Advertisement
Advertisement
Xalflu

Xalflu Dosage/Direction for Use

salmeterol + fluticasone

Manufacturer:

Mega Lifesciences

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Posology: Route of administration: Inhalation use.
Patients should be made aware that salmeterol and fluticasone propionate dry powder inhaler must be used daily for optimum benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the strength of salmeterol and fluticasone propionate they are receiving remains optimal and is only changed on medical advice.
Patients should be given the strength of salmeterol and fluticasone propionate 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.
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 and fluticasone propionate 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 salmeterol and fluticasone propionate 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. Salmeterol and fluticasone propionate is not intended for the initial management of mild asthma. Salmeterol and fluticasone propionate 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 salmeterol and fluticasone propionate dry powder inhaler in children is 100 microgram twice daily.
There are no data available for use of salmeterol and fluticasone propionate in children aged under 4 years.
COPD: Adults: The recommended dosage for patients with COPD: One inhalation of 50 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily may be a consideration in patients who are at a greater risk of inhaled corticosteroid adverse effects.
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 and fluticasone propionate in patients with hepatic impairment.
Using the inhaler: Salmeterol and fluticasone propionate dry powder inhaler must be used correctly in order to achieve effective treatment. All patients must be advised to read the patient information leaflet carefully and follow the instructions for use as detailed in the leaflet. All patients must be trained by the prescribing health care professional on how to use the inhaler, especially if this is their first time in using this inhaler. This is to ensure that they understand how to use the inhaler correctly.
The use of inhaler follows three simple steps, which are outlined as follows: The device is opened by depressing the red safety lock and primed by sliding the light pink (for 50/100 microgram strength) or pink (for 50/250 microgram strength) mouthpiece cover until a "click" is heard.
The mouthpiece is then placed in the mouth and the lips closed round it. The dose can then be inhaled through the inhaler by breathing in steadily and deeply. The inhaler is then removed from the mouth and the patient must hold their breath for about 10 seconds or as long as is comfortable.
The patient must then be instructed to breathe out gently and close the inhaler cover until a "click" is heard.
Patients must also be advised to rinse their mouth afterwards with water and spit it out and/or brush their teeth after inhaling.
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement