Active substanceAmbroxolAmbroxol
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  • Dosage form: & nbsppills
    Composition:

    One tablet contains:

    Active substance: Ambroxol hydrochloride 30 mg

    Excipients: sugar milk (lactose), potato starch, calcium stearate, aerosil (silicon dioxide colloidal).

    Description:

    Tablets are white or white with a yellowish tint of color, flat-cylindrical, with a facet on both sides.

    Pharmacotherapeutic group:Expectorant, mucolytic agent
    ATX: & nbsp

    R.05.C.B.06   Ambroxol

    Pharmacodynamics:

    Mucolytic agent, stimulates prenatal lung development (increases synthesis, secretion of surfactant and blocks its disintegration).Has a secreto-motor, secretolitic and expectorant action; stimulates serous cells of the glands of the mucous membrane of the bronchi, increases the content of mucous secretions and the release of surfactant (surfactant) in the alveoli and bronchi; normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolysing enzymes and enhancing the release of lysosomes from Clark cells, reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport.

    Pharmacokinetics:

    After application, the absorption of the drug from the gastrointestinal tract is high. Time to reach the maximum concentration in the blood (TCmah) - about 2 hours. Binding to plasma proteins - 80-90%.

    The drug is metabolized in the liver to inactive metabolites (dibromantranilic acid and glucuronic conjugates). Half-life (T1/2) - 7-12 hours. Penetrates through the histohematological barriers, excreted into breast milk. It is excreted by the kidneys: 90% in the form of metabolites, 5% in unchanged form. T1/2 increases with severe chronic renal failure, does not change if the liver function is impaired.

    Indications:

    Diseases of the respiratory tract with the formation of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease (COPD), bronchial asthma with difficulty in sputum discharge, bronchiectasis, cystic fibrosis.

    Contraindications:

    - Hypersensitivity to any component of the drug.

    - Pregnancy (first trimester).

    - Children under 12 years.

    Carefully:

    The drug should be used with caution in patients with gastric ulcer and duodenal ulcer, as well as in patients with renal and hepatic insufficiency.

    Pregnancy and lactation:

    The drug is not recommended for use during the first trimester of pregnancy. If it is necessary to use ambroxol in II-III trimester of pregnancy and during breastfeeding should evaluate the potential benefit to the mother, the possible risk to the fetus / child.

    Dosing and Administration:

    The drug is used inside after eating with a sufficient amount of liquid.

    Adults and children over 12 years of age:

    1 tablet 30 mg 3 times a day for the first 2-3 days, then the dose of the drug should be reduced to 1 tablet 2 times a day.

    It is not recommended to use without medical appointment for more than 4-5 days.
    Side effects:

    Allergic reactions: skin rash, hives, angioedema, in some cases - allergic contact dermatitis, anaphylactic shock.

    Rarely - weakness, headache, diarrhea, dry mouth and respiratory tract, exanthema, rhinorrhea, constipation, dysuria. With prolonged use in high doses - gastralgia, nausea, vomiting.

    Overdose:

    Symptoms: nausea, vomiting, gastralgia.

    Treatment: artificial vomiting, gastric lavage for the first time 1-2 hours after taking the drug, taking fat-containing foods.

    Interaction:

    When used with antitussive drugs, it may be difficult for sputum to escape as a result of suppressing the cough reflex. With simultaneous use with amoxicillin, cefuroxime, erythromycin, doxycycline ambroxol increases their concentration in the bronchial secretion.

    Special instructions:

    Ambroxol should be used with caution in patients with a weakened cough reflex or disturbed mucociliary transport due to the possibility of sputum congestion.

    In patients with bronchial asthma ambroxol can strengthen cough.

    Ambroxol should not be taken concomitantly with antitussive drugs, which can inhibit cough reflex, for example, with codeine, since it can make it difficult to remove diluted sputum from the bronchial tree.

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

    The use of the drug does not affect the ability to drive a car and engage in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Tablets, 30 mg.

    Packaging:

    For 10 tablets in a planar cell package.

    2, 3 or 5 contour cell packs of 10 tablets 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:

    3 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-006142/10
    Date of registration:30.06.2010 / 15.12.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC Republic of Belarus
    Manufacturer: & nbsp
    Information update date: & nbsp01.08.2017
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