FLIXOTIDE is for administration by oral inhalation only. It is intended that each prescribed dose is given by a minimum of 2 inhalations.
In patients who find coordination of a pressurised metered-dose inhaler difficult, a spacer may be used with FLIXOTIDE Inhaler.
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. The onset of therapeutic effect is within 4 to 7 days.
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.
The dosage of fluticasone propionate should be adjusted according to the individual response.
Adults and adolescents 16 years of age and older: 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.
Children 4 to <16 years of age: 50 to 200 micrograms twice daily.
It should be noted that only the 50 microgram device is suitable for the administration of this dose.
Many children's asthma will be well controlled using the 50 to 100 micrograms twice daily dosing regime. For those patients whose asthma is not sufficiently controlled, additional benefit may be obtained by increasing the dose up to 200 micrograms twice daily.
Children should be given a starting dose of inhaled FLIXOTIDE which is appropriate for the severity of their disease. The dose may then be adjusted until control is achieved or reduced to the minimum effective dose according to the individual response.
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 12 months to 4 years of age: 100 micrograms twice daily administered via a paediatric spacer device with a face mask.
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. Higher doses of inhaled drug are required in younger children compared to older children because of reduced efficiency of drug delivery due to smaller airways, use of a spacer device and increased nasal breathing.
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.