Active substanceBromhexineBromhexine
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  • Dosage form: & nbsppills
    Composition:
    One tablet of 4 mg contains:
    active substance: bromhexine hydrochloride in terms of 100% substance - 4 mg;
    Excipients: lactose monohydrate - 77.5 mg, microcrystalline cellulose - 15 mg, croscarmellose sodium - 2 mg, silicon dioxide colloid - 1 mg, calcium stearate - 0.5 mg.
    One 8 mg tablet contains:
    active substance: bromhexine hydrochloride in terms of 100% substance - 8 mg;
    Excipients: lactose monohydrate 155 mg, microcrystalline cellulose 30 mg, croscarmellose sodium 4 mg, silicon dioxide colloid 2 mg, calcium stearate 1 mg.
    Description:
    Round flat-cylindrical tablets from white to white with a yellowish or grayish shade of color, with a bevel. Presence of "marble" is admissible.
    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 sputum (depolymerizes mukoproteinovye 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:

    Ingestion bromohexine almost completely (99%) is absorbed within 30 minutes. About 80% of bromhexine undergoes intensive metabolism due to the effect of the first "passage" through the liver. In the plasma bromohexine binds to proteins, penetrates through blood-brain and placental barriers. In the liver bromohexine is demethylated and oxidized to form an active metabolite - ambroxol. The half-life is 15 hours due to slow reverse diffusion from the tissues. It is excreted by the kidneys.In chronic renal failure, excretion of metabolites of bromhexine is impaired. With repeated use bromohexine can cumulate.

    Indications:

    Diseases of the respiratory tract, accompanied by difficulty in moving away viscous sputum: tracheobronchitis, bronchitis of different etiology (including 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, pregnancy (I trimester), lactation period, gastric ulcer (at the stage of exacerbation), children under 6 years of age, lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

    Carefully:

    Gastric bleeding in the history, renal and / or hepatic insufficiency, bronchial diseases, accompanied by excessive accumulation of secretions.

    Dosing and Administration:

    Inside, regardless of food intake.

    Adults and children over 14 years of age - 8-16 mg 3-4 times a day. Children 6-14 years - 8 mg 3 times a day.

    The course of treatment is from 4 to 28 days.

    Side effects:

    Rarely, with long-term administration of the drug, allergic reactions, dyspepsia, incl. nausea, vomiting; exacerbation of peptic ulcer of stomach and duodenum, dizziness, headache, increased activity of "liver" transaminases. In these cases, the drug should be discontinued.

    Overdose:

    Symptoms: nausea, vomiting, diarrhea.

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

    Interaction:

    Bromhexine Do not prescribe concomitantly with drugs that suppress the cough center (including those containing codeine), as this makes it difficult to evacuate diluted sputum.

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

    Bromhexine not compatible with alkaline solutions.

    Special instructions:

    In the course of treatment, it is recommended to take a sufficient amount of liquid, which maintains the secretolitic action of bromhexine.

    In children, treatment should be combined with postural drainage or vibration massage of the chest, facilitating the evacuation of secretions from the bronchi.

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

    Form release / dosage:

    Tablets 4 mg and 8 mg.

    Packaging:

    For 10 tablets in a planar cell package.

    2 contiguous cell packs for tablets with a dosage of 8 mg or 5 contiguous cell packs for tablets with a dosage of 4 mg together with instructions for use in a pack of cardboard.

    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:
    2 years. Do not apply but the expiration date.
    Terms of leave from pharmacies:Without recipe
    Registration number:P N002461 / 01
    Date of registration:06.05.2008 / 03.12.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia
    Manufacturer: & nbsp
    Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia
    Information update date: & nbsp25.02.2017
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