Description
Pharmacological action of
GCS for inhalation use. Beclomethasone in the form of dipropionate is a prodrug and has a weak tropism 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 chemotaxis substance (effect on delayed-type allergic reactions).
Suppressing the production of metabolites of arachidonic acid and reducing the release of inflammatory mediators from mast cells, inhibits the development of an immediate type of 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, edge accumulation of neutrophils, inflammatory exudate and lymphokine production, inhibits macrophage migration, and reduces the intensity of infiltration and granulation processes.
After inhalation, it has practically no resorptive effect. Does not stop bronchospasm. The therapeutic effect develops gradually, usually after 5-7 days of course use.
Increases the number of active -adrenoreceptors, neutralizes their desensitization, restores the patient’s reaction to bronchodilators, allowing to reduce the frequency of their use.
Indications
Basic treatment of various forms of bronchial asthma in adults and children over 4 years of age.
Contraindications
Tuberculosis (active and inactive) children under 4 years of age children and adolescents under 18 years of age (for dosage forms, containing 1 dose of 250 mcg beclomethasone) hypersensitivity to beclomethasone.
With caution
Glaucoma systemic infections (bacterial, viral, fungal, parasitic) osteoporosis liver cirrhosis hypothyroidism pregnancy lactation (breastfeeding).
Use during pregnancy and lactation
During pregnancy and during breastfeeding, beclomethasone aeronativ can be prescribed only if the intended benefit to the mother outweighs any possible risk to the fetus or baby.
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 observed.
With extreme caution and under the close supervision of a physician, beclomethasone should be used in patients with adrenal insufficiency.
Transfer of patients who are constantly taking corticosteroids into the inhalation form can only be done in a stable condition.
In the case of the likelihood of developing paradoxical bronchospasm 10-15 minutes before the administration of beclomethasone, bronchodilators (e.g., salbutamol) are inhaled.
With the development of candidiasis of the oral cavity and upper respiratory tract, local antifungal therapy is indicated without stopping beclomethasone treatment. Infectious and inflammatory diseases of the nasal cavity and paranasal sinuses when prescribing appropriate therapy are not a contraindication for the treatment of beclomethasone.
Inhalation preparations containing 250 Ојg beclomethasone in 1 dose are not intended for children under 12 years of age.
Composition
Active ingredient:
0.555 mg beclomethasone dipropionate.
Excipients:
polysorbate 80,
dextrose,
microcrystalline cellulose,
benzalkonium chloride,
sodium hydroxide solution (1M) or hydrochloric acid solution (1M),
purified water.
Dosage and administration of
beclomethasone is used regularly (even in the absence of symptoms of the disease).
Dose and treatment regimen depends on age, severity of bronchial asthma, clinical effect in each case.
For inhalation administration of beclmentazone dipropionate, special inhalation devices may be used (in accordance with the dosage form used).
Adults and children 12 years of age and older: The daily dose is 200-2000 mcg.
Children aged 4 to 12 years: daily dose is 100-400 mcg.
Side effects of
Metabolism: rare – hypercorticism is very rare – symptoms of systemic glucocorticosteroid effects (including adrenal hypofunction, Cushing’s syndrome).
On the part of the immune system: rarely – hypersensitivity reactions, rash, urticaria, angioedema, pruritus.
From the musculoskeletal system: a decrease in bone mineral density.
From the respiratory system: often – cough rarely – paradoxical bronchospasm, pharyngeal irritation, dysphonia, disappearing after discontinuation of therapy or dose reduction.
Other: often – candidiasis of the mucous membrane of the oral cavity and larynx.
The systemic effect of inhaled corticosteroids can be observed when taking the drug in high doses for a long time.
Drug Interactions
Beta-adrenergic agonists – beclomethasone enhances the effect of beta-adrenergic agonists. Beclomethasone restores the patient’s reaction to beta-adrenergic agonists, allowing to reduce the frequency of their use.
Inductors of microsomal oxidation (including phenobarbital, phenytoin, rifampicin) – a decrease in the effectiveness of beclomethasone is possible.
Methandienone, estrogens, beta2-adrenergic agonists, theophylline, systemic corticosteroids – increased effects of beclomethasone.
Overdose of
An acute overdose of the drug can lead to a temporary decrease in adrenal cortex function, 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 plasma cortisol.
In chronic overdose, persistent suppression of adrenal cortex function may be noted. In such cases, it is recommended to monitor the reserve function of the adrenal cortex.
In case of overdose, beclomethasone dipropionate treatment may be continued in doses sufficient to maintain a therapeutic effect. In order to avoid overdose, patients should not use beclomethasone-aeronativ in doses exceeding the recommended ones.
Regular evaluation of the effectiveness of therapy and reducing the dose of beclomethasone-aeronativ to the minimum level that provides effective control of the symptoms of the disease is of great importance.
active substance
Beclomethasone
Pharmacy conditions
prescription
lekarstvennaja form
aerosols for ynhalyatsyy
Prescription
For adults as prescribed by the doctor, For children prescribed by a doctor
Indications
Hronicheskaya obstruktivnaya bolezny legkih, Bronhialynaya asthma
Nativ, Russia
