Foxair

Foxair is indicated in the regular treatment of asthma where use of a combination product (long-acting β₂ agonist and inhaled corticosteroid) is appropriate:

- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short- acting β₂ agonist

or

- patients already adequately controlled on both inhaled corticosteroid and long-acting β₂ agonist

Posology

Route of administration: Inhalation use.

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

Patients should be regularly reassessed by a doctor, so that the strength of Foxair 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 Foxair 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 Foxair containing the appropriate fluticasone propionate dosage for the severity of their disease. Note: Foxair 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:

- Two inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily.

or

- Two inhalations of 25 micrograms salmeterol and 125 micrograms fluticasone propionate twice daily.

or

- Two inhalations of 25 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily.

A short-term trial of Foxair 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. Foxair is not intended for the initial management of mild asthma. Foxair 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:

- Two inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily.

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

There are no data available for use of Foxair inhaler 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 Foxair inhaler is recommended in patients who have, or are likely to have difficulties to coordinate actuation with inspiration. A recent clinical study has shown that paediatric patients using a spacer achieved exposure similar to adults not using spacer and paediatric patients using Diskus, confirming that spacers compensate for poor inhaler technique.

Either the Volumatic or AeroChamber Plus spacer device can be used (depending on National Guidance). Limited data are available that demonstrate an increase in systemic exposure when the AeroChamber Plus spacer device is used compared with the Volumatic spacer device.

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.

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 Foxair in patients with hepatic impairment.

Instructions for Use

Patients should be instructed in the proper use of their inhaler (see patient information leaflet)

During inhalation, the patient should preferably sit or stand. The inhaler has been designed for use in a vertical position.

Testing the inhaler:

Before using for the first time patients should remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhaler well, hold the inhaler between the fingers and thumb with their thumb on the base, below the mouthpiece and release puffs into the air until the counter reads 120 to make sure that it works. The inhaler should be shaken immediately before releasing each puff. If the inhaler has not been used for a week or more the mouthpiece cover should be removed, the patient should shake the inhaler well and should release two puffs into the air. Each time the inhaler is activated the number on the counter will count down by one.

Use of the inhaler:

1. Patients should remove the mouthpiece cover by gently squeezing the sides of the cover

2. Patients should check inside and outside of the inhaler including the mouthpiece for the presence of loose objects.

3. Patients should shake the inhaler well to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed

4. Patients should hold the inhaler upright between fingers and thumb with their thumb on the base, below the mouthpiece.

5. Patients should breathe out as far as is comfortable and then place the mouthpiece in their mouth between their teeth and close their lips around it, Patients should be instructed not to bite the mouth piece.

6. Just after starting to breathe in through their mouth, patients should press firmly down on the top of the inhaler to release Foxair, while still breathing in steadily and deeply.

7. While holding their breath, patients should take the inhaler from their mouth and take their finger from the top of the inhaler. Patients should continue holding their breath for as long as is comfortable.

8. To take a second inhalation, patients should keep the inhaler upright and wait about half a minute before repeating steps 3 to 7.

9. Patients should immediately replace the mouthpiece cover in the correct orientation by firmly pushing and snapping the cap into position. This does not require excessive force, the cover should click into position.

IMPORTANT

Patients should not rush stages 5, 6 and 7. It is important that patients start to breathe in as slowly as possible just before operating their inhaler. Patients should practise in front of a mirror for the first few times. If they see "mist" coming from the top of their inhaler or the sides of their mouth they should start again from stage 3.

Patients should rinse their mouth out with water and spit out, and/or brush their teeth after each dose of medicine, in order to minimise the risk of oropharyngeal candidiasis and hoarseness.

Patients should consider getting a replacement when the counter shows the number 020. The counter will stop at 000 when all the recommended puffs have been used. Replace the inhaler when the counter reads 000.

Patients should never try to alter the numbers on the counter or detach the counter from the metal canister. The counter cannot be reset and is permanently attached to the canister.

Cleaning (also detailed in patient information leaflet):

Your inhaler should be cleaned at least once a week.

1. Remove the mouth piece cover.

2. Do not remove the canister from the plastic casing.

3. Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue.

4. Replace the mouthpiece cover in the correct orientation. This does not require excessive force, the cover should click into position.

DO NOT PUT THE METAL CANISTER IN WATER