Active substanceBeclomethasoneBeclomethasone
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  • Dosage form: & nbspaerosol for inhalation dosed
    Composition:

    1 dose of the drug contains:

    Active substance: beclomethasone dipropionate 0.05 mg (in terms of 100% substance)

    Excipients: ethanol 96% 2.1 mg, norflurane (tetrafluoroethane) 87.2 mg.

    1 dose of the drug contains:

    Active substance: beclomethasone dipropionate 0.1 mg (in terms of 100% substance)

    Excipients: ethanol 96 % 4.2 mg, norflurane (tetrafluoroethane) 84.0 mg.

    1 dose of the drug contains:

    Active substance: beclomethasone dipropionate 0.25 mg (calculated as 100% substance)

    Excipients: ethanol 96% 10.5 mg, norflurane (tetrafluoroethane) 74.4 mg.

    Each inhaler contains 200 doses.

    Description:The preparation is a colorless or almost colorless solution that is pressurized in an aluminum bottle with a metering valve equipped with a spray nozzle with a protective cap; The drug is sprayed out of the balloon as an aerosol spray.
    Pharmacotherapeutic group:Glucocorticosteroid for topical application
    ATX: & nbsp

    R.01.A.D.01   Beclomethasone

    Pharmacodynamics:

    Beclomethasone dipropionate is a prodrug and has a weak tropism for GCS receptors. Under the action of esterases, 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 the chemotaxis substance (effect on the "late" allergy reaction), inhibits the development of an "immediate" allergic reaction (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells) and improves mucociliary transport. Under the action of beclomethasone, the number of mast cells in the bronchial mucosa decreases, the epithelial edema diminishes, the mucus secretion by the bronchial glands, the bronchial hyperreactivity, the neutrophil vascular congestion, the inflammatory exudate and the production of lymphokines, the macrophage migration is inhibited, the intensity of the 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 does not have a resorptive effect after inhalation.

    Do not stop bronchospasm, the therapeutic effect develops gradually, usually after 5-7 days of course use beclomethasone dipropionate.

    Pharmacokinetics:

    In the lung tissue of beclomethasone, dipropionate is rapidly hydrolyzed to beclomethasone monopropionate, which in turn hydrolyses to beclomethasone. Part of the dose, which is accidentally swallowed, is largely inactivated by "first passing" through the liver. In the liver, the process of conversion of beclomethasone dipropionate into beclomethasone monopropionate and then - into polar metabolites. The binding with plasma proteins of the active substance in the systemic circulation is 87%. The main part of the preparation (35-76%) is excreted within 96 hours of the gastrointestinal tract, mainly in the form of polar metabolites, 10-15% - by the kidneys.

    Indications:

    Basic therapy of various forms of bronchial asthma in adults and children older than 4 years.

    Contraindications:

    Hypersensitivity to any component of the drug.

    Pulmonary tuberculosis.

    Children up to 4 years. Beclomethasone, containing 250 mcg in 1 dose, is not intended for use in pediatrics (ie in children under 18 years of age).

    Carefully:

    Applied with glaucoma, systemic infections (bacterial, viral, fungal, parasitic), osteoporosis, liver cirrhosis, hypothyroidism, pregnancy, lactation.

    Pregnancy and lactation:

    Beclomethasone should be used during pregnancy and lactation and only if the potential benefit to the mother exceeds the possible risk to the fetus and the baby.

    Dosing and Administration:

    Beclomethasone is intended for inhalation use only.

    Beclomethasone is used regularly (even in the absence of symptoms of the disease), the dose of beclomethasone dipropionate is selected taking into account the clinical effect in each specific case.

    With an easy course of bronchial asthma, the volume of forced inspiration (FEV) or peak expiratory flow (PSV) is more than 80% of the required values ​​with a PSV score of less than 20%.

    In the medium-heavy course of FEV or PSV is 60-80% of the required values, the daily spread of PSV indicators is 20-30%.

    In the severe course of FEV or PSV is 60% of the required values, the daily spread of PSV indicators is more than 30%.

    When switching to a high dose of inhaled beclomethasone dipropionate, many patients receiving systemic glucocorticosteroids will be able to reduce their dose, cancel them altogether.

