Continuous anti-inflammatory treatment of persistent asthma *.

* Persistent asthma is defined by the existence of diurnal, multi-weekly symptoms and / or nocturnal symptoms more than 2 times a month.


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.


In persistent asthma, mild to moderate initial dose is recommended

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

· In adults: between 500 and 1000 μg per day

Light persistent asthma is defined by the existence of diurnal symptoms more than 1 times a week and less than 1 times a day and / or nocturnal symptoms more than twice a month, peak expiratory flow ( DEP) or a maximum expiratory volume per second (FEV1) greater than 80% of the predicted values, a variability of DEP * between 20 and 30%.
Persistent, moderate asthma is defined as the existence of daily diurnal symptoms, crises resounding on: activity and sleep, asthma symptoms, nocturnal more than once a week, daily use of beta -2 inhaled mimics of action, short, DEP or FEV1 of between 60 and 80% of the predicted values, variability of DEP * greater than 30%
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In persistent asthma, severe the recommended initial dose, is up to

· In children: 1000 μg per day.

· In adults: 2000 μg per day

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

* The variability of the DEP, is evaluated on the day, DEP in the evening - DEP in the morning) 1/2 (DEP in the evening + DEP in the morning) Code>
Or over a week.

The stronger dosage formulations are better suited for the administration of high dosages.

Rhythm of administration

The daily dose is usually divided into 2 doses per day.
In the case of unstable asthma, the dose and number of catches should be increased to 3 to 4 doses per day depending on the clinical condition of the patient. >

Mode of administration

Inhalation by distributor with mouthpiece.

It is desirable that the physician ensure by himself the correct use of the inhalation system by the patient.

In small children and in general, when there is evidence of poor synchronization in the patient, hand / lung prevents coordination of movement, inspiration / triggering of the device, use of , The appropriate inhalation chamber is indicated.

After stirring the appliance and removing the cap from the mouthpiece the patient should

· Expire, deeply

· Present the mouthpiece at the entrance of the mouth, the bottom of the metal cartridge pointing upwards

· Start inspiring by pressing on the metal cartridge while continuing, inspiring slowly and deeply

· Remove mouthpiece and hold breath for at least 10 seconds

· Rinse mouth after inhalation of the product

· The mouthpiece of the appliance must be cleaned after use after removing the cartridge, rinsing the nozzle with water, warm, drying and replacing the cartridge < Code>
· Replace the protective cap on the mouthpiece.

If the device is used for the first time or 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.

Pharmacotherapeutic group: Inhaled glucocorticoid, asthmatic

ATC code: R03BA01

(R: respiratory system)

Inhalation dipropionate of beclometasone exerts a mainly local anti-inflammatory effect on the mucosa, bronchial. In adults, its brake effect on the pituitary adrenal axis only occurs at a dose of 2000 μg or more per 24 hours.



Not applicable.

Intolerance to this drug (occurrence of cough or bronchospasm, after inhalation of the product). In this case, it shall be necessary to discontinue such treatment and to prescribe other therapeutics or other forms of administration.

Special warnings

Prevent the patient that this drug is not intended to curb a declared asthma attack, but is a continuous treatment of the background of the asthmatic disease to be continued regularly, daily and at prescribed doses, and Effects on the symptoms of asthma, will be felt only after a few days to a few weeks.
If, despite proper treatment, paroxysmal dyspnea occurs, the use of a beta-2 bronchodilator, short-acting inhaled mimetic, should be used to treat acute symptoms. It will be advisable to inform the patient and to inform him that an immediate medical consultation is necessary if, in this case, the relief usually obtained is not rapidly observed after inhalation of the beta-2 mimetic bronchodilator.

If a patient develops within a few days a rapid increase in his consumption of rapid-acting mimetic beta-2 bronchodilators, and short-lived by inhalation, there is a risk (especially if peak flow-meter values; Lowering and / or becoming irregular), decompensation of its disease and the possibility of an evolution towards severe acute asthma (state of asthma). >
The physician should also inform the patient of the need in this case for immediate consultation. The therapeutic conduct should then be re-evaluated.

