Active substanceBeclomethasoneBeclomethasone
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  • Dosage form: & nbspaerosol for inhalation
    Composition:
    Each inhaler contains 200 doses of the drug.

    Each dose of the drug contains active substance: beclomethasone dipropionate 50.0 μg / 100.0 μg / 250.0 μg; Excipients: hydrofluoroalkane (HFA-134a) 75.86 mg / 74.79 mg / 71.75 mg, ethanol 2.09 mg / 3.11 mg / 6.00 mg
    Description:Aerosol for inhalation in an aluminum canister under pressure with an outlet valve and a nebulizer. There must be no external damage, corrosion or leakage. The contents of the can is a solution that when sprayed onto the glass leaves a colorless spot. The balloon is placed in an inhaler consisting of two parts and a safety cover.
    Pharmacotherapeutic group:Glucocorticosteroid (GCS) 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 due to decreased formation of chemotaxis substance (influence on "late" allergy reactions),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:

    Absorption. Up to 56% of the dose of the inhaled drug settles in the lower respiratory tract; The remaining amount settles in the mouth, pharynx and is swallowed.In the lungs, before absorption of beclomethasone, dipropionate 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) and in the gastrointestinal tract (26% of the dose that has been ingested here when the dose is ingested). The absolute bioavailability of unchanged beclomethasone dipropionate and B-17-MP is approximately 2% and 62% of the inhalation dose, respectively. Beclomethasone dipropionate is rapidly absorbed, the time to reach the maximum concentration in the blood plasma (Tmax) is 0.3 hours. B-17-MP is absorbed more slowly, Tmah is 1 hour. There is an approximately linear relationship between the increase in the inhaled dose and the system exposure of the drug.

    Distribution.

    Distribution in tissues is 20 liters for beclomethasone dipropionate and 424 liters for B-17-MP.

    The connection with plasma proteins is relatively high - 87%.

    Elimination.

    Beclomethasone dipropionate and B-17-MP have a 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 older than 4 years.
    Contraindications:Hypersensitivity to any component of the drug. Children up to 4 years.
    Carefully:Use with caution in glaucoma, systemic infections (bacterial, viral, fungal, parasitic), osteoporosis, pulmonary tuberculosis, liver cirrhosis, hypothyroidism, pregnancy, lactation.
    Pregnancy and lactation:With extreme caution Beklason Eco Light Breath 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:Beklazone Eco Light Breath is only for inhalation. Beklazone Eco Light Breathing is used regularly (even in the absence of symptoms disease), the dose of beclomethasone dipropionate is selected taking into account the clinical effect in each specific case.

    With an easy flow of bronchial asthma, the volume of forced expiration (FEV1) or peak expiratory flow rate (PSV) is more than 80% of the required values ​​with a PSV score of less than 20%. With an average severity of FEV1 or PSV is 60-80% of the required values, the daily spread of PSV indicators is 20-30%. In severe FEV1 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 GCS will be able to reduce their dose or cancel them altogether.

    Initial dose of Beklazone Eco Light Breath 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.

    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;

    - Bronchial asthma of severe course - 1000 - 2000 mcg / day

    Children between the ages of 4 and 12

    Up to 400 mcg per day in several doses.

    Special patient groups

    There is no need to adjust the dose of Beklazone Eco Light Breathing 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.

    Beklazone Eco Light Breath containing 250 μg in 1 dose is not intended for pediatric use.

    Instructions for the patient on the operation of the inhaler

    Hold the inhaler in an upright position, open the lid. Take a deep breath out. Tightly grasp the mouthpiece with your lips. Make sure that your hand does not block the ventilation holes on the top of the inhaler and that you keep the inhaler in an upright position. Take a slow maximum breath through the mouthpiece. Hold your breath for 10 seconds or as long as you feel comfortable. Then remove the inhaler from the oral cavity and exhale slowly. After application Continue to hold the inhaler in an upright position. Close the cover. If you need to do more than one inhalation, close the lid, wait at least one minute, and then repeat the inhalation process.

    Cleaning the inhaler

    Unscrew the top of the inhaler. Remove the metal can. Rinse the bottom of the inhaler in warm water and dry. Insert the can into place. Close the lid and screw the upper part of the inhaler to its housing. Do not wash the top of the inhaler.If the inhaler does not work properly, unscrew the upper part of the inhaler and manually press the can.