    The initial dose of Beclomethasone is determined by the severity of bronchial asthma. The daily dose is divided into several doses.

    Depending on the individual response of the patient, the dose of the drug can be increased until the appearance of a clinical effect or reduced to the minimum effective dose.

    Children between the ages of 4 and 12

    The initial dose is 50 μg 2 times a day. If necessary, the initial dose can be increased to 100 mcg 2 times a day. The maximum single dose of 200 mcg.

    The maximum daily dose is 400 mcg. The daily dose is divided into 2-4 admission.

    Adults and children aged 12 years and over:

    Recommended initial doses of the drug:

    - bronchial asthma of mild course - 200-600 mcg / day;

    - bronchial asthma of moderate course - 600-1000 mcg / day;

    - A bronchial asthma of a heavy current - 1000-2000 mkg / sut.

    Treatment of bronchial asthma is based on a stepwise approach - therapy is started according to the stage corresponding to the severity of the disease.

    Inhalation GCS is prescribed at the second stage of therapy.

    Step 2. Basic therapy.

    Beclomethasone dipropionate is 100-400 mcg 2 times a day.

    Step 3. Basic therapy.

    Apply inhaled GCS in high dose or in a standard dose, but in combination with inhaled (3-2-adrenomimetics long-acting.

    Beclomethasone dipropionate in high dose - 800-1600 mcg / day, in individual cases of megadoses up to 2000 mcg / day.

    Step 4. Severe asthma.

    Beclomethasone dipropionate in high dose - 800-1600 mcg / day, in individual cases of megadoses up to 2000 mcg / day.

    Step 5. Severe asthma.

    Beclomethasone dipropionate in a high dose (see steps 3 and 4).

    Special patient groups

    There is no need to adjust the dose of Beclomethasone in the elderly, in patients with renal or hepatic insufficiency.

    Skipping a single dose of the drug

    If you miss an inhalation accidentally, the next dose should be taken at the appropriate time in accordance with the treatment regimen.

    Side effects:

    Undesirable reactions are listed depending on anatomophysiological classification and occurrence. The frequency of occurrence is determined in this way: very often> 1/10, often> 1/100 and <1/10, infrequently> 1/1000 and <1/100, rarely> 1/10000 and <1/1000 and very rarely <1 / 10000.

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

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

    From the endocrine system: systemic effects are possible: very rarely - oppression of adrenal cortex function, growth retardation in children and adolescents, cataract, glaucoma.

    From the respiratory system: often dysphonia (hoarseness) or irritation of the mucous membrane of the pharynx, very rarely - paradoxical bronchospasm, which must be immediately stopped with the help of inhalation β-2-adrenostimulator of short action. In the case of paradoxical bronchospasm, it is necessary to immediately stop the use of the drug in inhalations, assess the patient's condition, conduct the necessary examination and prescribe the necessary treatment.

    From the skin and subcutaneous fat: often - bruising, thinning of the skin.

    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 for several days, which is confirmed by the concentration of cortisol in the plasma. With a chronic overdose, there can be a persistent suppression of the function of the adrenal cortex.In such cases, it is recommended to monitor the reserve function of the adrenal cortex. In case of an overdose, treatment with beclomethasone dipropionate can be continued at doses sufficient to maintain a therapeutic effect.
    Interaction:

    Beclomethasone restores the patient's response to beta-adrenomimetics, thereby reducing the frequency of their use.

    When combined with inducers of microsomal oxidation (incl. phenobarbital, phenytoin, rifampicin and others) may reduce the effectiveness of beclomethasone.

    With simultaneous use with methandienone, estrogens, beta2-adrenomimetics, theophylline, as well as systemic GCS, the efficacy of beclomethasone increases.

    With simultaneous application beclomethasone enhances the effect of beta-adrenomimetics.

    Special instructions:

    Before prescribing inhalants, the patient should be instructed on the rules for their use, ensuring the most complete entry of the drug into the right areas of the lungs. The development of oral candidiasis is most likely in patients with a high level of precipitating antibodies in the blood against the fungus Candida, which indicates an earlier transferred fungal infection. After inhalation, rinse the mouth and throat with water. For the treatment of candidiasis, antifungal agents of local action can be used while continuing therapy with Beclomethasone.

