Active substanceAmbroxolAmbroxol
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  • Dosage form: & nbsppills
    Composition:

    Each tablet contains:

    Active substance: Ambroxol hydrochloride 30 mg.

    Excipients: lactose monohydrate 147 mg, corn starch 21.4 mg, microcrystalline cellulose 38 mg, magnesium stearate 2.4 mg, silicon dioxide colloid 1.2 mg.

    Description:

    Round biconvex tablets white or almost white.

    Pharmacotherapeutic group:Expectorant, mucolytic agent
    ATX: & nbsp

    R.05.C.B.06   Ambroxol

    Pharmacodynamics:

    Ambroxol is a mucolytic drug.Increases synthesis, secretion of surfactant and blocks its decay. Has a secreto-motor, secretolitic and expectorant action. Stimulates the serous cells of the glands of the bronchial mucosa, increases the content of mucous secretions and the release of 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 Clara cells, reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport.

    Pharmacokinetics:

    The drug has a high absorption in any way of administration. The maximum concentration in the blood plasma is reached approximately 2 hours after ingestion. The connection with plasma proteins is 80%. Penetrates through the blood-brain barrier, placental barrier, excreted in breast milk.

    The drug is extensively metabolized in the liver. The half-life is 9-10 hours. 90% is excreted by the kidneys in the form of water-soluble metabolites, 5% is unchanged.

    Indications:

    - Acute and chronic bronchitis

    - Pneumonia

    - Chronic obstructive pulmonary disease (COPD)

    - Bronchial asthma with difficulty in sputum discharge

    - Bronchoectatic disease

    Contraindications:

    Hypersensitivity to any of the components of the drug, galactose intolerance, lactase deficiency or glucose-galactose malabsorption, the first trimester of pregnancy, children under 12 years (for this dosage form).

    Carefully:

    Hepatic insufficiency, renal failure, peptic ulcer of stomach and duodenum, pregnancy (second and third trimester), lactation period.

    Dosing and Administration:

    Tablets are taken orally, after eating, with a sufficient amount of warm liquid.

    Adults and children over 12 years of age: in the first 2-3 days appoint 30 mg (1 tablet) 3 times a day, then 30 mg twice a day.

    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:

    It is not recommended to take the drug together with drugs that have antitussive activity (for example, containing codeine) because of the difficulty of excretion of sputum from the bronchi on the background of suppression of the cough reflex. Increases penetration into the bronchial secretion of amoxicillin, cefuroxime, erythromycin and doxycycline.

    Possible use with cardiac glycosides, diuretics and antibiotics.

    Special instructions:

    Do not combine with antitussive drugs that make it difficult to withdraw phlegm.

    Form release / dosage:

    Tablets 30 mg.

    Packaging:

    For 10 tablets in a planar cell packaging made of polyvinylchloride film and aluminum foil printed lacquered.

    2 contour squares, together with instructions for use, are placed in a cardboard box.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years. Do not use after the time specified on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N015425 / 01
    Date of registration:08.09.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:LEKHIM-KHARKOV, CJSC LEKHIM-KHARKOV, CJSC Ukraine
    Manufacturer: & nbsp
    Information update date: & nbsp01.08.2017
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