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Instructions

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Instruction for use: Beclazone Eco Easi Breath

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ATX Code R03BA01 Beclometasone

Active substance: Beclometasone

Pharmacological group

Glucocorticosteroid for topical use [Glucocorticosteroids]

Nosological classification (ICD-10)

J45 Asthma

Asthma physical effort, status asthmaticus, Bronchial asthma, Asthma lung flow, Bronchial asthma with obstruction of sputum discharge, Bronchial asthma heavy currents, Bronchial asthma physical effort, hypersecretory asthma, Hormone-dependent form of bronchial asthma, Relief of asthma attacks in bronchial asthma, Non-allergic asthma, nocturnal asthma, Exacerbation of asthma, Asthma attacks, Endogenous forms of asthma, Night asthma, Cough with bronchial asthma

Composition and form of release

Beclazone Eco

Aerosol for inhalation dosage 1 dose

active substance:

Beclometasone dipropionate 50 μg

100 μg

250 μg

Auxiliary substances: ethanol; Hydrofluoroalkane (HFA-134a)

200 doses in an aluminum canister with a metering valve, equipped with an inhalation device with a protective cap; In a cardboard bundle 1 cylinder.

Beclazone Eco Easi Breath

Aerosol for inhalation dosage, activated by inhalation 1 dose

active substance:

Beclometasone dipropionate 50 μg

100 μg

250 μg

Auxiliary substances: ethanol; Hydrofluoroalkane (HFA-134a)

200 doses in an aluminum canister located in an aerosol inhaler, activated by inhalation (Easi Breathing); In a cardboard bundle 1 an aerosol inhaler with a can and an optimizer.

Description of dosage form

Beclazone Eco

Aerosol for inhalation in an aluminum can under pressure. There must be no external damage, corrosion or leakage. The contents of the canister leave a spot of white when sprayed onto the glass.

Beclazone Eco Easi Breath

Aerosol for inhalation in an aluminum canister under pressure with an outlet valve and a nebulizer. There must be no external damage, corrosion or leakage. The contents of the can is a solution that when sprayed onto the glass leaves a colorless spot. The balloon is placed in an inhaler consisting of two parts and a safety cover.

pharmachologic effect

Pharmacological action - glucocorticoid, anti-inflammatory local.

Pharmacodynamics

Beclometasone dipropionate is a prodrug and has a weak tropism for GCS receptors. Under the action of esterases, it turns into an active metabolite - B-17-MP, which has a pronounced local anti-inflammatory effect. Reduces inflammation by reducing the formation of the chemotaxis substance (influence on late allergy reactions), inhibits the development of an immediate allergic reaction (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells) and improves mucociliary transport. Under the action of Beclometasone, the number of mast cells in the mucous membrane of the bronchi decreases, the epithelial edema decreases, the mucus secretion by the bronchial glands, the hyperreactivity of the bronchi, the neutrophils peripheral cluster, the inflammatory exudate and the production of lymphokines; The migration of macrophages is inhibited; The intensity of infiltration and granulation processes decreases. Increases the number of active beta-adrenergic receptors, restores the patient's response to bronchodilators, and reduces the frequency of their use. Virtually does not have a resorptive effect after inhalation.

Do not stop bronchospasm, the therapeutic effect develops gradually, usually after 5-7 days of course use Beclometasone dipropionate.

Pharmacokinetics

Absorption

More than 25% of the dose of the inhaled drug Beclazone Eco settles in the airways and up to 56% of the dose of the inhaled drug Beclazone Eco Easi Breath settles in the lower respiratory tract; The remaining amount settles in the mouth, pharynx and is swallowed. In the lungs before absorption of Beclometasone, dipropionate is intensively metabolized to the active metabolite Beclometasone-17-monopropionate (B-17-MP). Systemic absorption of B-17-MP occurs in the lungs (36% of the pulmonary fraction) and in the gastrointestinal tract (26% of the dose received when the dose is ingested). The absolute bioavailability of unchanged Beclometasone dipropionate and B-17-MP is approximately 2% and 62%, respectively, of the inhalation dose. Beclometasone dipropionate is rapidly absorbed, Tmax in blood plasma is 0.3 hours. B-17-MP is absorbed more slowly. Tmax is 1 hour. There is an approximately linear relationship between the increase in the inhaled dose and the system exposure of the drug.

Distribution

The distribution in tissues is 20 liters for Beclometasone dipropionate and 424 liters for B-17-MP. The connection with plasma proteins is relatively high - 87%.

