BECLAZON ECO 250MKG / DOSE

Characteristics

Active ingredients Beclomethasone

Country of origin: Ireland

Manufacturer Norton Waterford-Iwax Pharmaceuticals Ireland

Release form

Aerosol for inhalation, dosed 250 μg / dose, 200 doses in an aluminum cylinder with a dosing valve, equipped with an inhalation device with a protective cap. 1 bottle, together with instructions for use, is placed in a cardboard box,

Store in a dark place

Keep out of reach of children

Dosage form

Aerosol for inhalation in a pressurized aluminum can. There must be no external damage, corrosion or leaks.

The contents of the spray can leave a white stain when sprayed on the glass.

Compound

1 dose of the drug contains:

active substance: beclomethasone dipropionate 250.00 mcg;

excipients: hydrofluoroalkane (HFA-134a) 71.75 mg, ethanol 6.00 mg

general description

GCS for inhalation

Special conditions

Before using the drug Beklazon Eco, you must make sure that the patient is using the inhalation device correctly to ensure that the drug is adequately dosed.

Patients using Beklazon Eco at home should be warned that if the effect of the usual dose becomes less effective or less prolonged, it is impossible to independently increase the dose or frequency of use of the drug, but should immediately consult a doctor.

With long-term use of beclomethasone in high doses (more than 400 μg / day), candidiasis of the oral cavity and pharynx develops, especially in patients who have previously had a fungal infection, which is confirmed by the high content of precipitating antibodies against Candida fungi in the blood. As a rule, the use of antifungal drugs contributes to the rapid elimination of the fungal infection. In this case, the dose of beclomethasone should not be changed.

If treatment with inhaled beclomethasone begins against the background of oral administration of corticosteroids, then a decrease in the dose of corticosteroids can be started only 1-2 weeks after the start of simultaneous use. The scheme for reducing the dose of GCS for oral administration depends on the dose and duration of GCS use. Regular use of inhaled beclomethasone in most cases allows you to reduce the dose of corticosteroids for oral administration. As a rule, patients taking no more than 15 mg of prednisolone can completely switch to inhaled beclomethasone alone. The first months after switching to inhaled therapy with beclomethasone, it is necessary to carefully monitor the state of the HPA in order to prevent its depression.

Patients with reduced adrenal function, transferred completely to treatment with inhaled beclomethasone, should always have a supply of GCS with them and carry a warning card with information that in stressful situations they need to use systemic GCS. After the end of the stressful situation, the dose of corticosteroids can be reduced or corticosteroids can be canceled.

An increase in the GCS dose is required in case of a sudden and progressive worsening of the course of bronchial asthma. An indirect indicator of the ineffectiveness of therapy is the more frequent use of short-acting beta2-adrenergic agonists.

When transferring patients from oral corticosteroids to inhaled corticosteroids, including beclomethasone, various allergic reactions may occur, including allergic rhinitis and allergic dermatitis, which did not appear during treatment with systemic corticosteroids.

Beclomethasone for inhalation is intended for regular daily use, and not for relieving attacks of bronchospasm. Beta2-adronomimetics, including salbutamol, are used to relieve attacks of bronchospasm. In severe bronchial asthma or insufficient effectiveness of inhaled beclomethasone, it is necessary to increase its dose, and also consider the use of GCS inside or, for example, the use of antibiotics in case of infectious inflammation.

With the development of paradoxical bronchospasm, beclomethasone should be canceled, the patient should be examined and the possibility of using another drug should be considered.

Do not abruptly stop treatment with inhaled beclomethasone.

With prolonged use of inhaled beclomethasone at a dose of more than 1.5 g / day, systemic reactions of a different nature may develop, including symptoms of suppression of the function of the adrenal cortex, a decrease in the growth rate in children, a decrease in bone mineral density, cataracts, glaucoma, Cushing's syndrome, characteristic signs of cushingoid, psychological or behavioral effects, including psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (especially in children). Therefore, when a therapeutic effect is achieved, the dose of inhaled beclomethasone should be reduced to the minimum effective dose that controls the course of the disease. Patients at high risk of developing adrenal insufficiency should be monitored by a physician.

With long-term use of beclomethasone in children, it is necessary to control the dynamics of their growth.

Caution should be exercised when using inhaled corticosteroids in patients with active and inactive forms of pulmonary tuberculosis.

It has been reported about visual impairment with systemic and local use of glucocorticosteroids. If a patient develops symptoms such as blurred vision or other visual impairments, referral to an ophthalmologist should be considered for possible causes, which may include cataracts, glaucoma, or rare conditions such as central serous chorioretinopathy (CSR).

It is necessary to protect the eyes from getting the drug Beklazon Eco.

The aluminum bottle with Beklazon Eco cannot be pierced, disassembled and heated, even if it is empty.

Influence on the ability to drive vehicles, mechanisms

Inhalation of the drug Beklazon Eco does not affect the ability to drive vehicles and mechanisms.

Drug interactions

Beclomethasone restores the patient's response to beta-adrenergic agonists, allowing to reduce the frequency of their use, and, with simultaneous use, enhances their effect.

With simultaneous use with phenobarbital, phenytoin, rifampicin and other inducers of microsomal liver enzymes, the effectiveness of beclomethasone decreases.

With simultaneous use with methandienone, estrogens, beta-adrenomimetics, theophylline, as well as systemic corticosteroids, the effectiveness of beclomethasone increases.