    Side effects:
    Some patients may develop candidiasis of the mouth and throat (the likelihood of developing candidiasis increases with beclomethasone dipropionate in doses exceeding 400 micrograms per day).
    Some patients may experience dysphonia (hoarseness) or irritation of the pharyngeal mucosa.
    Inhalation drugs can cause a paradoxical bronchospasm, which must be immediately stopped with a short-acting inhaled β-2-adrenostimulator.
    There are some reports of the development of hypersensitivity reactions, including rash, hives, itching, redness and swelling of the eyes, face, lips and mucous membranes of the mouth and pharynx. Possible systemic effects characteristic of GCS include headache, nausea, bruising or thinning of the skin, unpleasant gustatory sensations, decreased adrenal cortex function, osteoporosis, growth retardation in children and adolescents, cataracts, glaucoma.
    Overdose:Acute overdose of the drug may lead to a temporary decrease in the function of the adrenal cortex,that 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 the plasma. In chronic overdosage, persistent suppression of adrenal cortex function can be noted. 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:There is no confirmed data on the interaction of beclomethasone dipropionate with other drugs.
    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 Candida fungus, indicating a previously 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 Beklazone Eco Light Breathing. If patients take GCS inside, then Beclason Eco Light Breathing is prescribed against the background of taking the previous dose of GCS, 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), and in the first months after the transition, the patient's condition should be carefully monitored until his pituitary-adrenal the system will not recover sufficiently to provide an adequate response to stressful situations (for example, 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). Sudden and progressive worsening of asthma symptoms is a potentially dangerous condition, often life-threatening patients, and requires an increase in the dose of GCS. An indirect indicator of the ineffectiveness of therapy is the more frequent, than before, use of short-acting β-2-adrenostimulators.
    Beklazone Eco Light Breath is not designed to stop seizures, but for regular daily use. For relief of attacks, β-2-adrenostimulators of short action (for example, salbutamol). In case of severe exacerbation of bronchial asthma or inadequate effectiveness of the therapy, increase the dose of Beclason Eco Light Breathing and, if necessary, prescribe a systemic SCS and / or antibiotic for the development of infection.
    With the development of paradoxical bronchospasm should immediately stop using Beklazone Eco Light Breathing, assess the patient's condition, conduct a survey 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 mcg / day, the drug in most patients does not cause significant suppression of the adrenal glands. 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 inwards to treatment with Beclason Eco Light Breathing.
    It is recommended to regularly monitor the dynamics of growth in children receiving inhaled glucocorticosteroids for a long time.
    It is not recommended to abruptly discontinue Beklazone Eco Light Breath.
    Special care should be taken when treating inhaled GCS patients with active or inactive forms of pulmonary tuberculosis.
    It is necessary to protect eyes from getting the drug. By washing after inhalation, it is possible to prevent damage to the skin of the eyelids and nose.
    Balloon with Beclazone Eco Light Breathing can not be pierced, disassembled or thrown into the fire, even if it is empty. Like most other inhalation agents in aerosol packs, Beclason Eco Light Breathing can be less effective at low temperatures. When cooling the can, it is recommended to remove it from the plastic case and warm it with your hands for several minutes.
    Form release / dosage:
    Aerosol for inhalation dosage activated by inhalation 50 μg / dose, 100 μg / dose, 250 μg / dose.
    Packaging:200 doses of the active substance in an aluminum canister filled with aerosol under pressure. The aluminum cylinder is in an aerosol inhaler, activated by inhalation (Light Breath). The aerosol inhaler with a balloon is placed in a cardboard box together with instructions for use.
    Storage conditions:At a temperature of no higher than 25 ° C, protecting from direct sunlight. Do not freeze. Keep out of the reach of children.
    Shelf life:
    3 years.
    Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:П N014096 / 01
    Date of registration:28.04.2007/10.02.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:Norton Waterford, acting under the trade name Ivex Pharmaceuticals IrelandNorton Waterford, acting under the trade name Ivex Pharmaceuticals Ireland Ireland
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp21.01.2017
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