Treatment of persistent asthma (mild, moderate and severe)

Inhaled exclusively.

To be effective, Bemedrex Easyhaler should be used regularly.
The initial dose administered to the patient will be determined according to the severity of the disease before treatment.
The recommended starting dose in patients with mild asthma (stage 2) is 400 micrograms / day and may be increased to 800 micrograms / day if necessary.

In the asthma patient, moderate (Tier 3) to severe (Tier 4), the initial dose may be 800 to 1600 micrograms / day. The dose will then be adjusted according to the individual results, always looking for the minimal dosage to maintain control of asthma.
(Note: doses up to 2000 micrograms / day of beclometasone in adults and up to 1000 micrograms per day of beclometasone in children are recommended in the consensus report; Asthma).

Bemedrex Easyhaler 200 micrograms / dose

In adults: the usual maintenance dose is one to two inhalations (200 to 400, micrograms) twice a day. If necessary, the dose can be increased up to 1600 micrograms / day, in two to four doses, and then reduced when the asthma is stabilized.
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Child 6-12 years: one inhalation (200 micrograms) twice daily depending on clinical response. In the most severe cases, the daily dose may be increased to 800 micrograms / day, divided into two to four times daily, and then reduced when the asthma is stabilized.

The therapeutic effect is observed after a few days of treatment and reached a maximum after a few weeks.
When starting treatment, by Easyhaler in a patient previously treated by another, the treatment must be adapted. The nature of the active ingredient and the method of administration must be taken into account.

It will be necessary to explain to the patient how to use the device by recommending to him to inspire, thoroughly by the device and never to expire in it.
Glucocorticoids. ATC code R03BA01

Beclometasone dipropionate is a synthetic steroid derivative. It exerts a powerful anti-inflammatory effect on the respiratory mucosa when administered locally. Long-term studies have shown that in patients with asthma, after the initiation stage of treatment with inhaled beclometasone, systemic corticosteroid therapy can be gradually decreased. There is no evidence of lesions of the mucosa, tracheobronchial or increased incidence of respiratory infections induced by treatment.

The exact mechanism of the anti-inflammatory action of beclometasone dipropionate is not known.

No effect on the ability to drive and use machinery has been observed.
A history of hypersensitivity to beclometasone dipropionate or to any of the components (see section Composition).
For proper use, it is desirable for the physician to ensure proper use of the device by the patient, and the patient should be advised that Bemedrex Easyhaler should be administered regularly to exercise its effect Maximum and shall not be interrupted abruptly

This medication is not intended to treat an asthma attack.

If acute asthma symptoms develop, a short-acting beta-2 mimetic bronchodilator should be used. If a patient increases his intake of bronchodilators, beta-2 mimics of short duration of action by inhaled route to treat his symptoms, he must fear decompensation of his disease. If short-acting bronchodilator therapy appears to be less effective or requires a larger dose than usual, a doctor should be consulted. After clinical examination, it will be necessary to re-evaluate the therapeutic conduct and consider the need to increase the treatment, anti-inflammatory: increased corticosteroids, inhaled or oral corticosteroid treatment. The severe exacerbations of asthma will be treated according to the usual recommendations.

Inhaled corticosteroids may have systemic effects, particularly in cases of prescription of high doses over prolonged periods. These effects are less likely than with oral corticosteroids. Possible systemic effects include Cushing's syndrome, manifestations, cushingoids, axial restraint, hypophyso-adrenal, growth retardation in children, and adolescent, decreased density, bone mineral , The occurrence of cataracts or glaucoma and, more rarely, changes in psychological and behavioral status including hyperactivity, psychomotor disorders, sleep disorders, anxiety, depression or aggression (particularly in children ). It is therefore important to always seek the minimal dosage of inhaled corticosteroid to maintain control of asthma.

It is advisable to regularly monitor the size of children who receive prolonged treatment with inhaled corticosteroids. In the event of slower growth, treatment should be re-evaluated by, if possible, endeavoring to reduce the dosage of inhaled corticosteroids to the minimum level necessary to maintain effective control of asthma. It will also be necessary to consider referring the patient to a pneumo-pediatrician.

Treatments prolonged by high doses of inhaled corticosteroids, in particular, when superior to those recommended, may cause the clinically significant pituitary-adrenal axis to slow down. A concomitant treatment with corticosteroid therapy should be considered during periods of stress or in case of scheduled surgery

Particular attention is needed in patients with viral, bacterial and fungal infections: ocular, buccal or respiratory infections. In case of respiratory infection, bacterial origin, antibiotic treatment may be necessary.

Special attention and appropriate treatment are recommended before the start of treatment with beclometasone in patients with pulmonary tuberculosis

Inhalation therapy may very occasionally result in bronchospasm after administration. In this case, treatment with Bemedrex Easyhaler should be discontinued immediately and, if necessary, replaced with another one.
Weaning of oral corticosteroids and switching to inhaled corticosteroid therapy should only be considered with caution and in stabilized patients. Inhaled corticosteroid therapy should then be introduced without altering the oral dose of oral corticosteroids. After about one week, the daily dose of oral corticosteroids may be gradually decreased. It is desirable that, during weaning, patients with altered cortico-adrenal function may have a card indicating that complementary general corticosteroids may be required during periods of stress, such as For example, during surgery, infection or exacerbation of asthmatic disease

When replacing oral corticosteroid therapy by inhaled corticosteroids, allergic reactions can be exacerbated.

During the first two weeks of weaning, some patients sometimes report feeling discomfort while their respiratory function remains the same or improves. These patients should be encouraged to continue treatment based on Bemedrex Easyhaler.

No interaction with other medicines has been reported. In the case of concomitant use with intranasal or systemic corticosteroids, the systemic (pituitary, pituitary-adrenal) repercussions of corticosteroid therapy may be potentiated.
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Not applicable.

The acute toxicity of beclometasone dipropionate is low. Even in the case of accidental administration of large doses, no emergency measures need be considered. The treatment will be resumed at the recommended doses in the treatment of asthma

Pregnancy

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

In the human species, epidemiological studies did not detect 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.
Breastfeeding

Corticosteroids pass into the milk, but due to the low systemic passage, when administered by inhalation, there is no reason to expect significant levels in maternal milk. >

The undesirable effects reported are presented in the table below

Uncommon side effects (> 1/100; 1/10 000;