Active substanceAmbroxolAmbroxol
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  • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    Active substance: Ambroxol hydrochloride 30 mg.

    Excipients: lactose monohydrate - 147.5 mg, potato starch - 5.5 mg, microcrystalline cellulose - 5.0 mg, magnesium stearate - 2.0 mg.

    Description:

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

    Pharmacotherapeutic group:Expectorant, mucolytic agent
    ATX: & nbsp

    R.05.C.B.06   Ambroxol

    Pharmacodynamics:

    The drug has an expectorant, mucolytic effect.Reducing the viscosity of sputum occurs as a result of depolymerization of mucopolysaccharides that are in sputum. Depolymerization of mucopolysaccharides is primarily associated with the disruption of disulfide bonds in their molecules. Ambroxol increases the motor activity of the ciliated epithelium, increases mucociliary transport, normalizes the 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. It facilitates the excretion of sputum from the respiratory tract. Ambroxol stimulates prenatal lung development by increasing the synthesis and secretion of surfactant in the alveoli. Synthesis of the surfactant is reduced as a result of chronic diseases of the respiratory system, in addition, the properties of the surfactant change due to the formation of bonds between the surface active phospholipids and inflammatory proteins.

    The drug appears for 30 minutes and is held for 6-12 hours.
    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). The half-life (T1/2) - 9-10 hours. Penetrates through the histohematological barriers, excreted into breast milk. It is excreted by the kidneys: 90% in the form of metabolites, 10% in unchanged form.

    Indications:

    Infectious and inflammatory diseases of the bronchopulmonary system, accompanied by the formation of difficult to separate sputum: acute and chronic bronchitis, tracheitis, chronic obstructive pulmonary disease, pneumonia, bronchial asthma, bronchiectasis, cystic fibrosis.

    Contraindications:

    Hypersensitivity to any component of the drug.

    Pregnancy (first trimester).

    Children under 12 years.

    Hereditary diseases, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption.

    Carefully:

    The drug should be used with caution in patients with gastric ulcer and duodenal ulcer, as there may be an exacerbation of peptic 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 necessary, the use of ambroxol in II-III trimester of pregnancy is possible if the potential benefit to the mother exceeds the possible risk to the fetus.

    During breastfeeding, use the drug with caution, as it is excreted into breast milk.

    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 in the first 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.

    Patients receiving ambroxol, do not recommend performing respiratory gymnastics; In seriously ill patients, aspiration of diluted sputum should be performed. In patients with bronchial asthma ambroxol can strengthen cough.

    Do not take ambroxol just before bed.

    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 speed of psychomotor reactions.

    Form release / dosage:Tablets 30 mg.
    Packaging:

    For 10 tablets in a planar cell package.

    2, 3, 4 or 5 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C in the secondary packaging.

    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-007836/09
    Date of registration:06.10.2009 / 24.04.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:TATHIMFARMPREPARATY, JSC TATHIMFARMPREPARATY, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp01.08.2017
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