Medicinal Products

BECLOMETASONE TEVA 250 μg / dose

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

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.

In mild, persistent childhood asthma, in the absence of definitive data on the effects on growth and bone metabolism of inhaled corticosteroids, it is desirable to initiate ongoing by a cromone before passing, in case of failure, an inhaled corticosteroid treatment.

Dosage BECLOMETASONE TEVA 250 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 between:
in adults: 500 and 1000 μg per day,
in children: 250 and 500 μg per day.

(Light persistent asthma is defined as the presence of daytime symptoms more than once a week and less than once a day and / or nocturnal symptoms more than twice a month, PEG or FEV1> 80% 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 mimetic beta2 action short, a PEFR 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 adults: 2000 μg per day,
in children: 1000 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, 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 on one week.

Rhythm of administration

The daily dose can be 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.

For correct use, it is desirable that the doctor ensures the proper use of the device.

If the patient is shown to have a poor hand / lung synchronization preventing the coordination of the inspiration / release movements of the apparatus, the use of an inhalation chamber is indicated.

After shaking the device and removing the cap, 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,

· The mouthpiece of the propulsion device must, for hygienic reasons, be cleaned after use.

Against indications

Intolerance to this medication (occurrence of cough or bronchospasm after inhalation of the product). In this case it will be necessary to interrupt this treatment and to prescribe other therapies or other forms of administration.

Adverse effects Beclometasone Teva

Local effects

· 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, raucousness of the way, which can be prevented by rinsing the mouth after inhalation of the product;

· 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

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

· Inhalant corticosteroids have been described with observations of cutaneous thinning, subcutaneous hematomas, depression of adrenal biological functions (decreased plasma cortisol and 24-hour cortisoluria) and bone scarcity. The clinical consequences of long-term administration, particularly on bone tissue and growth, are not clearly established. The administration of large doses in the long term may therefore require monitoring especially in children and the elderly.

In the current state of knowledge, although the search for the minimum effective dosage is always recommended, the risk to consider as a priority is that of insufficient control of asthma and should always 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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