Active substanceAmbroxolAmbroxol
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  • Dosage form: & nbspsolution for ingestion and inhalation
    Composition:

    1 ml of the solution contains:

    Active substance: Ambroxol hydrochloride - 7,500 mg

    Excipients: Benzalkonium chloride 0.225 mg, sodium chloride 6.220 mg, citric acid 2,000 mg, sodium hydrogen phosphate dihydrate 4,350 mg, water 989,705 mg.
    Description:Transparent, colorless or brownish solution with a weak characteristic odor.
    Pharmacotherapeutic group:Expectorant, mucolytic agent
    ATX: & nbsp

    R.05.C.B.06   Ambroxol

    Pharmacodynamics:

    Ambroxol has a secreto-motor, secretolitic and expectorant action: it stimulates serous cells of the glands of the bronchial mucosa,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 by increasing the release of lysosomes from Clara cells, reduces the viscosity of sputum. Increases the motor activity of the cilia of the ciliated epithelium. Increases the motor activity of the ciliated epithelium, increases mucociliary transport, facilitates the excretion of phlegm from the respiratory tract.

    Pharmacokinetics:

    For ambroksola characterized by rapid and almost complete absorption from the gastrointestinal tract (GIT) with a linear dose dependence in the therapeutic interval concentration. Bioavailability is 70-80%. The maximum concentration (Cmah) in plasma of blood at oral reception is reached in 0,5 - 3 hours. In the therapeutic the concentration of binding to plasma proteins is approximately 90%.

    The transfer of ambroxol from the blood to the tissue with oral administration occurs rapidly.

    The highest concentrations of the active component of the drug are observed in the lungs.

    Penetrates through the blood-brain barrier, placental barrier, stands out with breast milk.

    Approximately 30% of the administered oral dose is subjected to the effect of a primary pass through the liver. Studies on microsomes of the human liver showed that the isoenzyme CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol. The rest of the ambroxol is metabolized in the liver to inactive metabolites. Half-life (T1/2) of ambroxol is 10 hours. It is excreted by the kidneys: 90% in the form of metabolites, 10% in unchanged form.

    There is no clinically significant effect of age and sex on the pharmacokinetics of ambroxol, so there is no basis for dose adjustment for these features.

    Indications:Acute and chronic diseases of the respiratory tract with the release of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma with difficulty in sputum discharge, bronchoectatic disease.
    Contraindications:

    Hypersensitivity to ambroxol or other components of the drug, pregnancy (I trimester), the period of breastfeeding.

    Carefully:

    Disturbance of motor function of the bronchi and increased sputum production (with the syndrome of immobile cilia), peptic ulcer of the stomach and duodenum during the exacerbation, pregnancy (II-III trimester).

    Patients with impaired renal function or severe liver disease should take ambroxol with extreme caution, observing large intervals between doses of the drug or taking the drug in a smaller dose.

    Pregnancy and lactation:

    The drug is contraindicated to apply during the first trimester of pregnancy. If you need ambroxol in the II-III trimesters of pregnancy, you should evaluate the potential benefit to the mother with a possible risk to the fetus.

    During the period of breastfeeding, use the drug it is contraindicated because it excreted in breast milk.

    Dosing and Administration:

    The mucolytic effect of the drug manifests itself when a large amount of liquid is taken. Therefore, during treatment is recommended to drink abundantly.

    Application inside:

    Inside the drug is used after eating, adding water, tea, milk or fruit juice.

    Adults and children over 12 years of age: the first 2-3 days of 4 ml 3 times a day (corresponding to 90 mg ambroksola per day), then 4 ml 2 times a day (corresponding to 60 mg ambroksola per day);

    Children from 6 to 12 years: 2 ml each 2-3 once a day (corresponding to 30 or 45 mg of ambroxol per day);

    Children from 2 to 6 years: 1 ml 3 times a day (corresponding to 22.5 mg ambroxol per day);

    Children up to 2 years: 1 ml 2 times a day (which corresponds to 15 mg ambroksola per day).

    Children younger than 2 years of age, the drug is prescribed only under the supervision of a doctor.

    The maximum daily intake for ingestion: for adults - 90 mg, for children 6-12 years - 45 mg, for children 2-6 years - 22.5 mg, for children up to 2 years - 15 mg.

    Application in the form of inhalations:

    The drug can be used using any modern equipment for inhalation (except for steam inhalers). Before Inhalation the preparation is mixed with 0.9% sodium chloride solution (for optimal air humidification - in the ratio 1: 1). Before inhalation it is recommended to warm up inhalation solution up to body temperature.

