Active substanceAmbroxolAmbroxol
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  • Dosage form: & nbspsyrup
    Composition:

    100 ml of syrup contain:

    Ambroxol hydrochloride - 0.3 g

    Excipients:

    Sodium benzoate 0.5 g

    Sorbitol 40.0 g

    Citric acid monohydrate - 0.067 g

    Sodium citrate pentasquihydrate 0.17 g

    1,2-Propylene glycol 20.0 g

    Riboflavin - 0.0025 g

    Aromatizer of fruit - 0.1 g

    (essences of aromatic food)

    Waters purified to 100 ml

    Description:Transparent liquid of yellow color with a fruity smell.
    Pharmacotherapeutic group:Expectorant, mucolytic agent
    ATX: & nbsp

    R.05.C.B.06   Ambroxol

    Pharmacodynamics:

    Has a secretion,secretion 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.

    After oral administration, the effect occurs after 30 minutes and lasts for 6-12 hours.
    Pharmacokinetics:

    Sufficiently absorbed in any way of administration. Penetrates through the blood-brain barrier, placental barrier, excreted in breast milk. The liver undergoes biotransformation, forms dibromantranilic acid and glucuronic conjugates. In the form of water-soluble metabolites for 90 % excreted in urine; in the unchanged form is deduced only 5%. The elimination half-life increases with severe renal failure, but 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 and bronchial asthma with difficulty of sputum discharge, bronchiectatic disease.

    Contraindications:

    Hypersensitivity to ambroxol or other components of the syrup, pregnancy (I trimester).

    Carefully:

    Hepatic insufficiency, renal failure, peptic ulcer of the stomach and duodenum.

    Pregnancy and lactation:

    The drug is not recommended for use during the first trimester of pregnancy. If it is necessary to use ambroxol inII-III trimesters of pregnancy should be evaluated for potential benefits to the mother with a possible risk to the fetus.

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

    Dosing and Administration:

    Syrup is taken orally after a meal with a sufficient amount of warm liquid. Adults: 3 times a day for 10 ml of syrup in the first 2-3 days of treatment, in the following days 10 ml of syrup 2 times a day or 5 ml of syrup 3 times a day.

    Children under 2 years: 2.5 ml syrup 2 times a day (15 mg / day).

    Children from 2 to 5 years: 2.5 ml 3 times a day (22.5 mg / day).

    Children from 5 to 12 years: 5 ml 2-3 times a day (30-45 mg / day).

    During the intake of the drug, a generous drink is recommended.

    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, diarrhea, indigestion.

    Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; reception of fat-containing products.

    Interaction:

    Increases the penetration into the bronchial secret of amoxicillin, cefuroxime, erythromycin and doxycycline.

    Joint use with antitussive drugs leads to difficulty in getting away from sputum while reducing the cough.

    Special instructions:

    Do not combine with antitussive drugs that hamper the excretion of phlegm.

    5 ml of syrup contain sorbitol in an amount of 2 g, which must be taken into account by patients suffering from diabetes mellitus.

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

    The drug does not affect the ability to drive vehicles and potentially dangerous mechanisms.

    Form release / dosage:Syrup 3 mg / ml.
    Packaging:

    To 50 or 100 ml in bottles of orange glass. Each bottle together with a measuring spoon for medicines and instructions for use are placed in a cardboard pack.

    Storage conditions:

    In 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 use after the expiry date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:LP-000899
    Date of registration:18.10.2011
    The owner of the registration certificate:TATHIMFARMPREPARATY, JSC TATHIMFARMPREPARATY, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp22.09.2015
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