Active substanceAmbroxolAmbroxol
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  • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    active substance: Ambroxol hydrochloride 30 mg;

    Excipients: potato starch - 25 mg, lactose monohydrate (sugar milk) - 44 mg, magnesium stearate - 1 mg.

    Description:

    Round flat-cylindrical white or almost white-colored tablets.

    Pharmacotherapeutic group:Expectorant, mucolytic agent
    ATX: & nbsp

    R.05.C.B.06   Ambroxol

    Pharmacodynamics:

    Mucolytic agent. Has a secreto-motor, secretolitic and expectorant action; stimulates serous cells of the glands of the bronchial mucosa,increases the content of mucous secretion and the release of surface-active substance (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:

    Absorption is high (for any route of administration), the maximum concentration is reached after 2 hours, the connection with plasma proteins is 80%. Penetrates through the blood-brain barrier, placental barrier, excreted in breast milk. Metabolized in the liver, forms dibromantranilic acid and glucuronic conjugates. The half-life is 7-12 hours. It is excreted by the kidneys: 90% in the form of water soluble metabolites, 5% - unchanged.

    The half-life period 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, bronchial asthma with difficulty in sputum discharge, bronchiectatic disease.

    Contraindications:

    Hypersensitivity, pregnancy (I trimester).

    Rare hereditary diseases, such as lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

    Children under 12 years.

    Carefully:

    Hepatic insufficiency, renal failure, peptic ulcer of stomach and duodenum, pregnancy (II - III trimester), lactation.

    Dosing and Administration:

    Inside, during meals, with a small amount of liquid. Adults and children over 12 years of age are prescribed 1 tablet (30 mg) 3 times a day for the first 2-3 days, then 1 tablet (30 mg) 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, allergic contact dermatitis, anaphylactic shock.

    Weakness, headache, diarrhea, dry mouth and respiratory tract, decreased sensitivity in the oral cavity and pharynx, changes in taste, 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:

    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:

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

    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 severe skin lesions - Stevens-Johnson syndrome or toxic epidermal necrolysis - temperature, body pain, rhinitis, cough and sore throat may appear in the early phase. With symptomatic treatment, it is possible to erroneously designate mucolytic agents, such as ambroxol. There are isolated reports of the detection of Stevens-Johnson syndrome and toxic epidermal necrolysis, coinciding with the appointment of the drug.However, there is no causal relationship with taking the drug. With the development of the above mentioned syndromes, it is recommended to stop treatment and immediately consult a doctor.

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

    Ambroxol does not adversely affect the ability to drive or work with machinery.

    Form release / dosage:

    Tablets 30 mg.

    Packaging:

    10 tablets are placed in a contour mesh box made of PVC film and aluminum foil. For 3 or 5 contour squares, together with the instructions for use, are placed in a pack of cardboard.

    Storage conditions:

    Store in a dry, 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-002101
    Date of registration:14.06.2013
    Expiration Date:14.06.2018
    The owner of the registration certificate:MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp01.08.2017
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