Beclomethasone-Aeronativ, inhalation aerosol 250 µg/dose, 200 doses

Composition

1 dose contains Beclomethasone 250 mcg.

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

For inhalation use: treatment of bronchial asthma (including those with insufficient effectiveness of bronchodilators and / or sodium cromoglycate, as well as hormone-dependent bronchial asthma of severe course in adults and children).

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

• Up to 4 years old.
• Hypersensitivity to any component of the drug.

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

Side effects

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

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

From the endocrine system:  very rarely – systemic effects (suppression of the adrenal cortex, delayed OST in children and adolescents, cataract glaucoma)

Respiratory system disorders:  often-dysphonia (hoarseness of voice) or irritation of the pharyngeal mucosa; very rarely-paradoxical bronchospasm, which must be immediately stopped with a short-acting inhaled beta-₂-adrenostimulator. In case of paradoxical bronchospasm, it is necessary to immediately stop inhalation use, assess the patient’s condition, conduct the necessary examination and prescribe the necessary treatment.

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

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

The drug “Beclomethasone-aeronative” is intended only for inhalation use.

Bronchial asthma

Adults and children aged 12 years and older: Beclomethasone-aeronative is used regularly (even in the absence of symptoms of the disease), the dose of Beclomethasone dipropionate is selected taking into account 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:

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

Depending on the individual response of the patient, the dose of the drug can be increased until the 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 aeronative for COPD is 2000 mcg per day. If you accidentally miss an inhalation, the next dose should be taken at the appropriate time in accordance with the treatment regimen. use can be carried out using special dispensers (spacers) that improve the distribution of the drug in the lungs and reduce the risk of side effects. Patients with impaired hepatic functionin patients with impaired liver function, no dose reduction is required. Patients with impaired renal function In patients with impaired renal function, no dose reduction is required.

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 aerosol for inhalation

Storage conditions

In a place protected from light, at a temperature not exceeding 25°C, away from heating devices. Do not freeze it. Keep out of reach of children.

Shelf

life is 2 years.

Active ingredient

Beclomethasone

Conditions of release from pharmacies

By prescription

Dosage form

aerosol for inhalation

Purpose

For adults as prescribed by a doctor, for children as prescribed by a doctor

Indications

Bronchial Asthma, Chronic Obstructive Pulmonary Disease