Beclomethasone-Aeronativ, aerosol 100 µg/dose 200 doses

GCS for inhaled use. Beclomethasone in the form of dipropionate is a prodrug and has weak tropicity to glucocorticoid receptors.

Esterase converts it 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 suppressing production of arachidonic acid metabolites and reducing release of inflammatory mediators from mast cells, it inhibits 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 action. It does not stop bronchospasm. Therapeutic effect is developed gradually, usually after 5-7 days of course of administration.

Adds the number of active β-adrenoreceptors, neutralizes their desensitization, restores the patient’s response to bronchodilators, allowing to reduce the frequency of their use.

Indications

Chronic Obstructive Pulmonary Disease, Bronchial Asthma

• Basic therapy for various forms of bronchial asthma in adults and children over 4 years
• Maintenance therapy for chronic obstructive pulmonary disease (COPD) in patients with values of forced expiratory volume (FEV1)

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Active ingredient

Beclomethasone

Composition

1 dose contains:

The active substance:

beclomethasone dipropionate;

Excipients:

Ethyl alcohol absolute grade A 10 mg,

Triethylcitrate 0.011 mg,

Propellant R134a (1,1,1,2-tetrafluoroethane) 60.45 mg.

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 starting doses of the drug:

Children aged 4 to 12 years:
Up to 400 mcg per day in several doses.

Depending on the patient’s individual response, the drug dose 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 cancel 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 no dose reduction is required.

Interaction

Beta-adrenomimetics – Beclomethasone enhances the effect of beta-adrenomimetics.

Beclomethasone restores the patient’s response to beta-adrenomimetics, allowing the frequency of their use to be reduced.

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

Metandienone, estrogens, beta₂-adrenomimetics, theophylline, systemic GCS – enhancement of beclomethasone effects.

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 routinely take oral GCS to inhaled forms should only be done when they are stable.

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

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

Inhaled preparations containing 250 mcg beclomethasone in 1 dose are not suitable 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

Metabolism: rare – hypercorticism; very rare – symptoms of systemic glucocorticosteroid effects (including adrenal hypofunction, Cushing’s syndrome).

Immune system: rare – hypersensitivity reactions, rash, urticaria, angioedema, pruritus.

Musculoskeletal system: decreased bone mineral density.

Respiratory system: frequently – cough, rarely – paradoxical bronchospasm, pharyngeal irritation, dysphonia, which disappears after discontinuation of therapy or reduction of the drug dose.

Other: often – candidiasis of the mucous membranes of the oral cavity and larynx.

Systemic effects of inhaled GCS may be observed when taking the drug in high doses for a long time.

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, since the adrenal cortex function is restored within a few days, as evidenced by the plasma level of cortisol.