Active substanceAmbroxolAmbroxol
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  • Dosage form: & nbsppills
    Composition:

    Composition per one tablet

    Active substance:

    Ambroxol hydrochloride 30.0 mg

    Excipients:

    lactose monohydrate 171.0 mg

    corn starch - 36.0 mg

    Silica colloidal dioxide (aerosil) - 1.8 mg

    magnesium stearate - 1.2 mg.

    Description:

    Round flat cylindrical tablets white or white with a yellowish tint of color with a facet and a risk.

    Pharmacotherapeutic group:Expectorant, mucolytic agent
    ATX: & nbsp

    R.05.C.B.06   Ambroxol

    Pharmacodynamics:

    Ambroxol is active N-detylated metabolite of bromhexine.

    Has a secreto-motor, secretolitic and expectorant action. It stimulates the work of the bronchial glands, increases the motor activity of the ciliated epithelium by influencing the pneumocytes of type 2 in the alveoli and the Clara cells in the bronchioles, enhances the formation of an endogenous surfactant, a surface-active substance that ensures the gliding of the bronchial secretion in the airway lumen. Ambroxol increases the proportion of the serous component in the bronchial secret, improving its structure and contributing to a decrease in viscosity and dilution of sputum; as a result of which mucociliary transport is improved and facilitated excretion of sputum from the bronchial tree.

    On average, when administered orally, the effect of the drug occurs 30 minutes later, the duration of the action is 6-12 hours, depending on the dose taken.
    Pharmacokinetics:

    Suction. After oral administration ambroxol quickly and almost completely absorbed from the gastrointestinal tract. The maximum concentration (CmOh) in the blood plasma is achieved after 1-3 hours. The volume of distribution is 552 liters.Absolute bioavailability of ambroxol with oral intake as a result of "primary passage" through the liver decreases by approximately 1/3.

    Distribution. Connection with blood plasma proteins - 80-90%. Ambroxol penetrates through the placental and blood-brain barrier, excreted in breast milk.

    Metabolism. Ambroxol metabolized in the liver by conjugation with the formation of pharmacologically inactive metabolites.

    Excretion. The terminal half-life of blood plasma (T1 / 2) is 7-12 hours. The total half-life of ambroxol and its metabolites is about 22 hours. The total clearance is within 660 ml / min. It is excreted by the kidneys: 90% in the form of metabolites (such as, dibromoanthranilic acid, glucuronides), about 10% - unchanged. With severe renal dysfunction (creatinine clearance less than 30 ml / min) accumulation of metabolites of ambroxol is possible; in severe hepatic insufficiency, ambroxol clearance is reduced by 20-40%.

    Due to the high degree of binding to blood plasma proteins and a significant volume of distribution, as well as a slow reverse distribution from tissues to the blood, effective elimination of ambroxol by dialysis or forced diuresis is unlikely.

    Indications:

    Disturbance of secretion and transport of sputum during acute and chronic respiratory diseases: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma, bronchoectatic disease.

    Contraindications:

    Hypersensitivity to the components of the drug, hereditary intolerance to galactose, lactase deficiency or malabsorption of glucose and galactose, I trimester of pregnancy and the period of breastfeeding, children under 6 years.

    Carefully:

    Disturbance of bronchial motility and increased secretion of mucus (for example, with rare a syndrome of a primary dyskinesia of cilia); renal failure and / or severe hepatic impairment); peptic ulcer of the stomach and duodenum, including in the anamnesis; II-III trimesters of pregnancy.

    Pregnancy and lactation:The use of the drug in the first trimester of pregnancy and during breastfeeding is contraindicated. Application of the drug in II-III trimester of pregnancy is possible only after a thorough assessment of the relationship between the benefits of treatment and the possible risks.
    Dosing and Administration:

    Inside, after eating, squeezed with enough liquid.

    Adults and children over 12 years of age: 30 mg (1 tablet) 3 times a day for the first 2-3 days, then the dose of the drug should be reduced to 1 tablet 2 times a day.

    Children from 6 to 12 years: 15 mg (1/2 tablet) 2-3 times a day.

    If the symptoms persist for 4-5 days after the start of treatment, it is recommended that you consult a doctor.

    Side effects:

    Classification of the incidence of adverse events according to the recommendations of the World Health Organization (WHO):

    very often> 1/10; often from> 1/100 to <1/10; infrequently from> 1/1000 to <1/100; rarely from> 1/10000 to <1/1000; very rarely <1/10000, including individual messages; the frequency is unknown - it is not possible to establish the frequency of occurrence from the available data.

    Allergic reactions:

    frequency is unknown - reactions of hypersensitivity, anaphylactic reactions (including anaphylactic shock), angioedema.

    From the digestive system:

    often - nausea, decreased sensitivity in the oral cavity or pharynx; infrequently - dyspepsia, vomiting, diarrhea, abdominal pain; 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 (discharge of mucus from the nose).

    From the skin:

    rarely - skin rash, hives; frequency unknown - skin itching, Stevens-Johnson syndrome (multi-form exudative erythema), Lyell's syndrome (toxic epidermal necrolysis), acute generalized exanthematous pustulosis.

    From the sense organs:

    infrequently - dysgeusia (a violation of taste sensations).

    Other:

    rarely - weakness, headache, dysuria (urination disorders), hyperthermia, fever.

    Overdose:

    Symptoms: nausea, vomiting, diarrhea, upper abdominal pain, heartburn, indigestion (indigestion). 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, taking fat-containing foods, symptomatic therapy. Due to the high degree of binding of ambroxol to blood plasma proteins and a large volume of distribution, it is not advisable to carry out hemodialysis or forced diuresis.
    Interaction:

    With the simultaneous use of ambroxol with antitussive drugs, it may be difficult to divert sputum as a result of suppressing the cough reflex.

    With simultaneous use with amoxicillin, cefuroxime, erythromycin, doxycycline ambroxol increases their concentration in the bronchial secretion.

    Special instructions:

    During treatment it is necessary to use a lot of liquid (juices, tea, water), as this enhances the mucolytic effect of the drug.

    Ambroxol should not be taken concomitantly with antitussive drugs that hamper the excretion of sputum.

    Ambroxol should be taken with caution to patients with a weakened cough reflex or disturbed mucociliary transport because of 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.

    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. 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 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.

    If the kidney function is impaired, the drug should be used only on the advice of a doctor.

    Indication for patients with diabetes: 1 tablet contains less than 0.01 bread units.

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

    There were no cases of drug effects on the ability to drive vehicles and mechanisms. Studies on the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions have not been carried out.

    Form release / dosage:Tablets, 30 mg.
    Packaging:

    For 10 tablets in a contour mesh box made of polyvinylchloride dyed film and aluminum foil printed lacquered.

    2, 3, 5 contour cell packs of 10 tablets with instructions for use are placed in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-004490
    Date of registration:10.10.2017
    Expiration Date:10.10.2022
    The owner of the registration certificate:UPDATE OF PFC, CJSC UPDATE OF PFC, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp21.11.2017
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