Elimination

Beclometasone dipropionate and B-17-MP have a high plasma clearance (150 and 120 l / h, respectively). T1 / 2 is 0.5 and 2.7 hours, respectively.

Indications

Basic therapy of various forms of bronchial asthma in adults and children older than 4 years.

Contraindications

Hypersensitivity to any component of the drug;

Children's age till 4 years.

With caution: glaucoma, systemic infections (bacterial, including viral, fungal, parasitic), osteoporosis, pulmonary tuberculosis, liver cirrhosis, hypothyroidism, pregnancy, lactation.

pregnancy and lactation

With extreme caution and only if the potential benefit to the mother exceeds the possible risk to the fetus and the baby.

Side effects

Some patients may develop candidiasis of the mouth and throat (the likelihood of developing candidiasis increases with Beclometasone dipropionate in doses exceeding 400 mcg / day).

Some patients may have dysphonia (hoarseness) or irritation of the pharyngeal mucosa. The use of a spacer reduces the likelihood of these side effects.

Inhalation drugs can cause a paradoxical bronchospasm, which must be immediately stopped with a short-acting inhaled β2-adrenostimulator.

There are reports of the development of hypersensitivity reactions, including rashes, hives, itching, redness and swelling of the eyes, face, lips and mucous membranes of the mouth and pharynx.

Possible systemic effects include headache, nausea, bruising or thinning of the skin, unpleasant gustatory sensations, decreased adrenal cortex function, osteoporosis, growth retardation in children and adolescents, cataracts, glaucoma.

Interaction

There is no confirmed data on the interaction of Beclometasone dipropionate with other drugs.

Dosing and Administration

Beclazone Eco and Beclazone Eco Easi Breath are intended only for inhalation.

The drugs are used regularly (even in the absence of symptoms of the disease), the dose of Beclometasone dipropionate is selected taking into account the clinical effect in each specific case.

With an easy course of bronchial asthma, the volume of forced expiration (FEV1) or peak expiratory flow (PSV) is more than 80% of the required values with a PSV score of less than 20%.

In the medium-heavy course of FEV1 or PSV are 60-80% of the required values, the daily spread of PSV indicators is 20-30%.

For severe FEV1 or PSV, 60% of the required values, the daily spread of PSV indicators is more than 30%.

When switching to a high dose of inhaled Beclometasone dipropionate, many patients receiving systemic GCS can reduce their dose or cancel them altogether.

The initial dose of drugs is determined by the severity of bronchial asthma. The daily dose is divided into several doses.

Depending on the individual response of the patient, the dose of drugs can be increased until the appearance of a clinical effect or reduced to the minimum effective dose.

Adults and children aged 12 years and over

Recommended initial doses of drugs:

- bronchial asthma of Easi course - 200-600 mcg / day;

- bronchial asthma of moderate course - 600-1000 mcg / day;

- a bronchial asthma of a heavy current - 1000-2000 mkg / sut.

Treatment of bronchial asthma is based on a stepwise approach - therapy is started according to the stage corresponding to the severity of the disease. Inhaled glucocorticosteroids are prescribed at the second stage of therapy.

Step 2. Basic therapy

Beclometasone dipropionate is 100-400 mcg 2 times a day.

Stage 3. Basic therapy

Inhaled glucocorticosteroids are used in high dose or in a standard dose, but in combination with long-acting inhaled β2-adrenomimetics.

Beclometasone dipropionate in a high dose of 800-1600 mcg / day, in some cases, megadoses up to 2000 mcg / day.

Step 4. Severe bronchial asthma

Beclometasone dipropionate in a high dose of 800-1600 mcg / day, in some cases, megadoses up to 2000 mcg / day.

Step 5. Severe bronchial asthma

Beclometasone dipropionate in a high dose (see step 3, 4)

Children between the ages of 4 and 12

Up to 400 mcg / day in several doses.

Special patient groups

There is no need to adjust the dose of drugs in the elderly, in patients with renal or hepatic insufficiency.

Missing one dose of drugs

If you miss an inhalation accidentally, the next dose should be taken at the appropriate time in accordance with the treatment regimen.

Preparations containing 250 μg in 1 dose are not intended for use in pediatrics.

The introduction can be carried out using a special optimizer that improves the distribution of the drug in the lungs and reduces the risk of side effects.

