Elmucin capsules 300mg, 10pcs

Composition

1 capsule contains:

Active ingredient: Erdosteine 300 mg;

excipients: microcrystalline cellulose, povidone K 30, magnesium stearate;

hard gelatin capsules: body and capsule cap-titanium dioxide, quinoline yellow dye, sunset yellow dye, gelatin.

Pharmacological action

Pharmacotherapy group

Expectorant mucolytic agent

ATX code: R05CB15

Pharmacological properties

Pharmacodynamics

The effectiveness of Erdosteine is determined by the action of active metabolites. Thiol groups of metabolites cause the rupture of disulfide bridges that bind glycoprotein fibers to each other, which leads to a decrease in the elasticity and viscosity of sputum. As a result, Erdosteine enhances and accelerates the release of secretions from the respiratory tract, improves the secretory function of the epithelium and increases the efficiency of mucociliary transport in the upper and lower respiratory tract.

Erdosteine has an antioxidant effect and transports free radicals. In particular, Erdosteine protects the respiratory tract from the damaging effects of cigarette smoke in relation to the inactivation of alpha-1-antitrypsin.

Erdosteine increases the concentration of immunoglobulin A (IgA) in the airway mucosa in patients with chronic obstructive airway diseases, and also reduces the suppressive effect of tobacco smoke on granulocyte function.

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

Pharmacokinetics

Erdosteine 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 elimination half-life (T_1/2) is more than 5 hours. Repeated use of Erdosteine or food intake does not affect the pharmacokinetic parameters. The maximum concentration (cmax) in blood plasma is 3.46 mcg / ml, the time to reach the maximum concentration (tmax) is 1.48 hours, and the area under the concentration-time curve (AUC_{0-24 hours}) is 12.09.

Erdosteine 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 impaired liver function, there is an increase in the following indicators: maximum concentration (cmax) and area under the concentration-time curve (AUC).

It is possible to increase the half-life (T_1/2) with severe liver dysfunction.

In case of renal failure, accumulation of metabolites is possible.

Indications

Respiratory tract diseases with the formation of viscous sputum that is difficult to separate (in complex therapy).

Use during pregnancy and lactation

Preclinical studies did not reveal the embryotoxic effect of Erdosteine. Experience with the use of Erdosteine during pregnancy and lactation is limited. Therefore, prescribing the drug is possible only as prescribed by a doctor in the second and third trimesters of pregnancy, if the intended benefit to the mother exceeds the potential risk to the fetus.

Contraindications

Hypersensitivity to the components that make up the drug.

Children under 18 years of age.

Impaired liver function.

Kidney failure.

Homocystinuria (the drug is a source of homocysteine, so there may be violations of amino acid metabolism in patients on a diet with a reduced content of free methionine).

Pregnancy (I trimester).

Breast-feeding period.

With caution

The drug should be used with caution in patients with severe liver function disorders; in 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 common (≥1/10 of cases), common (≥1/100 and <1/10 of cases), infrequent (≥1/1000 and <1/100 of cases), rare (≥1/10000 and <1/1000 of cases) and very rare (

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

Skin and subcutaneous tissue disorders: very rare – allergic reactions: redness of the skin, edema, eczema; frequency unknown-angioedema.

Respiratory, thoracic and mediastinal disorders: very rare – shortness of breath.

Interaction

When used together, Erdosteine increases the concentration of amoxicillin in the bronchial secretions, which allows for a faster response to therapy compared to monotherapy with amoxicillin.

How to take, course of use and dosage

Take 1 capsule (300 mg) 2 times a day.

If there is no improvement within 5 days after starting the drug or if it gets worse, you should consult your doctor.

Overdose

No overdose cases have been reported. However, in cases of overdose or accidental use by children, gastric lavage and symptomatic therapy are recommended.

Description

Solid gelatin capsules No. 1 with a yellow body and lid. The contents of the capsules are a mixture of granules and powder of white or almost white color.

Special instructions

During treatment, it is necessary to take a sufficient amount of liquid, which increases the expectorant effect. In cases of impaired bronchial motility or with a significant volume of sputum secreted, the use of the drug requires caution due to the risk of retention of discharge in the respiratory tract and an increased risk of infection or bronchospasm.

Influence on the ability to drive vehicles and mechanisms

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

Storage conditions

Keep out of reach of children at a temperature not exceeding 25 ° C.

Shelf

life is 3 years. Do not use after the expiration date indicated on the package.

Active ingredient

Erdosteine

Dosage form

Capsules