Active substanceBromhexineBromhexine
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  • Dosage form: & nbsppills
    Composition:

    Active substance:

    Bromhexine hydrochloride 0.008 g

    Excipients:

    Lactose (sugar milk) - 0.09 g;

    Potato starch - 0.032 g;

    Calcium stearate - 0.002 g;

    Sucrose (sugar) - 0.068 g.

    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:

    The drug has mucolytic (secretolitic) and expectorant action. Mucolytic effect is associated with depolymerization and liquefaction of mucoprotein and mucopolysaccharide fibers. Bromhexine has a weak anti-smoking effect. Reduces the viscosity of sputum, increases the serous component of 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. Bioavailability is 80 % due to the effect of "first passage" through the liver. In the plasma bromohexine binds to proteins, penetrates through blood-brain and placental barriers. In the liver bromohexine is subjected to demethylation and oxidation. The half-life is 15 hours due to slow reverse diffusion from the tissues. Excreted by the kidneys. In chronic renal failure, the release of metabolites of bromhexine is disrupted. With repeated use bromohexine can cumulate.

    Indications:
    • treatment of bronchopulmonary diseases accompanied by the formation of sputum of increased viscosity (bronchial asthma, cystic fibrosis, tuberculosis, pneumonia, tracheobronchitis, obstructive bronchitis, bronchiectasis, pulmonary emphysema, pneumoconiosis);

    • sanitation of the bronchial tree in the preoperative period and during the medical and diagnosticintrabronchial manipulation;

    • prevention of congestion in the bronchi of thick viscous sputum after surgery.

    Contraindications:
    • hypersensitivity to the components of the drug;

    • peptic ulcer of stomach in the stage of exacerbation;

    • hereditary intolerance to galactose, a deficiency of lactase or glucose-galactose malabsorption;

    • children's age till 6 years.

    Carefully:
    • renal and / or liver failure;

    • bronchial diseases accompanied by excessive accumulation of secretions;

    • in the anamnesis - gastric bleeding.

    Pregnancy and lactation:

    The drug is contraindicated in pregnancy and during breastfeeding.

    Dosing and Administration:

    How to use: inside regardless of food intake.

    Adults and children over 14 years of age are prescribed 1 - 2 tablets (8-16 mg) 3-4 times a day; children from 6 to 14 years, 1 tablet (8 mg) 3 times a day.

    Side effects:

    From the nervous system: dizziness, headaches.

    From the skin: possible allergic reactions (skin rash).

    From the digestive tract: nausea, vomiting, dyspepsia, exacerbation of peptic ulcer of the stomach and duodenum, an increase in the level of "liver" transaminases in the blood serum.

    From the respiratory system: allergic reactions (rhinitis).

    In these cases, the drug should be discontinued.

    Overdose:

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

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

    Interaction:

    Bromhexine Do not prescribe concomitantly with drugs containing codeine, since this makes it difficult to cough up thinned phlegm.

    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.

    Incompatible with alkaline solutions.

    Special instructions:

    During the treatment it is recommended to use a sufficient amount of liquid that supports the secretolitic action of bromhexine.

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

    The half-life of bromhexine increases with severe renal dysfunction, so patients with impaired renal function should be prescribed bromohexine in smaller doses or in usual doses, but at longer intervals.

    In cases of violation of bronchial motility or a significant amount of sputum produced (for example, with rare malignant cilia syndrome), the use of bromhexine requires caution in connection with the risk of delayed discharge in the airways. During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Tablets 8 mg.

    Packaging:

    For 10 tablets in a contour mesh box made of polyvinylchloride film and foil of aluminum printed lacquered or paper with a polymer coating.

    Contoured cell packs in a place with an equal number of instructions for use are placed in a group package.

    Storage conditions:

    Store in a dry place protected from light.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N002104 / 01-2003
    Date of registration:15.12.2008 / 25.08.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:DALHIMFARM, OJSC DALHIMFARM, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspDALHIMFARM, OJSCDALHIMFARM, OJSC
    Information update date: & nbsp24.02.2017
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