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Instructions

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Instruction for use: Becloforte

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ATX Code R03BA01 Beclometasone

Active substance: Beclometasone

Pharmacological group

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

1 dose of aerosol for inhalation contains beclometasone dipropionate 250 μg; In an aerosol container with a metering valve of 80 or 200 doses, in a box 1 cylinder.

pharmachologic effect

Pharmacological action - anti-inflammatory, glucocorticoid.

Pharmacokinetics

When inhaled, it undergoes systemic absorption in the lungs and gastrointestinal tract (after partial ingestion) in unchanged form and in the form of an active metabolite-beclometasone-17-monopropionate, formed as a result of presystemic metabolism with the participation of tissue esterases. Absolute bioavailability of unchanged beclometasone dipropionate and active metabolite is 2% and 62% (36% absorbed in the lungs, 26% in the GIT) of the inhaled dose, respectively. Time to achieve Cmax beclometasone dipropionate - 0.3 h; Active metabolite - 1 hour. Binding to plasma proteins - 87%. The volume of distribution for beclometasone dipropionate and active metabolite is 20 l and 424 l, plasma Cl is 150 l / h and 120 l / h, T1 / 2 is 0.5 and 2.7 h respectively. Excreted mainly in the form of free and conjugated polar metabolites, mainly with feces (about 60% of the administered dose for 96 hours) and urine (12%).

Indications

Bronchial asthma in adults and children older than 4 years (basic anti-inflammatory therapy), incl. In patients with severe disease, who are dependent on systemic glucocorticoids.

Contraindications

Hypersensitivity.

pregnancy and lactation

Perhaps, if the expected effect of therapy exceeds the potential risk to the fetus and newborn.

Side effects

Hoarseness, irritation of the pharyngeal mucosa; Paradoxical bronchospasm; Oropharyngeal candidiasis, allergic reactions (rash, hives, itching, redness and swelling of the eyes, face, lips and mucous membranes of the mouth and pharynx); Systemic effects: oppression of adrenal cortex function, osteoporosis, growth retardation in children, cataract, glaucoma.

Interaction

Not found.

Dosing and Administration

Inhalation. Adults and adolescents aged 12 years and older - 500 mcg / day in several doses (for bronchial asthma of mild severity), 750-1000 mcg / day (at moderate severity), up to 1000-2000 mcg / day (in severe cases ); The dose can be gradually increased or decreased depending on the clinical effect.

Children aged 4 to 12 years - 250 mcg 2 times a day (with bronchial asthma of moderate severity) or 3 times a day (with severe). Do not use in children with mild disease.

Overdose

Symptoms: a decrease in the function of the adrenal cortex (with acute overdose) or suppression of its function (for chronic).

Treatment: with acute overdose - not required, with chronic - recommended monitoring of the reserve function of the adrenal cortex.

Precautionary measures

In case of hoarseness or irritation of the mucous membrane of the pharynx, immediately after inhalation it is recommended to rinse the mouth and throat with water. To treat candidiasis, antifungal agents of local action can be used. Do not abruptly stop treatment. When a paradoxical bronchospasm occurs, it is necessary to immediately stop it with the help of a short-acting inhaled bronchodilator, stop treatment and prescribe therapy with other drugs. Care should be taken when treating patients with active or inactive forms of tuberculosis.

special instructions

It is not intended for relief of bronchospasm attacks.

Storage conditions

At temperatures not higher than 30 C (do not freeze).

Keep out of the reach of children.

Shelf life

3 years.

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

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