    If patients take GCS inside, then Beclomethasone is appointed on the background of receiving the previous dose of SCS, while patients should be in a relatively stable state. After about 1-2 weeks, the daily dose of oral glucocorticosteroids is gradually reduced. The dose reduction scheme depends on the duration of the previous therapy and on the initial dose of GCS. Regular use of inhaled glucocorticosteroids allows in most cases to cancel oral GCS (patients who need to take no more than 15 mg of prednisolone can be fully switched to inhalation therapy). In the first months after the transition, the patient's condition should be carefully monitored until his pituitary-adrenal system is restored sufficiently to provide adequate response to stressful situations (eg, trauma, surgery or infection).

    When transferring patients from receiving systemic GCS to inhalation therapy, allergic reactions (for example, allergic rhinitis, eczema), which were previously suppressed by systemic drugs, may appear.

    Patients with a reduced function of the adrenal cortex, transferred to inhalation treatment, should have a stock of GCS and always carry a warning card, which should indicate that they need additional systemic appointment of SCS in stressful situations (after a stressful situation, the dose of GCS can be again reduce). A sudden and progressive worsening of asthma symptoms is a potentially dangerous condition, not uncommon for the patient's life, and requires an increase in the dose of GCS. An indirect indicator of the ineffectiveness of therapy is the more frequent, than before use (3-2-adrenergic stimulants of short action.

    Beclomethasone dipropionate for inhalations is not intended for relief of seizures, but for regular daily use. To stop seizures apply (3-2-adrenergic stimulants of short action (for example, salbutamol).In case of severe exacerbation of bronchial asthma or inadequate efficacy of the therapy, the dose of inhaled beclomethasone dipropionate should be increased and, if necessary, a systemic SCS and an antibiotic should be prescribed for the development of infection.

    With the development of paradoxical bronchospasm should immediately stop using Beclomethasone, assess the patient's condition, examination and, if necessary, prescribe therapy with other medications. With long-term use of any inhaled glucocorticosteroids, especially at high doses, systemic effects can be noted (see "Side Effects"), but the likelihood of their development is significantly lower than when ingesting GCS inside. Therefore, it is especially important that, when the therapeutic effect is achieved, the dose of inhaled glucocorticosteroids is reduced to the lowest effective dose controlling the course of the disease. At a dose of 1500 μg / day, the drug in most patients does not cause significant suppression of adrenal function. In connection with a possible adrenal insufficiency, one should be extra careful and regularly monitor the indices of the function of the adrenal cortex when transferring patients taking SCS inward to beclomethasone.

    It is recommended to regularly monitor the dynamics of growth in children receiving inhaled glucocorticosteroids for a long time.

    The introduction can be carried out with the help of special dispensers (spacers), which improve the distribution of the drug in the lungs and reduce the risk of side effects.

    It is not recommended to abruptly cancel the drug Beclomethasone aerosol.

    It is necessary to protect eyes from getting the drug. By washing after inhalations it is possible to prevent damage to the skin of the eyelids and nose.

    A balloon with Beclomethasone should not be pierced, disassembled or thrown into a fire, even if it is empty. Like most other means for inhalation in aerosol packages, Beclomethasone may be less effective at low temperatures. When cooling the cylinder, it is recommended to remove the inhaler from it and warm it with your hands for several minutes.

    Effect on the ability to drive transp. cf. and fur:

    No data.

    Form release / dosage:

    Aerosol for inhalation dosed with 50 μg / dose, 100 μg dose or 250 μg / dose.

    Packaging:For 200 doses in aluminum cylinders with a protective coating, sealed by a metering valve and equipped with a spray nozzle with a protective cap.Each cylinder, together with a nozzle-sprayer and protective cap, as well as instructions for use, is placed in a bundle.
    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep away from heating system and direct sunlight.

    Keep out of the reach of children!

    Protect from falls and shocks.

    Shelf life:

    3 years. Do not use after the expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002700
    Date of registration:10.11.2014 / 15.03.2016
    Expiration Date:10.11.2019
    The owner of the registration certificate:BINNOFARM, CJSC BINNOFARM, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp21.01.2017
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