Elmucin (Elmucin)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceErdosteinErdostein
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  • Elmucin
    capsules inwards 
    OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC     Russia
  • Erdomed
    granules inwards 
    Medcom International sr.o.     Czech Republic
  • Erdomed
    capsules inwards 
    Medcom International sr.o.     Czech Republic
    • Dosage form: & nbspTOthe apsules.
    Composition:

    1 capsule contains:

    active substance: Erdosteine ​​300 mg;

    Excipients: cellulose microcrystalline 13.0 mg, povidone K30 8.0 mg, magnesium stearate 3.0 mg;

    capsules, hard gelatinous: body and cap capsule - titanium dioxide 1.3333%, dye quinoline yellow 0.9197%, dye sunset yellow 0.0044%, gelatin - up to 100%.

    Description:Tverst gelatin capsules №1 with a case and a lid of yellow color. The contents of capsules are white or almost white powder.

    Pharmacotherapeutic group:expectorant mucolytic
    ATX: & nbsp

    R.05.C.B   Mucolytics

    R.05.C.B.15   Erdostein

    Pharmacodynamics:

    The efficacy of ergodein is due to the action of active metabolites. Thiol groups of metabolites cause disruption of disulfide bridges, which bind one to another glycoprotein fibers, which leads to a decrease in the elasticity and viscosity of phlegm. As a result, ergostein strengthens and accelerates the release of respiratory tracts from secretion, improves the secretory function of the epithelium and increases the efficiency of mucociliary transport in the upper and lower divisions of the respiratory tract.

    Erdosteine ​​has an antioxidant effect and carries free radicals. In particular ergostein protects the respiratory tract from the damaging effect of cigarette smoke with respect to the inactivation of alpha-1-antitrypsin.

    Erdostein increases the concentration of immunoglobulin A (IgA) in the mucosa of the respiratory tract in patients with chronic obstructive airway disease, and also reduces the inhibitory effect of tobacco smoke on the function of granulocytes.

    The effect of therapy with ergotosterin is developed on 3-4 days of treatment. Erdostein as such does not contain free SH-radicals, so it does not have a damaging effect on the gastrointestinal tract, and the side effects of the digestive system do not differ from the placebo effects.

    Pharmacokinetics:

    Erdosteine ​​is rapidly absorbed from the gastrointestinal tract and metabolized in the liver to three active metabolites, the most important of which - N-tiodiglycolyl homocysteine ​​(Metabolite 1 or M1). Half-life (T1/2) is more than 5 hours. Repeated use of ergodicity or food intake does not affect the pharmacokinetic parameters. The maximum concentration (CmOh) in blood plasma is 3.46 μg / ml, the time to reach the maximum concentration (TmOh) - 1.48 hours, the area under the curve "concentration-time" (AUC0-24h) - 12,09.

    Erdostein binds to plasma proteins by 64.5%. It is excreted in the form of inorganic sulfates through the kidneys and intestines.

    In the case of a violation of liver function, there is an increase in the indices: the maximum concentration (CmOh) and the area under the curve "concentration-time" (AUC).

    It is possible to increase the half-life (T1/2) with pronounced impaired liver function.

    With renal failure, metabolites can be accumulated.

    Indications:

    Diseases of the respiratory tract with the formation of viscous sputum:

    - acute and chronic bronchitis;

    - pneumonia;

    - chronic obstructive pulmonary disease (COPD);

    - bronchial asthma with difficulty in sputum discharge;

    - bronchiectatic disease.

    Prevention of pneumonia and lung atelectasis after surgical interventions.
    Contraindications:

    - Dhypersensitivity to the components that make up the preparation;

    - children's age till 18 years;

    - impaired liver function;

    - renal failure (creatinine clearance <25 ml / min);

    - homocysteinuria (the drug is a source of homocysteine, so there may be abnormalities in the metabolism of amino acids in patients on a diet with a reduced content of free methionine);

    - Pregnancy (I trimester), the period of breastfeeding;

    Carefully:The drug should be administered with caution to patients with severe violations of the liver (may increase half-life); with renal insufficiency (creatinine clearance> 25 ml / min) metabolites can be accumulated.
    Pregnancy and lactation:

    Preclinical studies did not reveal the embryotoxic effect of ergodein. The experience with the use of ergotosterin during pregnancy and during breastfeeding is limited. Therefore, the administration of the drug is possible only in II and III trimesters of pregnancy if the intended benefit to the mother exceeds the potential risk to the fetus.

    Dosing and Administration:

    1 capsule (300 mg) 2-3 times a day.

    If there is no improvement within 5 days after the beginning of the use of the drug or if there is a worsening, it is necessary to consult a doctor.

    Side effects:

    The incidence of unwanted reactions is presented according to WHO classification: very often (≥1 / 10 cases), often (≥1 / 100 and <1/10 cases) infrequently (≥1 / 1000 and <1/100 cases),rarely (≥1 / 10000 and <1/1000 cases) and very rarely (<1/10000 cases).

    From the gastrointestinal tract: rarely - heartburn, nausea, diarrhea; rarely - loss or change in taste sensitivity at the beginning of treatment.

    From the skin and subcutaneous tissues: rarely - allergic reactions: redness of the skin, hives.

    Overdose:

    No cases of overdose have been reported. In case of an overdose, symptomatic therapy is recommended.

    Interaction:

    With simultaneous application ergostein increases the concentration of amoxicillin in the bronchial secret, which allows for a faster response to therapy than monotherapy with amoxicillin.

    Special instructions:

    With irrational use in antitussive therapy, the accumulation of liquid secretions in the bronchi and an increased risk of developing superinfection or bronchospasm.

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

    Does not affect the ability to drive vehicles, mechanisms and engage in other activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:Capsules, 300 mg.
    Packaging:

    For 10 or 20 capsules in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    For 1, 2, 3, 4 contour squares, together 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:

    3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003628
    Date of registration:13.05.2016
    Expiration Date:13.05.2021
    The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCRussia
    Information update date: & nbsp12.07.2016
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