Active substanceBromhexineBromhexine
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  • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    Active substance: bromhexine hydrochloride 8 mg

    Excipients: lactose (milk sugar), potato starch, calcium stearate monohydrate (calcium stearate 1-water), povidone (polyvinylpyrrolidone).

    Description:

    Tablets of white color, flat-cylindrical with a bevel.

    Pharmacotherapeutic group:Expectorant mucolytic agent
    ATX: & nbsp

    R.05.C.B   Mucolytics

    R.05.C.B.02   Bromhexine

    Pharmacodynamics:

    Mucolytic (secretolitic), has an expectorant and weak antitussive effect. Reduces the viscosity of phlegm (depolymerizes mucoprotein and mucopolysaccharide fibers,increases the serous component of the bronchial secretion); activates ciliated epithelium, increases volume and improves sputum discharge. Stimulates the production of endogenous surfactant, which ensures the stability of alveolar cells in the process of breathing. The effect is manifested after 2-5 days from the beginning of treatment.

    Pharmacokinetics:

    When ingested almost completely (99%) is absorbed in the gastrointestinal tract for 30 minutes. Bioavailability is low (the effect of "primary transmission" through the liver). It penetrates the placental barrier and the blood-brain barrier.

    In the liver it is demethylated and oxidized, metabolized to pharmacologically active ambroxol. The half-life (T1 / 2) is 15 hours (due to slow back diffusion from the tissues). It is excreted by the kidneys. With chronic renal failure, excretion of metabolites is impaired. With multiple applications can cumulate.

    Indications:

    Diseases of the respiratory tract, accompanied by difficulty in withdrawing viscous sputum: tracheobronchitis, bronchitis of different etiology (including those complicated by bronchiectasis), bronchial asthma, pulmonary tuberculosis, pneumonia, cystic fibrosis.

    Sanitation of the bronchial tree in the preoperative period and during the medical and diagnostic intrabronchial manipulation, prevention of congestion in the bronchi of thick viscous sputum after the operation.

    Contraindications:

    Hypersensitivity, peptic ulcer of the stomach, children under 6 years of age, sugar / isomaltase / lactase deficiency, fructose / galactose intolerance, glucose-galactose malabsorption.

    Carefully:

    Renal and / or liver failure; bronchial diseases, accompanied by excessive accumulation of secretion, in the anamnesis - gastric bleeding.

    Pregnancy and lactation:

    The use is contraindicated in pregnancy (I trimester), during lactation.

    Dosing and Administration:

    Inside, adults and children over 14 years - 8-16 mg 3-4 times a day.

    If necessary, the dose may be increased by an adult to 16 mg 4 times in day.

    Children aged 6-14 years - 8 mg 3 times a day.

    Therapeutic: The effect can occur on the 4-6th day of treatment.

    Patients with renal insufficiency are prescribed smaller doses or increase the interval between administrations.

    Side effects:

    Allergic reactions (skin rash, renite), dyspepsia, including nausea,vomiting; exacerbation of peptic ulcer: stomach and duodenum, dizziness, headache, increased activity of "liver" transaminases.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    Symptoms: dyspeptic disorders, including nausea, vomiting, diarrhea.

    Treatment: artificial vomiting, gastric lavage (in the first 1-2 hours after, admission).

    Interaction:

    Do not prescribe concomitantly with drugs that suppress, cough center (including codeine), as this makes it difficult to escape the diluted sputum (accumulation of bronchial secretions in the airways).

    Incompatible with alkaline solutions.

    Bromhexine contributes to the penetration of antibiotics (amoxicillin, erythromycin, cephalexin, oxytetracycline), sulfonamide drugs in the bronchial secret in the first 4-5 days, antimicrobial therapy.

    Special instructions:

    When treating, you must take a sufficient amount of fluid, which increases the expectorant effect of bromhexine.

    In children, treatment should be combined with postural drainage or vibratory chest massage, which facilitates the secretion of bronchial secretions.

    During the treatment period, care must be taken when managing, transporting vehicles and engaging in other potentially hazardous activities requiring increased concentration of attention and speed, psychomotor reactions.

    Form release / dosage:
    Tablets of 8 mg.
    Packaging:
    For 10 tablets in a contoured cell pack of a film of polyvinyl chloride colorless or light-shielded and aluminum foil or paper with a polymer coating.
    By 20, 25, 30, 40, 50, 60 tablets in cans of polymeric.
    Each jar or 1, 2, 3, 5 cell packs, together with instructions for use, are placed in a cardboard pack.
    Banks of polymeric or contoured cells from a film of polyvinylchloride light-shielding with an equal number of instructions for use are placed in a group package.
    Storage conditions:

    In dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N002243 / 01
    Date of registration:31.07.2008 / 31.01.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:URALBIOFARM, OJSC URALBIOFARM, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspURALBIOFARM, OJSCURALBIOFARM, OJSCRussia
    Information update date: & nbsp25.02.2017
    Illustrated instructions
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