventilation, which could be misinterpreted as a sign of asthma treatment failure and lead to inappropriate intensification of short-acting beta-agonist treatment. It is therefore recommended that patients are monitored for the development of elevated serum lactate and consequent metabolic acidosis in this setting.
Use in pregnancy & lactation: Fertility: There is no information on the effects of VENTOLIN on human fertility. There were no adverse effects on fertility in animals.
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. During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb defects have been reported in the offspring of patients being treated with salbutamol. Some of the mothers were taking multiple medications during their pregnancies. As no consistent pattern of defects can be discerned, and baseline rate for congenital anomalies is 2-3%, a relationship with salbutamol use cannot be established.
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.
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