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Composition:


active ingredient: erdosteine;


1 capsule contains ergostein 300 mg;


excipients: microcrystalline cellulose, povidone, magnesium stearate;


shell composition: gelatin, titanium dioxide (e 171), iron oxide yellow (E 172), indigocarmine (E 132).


Dosage form. Solid capsules.


Basic physical and chemical properties: gelatin capsules with a yellow body and a green lid, containing powder from white to almost white in color.


Pharmacotherapeutic group. Remedies used for coughs and colds. Expectorants, with the exception of combined medications that contain antitussives. Mucolytic agents. Ergostein. ATX code R05C B15.


Pharmacological properties.


Pharmacodynamics.


Erbostein is a mucolytic compound whose action is mediated by its active metabolites. These metabolites have free thiol groups that cause the destruction of disulfide bridges that bind glycoprotein fibers, and thus reduce the elasticity and viscosity of mucus. As a result, the product helps to clear the airways of secretions and increases the effectiveness of the mucociliary mechanism in removing mucus and mucopurulent secretions from the upper and lower respiratory tracts.


In addition to its mucolytic properties, ergostein has an antagonistic effect on local free radical formation and inhibits the activity of the elastase enzyme.


Ergostein also reduces the adhesive ability of Gram-positive and Gram-negative bacteria against the epithelium of the respiratory tract. As a result of this antibacterial anti-adhesive effect, which has been proven in in vitro studies, bacterial colonization of the respiratory tract can be reduced and the risk of bacterial superinfection can be reduced.


Ergostein also acts as an acceptor of oxygen free radicals, prevents their formation locally, and significantly reduces the level of 8-isoprostane as a marker of lipid peroxidation. The anti-inflammatory effect of ergostein in vitro and in vivo was also indicated by a decrease in the synthesis of some pro-inflammatory cytokines (IL-6, IL-8).


Ergostein prevents the inhibition of alpha-1-antitrypsin by tobacco smoke, thus preventing damage caused by smog or tobacco smoking.


In addition, ergostein increases airway IGA concentrations in patients with chronic obstructive pulmonary disease (COPD) and prevents granulocyte inhibition caused by tobacco smoking. Ergostein also increases the concentration of amoxicillin in the bronchial secretions, and thus the therapeutic effect with simultaneous use of these drugs will be faster compared to the therapeutic effect of amoxicillin monotherapy. In patients with COPD, ectostein therapy lasting 8 months reduced the frequency of exacerbations of the disease and improved the quality of life.


The effect of the drug manifests itself approximately 3 to 4 days after the start of therapy.


Ergostein itself does not contain free sh radicals, which are attributed to activity, since they are chemically blocked and become free only after metabolism or in an alkaline environment. Therefore, it is characterized by a slight effect on the gastrointestinal tract (git) when using the recommended doses, the absence of an unpleasant taste and belching, good tolerability, and the profile of adverse events from the gastrointestinal tract does not differ from that with placebo.


Pharmacokinetics.


Ergostein is rapidly absorbed; it is metabolized by the liver to form at least 3 active metabolites, the most common (in percentage terms) and active of which is N-thiodiglycolylhomocysteine (metabolite 1, or M1). Main pharmacokinetic parameters (for M1): Cmax 3.46 mcg/ml; Tmax 1.48 hours; AUC (0-24 hours) 12.09 mg/l/h. The level of Binding of erbostein to plasma proteins is 64.5%. Elimination occurs in the urine and feces, in which only inorganic sulfates have been detected.


The elimination half-life (in general, i.e. for ergostein and its metabolites) is more than 5 hours. Repeated use and food intake do not change the pharmacokinetic profile of the drug. No signs of accumulation or induction of enzymes were observed.


With impaired liver function, an increase in Cmax and AUC values was observed.


In addition, an increase in the Half-Life of the drug was observed in severe liver function disorders. In severe renal failure, there is a risk of accumulation of metabolites.


Clinical characteristics.


Indications. Reducing the viscosity and relieving expectoration of bronchial secretions in the treatment of acute and chronic diseases of the upper and lower respiratory tract, such as bronchitis, rhinitis, sinusitis, laryngopharyngitis, exacerbation of chronic bronchitis, chronic obstructive pulmonary disease (COPD), hypersecretory bronchial asthma, bronchiectasis.


Contraindications.


Hypersensitivity to the active substance or to any of the excipients containing free SH groups.


You should stop using this drug in the following cases::


- for liver disorders (for example, with an increase in the level of alkaline phosphatase or transaminases in the blood serum), including liver cirrhosis;


- in case of renal failure (creatinine clearance


- with homocystinuria (this drug is a source of homocysteine, today there are no available data on the use of ergostein in the case of congenital disorders of amino acid metabolism, especially in patients who are forced to adhere to a methionine-free diet) and with insufficient enzyme cystathionine synthetase, since it may affect the metabolism of methionine;


- for peptic ulcer disease in the active phase.

Interactions with other drugs and other types of interactions.


No adverse interactions were observed with other medications commonly used for respiratory tract infections and COPD, such as theophylline, bronchodilators, erythromycin, amoxicillin, or sulfamethoprim. Ergostein potentiates the action of certain antibiotics (for example, amoxicillin, clarithromycin), which can be used for therapeutic purposes, and can also be used together with bronchodilators (theophylline or beta-2-adrenomimetics, cough medications, etc.). The synergistic effect of ergostein when co-administered with budesonide and Salbutamol has been proven.


Application features.


If classic symptoms of hypersensitivity occur, erbostein therapy should be discontinued immediately.


Concomitant use of antitussives is impractical and can cause the accumulation of secretions in the bronchial tree, increasing the risk of superinfection or bronchospasm.


The presence of a sulfur smell is possible, which is a characteristic feature of the active substance, and not a sign of drug conversion.


Use during pregnancy or lactation.


The safety of using ergostein during pregnancy and lactation has not been proven, so its use, like any new drug, is not recommended.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


No negative effects were observed on the ability to drive vehicles, work with other mechanisms, or concentrate.


Dosage and administration.


Imucin® is intended for adults to take 1 capsule (300 mg) 2 times a day. Treatment can last up to 10 days.


Solid capsules are intended for direct oral administration.


Children. This dosage form is not used in children.


Overdose.


Sweating, dizziness, and hot flashes were observed when the recommended dose (1200 mg/day) was exceeded.


In case of overdose or accidental use of this remedy by a child, symptomatic therapy (gastric lavage and other supportive measures) is recommended.


Adverse reactions.


The frequency of adverse reactions is determined as follows: very often (≥1/10); often (≥1/100,  


Nervous system disorders: very rarely – headache.


From the respiratory system, chest and mediastinal organs: very rarely – shortness of breath.


From the gastrointestinal tract: very rarely-taste disorders (ageusia or dysgeusia), nausea, vomiting, diarrhea, burning sensation and stomach pain.


From the skin and subcutaneous tissue: very rarely – urticaria, redness, eczema.


Immune system disorders: rarely-angioedema.


Common disorders: rarely-unexpected hyperpyrexia.


Expiration date. 5 years old.


Storage conditions.


Store at a temperature not exceeding 25 °C.

Tags: Erdostein