Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
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 section 4.2) or oral corticosteroid therapy. Sudden worsening of symptoms may require increased corticosteroid dosage which should be administered under urgent medical supervision.
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 other 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.
Children who require prophylactic asthma medication.
Becotide Evohaler is for oral inhalation use only.
Patients should be made aware of the prophylactic nature of therapy with inhaled beclometasone dipropionate and that it should be taken regularly even when they are asymptomatic.
The dosage of beclometasone dipropionate should be adjusted according to the individual response.
If patients find that short-acting relief bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought.
In patients who find co-ordination of a pressurised metered dose inhaler difficult, a spacer may be used with Becotide Evohaler.
The Babyhaler spacer device is available for use in young children.
Patients should be given a starting dose of inhaled beclometasone dipropionate, which is appropriate for the severity of their disease based on the following guidance:
Mild asthma: 200 to 600 micrograms per day in divided doses.
Moderate asthma: 600 to 1000 micrograms per day in divided doses.
Severe asthma: 1000 to 2000 micrograms per day in divided doses.
The dose may then be adjusted until control is achieved or reduced to the minimum effective dose according to the individual response.
Up to 400 micrograms per day in divided doses.
Children should be given a starting dose of inhaled beclometasone dipropionate, 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.
There is no need to adjust the dose in older people or in those with hepatic or renal impairment.
Before using for the first time or if the inhaler has not been used for three days or more: Remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhaler well, and release one puff into the air to make sure that it works.
1. Remove the mouthpiece cover by gently squeezing the sides of the cover.
2. Check the inside and outside of the inhaler including the mouthpiece for the presence of loose objects.
3. Shake the inhaler well to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed.
4. Hold the inhaler upright between fingers and thumb with your thumb on the base, below the mouthpiece.
5. Breathe out as far as is comfortable and then place the mouthpiece in your mouth between your teeth and close your lips around it but do not bite it.
6. Just after starting to breathe in through your mouth press down on the top of the inhaler to release beclometasone dipropionate while still breathing in steadily and deeply.
7. While holding your breath, take the inhaler from your mouth and take your finger from the top of the inhaler. Continue holding your breath for as long as is comfortable.
8. If you are to take further puffs keep the inhaler upright and wait about half a minute before repeating steps 3 to 7.
9. Replace the mouthpiece cover by firmly pushing and snapping the cap into position.
IMPORTANT:
Do not rush stages 5, 6 and 7. It is important that you start to breathe in as slowly as possible just before operating your inhaler. Practise in front of a mirror for the first few times. If you see mist coming from the top of your inhaler or the sides of your mouth you should start again from stage 2.
If your doctor has given you different instructions for using your inhaler, please follow them carefully. Tell your doctor if you have any difficulties.
The inhaler should be cleaned at least once a week:
Pull the metal canister out of the plastic casing of the inhaler and remove the mouthpiece cover.
Wipe the plastic casing and mouthpiece with a damp cloth.
Leave to dry in a warm place. Avoid excessive heat.
Replace the canister and mouthpiece cover.
DO NOT PUT THE METAL CANISTER INTO WATER.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
There is no specific treatment for an overdose of beclometasone dipropionate. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Acute inhalation of beclometasone dipropionate doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not need emergency action as adrenal function is recovered in a few days, as verified by plasma cortisol measurements.
However, if higher than recommended dosage is continued over prolonged periods, some degree of adrenal suppression may result. Monitoring of adrenal reserve may be necessary. In cases of beclometasone dipropionate overdose, therapy may still be continued at clinically appropriate dosage (within the approved range) for symptom control.
2 years.
Do not store above 30°C.
Protect from frost and direct sunlight. Do not refrigerate or freeze.
As with most inhaled medications in aerosol canisters, the therapeutic effect of this medication may decrease when the canister is cold.
The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. The canister should not be punctured, broken or burnt, even when apparently empty.
The inhaler comprises an aluminium can fitted with a 50 microlitre metering valve, plastic actuator and dust cap. Each canister contains 200 metered doses.
Any used medicinal product or waste material should be disposed of in accordance with local requirements. Patients should be carefully monitored in the proper use of their inhaler.
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