Beclomethasone-Aeronativ, aerosol 250 mcg/dose 200 doses

GCS for inhaled use. Beclomethasone in dipropionate form is a prodrug and has poor tropicity to glucocorticoid receptors. Under the action of esterases it is converted into the active metabolite – beclomethasone-17-monopropionate, which has a pronounced local anti-inflammatory effect by reducing the formation of chemotaxis substance (effect on delayed-type allergic reactions).

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

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

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

Enhances the number of active β-adrenoreceptors, neutralizes their desensitization, restores the patient’s response to bronchodilators, allowing a reduction in the frequency of their use.

Indications

Chronic Obstructive Pulmonary Disease, Bronchial Asthma

For inhaled use: treatment of bronchial asthma (including when bronchodilators and/or sodium cromoglycate are not effective, as well as hormone-dependent bronchial asthma of a severe course in adults and children).

Active ingredient

Beclomethasone

Composition

One dose contains beclomethasone 250 mcg.

How to take, the dosage

Beclomethasone-aeronativ is for inhaled administration only.

Bronchial asthma

Adults and children aged 12 years and older:
Beclomethasone-aeronativ is used regularly (even in the absence of symptoms of the disease), the dose of beclometasone dipropionate is selected according to the severity of bronchial asthma and the clinical effect in each case.

The daily dose is divided into several doses.
Recommended initial doses of the drug:

• bronchial asthma of mild course – 200 – 600 mcg/day
• bronchial asthma of moderate course – 600 – 1000 mcg/day
• severe bronchial asthma – 1000 – 2000 mcg/day
• Children aged 4 to 12 years: Up to 400 mcg per day in multiple doses

Depending on the individual response of the patient, the dose of the drug may be increased until clinical effect appears or reduced to the minimum effective dose.

When switching to a high dose of inhaled beclomethasone dipropionate, many patients receiving systemic glucocorticosteroids will be able to reduce their dose or discontinue them altogether. Chronic Obstructive Pulmonary Disease The maximum recommended dose of Beclomethasone Aeronativ in COPD is 2000 mcg per day.

If inhalation is accidentally missed, the next dose should be taken at the right time according to the treatment regimen.

Injection can be done using special dispensers (spacers) to improve distribution of the drug in the lungs and reduce the risk of side effects.

Patients with hepatic impairment
In patients with hepatic impairment the dose reduction is not required.

Patients with renal impairment
In patients with renal impairment, dose reduction is not required.

Interaction

Beta-adrenomimetics – Beclomethasone enhances the effect of beta-adrenomimetics. Beclomethasone restores the patient’s response to beta-adrenomimetics, allowing a reduction in the frequency of their use.

Microsomal oxidation inducers (including phenobarbital, phenytoin, rifampicin) may decrease the effectiveness of beclomethasone.

Methandienone, estrogens, beta₂-adrenomimetics, theophylline, systemic GCS – increase the effects of beclomethasone.

Special Instructions

Beclomethasone is not intended to relieve acute asthma attacks. It should also not be used in severe attacks of bronchial asthma requiring intensive therapy. The recommended route of administration for the dosage form used should be strictly observed.

Beclomethasone should be used with extreme caution and under close medical supervision in patients with adrenal insufficiency.

Transfer patients who are always taking oral GCS to inhaled forms should only be done when they are stable.

If paradoxical bronchospasm is likely to develop, bronchodilators (e.g., salbutamol) should be inhaled 10-15 minutes before inhaling beclomethasone.

If candidiasis of the oral cavity and upper respiratory tract develops, local antifungal therapy is indicated without stopping treatment with beclomethasone. Infectious inflammatory diseases of the nasal cavity and sinuses are not contraindications to beclomethasone therapy when therapy is indicated.

Inhaled preparations containing 250 mcg beclometasone in 1 dose are not indicated for children under 12 years of age.

Contraindications

• Age up to 4 years.
• High sensitivity to any component of the drug.

Beclomethasone Aeronativ should be used with caution in glaucoma, systemic infections (bacterial, viral, fungal, parasitic), osteoporosis, pulmonary tuberculosis, liver cirrhosis, hypothyroidism, pregnancy, during lactation.

Side effects

Infections: very common: oral and pharyngeal candidiasis. Use of spacer and rinsing the mouth and throat with water after inhalation reduces the likelihood of these side effects.

Immune system disorders: infrequent – skin hypersensitivity reactions, including rash, urticaria, itching, redness and swelling of the eyes, face, lips, and mucous membranes of the mouth and throat; very rare – angioedema, anaphylactic reactions.

Endocrine system disorders: very rarely – systemic effects (inhibition of adrenal cortex function, stasis in children and adolescents, cataract glaucoma)

Respiratory system disorders: frequent – dysphonia (hoarseness of voice) or irritation of the pharyngeal mucosa; very rarely – paradoxical bronchospasm, which should be immediately stopped with inhaled beta₂-adrenergic stimulator of short action. If paradoxical bronchospasm occurs, inhalation use should be discontinued immediately, the patient’s condition should be evaluated, the necessary examination should be performed, and the necessary treatment should be prescribed.

Skin and subcutaneous fat: often – bruising, thinning of the skin.

Overdose

An acute overdose of the drug may lead to a temporary decrease in adrenal cortical function, which does not require emergency therapy, since adrenal function recovers within a few days, as confirmed by plasma cortisol levels.

In chronic overdose, there may be persistent suppression of adrenal cortical function.

In such cases it is recommended to monitor the reserve function of the adrenal cortex. In cases of overdose, treatment with beclomethasone dipropionate may be continued in doses sufficient to maintain the therapeutic effect.

In order to avoid overdose, patients should not use beclomethasone dipropionate in doses greater than recommended. Regular evaluation of the effectiveness of therapy and reduction of the dose of Beclomethasone Aeronativ to the lowest level that provides effective control of disease symptoms is important.

Pregnancy use

In pregnancy and during breastfeeding, Beclomethasone Aeronativ may be administered only if the anticipated benefit to the mother outweighs any possible risk to the fetus or baby.

Similarities

Beclamethasone Echo easy breathing, Beclamethasone Echo, Beclamethasone-aeronative