Active substanceBeclomethasoneBeclomethasone
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  • Dosage form: & nbspnasal dosed aerosol
    Composition:

    Active ingredient: beclomethasone 50 μg;

    Auxiliary components: ethanol dehydrated - 5.0 mg, 1,1,1,2-tetrafluorochloroethane - 81.5 mg.

    Description:Aerosol nasal in an aluminum can 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:

    It belongs to the group of glucocorticosteroids of local action, it has anti-inflammatory and anti-allergic effect. It inhibits the release of inflammatory mediators, increases the production of lipocortin (annexin), an inhibitor of phospholipase A2, which leads to a decrease in the formation of arachidonic acid and the products of its transformation: Pg and leukotrienes, inhibits the synthesis of metabolic products of arachidonic acid-cyclic endoperoxides, Pg, as well as a factor that activates platelets.

    Reduces the formation of the chemotaxis substance (this explains the 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 reduced release from mast cells of inflammatory mediators) and improves mucociliary transport.Under the influence of beclomethasone, the number of mast cells in the mucous membrane of the nasal cavity and paranasal sinuses decreases, edema decreases, mucus secretion, neutrophil accumulation, inflammatory exudate and cytokine production, macrophage migration is inhibited, the intensity of infiltration and granulation processes decreases, which plays a significant role in the development of allergic rhinitis. Increases the number of active beta-adrenergic receptors.

    Virtually does not have mineralocorticosteroid activity and resorptive effect after intranasal administration. In therapeutic doses, it has an active local effect without the development of side effects characteristic of systemic glucocorticosteroids.

    The therapeutic effect develops gradually, usually after 5-7 days of course use of beclomethasone dipropionate, in some patients - in 2-3 weeks.

    Pharmacokinetics:

    Quickly absorbed from the nasal mucosa. Part of the injected drug is swallowed. Absorption from the gastrointestinal tract is low. The connection with plasma proteins is 87%.

    T1/2 - 15 hours The main part of the preparation (35-76%), regardless of the mode of administration, is excreted for 96 hours by the intestine, mainly in the form of polar metabolites, 10-15% by the kidneys.

    Indications:

    Seasonal and all-the-year-round allergic rhinitis, vasomotor rhinitis.

    Contraindications:Hypersensitivity, ulceration of the nasal septum, recent surgical interventions in the nasal cavity, recent nose trauma, children's age (under 6 years).
    Carefully:

    Tuberculosis of the respiratory system. (including latent), herpes eye, glaucoma, systemic infections (fungal, bacterial, viral), severe hepatic insufficiency, adrenal insufficiency, simultaneous use with other glucocorticosteroids, pregnancy, lactation.

    Pregnancy and lactation:

    During pregnancy and lactation beclomethasone should be used with caution and only if the benefit of its use for the mother exceeds the potential risk to the fetus and the baby.

    Dosing and Administration:

    Intranasally. Recommended dose for adults and children over 12 years: 50-100 μg (1-2 metered sprays) 2-4 times a day in each nasal passage. The maximum daily dose is 400 mcg.

    Children 6-12 years old: 50 μg (1 metered spraying), if necessary 100 μg (2 metered sprays) 2 times a day in each nasal passage.

    The maximum daily dose is 200 mcg.

    When the therapeutic effect is achieved, the drug is canceled, gradually reducing the dose. The maximum duration of application is not more than 4 weeks.

    Side effects:

    From the respiratory system: pain in the nasal cavity and throat, dryness and irritation of the mucous membrane of the nasal cavity and upper respiratory tract, rhinorrhea, cough, sneezing, epistaxis, mucosal ulceration - nasal membranes, nasal perforation, mucosal atrophy.

    From the nervous system: headache, dizziness, drowsiness.

    From the sense organs: pain in the eyes, visual impairment, conjunctival hyperemia, increased intraocular pressure, decreased taste sensations, unpleasant aftertaste and odor.

    Allergic reactions: skin rash, hives, bronchospasm.

    Other: Myalgia, candidiasis of the oral cavity and upper respiratory tract (long-term use and / or high doses - more than 400 mcg / day), growth retardation in children (with prolonged use) is possible.

    Overdose:

    Symptoms: systemic side effects are possible, incl. - Increased blood pressure, increased myocardial contractility,bone resorption, erosive lesions of the gastrointestinal tract, bleeding, oppression of the adrenal cortex function.

    Treatment: decrease in the dose of the drug.

    Interaction:

    Phenobarbital, phenytoin, rifampicin decrease efficiency (induction of microsomal oxidation enzymes). Methandrostenolone, estrogens, beta-adrenomimetics, theophylline, glucocorticoids taken internally, enhance the action of beclomethasone. Increases the effect of beta-adrenomimetics.

    Special instructions:

    Avoid contact with the eye.

    In children with prolonged use, growth retardation is possible. If growth slows down, it is recommended that the dose be reduced to a minimum effective dose.

    Patients who, with glucocorticosteroid therapy, may have decreased immunity (especially children) should be avoided, contact with patients with chicken pox and measles. When contacting a patient with measles, it is recommended that a specific Ig. Because the drug slows wound healing, patients with ulceration of the nasal septum, after recent surgical procedures in the nasal cavity, recent, nose trauma should not take the drug until the wound is completely healed.Patients with long-term and systemic therapy receiving glucocorticosteroids need control of the function of the adrenal cortex (possibly additive action).

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

    The drug intake affects the ability to drive vehicles and engage in other potentially dangerous activities requiring increased concentration and speed of psychomotor reactions, as the drug may cause dizziness, drowsiness and other side effects that may affect these abilities.

    Form release / dosage:

    Aerosol nasal dosed 50 mcg / dose.

    Packaging:Aerosol nasal dosed 50 μg / dose of 200 doses in an aluminum can with a plastic dispensing valve system for nasal use. 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.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001559
    Date of registration:02.03.2012
    Expiration Date:02.03.2017
    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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