Concomitant administration with oral glucocorticosteroids or potassium-sparing diuretics such as thiazides or furosemide may cause excessive loss of potassium.

Pharmacodynamics

Beclomethasone is a glucocorticosteroid (GCS) and has a weak tropism for GCS receptors. Under the action of enzymes, it turns into an active metabolite - beclomethasone-17-monopropionate (B-17-MP), which has a pronounced local anti-inflammatory effect. Reduces inflammation by reducing the formation of chemotaxis substance (effect on "late" allergy reactions), inhibits the development of an "immediate" allergic reaction (due to inhibition of the production of metabolites of arachidonic acid and a decrease in the release of inflammatory mediators from mast cells) and improves mucociliary transport. Under the influence of beclomethasone, the number of mast cells in the bronchial mucosa decreases, epithelial edema, mucus secretion by the bronchial glands, bronchial hyperreactivity, marginal accumulation of neutrophils, inflammatory exudate and lymphokine production decrease, macrophage migration is inhibited, and the intensity of infiltration and granulation processes decreases. Increases the number of active beta-adrenergic receptors, restores the patient's response to bronchodilators, and reduces the frequency of their use. Virtually no resorptive effect after inhalation.

Does not relieve bronchospasm, the therapeutic effect develops gradually, usually after 5-7 days of the course of beclomethasone.

Pharmacokinetics

More than 25% of the dose of inhaled beclomethasone is deposited in the respiratory tract; the remaining amount settles in the mouth, throat and is swallowed. In the lungs, before absorption, beclomethasone is extensively metabolized to the active metabolite B-17-MP. Systemic absorption of B-17-MP occurs in the lungs (36% of the pulmonary fraction), in the gastrointestinal tract (26% of the dose received here by swallowing). The absolute bioavailability of unchanged beclomethasone and B-17-MP is, respectively, about 2% and 62% of the inhalation dose. Beclomethasone is rapidly absorbed, the time to reach the maximum plasma concentration (Tmax) is 0.3 hours. B-17-MP is absorbed more slowly, Tmax is 1 hour. There is an approximately linear relationship between the increase in the inhaled dose and the systemic exposure of beclomethasone.

Distribution in tissues is 20 liters for beclomethasone and 424 liters for B-17-MP. The connection with blood plasma proteins is relatively high - 87%.

Beclomethasone and B-17-MP have high plasma clearance (150 l / h and 120 l / h, respectively). The half-life is 0.5 hours and 2.7 hours, respectively.

Indications

Basic therapy of various forms of bronchial asthma in adults and children.

Contraindications

Hypersensitivity to beclomethasone and other components of the drug; children under 4 years of age.

Carefully

With glaucoma, systemic infections (bacterial, viral, fungal, parasitic), osteoporosis, pulmonary tuberculosis, liver cirrhosis, hypothyroidism, pregnancy, during breastfeeding, in patients with reduced immunity. See also the section "Special instructions".

Application during pregnancy and during breastfeeding

With extreme caution, Beklazon Eco should be used during pregnancy and during breastfeeding, only if the expected benefit to the mother outweighs the possible risk to the fetus and baby.

Overdose

An acute overdose of the drug can occur with inhalation of a high single dose of more than 1 g. The manifestation, in this case, of symptoms of suppression of the function of the adrenal cortex does not require emergency therapy, since the function is restored within a few days, which is confirmed by the level of cortisol in the plasma.

In chronic overdose (long-term treatment with a dose of more than 1.5 g), 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, beclomethasone treatment can be continued in doses sufficient to maintain the therapeutic effect.

Side effects

The incidence of side effects is classified according to the recommendations of the World Health Organization: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10 000, <1/1000); very rare (<1/10 000), frequency unknown (cannot be estimated from available data).

Infectious and parasitic diseases: very often - laryngitis, pharyngitis; often - candidiasis of the oral cavity and upper respiratory tract and pharynx (with prolonged use in high doses of more than 400 mcg per day); pneumonia (in patients with COPD). Immune system disorders: rarely - allergic reactions: angioedema of the eyes, throat, lips and face.

Disorders from the endocrine system: very rarely - suppression of the hypothalamic-pituitary-adrenal system (HPA) (with prolonged use of high doses of more than 1.5 g / day), including growth retardation in children and adolescents.

Mental disorders: the frequency is unknown - psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavior change (mainly in children). Nervous system disorders: infrequently - headache.

Violations of the organ of vision: infrequently - impaired clarity of vision (see the section "Special instructions"); very rarely - cataract, glaucoma (systemic effect); frequency unknown - central serous retinopathy.

Disturbances from the respiratory system, chest and mediastinal organs: often - hoarseness, irritation of the mucous membrane of the throat (the use of a spacer reduces the likelihood of these side effects); rarely - paradoxical bronchospasm (stopped with short-acting inhaled beta2-adrenergic agonists); very rarely - eosinophilic pneumonia.

Violations of the skin and subcutaneous tissues: very rarely - urticaria, rash, itching, redness.

Musculoskeletal and connective tissue disorders: very rarely - a decrease in bone mineral density (systemic effect).

With inhalation treatment of GCS (including beclomethasone dipropionate), other systemic effects may occur, especially with long-term treatment with high doses. The likelihood of such effects is much less than in the treatment of GCS for oral administration. Headache, nausea, bruising or thinning of the skin.

Special storage conditions

Store at a temperature not exceeding 25 ° C, protected from direct sunlight.

Do not freeze.

Keep out of the reach of children.