Beclomethasone-Aeronativ, inhalation aerosol 50 µg/dose, 200 doses

Composition

Active ingredient:  

0.555 mg of Beclomethasone dipropionate.

Auxiliary substances:  

polysorbate 80,

dextrose,

microcrystalline cellulose,

benzalkonium chloride,

sodium hydroxide solution (1 M) or hydrochloric acid solution (1 M),

purified water.

Pharmacological action

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

Under the action of esterases, it is converted to the active metabolite – Beclomethasone-17-monopropionate, which has a pronounced local anti-inflammatory effect by reducing the formation of the chemotaxis substance (the effect 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 epithelial edema, mucus secretion by bronchial glands, bronchial hyperreactivity, marginal accumulation of neutrophils, inflammatory exudate and lymphokine production, inhibits macrophage migration, reduces the intensity of infiltration and granulation processes.

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

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

Indications

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

Use during pregnancy and lactation

During pregnancy and lactation, Beclomethasone aeronative can only be prescribed if the intended benefit to the mother exceeds any possible risk to the fetus or child.

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 Beclomethasone in 1 dose); hypersensitivity to Beclomethasone.

With caution

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

Side effects

From the side of metabolism:  rarely-hypercorticism; very rarely-symptoms of systemic glucocorticoid effects (including adrenal hypofunction, Cushing’s syndrome). From the immune system:  rarely – hypersensitivity reactions, rash, urticaria, angioedema, pruritus. From the musculoskeletal system:  reduced bone mineral density. Respiratory system disorders:  often-cough; rarely-paradoxical bronchospasm, pharyngeal irritation, dysphonia that disappears after stopping therapy or reducing the dose of the drug. Other services:  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

of Beta-adrenomimetics-Beclomethasone enhances the effect of beta-adrenomimetics. Beclomethasone restores the patient’s response to beta-adrenomimetics, reducing the frequency of their use.

Inducers of microsomal oxidation ( including phenobarbital, phenytoin, rifampicin) – it is possible to reduce the effectiveness of Beclomethasone.

Methandienone, estrogens, beta_-2-adrenomimetics, theophylline, systemic corticosteroids-increased effects of Beclomethasone.

How to take, course of use and dosage

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

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

For inhalation use of beclomentazone dipropionate, special inhaling devices can be used (in accordance with the dosage form used).

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

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

Overdose

Acute overdose of the drug can lead to a temporary decrease in the function of the adrenal cortex, which does not require emergency therapy, since the function of the adrenal cortex is restored within a few days, which is confirmed by the level of cortisol in plasma. With chronic overdose, persistent suppression of the function of the adrenal cortex may occur. In such cases, it is recommended to monitor the reserve function of the adrenal cortex. In case of overdose, treatment with Beclomethasone dipropionate can be continued in doses sufficient to maintain the therapeutic effect. To avoid overdose, patients should not use Beclomethasone-aeronative in doses exceeding the recommended ones. It is very important to regularly evaluate the effectiveness of therapy and reduce the dose of Beclomethasone-aeronative to a minimum level that provides effective control of the symptoms of the disease.

Special instructions

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

Beclomethasone should be used with extreme caution and under the close supervision of a doctor in patients with adrenal insufficiency.

Transfer of patients who are constantly taking corticosteroids inside, to inhaled forms can be made only in a stable condition.

If paradoxical bronchospasm is likely to develop, bronchodilators (for example, salbutamol) are inhaled 10-15 minutes before the introduction of Beclomethasone.

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

Preparations for inhalation use containing 250 mcg of Beclomethasone in 1 dose are not intended for children under 12 years of age.

Form of production

Metered-dose nasal spray.

Storage conditions

At a temperature not exceeding 25 °C (do not freeze)

Shelf life

2 years

Active ingredient

Beclomethasone

Conditions of release from pharmacies

By prescription

Dosage form

aerosol for inhalation

Description

Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Chronic obstructive pulmonary disease, Bronchial asthma