Active substanceAmbroxolAmbroxol
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  • Dosage form: & nbspsyrup
    Composition:

    Each 100 ml of syrup contains:

    active substance: Ambroxol hydrochloride 0.300 g;

    Excipients: sorbitol liquid (non-crystalline) 20.430 g, glycerol 85%, 10,000 g, hydroxyethylcellulose 0.400 g, sodium benzoate 0.250 g, purified honey 1,000 g, honey flavor 78845-33 0.130 g, sodium saccharin 0.100 g, color Fuscum aureum CH - 0.005 g (Quinoline yellow (E104) - 21.71% -26.53%, Yellow- SY(E 110) - 9,94%-12,16%; Brilliant blak BN E 151 - 2,ll%-2,59%, -Azombine(E122) - 0,24% -0,30%, sodium sulfate calcined (Е 514) - up to 100%), purified water - up to 100 ml.
    Description:

    From light yellow to yellow with a brown shade of color, slightly opalescent syrup with a characteristic smell of honey. A small deposit of honey is allowed.

    Pharmacotherapeutic group:Expectorant, mucolytic agent
    ATX: & nbsp

    R.05.C.B.06   Ambroxol

    Pharmacodynamics:Ambroxol - an active metabolite of bromhexine - is a compound with pronounced secretion and secretion properties. It regulates the disturbed formation of mucus in the glandular cells, facilitating the release of the accumulated and tightly adherent secretion from the bronchi, and accelerates the excretion of mucus, stimulating mucociliary mobility.
    Pharmacokinetics:

    Absorption is high, the time to reach a maximum concentration of about 2 hours, the connection with plasma proteins is 80%. Penetrates through the blood-brain barrier, placental barrier, excreted in breast milk.

    Metabolism - in the liver, forms dibromantranilic acid, and glucuronic conjugates. Half-life is 7-12 hours. It is excreted by the kidneys: 90% in the form of water-soluble metabolites, unchanged - 5%.

    The half-life period increases with severe chronic renal failure, does not change if the liver function is impaired.

    Indications:

    Symptomatic treatment of acute and chronic respiratory diseases accompanied by a cough with the formation of difficult to separate phlegm viscosity: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma with difficulty in sputum discharge, bronchiectatic disease.

    Contraindications:

    Hypersensitivity to the components of the drug;

    pregnancy (I trimester).

    Carefully:FROM caution should be used in patients with diabetes, pollinosis, hepatic insufficiency.
    Pregnancy and lactation:

    Ambroxol penetrates into breast milk. Therefore, it is necessary to carefully determine the benefit and risk of its use by nursing mothers.

    Dosing and Administration:

    Daily therapeutic doses are in the range of 1.2-1.6 mg ambroksola per kg body weight.

    The daily dose of syrup should be divided into two or three doses, regardless of intake food, and should drink plenty of liquid.

    If the doctor does not prescribe other doses, the dose of the drug should normally be the following:

    children under 2 years: 2.5 ml of syrup 2 times a day;

    children 2-5 years old: 2.5 ml of syrup 3 times a day;

    children 5-12 years old: 5 ml of syrup 2 or 3 times a day;

    children over 12 years and adults: usually 10 ml of syrup 3 times a day during the first 2-3 days of treatment, then the dose can be reduced to 5 ml 3 times a day.

    To measure the dose, a measuring spoon with divisions 1/4 (1.25 ml) and 1/2 (2.5 ml).

    A fully filled spoon contains 5 ml - syrup. Before application by shaking, it is necessary to eliminate the sediment of honey, which over time can be formed at the bottom of the vial.

    The syrup can be taken irrespective of food intake, squeezed with enough liquid.

    Instructions for opening the vial with a closure system that provides safety.

    The bottle is provided with a closure system that ensures safety, which prevents children from opening. For opening: press on top of the cap, turn counterclockwise. After application, tighten the cap again tightly.

    Side effects:

    Medox® is usually well tolerated.

    Infrequent fatigue, nausea, discomfort in the digestive tract (vomiting, vomiting, diarrhea, or constipation), dry mouth can occur.

    Rarely allergic reactions: skin rash, hives. It is extremely rare occurrence of acute severe reactions of anaphylactic type (angioedema, anaphylactic shock). In some cases - allergic contact dermatitis. According to the literature, when taking ambroxol, headache, dryness in the airways, exanthema, rhinorrhea, dysuria may occur.

    In the event of such undesirable effects or other unusual reactions, it is necessary to consult a doctor regarding the advisability of further taking the drug.

    Overdose:

    Symptoms: nausea, vomiting, diarrhea.

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

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

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

    Special instructions:

    Usually the duration of medox medication is 7-10 days. Longer treatment should be carried out on the recommendation of a doctor.

    If the state of health does not improve within 3 days of starting the drug or if there are undesirable reactions, you should consult your doctor.

    The preparation contains 0.135 g of sugar in each 5 ml of syrup. Patients with diabetes can use MEDOX® only after consulting with a doctor, provided that the recommended dose and correction of therapy for hypoglycemic drugs.

    When taking the drug, you need to drink a lot of liquid to facilitate the formation and dilution of mucus in the airways.

    Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities.
    Form release / dosage:Syrup 15 mg / 5 ml.
    Packaging:For 100 ml in bottles of dark glass with a plastic screw cap. Each bottle is supplied with a measuring spoon in a cardboard bundle along with instructions for use.
    Storage conditions:

    At temperatures up to 25 ° С.

    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:LS-002492
    Date of registration:24.10.2011
    Date of cancellation:2017-11-14
    The owner of the registration certificate:Zentiva c.s.Zentiva c.s. Czech Republic
    Manufacturer: & nbsp
    ZENTIVA, k.s. Czech Republic
    Representation: & nbspZENTIVA ZENTIVA Czech Republic
    Information update date: & nbsp14.11.2017
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