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

    Active ingredient: beclomethasone dipropionate 250 mcg;

    Auxiliary components: ethanol is dehydrated - 7,440, isopropanol 1.315 mg, 1.1, 1.2-tetrafluoroethane - 66.50 mg.

    Description:Aerosol for inhalation in an aluminum canister under pressure. The contents of the can is a colorless or pale yellow liquid.

    Pharmacotherapeutic group:Glucocorticosteroid for topical application
    ATX: & nbsp

    R.01.A.D.01   Beclomethasone

    Pharmacodynamics:

    Glucocorticosteroid local action, is used as a basic therapy of bronchial asthma, has anti-inflammatory and anti-allergic. act. It inhibits the release of inflammatory mediators, increases the production of lipocortin (annexin) - inhibitor phospholipase A2, reduces the release of arachidonic acid, inhibits the synthesis of metabolic products of arachidonic acid - cyclic endoperoxides, Pg.

    Reduces inflammation beyond. reduction of the formation of the chemotactic substance (this explains the influence on the "late" reaction of allergy), 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 hyperreactivity of the bronchi, the neutrophil vascular accumulation, the inflammatory exudate and the production of cytokines, the macrophage migration is inhibited, the intensity of the infiltration and granulation processes decreases, which ultimately improves indicators of the function of external respiration. 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 mineralocorticoid activity and resorptive effect after inhalation. In therapeutic doses, it has an active local effect without the development of side effects characteristic of systemic glucocorticosteroids.

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

    Pharmacokinetics:

    Absorption is low, with an inhalation mode of administration in the recommended doses does not have a significant systemic activity.10-20% of the dose goes to the lungs, where there is hydrolysis of beclomethasone dipropionate into its active metabolite - beclomethasone monopropionate.

    Most of the drug that enters the gastrointestinal tract is inactivated by the "first pass" through the liver. The connection with plasma proteins is 87%.

    The main part of the preparation (35-76%) is excreted for 96 hours with caloric masses, mainly in the form of polar metabolites, 10-15% -tips.

    Indications:Bronchial asthma requiring maintenance therapy with glucocorticosteroids. Chronic obstructive pulmonary disease (COPD).
    Contraindications:Hypersensitivity, acute bronchospasm, asthmatic status (as a primary means), children's age to 6 years.
    Carefully:

    Cirrhosis of the liver, glaucoma, hypothyroidism, systemic infections (bacterial, fungal, parasitic, viral), osteoporosis, pregnancy, lactation. The drug is usually not prescribed for children under 12 years, unless the appointment of high doses of beclomethasone (500 μg or more) is dictated by the severity of the patient's condition.

    Pregnancy and lactation:

    During pregnancy and lactation beclomethasone should be used with caution and only if, the benefit of, its use exceeds potential risk. Data on the safety of beclomethasone dipropionate in pregnant women and on the isolation of it with breast milk of women is not enough.

    Dosing and Administration:

    Inhalation. Adults (including elderly patients) and children over 12 years of age:

    - bronchial asthma of mild severity (FEV or peak exhalation rate (PSV) of more than 80%, daily spread of PSV parameters is less than 20%) - 250-500 mcg / day for 1-2 inhalations;

    - bronchial asthma of moderate severity (FEV or PSV - 60-80%, diurnal spread of PSV parameters - 20-30%) - 0.5-1 mg / day for 2-4 inhalations;

    - bronchial asthma of a serious degree (FEV or PSV - 60%, daily dispersion of PSV parameters - 30%) - 1-2 mg / day for 2-4 inhalations.

    The maximum daily dose of the drug in adults should not exceed 1 mg, in very severe cases -1.5-2 mg / day for 3-4 doses.

    Use of Beclomethasone DS 250 μg / dose in children aged 6 to 12 years is only possible if the required daily dose is 500 μg or more.

    After each inhalation, rinse the oral cavity with water.

    The introduction can be carried out using special dispensers (spacers),improving the distribution of the drug in the lungs and reducing the risk of side effects.

    Side effects:

    Hoarseness, irritation in the throat, coughing, sneezing; paradoxical bronchospasm (it is stopped by the introduction of inhalation bronchodilators), eosinophilic pneumonia; allergic reactions, candidiasis of the oral cavity and upper respiratory tract (with long-term use and / or when used in high doses - more than 400 μg / day), performed with local antifungal therapy without discontinuing treatment. With long-term use in doses of more than 1.5 mg / day - systemic side effects (including adrenal insufficiency), headaches, dizziness, cataracts, increased intraocular pressure, leukocytosis, lymphopenia, eosinopenia: With a single inhalation of high doses of beclomethasone dipropionate (more 1 mg) is possible some decrease in the function of the hypothalamic-pituitary-adrenal system, which does not require the adoption of any emergency measures, and treatment should be continued; Function hypothalamic-pituitary-adrenal system is restored in 1-2 days.

