Product Overview
Structure
| 1 caps. | |
| erdostein | 300 mg |
Excipients:
microcrystalline cellulose - 13 mg,
povidone (K-30) - 8 mg,
magnesium stearate - 3 mg.
Hard gelatin capsules:
the body and cap of the capsule - titanium dioxide - 1.3333%,
quinoline yellow dye - 0.9197%,
dye sunny sunset yellow - 0.0044%,
gelatin - up to 100%.
pharmachologic effect
Pharmacotherapeutic group
ATX Code: R05CB15
Pharmacological properties
Pharmacodynamics
The effectiveness of erdostein is due to the action of active metabolites. Thiol groups of metabolites cause rupture of disulfide bridges that bind glycoprotein fibers to one another, which leads to a decrease in the elasticity and viscosity of sputum. As a result, erdostein enhances and accelerates the release of the respiratory tract from secretions, improves the secretory function of the epithelium and increases the efficiency of mucociliary transport in the upper and lower parts of the respiratory tract.
Erdostein has an antioxidant effect and carries free radicals. In particular, erdostein protects the airways from the damaging effects of cigarette smoke in relation to inactivation of alpha-1-antitrypsin.
Erdostein increases the concentration of immunoglobulin A (IgA) in the mucous membrane of the airways in patients with chronic obstructive airway diseases, and also reduces the inhibitory effect of tobacco smoke on granulocyte function.
The effect of erdostein therapy develops on the 3-4th day of treatment. Erdostein as such does not contain free SH-radicals, therefore, it does not have a damaging effect on the gastrointestinal tract, and side effects from the digestive system do not differ from the effects of placebo.
Pharmacokinetics
Erdostein is 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 erdostein or food intake does not affect pharmacokinetic parameters. The maximum concentration (Cmax) in plasma is 3.46 μg / ml, the time to reach the maximum concentration (Tmax) is 1.48 hours, the area under the concentration-time curve (AUC0-24h) is 12.09.
In case of impaired liver function, an increase in indicators is noted: maximum concentration (Cmax) and the area under the concentration-time curve (AUC).
It is possible to increase the half-life (T1 / 2) with severe impaired liver function.
Indications
Respiratory diseases with the formation of viscous sputum (in complex therapy).
Contraindications
Hypersensitivity to the components that make up the drug.
Impaired liver function.
Homocysteinuria (the drug is a source of homocysteine, therefore, metabolic disorders of amino acids in patients on a diet with a reduced content of free methionine are possible).
With caution.
The drug should be prescribed with caution to patients with severe impaired liver function; with diseases of the bronchi, accompanied by excessive accumulation of secretions.
Children under 18 years old.
Renal failure.
Pregnancy (I trimester).
The period of breastfeeding.
The drug should be prescribed with caution to patients with severe impaired liver function; with diseases of the bronchi, accompanied by excessive accumulation of secretions.
Side effects
The frequency of adverse reactions is presented according to the 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), the frequency is unknown.
From the gastrointestinal tract: rarely - heartburn, nausea, diarrhea; very rarely nausea, epigastric pain, loss or change in taste sensitivity at the beginning of treatment.
On the part of the skin and subcutaneous tissues: rarely - allergic reactions: redness of the skin, edema, eczema; angioedema.
Interaction
With the simultaneous use of erdostein increases the concentration of amoxicillin in bronchial secretion, which allows to achieve a faster response to therapy compared with monoxysilone amoxicillin.
How to take, course of administration and dosage
1 capsule (300 mg) 2 times a day.
Overdose
No cases of overdose have been reported.
However, in cases of overdose or in case of accidental use by children, gastric lavage and symptomatic therapy are recommended.
Special instructions
During treatment, it is necessary to take a sufficient amount of fluid, which increases the expectorant effect.
In cases of impaired bronchial motility or with a significant amount of sputum excreted, the use of the drug requires caution, due to the risk of delayed discharge in the respiratory tract and an increased risk of infection or bronchospasm.
Influence on the ability to drive vehicles, mechanisms
Release form
Capsules
Storage conditions
At a temperature of no higher than 25 ° C.
Shelf life
3 years.
