Erdomed (Erdomed)

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: & nbspcapsules
    Composition:

    Each capsule contains:

    Active substance: Erdosteine ​​300 mg

    Excipients: cellulose microcrystalline 10 mg, povidone 8 mg, magnesium stearate 3 mg.

    Components of the capsule shell: gelatin 75.379 mg, titanium dioxide 2.00 mg, iron oxide yellow 0.759 mg, indigocarmine 0.092 mg.

    Description:Hard gelatin capsules (number 1), having a body of yellow color and a lid of green color. Contents of capsules: white powder with a yellowish tinge
    Pharmacotherapeutic group:expectorant mucolytic agent.
    ATX: & nbsp

    R.05.C.B   Mucolytics

    R.05.C.B.15   Erdostein

    Pharmacodynamics:

    Erdomed is a new drug whose effectiveness is due to the action of active metabolites. Thiol groups of metabolites cause rupture, disulfide bridges, which bind one to another fiber glycoproteins, this leads to a decrease in the elasticity and viscosity of sputum. As a result, ergostein strengthens and accelerates the release of respiratory tracts from secretions, improves secretory, epithelial function and increases the effectiveness of mucociliary transport in the upper and lower parts 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 IgA in the mucosa of the respiratory tract in patients with chronic obstructive airways diseases, and also reduces the inhibitory effect of tobacco smoke on the function of granulocytes.

    The effect of therapy with the drug develops on the 3rd - 4th day of treatment. Erdostein as such, does not contain free SH radicals. Therefore, the drug does not have a deleterious effect on the gastrointestinal tract, and, side effects, on the part of the digestive system do not differ from the placebo effects.

    Pharmacokinetics:

    Rapidly absorbed from the gastrointestinal tract and metabolized in the liver to three active metabolites, the most important of which is N-thiodiglycolyl homocysteine ​​(Metabolite 1 or M1). The half-life (T1 / 2) is more than 5 hours. Repeated use of the drug or food intake does not affect the pharmacokinetic parameters. The maximum concentration (Cmah) - 3.46 μg / ml; time to reach the maximum concentration (Tmax) - 1.48 h; the area under the concentration-time curve (AUC (0-24 hours)) is 12.09.

    64.5% of ergodosterum is bound by plasma proteins. The drug 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 (Cmax) and the area under the concentration-time curve (AUC).

    It is possible to increase the half-life (T1 / 2) with a marked: a violation of the liver.

    With renal failure, metabolites can be accumulated
    Indications:

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

    acute and chronic bronchitis;

    pneumonia;

    COPD;

    bronchial asthma with difficulty in sputum discharge; bronchiectatic disease.

    Prevention of pneumonia and lung atelectasis after surgical interventions.

    Contraindications:

    Hypersensitivity to ingredients in the formulation.

    Children under 18 years.

    Violation of the function of the liver.

    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.

    Pregnancy and lactation:

    Preclinical studies did not reveal the embryotoxic effect of ergomed. However, the experience of using the drug during pregnancy and breastfeeding is limited.

    Therefore, the appointment of the drug during pregnancy, especially in the first trimester, and lactation is possible only if the intended benefit for the mother exceeds the potential risk to the fetus or baby.,

    Dosing and Administration:

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

    If there is no improvement within 5 days after starting the use of the drug, or if there is a worsening, it is necessary to contact the attending physician.

    Precautions for use:

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

    · With renal failure, metabolites can be accumulated.

    · If there is a marked violation of the liver function, an increase in the half-life period is possible.

    Side effects:

    In rare cases, there may be side effects from the gastrointestinal tract: heartburn, nausea, rarely - diarrhea.Very rarely at the beginning of treatment, loss or change in taste sensitivity is possible.

    In rare cases, allergic reactions are possible: redness of the skin, hives.

    Overdose:

    No cases of drug overdose have been reported. However, in cases of overdose or in case of accidental use by children, symptomatic therapy is recommended.

    Interaction:

    When combined ergostein increases the concentration of amoxicillin in bronchial secretion, which allows to achieve a faster response to therapy than monotherapy with amoxicillin.

    Effect on the ability to drive transp. cf. and fur:The use of the drug does not affect the ability to drive vehicles and other activities requiring increased attention.
    Form release / dosage:Capsules 300 mg
    Packaging:

    10 capsules per blister of PVC / PVDC film and aluminum foil.

    1 or 2 blisters together with instructions for use are placed in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children!

    Shelf life:

    5 years

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

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000990
    Date of registration:18.10.2011
    The owner of the registration certificate: Medcom International sr.o. Medcom International sr.o. Czech Republic
    Manufacturer: & nbsp
    Representation: & nbspCI ES CJSC, CJSCCI ES CJSC, CJSC
    Information update date: & nbsp26.11.2015
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