FLIXOTIDE EVOHALER 125 mcg

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Therapeutic

Prescription Only

AEROSOL, SPRAY

**Dosage and Administration** Pharmaceutical form: Pressurised metered-dose aerosol Patients should be made aware of the prophylactic nature of therapy with inhaled _FLIXOTIDE_ and that it should be taken regularly even when they are asymptomatic. _FLIXOTIDE_ is for inhalation by oral inhalation only. It is intended that each prescribed dose is given by a minimum of two inhalations. In patients who find co-ordination of a pressurised metered dose inhaler difficult, a spacer may be used with _FLIXOTIDE_ inhaler. **ASTHMA** The onset of therapeutic effect is four to seven 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 to 1000 micrograms twice daily. Patients should be given a starting dose of inhaled FLIXOTIDE 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 4 years of age and over** 50 to 100 micrograms twice daily. Children should be given a starting dose of inhaled _FLIXOTIDE_ that is appropriate for the severity of the disease. The dose may then be adjusted until control is achieved, or reduced to the minimum effective dose, according to individual response. It should be noted that only the 50 microgram device is suitable for the administration of this dose. This presentation of _FLIXOTIDE_ may not offer the required paediatric dose, in which case an alternative presentation of _FLIXOTIDE_ should be considered (e.g. dry powder inhalers). - **Children aged 1 to 4 years** Inhaled _FLIXOTIDE_ is of benefit to younger children in the control of frequent and persistent asthma symptoms. Clinical trials in 1 to 4 year old children have shown that the optimal control of asthma symptoms is achieved with 100 micrograms twice daily, administered via a paediatric spacer device with a face mask (such as the _BABYHALER_ ™). The diagnosis and treatment of asthma should be kept under regular review. - **Special patient groups** There is no need to adjust the dose in elderly patients or in those with hepatic or renal impairment.