Overdose

Acute overdose of the drug may lead to a temporary decrease in the function of the adrenal cortex, which does not require emergency therapy, because The function of the adrenal cortex is restored within a few days, which is confirmed by the level of cortisol in the plasma. In chronic overdose, there can be a persistent suppression of the function of the adrenal cortex. In such cases, it is recommended to monitor the reserve function of the adrenal cortex. In case of an overdose, treatment with Beclometasone dipropionate may be continued at doses sufficient to maintain a therapeutic effect.

special instructions

Before prescribing inhalants, the patient should be instructed on the rules for their use, ensuring the most complete entry of the drug into the right areas of the lungs. The development of oral candidiasis is most likely in patients with a high level of precipitating antibodies in the blood against the Candida fungus, which indicates an earlier fungal infection. After inhalation, rinse mouth and throat with water. To treat candidiasis, antifungal agents of local action can be used while continuing treatment with Beclometasone dipropionate.

If patients take GCS inside, then inhalations are prescribed against the background of receiving the previous dose of SCS, while patients should be in a relatively stable state. After about 1-2 weeks, the daily dose of oral glucocorticosteroids is gradually reduced. The scheme of dose reduction depends on the duration of previous therapy and the initial dose of GCS. Regular use of inhaled glucocorticosteroids allows in most cases to cancel oral GCS (patients who need to take no more than 15 mg of prednisolone can be fully switched to inhalation therapy), and in the first months after the transition, the patient's condition should be carefully monitored until his pituitary-adrenal The system does not recover sufficiently to provide an adequate response to stressful situations (eg trauma, surgery or infection).

When transferring patients from receiving systemic GCS to inhalation therapy, allergic reactions (for example, allergic rhinitis, eczema), which were previously suppressed by systemic drugs, may appear.

Patients with a reduced function of the adrenal cortex who are transferred to inhalation treatment should have a stock of GCS and always carry a warning card, which should indicate that they need additional systemic administration of SCS in stressful situations (after a stressful situation, the dose of GCS can be again Reduce). Sudden and progressive worsening of asthma symptoms is a potentially dangerous condition, often life-threatening patients, and requires an increase in the dose of GCS. An indirect indicator of the ineffectiveness of therapy is the more frequent than before use of short-acting β2-adrenostimulators.

Beclometasone dipropionate for inhalations is not intended for relief of seizures, but for regular daily use. To stop seizures, short-acting β2-adrenostimulators (for example, salbutamol) are used. In case of severe exacerbation of bronchial asthma or insufficient effectiveness of the therapy, increase the dose of Beclometasone dipropionate and, if necessary, prescribe a systemic SCS and / or an antibiotic for the development of infection.

With the development of paradoxical bronchospasm should immediately stop using Beclometasone dipropionate, assess the patient's condition, conduct a survey and, if necessary, prescribe therapy with other medications. With long-term use of any inhaled glucocorticosteroids, especially at high doses, systemic effects can be noted (see the section "Side effects"), but the probability of their development is much lower than when ingesting GCS inside. Therefore, it is particularly important that, when the therapeutic effect is achieved, the dose of inhaled glucocorticosteroids is reduced to the lowest effective dose that controls the course of the disease. At a dose of 1500 μg / day, the drugs in most patients do not cause significant suppression of the adrenal glands. In connection with a possible adrenal insufficiency, one should be extra careful and regularly monitor the indices of the function of the adrenal cortex when transferring patients taking SCS inwards to treatment with Beclazone Eco and Beclazone Eco Easi breath.

It is recommended to regularly monitor the dynamics of growth in children receiving inhaled glucocorticosteroids for a long time. It is not recommended to abruptly stop the inhalation of Beclometasone dipropionate.

Special care must be taken when treating inhaled GCS patients with active or inactive forms of pulmonary tuberculosis.

It is necessary to protect the eyes from getting medications. By washing after inhalation it is possible to prevent damage to the skin of the eyelids and nose.

Balloons with preparations can not be pierced, disassembled or thrown into the fire, even if they are empty. Like most other inhalation agents in aerosol packages, Beclason Eco and Beclazone Eco Easi Breathing can be less effective at low temperatures. When cooling the bottle, it is recommended to get it out of the plastic case and warm it up for several minutes.

Impact on the ability to drive / machinery

No data.

Terms of leave from pharmacies

On prescription.

storage Conditions

In a place protected from direct sunEasi, at a temperature not exceeding 30 C. Do not freeze.

Keep out of the reach of children.

Shelf life

3 year

Do not use after the expiry date printed on the package.

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