    Since inhalation therapy can cause a deep inhalation of a cough, inhalation should be performed in the usual breathing mode. Patients with bronchial asthma should be given inhalation after taking bronchodilators, to avoid nonspecific irritation of the respiratory tract and their spasm.

    Dosage for inhalation:

    Adults and children over 6 years of age: 1 - 2 inhalations per day for 2-3 ml of solution (corresponding to 15-45 mg of ambroxol per day).

    Children up to 6 years of age: 1-2 inhalations per day for 2 ml of solution (corresponding to 15-30 mg of ambroxol per day).

    Taking the drug for more than 4-5 days is possible only on the advice of a doctor.

    Side effects:

    The frequency of side effects is presented in the following gradation: very often (≥ 1/10); often (≥ 1/100 to <1/10); infrequently (≥ 1/1000 to <1/100), rarely (≥ 1/10000 to <1/1000), very rarely (<1/10 000), is unknown (can not be estimated based on available data).

    Gastrointestinal disorders: often - nausea, decreased sensitivity in the oral cavity and pharynx; infrequently - dyspepsia; pain in the upper abdomen, vomiting, diarrhea; rarely - heartburn, dryness of the mucous membrane of the mouth and throat, constipation.

    From the respiratory system: rarely - dryness of the mucous membrane of the respiratory tract, rhinorrhea.

    Disorders from the nervous system: often - dysgeusia (a violation of taste sensations).

    Allergic reactions: rarely - hypersensitivity reactions, skin rash, urticaria, itching, angioedema; very rarely - anaphylactic reactions, including anaphylactic shock, Stevens-Johnson syndrome, Lyell's syndrome.

    Other: rarely - adynamia, fever.

    Overdose:

    Symptoms: heartburn, indigestion, diarrhea, nausea, vomiting, pain in the upper abdomen. There are reports of short-term anxiety. With severe overdose, a significant reduction in blood pressure is possible.

    Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; reception of fat-containing products, symptomatic therapy.
    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, doxycycline, cefuroxime, erythromycin ambroxol increases their concentration in the bronchial secretion. No clinically relevant adverse interactions with other drugs have been reported.
    Special instructions:

    Ambroxol should not be taken concomitantly with antitussive drugs that can inhibit cough reflex.

    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 patients with severe disease, aspiration of diluted sputum should be performed.

    In patients with bronchial asthma ambroxol can strengthen cough.

    Do not take ambroxol just before bed.

    In patients with severe skin lesions - Stevens-Johnson syndrome or Lyell's syndrome - in the early phase, fever, body pain, rhinitis, cough and sore throat may appear. With symptomatic treatment, it is possible to erroneously administer mucolytic agents, such as ambroxol hydrochloride. There are isolated reports of the detection of Stevens-Johnson syndrome and Lyell's syndrome, coinciding with the appointment of the drug; but there is no causal relationship with taking the drug.

    With the development of the above syndromes, it is recommended to stop treatment and immediately seek medical help.

    In case of impaired renal function ambroxol should be used only on the advice of a doctor.

    A solution of ambroxol is not recommended to be mixed with cromoglycic acid and alkaline solutions.

    Patients who observe the hyponatric diet, it should be borne in mind that in 1 ml of ambroxol solution contains 10 mg of sodium. The maximum daily dose for adults and children over 12 years old contains 120 mg of sodium.

    Ambroxol solution contains benzalkonium chloride (preservative). In patients with the presence of hyperactivity of the respiratory tract, this preservative can cause bronchial spasm during inhalation.

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

    The impact on the ability to drive vehicles and control mechanisms is not known to this day.

    Form release / dosage:

    Solution for oral administration and inhalations of 7.5 mg / ml.

    Packaging:

    For 40 or 100 ml of solution in a bottle of glass of orange glass, or in a bottle of polymer, or in a bottle of polyethylene terephthalate, equipped with plastic a dissector closed with a plastic lid with a ring of the first opening.

    A label is attached to the vial on the basis of a self-adhesive film or a label of label paper.

    One bottle together with the instruction for use is placed in a cardboard package (pack) of cardboard for consumer containers. In a cardboard package, insert a measuring cup or measuring spoon.

    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:

    3 years. Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-002785
    Date of registration:24.12.2014 / 12.08.2015
    Expiration Date:24.12.2019
    The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp31.07.2017
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