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: & nbspGranules for preparation of suspension for oral administration
    Composition:

    1 bottle (50 g) contains:

    Active substance: Erdosteine ​​3.50 g.

    Excipients: sucrose 41.55 g; sodium benzoate 0.20 g; sodium carboxymethyl-starch 3.00 g; aspartame 0.80 g; sodium saccharinate 0.20 g; orange flavoring 0,75 g.

    Description:small loose granules of white color with a characteristic orange smell. After the granules are dissolved in water, a white suspension with a grayish hue of color is formed
    Pharmacotherapeutic group:expectorant mucolytic agent.
    ATX: & nbsp

    R.05.C.B   Mucolytics

    R.05.C.B.15   Erdostein

    Pharmacodynamics:

    Erdostein is a drug whose effectiveness is caused by the action of active metabolites. Thiol groups of metabolites cause disruption of disulfide bridges, which bind one to another glycoprotein fibers, this leads to a decrease in the elasticity and viscosity of phlegm. As a result, ergostein intensifies and accelerates the release of respiratory tracts from bronchial secretions, improves the secretory function of the epithelium and increases the effectiveness of mucociliary transport in the upper and lower parts of the respiratory tract.

    Erdosteine ​​topically, through amine groups, antagonistically acts on free radicals of oxygen and prevents the suppression of alpha-1-antitrypsin in tobacco-smoking, thereby reducing the damaging effect of tobacco smoke in chronic smokers.

    Erdosteine ​​increases concentration IgA in the mucosa of the respiratory tract in patients with chronic obstructive airways disease. The effect of therapy with the drug develops on 3-4 days of treatment. By itself ergostein does not contain free SH-radicals, therefore, it has virtually no effect on the gastrointestinal tract when taken at the recommended dose.

    Pharmacokinetics:

    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 Ml). The half-life (T1/2) for more than 5 hours. Repeated use of the drug or food intake does not affect the pharmacokinetic parameters. The maximum concentration (Cmax) - 3.46 μg / ml; the time to reach the maximum concentration (Tmax) - 1.48 h; area under the curve "concentration-time" (AUC (0 - 24 hours)) - 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 indicators: the maximum concentration (Cmax) and the area under the "concentration-time" curve (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;

    - 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).

    · Phenylketonuria (because the composition of the drug is aspartame).

    · Deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption (because the formulation includes sucrose).

    · Pregnancy I trimester.

    · Breastfeeding period.

    Carefully:

    The drug should be administered with caution to patients with bronchial asthma; with hepatic insufficiency (it is possible to increase the half-life (T1/2)); 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. However, the experience of using the drug during pregnancy and breastfeeding is limited. Therefore, the prescription of the drug is only possible in the II and III trimesters of pregnancy, if the intended benefit to the mother exceeds the potential risk to the fetus.

    Dosing and Administration:

    Granules for the preparation of a suspension for ingestion 175 mg / 5 ml: 8.5 ml (about 300 mg) twice a day (a measuring cup is attached).

    Dosage per body weight: 10 mg / kg body weight twice a day.

    Method of preparation of the suspension:

    pour boiled water at room temperature the contents of the vial (granules) to a special label.Thoroughly shake until a uniform suspension is formed. Check the contents of the vial and, if necessary, add water and shake the bottle again.

    Shake before use!

    The course of treatment is determined by the doctor.

    Side effects:

    From the digestive tract: heartburn, nausea, pain in the epigastric region, diarrhea;

    From the skin and subcutaneous tissues: redness, itching of the skin;

    From the immune system: allergic reactions;

    Other: headache; at the beginning of treatment loss or change of taste sensitivity is possible.
    Overdose:

    No cases of drug overdose have been reported.

    Symptoms with an overdose: diarrhea, vomiting, stomach pain, heartburn, nausea are possible.

    Treatment: symptomatic therapy.

    Interaction:

    When combined ergostein increases the concentration of amoxicillin in a bronchial secretion.

    With the simultaneous use of the drug with tetracyclines (with the exception of doxycycline), as well as amphotericin B, there may be a mutual decrease in the effectiveness of the drugs.

    Do not use ergostein with drugs that depress the cough reflex because of the possible reduction in excretion of infected sputum.

    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:

    The use of the drug does not affect the ability to drive vehicles and other activities requiring increased attention.

    Form release / dosage:Granules for oral suspension 175 mg / 5 ml
    Packaging:

    For 50 g of the drug in bottles of brown glass with a capacity of 125 ml, labeled at 100 ml, with an aluminum lid with protection and a polyethylene liner inside.

    1 bottle with a measuring cup and instructions for use are placed in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    The ready suspension should be stored in the refrigerator at a temperature of 2-8 ° C, not more than 10 days. Keep out of the reach of children!

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001902
    Date of registration:14.11.2012
    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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