Ventolin Diskus

/ GSK

Adults (including the elderly): For the relief of acute asthma symptoms including bronchospasm, 100 mcg may be administered (with Ventolin Inhaler CFC Free) as a single minimum starting dose. This may be increased to 200 mcg if necessary. To prevent allergen or exercise-induced symptoms, 200 mcg should be taken 10-15 minutes before challenge. For chronic therapy, 200mcg up to four times a day.
Children: For the relief of acute asthma symptoms including bronchospasm, or before allergen exposure or exercise, 100 mcg (with Ventolin Inhaler CFC Free), or 200 mcg if necessary. For chronic therapy, 200 mcg up to four times a day.
On-demand use of Ventolin Diskus should not exceed four times daily (800 mcg in any 24 hours). Reliance on such frequent supplementary use, or a sudden increase in dose, indicates poorly controlled or deteriorating asthma.
For full details see prescribing information.

Relief of bronchospasm in broncial asthma of all types, chronic, bronchitis and emphysema.

• Hypersensitivity to the active substance or any of the excipients.
• Severe milk-protein allergy.

Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment, including lung-function testing, as patients are at risk of severe attacks and even death. Physicians should consider using the maximum recommended dose of inhaled corticosteroid and/or oral corticosteroid therapy in these patients.

Patients who are prescribed regular anti-inflammatory therapy (e.g., inhaled corticosteroids) should be advised to continue taking their anti-inflammatory medication even when symptoms decrease, and they do not require salbutamol.

Increasing use of bronchodilators, in particular short-acting inhaled b2-agonists to relieve symptoms, indicates deterioration of asthma control, and patients should be warned to seek medical advice as soon as possible. Under these conditions, the patient’s therapy plan should be reassessed.

Overuse of short-acting beta-agonists may mask the progression of the underlying disease and contribute to deteriorating asthma control, leading to an increased risk of severe asthma exacerbations and mortality.

Patients who take more than twice a week “as needed” salbutamol, not counting prophylactic use prior to exercise, should be re-evaluated (i.e., daytime symptoms, night-time awakening, and activity limitation due to asthma) for proper treatment adjustment as these patients are at risk for overuse of salbutamol.

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.

The patient should be instructed to seek medical advice if short-acting relief bronchodilator treatment becomes less effective, or more inhalations than usual are required. In the event of a previously effective dose of inhaled salbutamol now failing to give relief for a duration of at least three hours following administration, the patient should be advised to promptly seek medical advice in order that any necessary additional steps may be taken. In this situation the patient should be assessed and consideration given to the need for increased anti-inflammatory therapy

(e.g., higher doses of inhaled corticosteroid or a course of oral corticosteroid).

Severe exacerbations of asthma must be treated in the normal way.

Cardiovascular effects may be seen with sympathomimetic drugs, including 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.
Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis.

Increasing use of b2-agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient’s therapy plan may be required and concomitant corticosteroid 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.

Potentially serious hypokalaemia may result from b2-agonist therapy, mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect maybe potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids and diuretics. Serum potassium levels should be monitored in such situations.

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator. Ventolin Diskus should be discontinued immediately, the patient assessed, and if necessary, a different fast-acting bronchodilator instituted for on-going use.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
See prescribing information for full details.

Common: Tremor, headache, tachycardia,
For full details see prescribing information.

Salbutamol and non-selective β-blocking drugs such as propranolol, should not usually be prescribed together.

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 fetus. As with the majority of drugs, there is little published evidence of the safety of salbutamol in the early stages of human pregnancy, but in animal studies there was evidence of some harmful effects on the fetus at very high dose levels.
Breast-feeding: As salbutamol is probably secreted in breast milk, its use in nursing mothers requires careful consideration. It is not known whether salbutamol has a harmful effect on the neonate, and so its use should be restricted to situations where it is felt that the expected benefit to the mother is likely to outweigh any potential risk to the neonate.

The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events, including tachycardia, tremor, hyperactivity and metabolic effects including hypokalaemia. 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.