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

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

Pharmacological effect

GCS for inhalation use. Beclomethasone in the form of dipropionate is a prodrug and has weak affinity for glucocorticoid receptors.

Under the influence of esterases, it turns into an active metabolite – beclomethasone-17-monopropionate, which has a pronounced local anti-inflammatory effect by reducing the formation of a chemotaxis substance (impact 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 allergic reaction.

Improves mucociliary transport, reduces the number of mast cells in the bronchial mucosa, reduces swelling of the epithelium, mucus secretion by bronchial glands, bronchial hyperreactivity, marginal accumulation of neutrophils, inflammatory exudate and the production of lymphokines, inhibits the migration of macrophages, reduces the intensity of infiltration and granulation processes.

After inhalation administration it has virtually no resorptive effect. Does not relieve bronchospasm. The therapeutic effect develops gradually, usually after 5-7 days of course use.

Increases the number of active β-adrenergic receptors, neutralizes their desensitization, restores the patient’s response to bronchodilators, allowing them to be used less often.

Special instructions

Beclomethasone is not intended for the relief of acute asthmatic attacks. It should also not be used for severe asthma attacks requiring intensive care. The recommended route of administration for the dosage form used should be strictly followed.

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

Transfer of patients constantly taking GCS orally to inhaled forms can only be done if their condition is stable.

If there is a possibility of developing paradoxical bronchospasm, bronchodilators (for example, salbutamol) are inhaled 10-15 minutes before beclomethasone administration.

With the development of candidiasis of the oral cavity and upper respiratory tract, local antifungal therapy is indicated without stopping treatment with beclomethasone. Infectious and inflammatory diseases of the nasal cavity and paranasal sinuses, if appropriate therapy is prescribed, are not a contraindication for treatment with beclomethasone.

Preparations for inhalation containing 250 mcg of beclomethasone per dose are not intended for children under 12 years of age.

Active ingredient

Beclomethasone

Composition

1 dose contains:

Active substance:

beclomethasone dipropionate;

Excipients:

absolute ethyl alcohol grade A 10 mg,

Triethyl citrate 0.011 mg,

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

Pregnancy

During pregnancy and breastfeeding, Beclomethasone aeronative can be prescribed only if the expected benefit to the mother outweighs any possible risk to the fetus or child.

Contraindications

Age up to 4 years.
Hypersensitivity to any component of the drug.

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

Side Effects

Metabolic disorders: rarely – hypercortisolism; very rarely – symptoms of systemic glucocorticosteroid effects (including adrenal hypofunction, Cushing’s syndrome).

From the immune system: rarely – hypersensitivity reactions, rash, urticaria, angioedema, itching.

From the musculoskeletal system: decreased bone mineral density.

From the respiratory system: often – cough; rarely – paradoxical bronchospasm, pharyngeal irritation, dysphonia, which disappears after stopping therapy or reducing the dose of the drug.

Other: often – candidiasis of the oral mucosa and larynx.

The systemic effect of inhaled corticosteroids can be observed when taking the drug in high doses for a long time.

Interaction

Beta-agonists – beclomethasone enhances the effect of beta-agonists.

Beclomethasone restores the patient’s response to beta-agonists, making it possible to reduce the frequency of their use.

Inducers of microsomal oxidation (including phenobarbital, phenytoin, rifampicin) – may reduce the effectiveness of beclomethasone.

Methandienone, estrogens, beta2-adrenergic agonists, theophylline, systemic corticosteroids – enhance the effects of beclomethasone.

Overdose

An acute overdose of the drug can lead to a temporary decrease in the function of the adrenal cortex, which does not require emergency treatment, since the function of the adrenal cortex is restored within a few days, as confirmed by the level of cortisol in the plasma.

In case of chronic overdose, persistent suppression of the function of the adrenal cortex may be observed. In such cases, it is recommended to monitor the reserve function of the adrenal cortex.

Manufacturer

Nativa, Russia