Salflusol MDI Dosage/Direction for Use

Posology: Route of administration: Inhalation use.
Patients should be made aware that Salmeterol + Fluticasone (Salflusol MDI) must be used daily for optimum benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the strength of Salmeterol + Fluticasone (Salflusol MDI) they are receiving remains optimal and is only changed on medical advice. 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 Salmeterol + Fluticasone (Salflusol MDI) 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.
Patients should be given the strength of Salmeterol + Fluticasone (Salflusol MDI) containing the appropriate fluticasone propionate dosage for the severity of their disease. Note: Salmeterol + Fluticasone (Salflusol MDI) 25 microgram/50 microgram strength is not appropriate for adults and children with severe asthma. If an individual patient should require dosages outside the recommended regimen, appropriate doses of β2 agonist and/or corticosteroid should be prescribed.
Recommended Doses: Adults and adolescents 12 years and older: ^aTwo inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily, or ^aTwo inhalations of 25 micrograms salmeterol and 125 micrograms fluticasone propionate twice daily, or ^aTwo inhalations of 25 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily.
A short-term trial of Salmeterol + Fluticasone (Salflusol MDI) 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 two inhalations of 25 micrograms salmeterol and 50 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. Salmeterol + Fluticasone (Salflusol MDI) is not intended for the initial management of mild asthma. Salmeterol + Fluticasone (Salflusol MDI) 25 micrograms/50 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: ^aTwo inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily.
The maximum licensed dose of fluticasone propionate delivered by Salmeterol + Fluticasone (Salflusol MDI) inhaler in children is 100 microgram twice daily. There are no data available for use of Salmeterol + Fluticasone (Salflusol MDI) in children aged under 4 years.
Children <12 years old may have difficulties synchronising aerosol actuation with inspiration of breath. Use of a spacer device with Salmeterol + Fluticasone (Salflusol MDI) is recommended in patients who have, or are likely to have difficulties to coordinate actuation with inspiration.
Patients should be instructed in the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled drug to the lungs. Patients should continue to use the same make of spacer device as switching between spacer devices can result in changes in the dose delivered to the lungs (see Precautions).
Re-titration to the lowest effective dose should always follow the introduction or change of a spacer device.
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 Salmeterol + Fluticasone (Salflusol MDI) in patients with hepatic impairment.