Medicinal Products

BECLOSPRAY 50 μg / dose

Generic drug of the therapeutic class: Pneumology
active ingredients: Beclometasone
laboratory: Chiesi

Solution for oral inhalation
Pressurized bottle of 200 doses
All forms

Indication

Continuous anti-inflammatory treatment of persistent asthma * .

* Persistent asthma is defined as the presence of multi-weekly diurnal symptoms and / or nocturnal symptoms more than twice a month.

Dosage BECLOSPRAY 50 μg / dose Solution for oral inhalation Pressurized bottle of 200 Doses

Dosage

The dosage is strictly individual. The initial dose will be determined according to the severity of the disease before treatment and will then be adjusted according to the individual results.

The minimum effective dosage should always be sought.

For information:

In mild to moderate persistent asthma the recommended starting dose is:

· In children: between 250 and 500 μg per day.

· In adults: between 500 and 1000 μg per day,

The mild persistent asthma is defined by the existence of diurnal symptoms more than once a week and less than once a day and / or nocturnal symptoms more than twice a month, a peak expiratory flow (PEF) or a forced expiratory volume per second (FEV1) greater than 80% of predicted values, variability of DEP * between 20 and 30%.

Moderate persistent asthma is defined as the presence of daily diurnal symptoms, seizures affecting activity and sleep, nocturnal asthma symptoms more than once a week, daily use of inhaled beta-2 mimetics. short course, a PEF or FEV1 between 60 and 80% predicted values, a variability of DEP * greater than 30%.

In severe persistent asthma the recommended starting dose is up to:

· In children: 1000 μg per day.

· In adults: 2000 μg per day,

Severe persistent asthma is defined as permanent symptoms, frequent seizures, frequent nocturnal asthma symptoms, physical activity limited by asthma symptoms, PEG or FEV1 less than 60% of predicted values., variability of DEP * greater than 30%.

* the variability of the DEP is evaluated on the day DEP of the evening - DEP of the morning)
1/2 (DEP of the evening + DEP of the morning)

or over a week.

The more highly dosed presentations are better suited for administering high dosages.

Rhythm of administration

The daily dose is usually divided into 2 doses per day.

In unstable asthma, the dose and number of doses should be increased to 3 to 4 doses per day depending on the clinical condition of the patient.

Administration mode

Inhalation by dispenser with mouthpiece.

It is desirable for the physician to ensure, by itself, the correct use of the inhalation system by the patient.

In small children and in general, when it is highlighted in the patient a poor hand / lung synchronization preventing the coordination of the movements inspiration / release of the apparatus, the use of a chamber of inhalation adapted is indicated.

After shaking the device and removing the cap from the mouthpiece the patient should:

· To exhale deeply,

· Present the mouthpiece at the entrance to the mouth, the bottom of the metal cartridge facing up,

· Begin to inhale by pressing on the metal cartridge while continuing to inhale slowly and deeply,

· Remove the mouthpiece and hold its breath for at least 10 seconds,

· Rinse the mouth after inhalation of the product,

· The mouthpiece of the propellant must, for hygienic reasons, be cleaned after use, after removing the cartridge, rinse the tip with warm water, dry and replace the cartridge,

· Replace the protective cap on the mouthpiece.

If the device is used for the first time or if it has not been used for at least three days, release a puff in the air without inhaling the puff expelled, to ensure its proper functioning.

Against indications

Intolerance to this medication (occurrence of cough or bronchospasm after inhalation of the product). In this case, this treatment should be discontinued and other therapies or other forms of administration prescribed.

Adverse effects Beclospray

· Possibility of oropharyngeal candidiasis. It usually gives way spontaneously or to appropriate treatment and it is exceptional that it requires the discontinuation of inhaled corticosteroid therapy. Its risk of appearance increases with the dose used and the number of shots. It can be prevented by rinsing the mouth with water after inhalation.

· Possibility of occurrence of pharyngeal discomfort, dysphonia, hoarseness of the voice, can be prevented by rinsing the mouth after inhalation.

· As with other inhaled products, possibility of coughing and rarely bronchospasm following inhalation. In this case, treatment should be discontinued and other therapies or other forms of administration prescribed.

· Systemic effects may occur during long-term treatment with high doses (see Warnings and Precautions section ).

· Have been described with inhaled corticosteroid therapy observations of cutaneous thinning, subcutaneous hematomas, depression of adrenal biological functions (decrease in plasma cortisol and 24-hour cortisoluria), loss of bone tissue, slow growth, cataracts and glaucoma.

· Long-term high doses may therefore require special monitoring in children and elderly patients.

· The search for the minimum effective dosage should always be recommended considering the risk of insufficient control of asthma that must be weighed against that of systemic impact.

· Very rare frequency: cataract and glaucoma.

· Psychiatric disorders:

Frequency not known: psychomotor hyperactivity, sleep disorders, anxiety, depressive syndrome, aggressiveness, behavioral disorders (mainly observed in children).

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