Flixotide Diskus

/ GSK

This formulation of   50, 100, 250, 500 mcg is indicated for the Prophylactic management of all grades of asthma. This formulation of   250 mcg and 500 mcg are also indicated for the symptomatic treatment of Chronic Obstructive Pulmonary Disease (COPD).
Dosage: Asthma: The onset of therapeutic effect is 4 to 7 days, although some benefit may be apparent as soon as 24 hours for patients who have not previously received inhaled steroids. If patients find that relief with short-acting bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought.
Adults and children over 16 years of age: 100 – 1000 micrograms twice daily. Patients should be given a starting dose of inhaled fluticasone propionate which is appropriate for the severity of their disease:
Mild asthma: 100 to 250 micrograms twice daily.
Moderate asthma: 250 to 500 micrograms twice daily.
Severe asthma: 500 to 1000 micrograms twice daily. The dose may then be adjusted until control is achieved or reduced to the minimum effective dose, according to the individual response. Alternatively, the starting dose of fluticasone propionate may be gauged at half the total daily dose of beclomethasone dipropionate or equivalent as administered by metered-dose inhaler.
Children over 4 years of age: 50 -100 micrograms twice daily. Children should be given a starting dose of inhaled fluticasone propionate which is appropriate for the severity of their disease; this may be 50 to 100 micrograms twice daily.Many children’s asthma will be well controlled using the 50 to 100 mcg twice daily dosing regimen. For those patients whose asthma is not sufficiently controlled, additional benefit may be obtained by increasing the dose up to 200 mcg twice daily. The dose may then be adjusted until control is achieved or reduced to the minimum effective dose according to the individual response.
Chronic Obstructive Pulmonary Disease (COPD: Adult dose: 500 micrograms twice daily. Medication must be used daily for optimum benefit which may take three to six months. If there is no improvement after three to six months then the patient should undergo medical assessment. Only the 250 or 500 microgram devices are suitable for the administration of this dose.

This formulation of 50, 100, 250, 500 mcg is indicated for the Prophylactic management of all grades of asthma. This formulation of   250 mcg and 500 mcg are also indicated for the symptomatic treatment of Chronic Obstructive Pulmonary Disease (COPD).

Hypersensitivity to the active substance or to any of the excipients.

The management of asthma should follow a stepwise programme and patient response should be monitored clinically and by lung function tests. Increasing use of short-acting inhaled β2-agonists to control asthma 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 increasing corticosteroid dosage. In patients considered at risk, daily peak flow monitoring may be instituted. This formulation is not for use in acute asthma attacks, but for routine long-term management. Patients will require a fast- and short-acting inhaled bronchodilator to relieve acute asthmatic symptoms. Lack of response or severe exacerbations of asthma should be treated by increasing the dose of inhaled fluticasone propionate and, if necessary, by giving a systemic steroid and/or an antibiotic if there is an infection.
Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is important, therefore, that the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored. Certain individuals can show greater susceptibility to the effects of inhaled corticosteroid than do most patients. Because of the possibility of impaired adrenal response, patients transferring from oral steroid therapy to inhaled fluticasone propionate therapy should be treated with special care, and adrenocortical function regularly monitored. Following introduction of inhaled fluticasone propionate, withdrawal of systemic therapy should be gradual. Similarly replacement of systemic steroid treatment with inhaled therapy may unmask allergies such as allergic rhinitis or eczema previously controlled by the systemic drug. These allergies should be symptomatically treated with antihistamine and/or topical preparations, including topical steroids. Treatment with this formulation should not be stopped abruptly. There have been very rare reports of increases in blood glucose levels and this should be considered when prescribing to patients with a history of diabetes mellitus. As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with a fast and short-acting inhaled bronchodilator. Fluticasone propionate should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. 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.

Candidiasis of mouth and throat, pneumonia (in COPD patients).
See prescribing information for full details.

Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after inhaled dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450 3A4 in the gut and liver. Hence, clinically significant drug interactions mediated by fluticasone propionate are unlikely. See prescribing information for full details.

Pregnancy: There are limited data in pregnant women. Administration of fluticasone propionate during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Lactation: The excretion of fluticasone propionate into human breast milk has not been investigated.
See prescribing information for full details.

Symptoms and Signs: Acute inhalation of fluticasone propionate doses in excess of those approved may lead to temporary suppression of the hypothalamic-pituitary-adrenal axis. This does not usually require emergency action, as normal adrenal function typically recovers within a few days. If higher than approved doses are continued over prolonged periods, significant adrenocortical suppression is possible. There have been very rare reports of acute adrenal crisis occurring in children exposed to higher than approved doses (typically 1000 micrograms daily and above), over prolonged periods (several months or years); observed features included hypoglycaemia and sequelae of decreased consciousness and/or convulsions. Situations which could potentially trigger acute adrenal crisis include exposure to trauma, surgery, infection or any rapid reduction in dosage.
Treatment: Patients receiving higher than approved doses should be managed closely and the dose reduced gradually.