    Overdose:When used at very high doses, systemic effects of glucocorticosteroids, such as hypercorticoidism and suppression of the function of the adrenal cortex, can be observed. When these symptoms appear, the dose should be reduced.
    Interaction:

    Significant interactions of inhaled glucocorticosteroids with other drugs have not been identified. Beclomethasone dipropionate restores the patient's response to beta-adrenergic stimulants, thereby reducing the frequency of their use.

    Phenobarbital, phenytoin, rifampicin and other inducers of microsomal oxidation reduces eEffective.

    Methandrostenolone, estrogens, beta2-adrenostimulators, theophylline and orally administered glucocorticosteroids increase the effect. Increases the effect of beta-adrenostimulyatorov.

    Special instructions:

    Before appointment inhalation medicines instruct the patient about the rules of application of the drug, ensuring the most complete entry of the drug in the right areas of the lungs. Beclomethasone It is not intended for relief of acute asthmatic attacks.Patients should be aware of the preventive nature of the drug and that to achieve the optimal effect, the inhaler should be used regularly, even in the absence of symptoms of asthma.

    With regular inhalations of beclomethasone, improvement in breathing usually occurs after 1 week of treatment. The lack of effect is possible in patients with increased sputum and mucus in the respiratory tract and severe bronchospasm, preventing the drug from reaching the zone of action. In such cases, appoint inhalation adrenostimulyatorov for 15-30 minutes before inhalation beclomethasone or.inachayut treatment with systemic use of glucocorticosteroids.

    The transfer of patients taking oral glucocorticosteroids on beclomethasone inhalation and subsequent treatment should be carried out with extreme caution, under daily control of the pyclofometry (pneumotachometry), since the suppression of the adrenal cortex caused by prolonged use of glucocorticosteroids is restored slowly.

    Before the appointment of inhalation forms of beclomethasone, patients should be in a relatively stable state, and their very appointment should supplement the usual maintenance dose of the systemic glucocorticosteroid.Approximately after 1 week, the daily dose of steroids begins to gradually decrease - 1 mg / week (in terms of prednisolone). Deterioration of the condition against the background of a maintenance dose of 400 mcg / day means the need to transfer patients to oral administration of prednisolone. Regular use allows in most cases to cancel oral glucocorticosteroids (patients who need to take no more than 15 mg of prednisone, 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 system will be restored sufficiently to provide a response to stressful situations (eg trauma, surgery or infection).

    Patients who have been transferred to inhalation treatment and have adrenal cortex disorder that have an impaired function should have a stock of glucocorticosteroids and a warning card with them, which should indicate that they need additional systemic administration of glucocorticosteroids in stressful situations (after a stressful situation the dose of steroids can be again reduce).Sometimes a transfer from the administration of systemic glucocorticosteroids to an inhalation administration may lead to the appearance of previously suppressed forms of allergy, for example, allergic rhinitis or eczema.

    It is necessary to protect eyes from getting the drug.

    It is advisable to rinse the mouth and throat after inhalation (prophylaxis of candidiasis), and when there are initial signs of fungal damage to the oral mucosa - the use of nystatin, fluconazole, amphotericin. By washing after inhalation, it is possible to prevent damage to the skin of the eyelids and nose.

    The maximum daily dose of the drug in adults should not exceed 1 mg. In a dose of up to 1.5 mg / day in most patients does not significantly suppress the function of the adrenal glands. If this dose is exceeded, some patients may experience some oppression of the adrenal glands. Treatment in doses of more than 1 mg / day is carried out under the supervision of a doctor.

    Beclomethasone in a dose of 250 mcg is not intended for use in pediatrics. It is recommended to regularly monitor the dynamics of the growth of children receiving inhaled glucocorticosteroids for a long period of time.

    Infectious-inflammatory diseases of the respiratory system are not a specific contraindication for treatment with beclomethasone.

    The drug should not be frozen and exposed to direct sunlight.

    A balloon can not be pierced, disassembled or thrown into a fire, even if it is empty. When cooling the can, it is recommended to remove it from the plastic case and warm it with hands (at low temperatures, the effectiveness of the drug is reduced).

    Form release / dosage:

    Aerosol for inhalation dosed with 250 mcg / dose.

    Packaging:Aerosol for inhalation dosed with 250 mcg / dose of 200 doses in an aluminum can with a plastic dispensing valve system. Each can is placed in a cardboard box together with instructions for medical use.
    Storage conditions:

    At a temperature of no higher than 30 ° C, protecting from direct sunlight.

    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:LP-001519
    Date of registration:16.02.2012 / 16.01.2015
    Expiration Date:16.02.2017
    The owner of the registration certificate:Danson Trading Pharmaceutical Company LimitedDanson Trading Pharmaceutical Company Limited Vietnam
    Manufacturer: & nbsp
    Representation: & nbspDominanta-Service CJSCDominanta-Service CJSC
    Information update date: & nbsp21.01.2017
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