Posology : מינונים

4.2    Posology and method of administration

Posology
Route of administration: Inhalation use.


Patients should be made aware that Seretide Diskus must be used daily for optimum benefit, even when asymptomatic.

Patients should be regularly reassessed by a doctor, so that the strength of Seretide they are receiving remains optimal and is only changed on medical advice.

Patients should be given the strength of Seretide containing the appropriate fluticasone propionate dosage for the severity of their disease. If an individual patient should require dosages outside the recommended regimen, appropriate doses of β2 agonist and/or corticosteroid should be prescribed.

Recommended Doses:

Asthma
Adults and adolescents 12 years and older:

One inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily.
or
One inhalation of 50 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily.
or
One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.

The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Where the control of symptoms is maintained with the lowest strength of the combination given twice daily then the next step could include a test of inhaled corticosteroid alone.

As an alternative, patients requiring a long-acting β2 agonist could be titrated to Seretide given once daily if, in the opinion of the prescriber, it would be adequate to maintain disease control. In the event of once daily dosing when the patient has a history of nocturnal symptoms the dose should be given at night and when the patient has a history of mainly daytime symptoms the dose should be given in the morning.

A short-term trial of Seretide may be considered as initial maintenance therapy in adults or adolescents with moderate persistent asthma (defined as patients with daily symptoms, daily rescue use and moderate to severe airflow limitation) for whom rapid control of asthma is essential. In these cases, the recommended initial dose is one inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily. Once control of asthma is attained treatment should be reviewed and consideration given as to whether patients should be stepped down to an inhaled corticosteroid alone. Regular review of patients as treatment is stepped down is important.

A clear benefit has not been shown as compared to inhaled fluticasone propionate alone used as initial maintenance therapy when one or two of the criteria of severity are missing. In general inhaled corticosteroids remain the first line treatment for most patients. Seretide is not intended for the initial management of mild asthma. Seretide 50 microgram/100 micrograms strength is not appropriate in adults and children with severe asthma; it is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed-combination can be used in patients with severe asthma.

Paediatric population

Children 4 years and older:
One inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily.

The maximum licensed dose of fluticasone propionate delivered by Seretide Diskus in children is 100 microgram twice daily.

There are no data available for use of Seretide in children aged under 4 years.

COPD
Adults:

- One inhalation of 50 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily.
or
One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.

Special patient groups:

There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available for use of Seretide in patients with hepatic impairment.

Using the Diskus:

The device is opened and primed by sliding the lever. The mouthpiece is then placed in the mouth and the lips closed round it. The dose can then be inhaled and the device closed.