FLIXOTIDE EVOHALER 125 MCG [SIN11347P]

Product Info

FLIXOTIDE EVOHALER 125 MCG

[SIN11347P]

Indication

Indications

ASTHMA

FLIXOTIDE has a marked anti-inflammatory effect in the lungs.

It reduces symptoms and exacerbations of asthma in patients previously treated with bronchodilator alone or with other prophylactic therapy.

Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited physical capacity, and PEF values below 60% predicted at baseline with greater than 30% variability, usually not returning entirely to normal after a bronchodilator. These patients will require high dose inhaled (see Dosage and Administration) or oral corticosteroid therapy. Sudden worsening of symptoms may require increased corticosteroid dosage which should be administered under urgent medical supervision.

• Adults

Prophylactic management in:

• Mild asthma (PEF values greater than 80% predicted at baseline with less than 20% variability): Patients requiring intermittent symptomatic bronchodilator asthma medication on more than an occasional basis.

• Moderate asthma (PEF values 60–80% predicted at baseline with 20–30% variability): Patients requiring regular asthma medication and patients with unstable or worsening asthma on currently available prophylactic therapy or bronchodilator alone.

• Severe asthma (PEF values less than 60% predicted at baseline with greater than 30% variability): Patients with severe chronic asthma. On introduction of inhaled FLIXOTIDE, many patients who are dependent on systemic corticosteroids for adequate control of symptoms may be able to reduce significantly or to eliminate their requirement for oral corticosteroids.

• Children

Any child who requires preventative asthma medication, including patients not controlled on currently available prophylactic medication.

Dosing

Dosage and Administration

Pharmaceutical form: Pressurised metered-dose aerosol

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.

FLIXOTIDE is for inhalation by oral inhalation only.

It is intended that each prescribed dose is given by a minimum of two inhalations.

In patients who find co-ordination of a pressurised metered dose inhaler difficult, a spacer may be used with FLIXOTIDE inhaler.

ASTHMA

The onset of therapeutic effect is four to seven days, although some benefit may be apparent as soon as 24 hours for patients who have not previously received inhaled steroids.

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.

• Adults and children over 16 years of age

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:

The dose may then be adjusted until control is achieved or reduced to the minimum effective dose, according to the individual response.

Alternatively, the starting dose of fluticasone propionate may be gauged at half the total daily dose of beclomethasone dipropionate or equivalent as administered by metered-dose inhaler.

• Children 4 years of age and over

50 to 100 micrograms twice daily.

Children should be given a starting dose of inhaled FLIXOTIDE that is appropriate for the severity of the disease.

The dose may then be adjusted until control is achieved, or reduced to the minimum effective dose, according to individual response.

It should be noted that only the 50 microgram device is suitable for the administration of this dose.

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 aged 1 to 4 years

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, administered via a paediatric spacer device with a face mask (such as the BABYHALER™). 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.

Contraindications

Contraindications

Hypersensitivity to any ingredient of the preparation.