Beclazone ECO (Aerosol) Instructions for Use

ATC Code

R03BA01 (Beclometasone)

Active Substance

Beclometasone (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Inhaled corticosteroids

Pharmacotherapeutic Group

Drugs for the treatment of obstructive airway diseases; other agents for inhalation administration used for the treatment of obstructive airway diseases; glucocorticoids

Pharmacological Action

Inhaled glucocorticosteroid. Beclometasone in the form of dipropionate is a prodrug and has low tropism for glucocorticoid receptors. Under the action of esterases, it is converted into an active metabolite – beclometasone-17-monopropionate, which exerts a pronounced local anti-inflammatory effect by reducing the formation of chemotaxis substance (influence on delayed-type allergic reactions).

By suppressing the production of arachidonic acid metabolites and reducing the release of inflammatory mediators from mast cells, it inhibits the development of an immediate-type allergic reaction.

It improves mucociliary transport, reduces the number of mast cells in the bronchial mucosa, reduces epithelial edema, secretion of mucus by bronchial glands, bronchial hyperreactivity, marginal accumulation of neutrophils, inflammatory exudate and the production of lymphokines, inhibits macrophage migration, and reduces the intensity of infiltration and granulation processes.

After inhalation administration, it has practically no resorptive effect. It does not relieve bronchospasm. The therapeutic effect develops gradually, usually after 5-7 days of course application.

It increases the number of active β-adrenergic receptors, neutralizes their desensitization, restores the patient’s response to bronchodilators, allowing to reduce the frequency of their use.

Pharmacokinetics

After inhalation administration, the part of the dose that enters the respiratory tract is absorbed in the lungs. In the lung tissue, beclometasone dipropionate is rapidly hydrolyzed to beclometasone monopropionate, which in turn is hydrolyzed to beclometasone.

The part of the dose that is unintentionally swallowed is largely inactivated during the “first pass” through the liver. In the liver, the process of converting beclometasone dipropionate into beclometasone monopropionate and then into polar metabolites occurs.

The binding to plasma proteins of the active substance present in the systemic circulation is 87%.

Indications

Basic therapy of various forms of bronchial asthma in adults and children over 4 years of age.

ICD codes

Dosage Regimen

Aerosol

Beclometasone is used regularly (even in the absence of disease symptoms).

The dose and treatment regimen depend on age, severity of bronchial asthma, and clinical effect in each specific case.

Special inhalation devices can be used for the inhalation administration of beclometasone dipropionate (in accordance with the dosage form used).

Adults and children aged 12 years and older: the daily dose is 200-2000 mcg.

Children aged 4 to 12 years: the daily dose is 100-400 mcg.

Adverse Reactions

Infections very common – candidiasis of the mouth and pharynx. Using a spacer and rinsing the mouth and throat with water after inhalation reduces the likelihood of these side effects.

From the immune system uncommon – hypersensitivity skin reactions, including rash, urticaria, itching, redness and swelling of the eyes, face, lips and mucous membrane of the mouth and pharynx; very rare – angioedema, anaphylactic reactions.

From the endocrine system very rare – systemic effects (suppression of adrenal cortex function, growth retardation in children and adolescents, cataract, glaucoma).

From the respiratory system common – dysphonia (hoarseness) or irritation of the pharyngeal mucosa; very rare – paradoxical bronchospasm, which must be immediately relieved with an inhaled short-acting beta₂-adrenergic agonist. In case of paradoxical bronchospasm, inhalation should be stopped immediately, the patient’s condition assessed, necessary examination performed and appropriate treatment prescribed.

From the skin and subcutaneous tissue common – bruising, thinning of the skin.

Contraindications

Tuberculosis (active and inactive); children under 4 years of age; children and adolescents under 18 years of age (for dosage forms containing 250 mcg of beclometasone per 1 dose); hypersensitivity to beclometasone.

With caution

Glaucoma; systemic infections (bacterial, viral, fungal, parasitic); osteoporosis; liver cirrhosis; hypothyroidism; pregnancy; lactation period (breastfeeding).

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy.

Use in the second and third trimesters of pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus. Newborns whose mothers received Beclometasone during pregnancy should be carefully examined for adrenal insufficiency.

If use during lactation is necessary, the issue of discontinuing breastfeeding should be considered.

Pediatric Use

Inhalation preparations containing 250 mcg of beclometasone per 1 dose are not intended for children under 12 years of age. For inhalation administration in children, a single dose is 50-100 mcg, frequency of application is 2-4 times/day.

Special Precautions

Beclometasone is not intended for the relief of acute asthmatic attacks. It should also not be used for severe attacks of bronchial asthma requiring intensive therapy. The recommended route of administration for the dosage form used must be strictly observed.

Beclometasone should be used with particular caution and under close medical supervision in patients with adrenal insufficiency.

Transfer of patients constantly taking oral glucocorticosteroids to inhalation forms can only be carried out in a stable condition.

In case of possible development of paradoxical bronchospasm, inhalation of bronchodilators (e.g., salbutamol) is performed 10-15 minutes before the administration of beclometasone.

If candidiasis of the oral cavity and upper respiratory tract develops, local antifungal therapy is indicated without discontinuing treatment with beclometasone. Infectious and inflammatory diseases of the nasal cavity and paranasal sinuses, when appropriate therapy is prescribed, are not a contraindication for treatment with beclometasone.

Inhalation preparations containing 250 mcg of beclometasone per 1 dose are not intended for children under 12 years of age.

Drug Interactions

Beta-adrenergic agonists – Beclometasone enhances the effect of beta-adrenergic agonists. Beclometasone restores the patient’s response to beta-adrenergic agonists, allowing to reduce the frequency of their use.

Inducers of microsomal oxidation (including phenobarbital, phenytoin, rifampicin) – a decrease in the effectiveness of beclometasone is possible.

Methandienone, estrogens, beta₂-adrenergic agonists, theophylline, systemic glucocorticosteroids – enhancement of the effects of beclometasone.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.