The patient should be warned that the improvement of his clinical condition should not lead to a modification of his treatment, in particular to the cessation of inhaled corticosteroid therapy without medical advice. >

The attention of sportsmen and sportswomen will be drawn to the fact that this specialty contains an active ingredient which can induce a positive reaction of the tests carried out during anti-doping tests. Code>
Precautions for use

In case of bronchial infection or abundant bronchorrhoea, appropriate treatment is necessary in order to promote the optimal diffusion of the product into the airways.

In the event of destabilization of asthma or inadequate control of exacerbations of asthma despite maximum doses of inhaled corticosteroids, treatment with short-course general corticosteroid therapy should be contemplated. It is then necessary to maintain the inhaled corticosteroid associated with the treatment, generally.



Care should therefore be taken to ensure that the minimum effective dosage is maintained in order to maintain control of asthma.

Joint administration of inhaled corticosteroids in asthmatics with long-term oral corticosteroids (patients with corticosteroids) does not provide precautions, necessary when reducing doses of oral corticosteroid. These will be diminished very gradually and the weaning will have to be carried out under careful medical supervision (in the search for the appearance of signs of insufficiency, acute or subacute adrenal) prolonging; Corticosteroids by the general route.

Patients should be informed that this medicinal product contains low amounts of ethanol and glycerol. However, at the usual dosages, the amounts of ethanol and glycerol are negligible.

Not applicable.

Not applicable.

Use of this medicament at doses well in excess of recommended doses reflects a worsening of the respiratory condition requiring prompt consultation for therapeutic re-evaluation.

Pregnancy

Dipropionate of beclometasone

In animal experiments, there is evidence of teratogenic effect of corticosteroids by species.

In the human species, epidemiological studies have not detected any malformative risk associated with the use of corticosteroids during the first trimester although there is a transplacental passage. >

In chronic diseases requiring treatment throughout pregnancy, mild intrauterine growth retardation is possible, neonatal adrenal insufficiency has been exceptionally observed after systemic high-dose corticosteroids. It seems justified to observe a period of clinical monitoring (weight, diuresis) and biological of the newborn.
Norflurane (tetrafluoroethane or HFA 134a): gas, propellant

The study of reproductive functions in animals did not demonstrate any adverse effect of the administration of norflurane (tetrafluoroethane or HFA 134a) contained in this drug. In the absence of teratogenic effect in animals, a malformative effect in the human species is not expected. However, there are currently no relevant or sufficient data to evaluate a possible malformative or fetotoxic effect of norflurane when administered during pregnancy. >

Breastfeeding

Dipropionate of beclometasone

The corticosteroids pass into the milk.

Norflurane (tetrafluoroethane or HFA 134a): gas, propellant

The passage of the propellant gas (HFA 134a) and its metabolites into milk is not known.

Possibility of occurrence of oropharyngeal candidiasis It usually yields spontaneously or to appropriate treatment and it is exceptional that it requires the cessation of inhaled corticosteroid therapy. Its risk of onset increases with the dose used and the number of catches. It can be prevented by rinsing the mouth with water, after inhalation.

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

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

· Systemic effects may occur during treatment with long-term treatment with high doses (see section 4.4).


Therefore, administration of large doses in the long term may require monitoring especially in children and elderly subjects.

· Very rare frequency: cataract and glaucoma.

· Psychiatric disorders

Frequency not known, psychomotor hyperactivity, sleep disorders, anxiety, depressive syndrome, aggression, behavioral disorders (mainly observed in children)
Continuous anti-inflammatory treatment of persistent asthma * Persistent asthma is defined by the existence of diurnal, multi-weekly and / or nocturnal symptoms more than 2 times a month. >