Instructions for Mucytus capsules 300 mg strip No. 12
Warehouse
active ingredient: erdosteine;
1 capsule contains erdosteine 150 mg or 300 mg;
excipients: microcrystalline cellulose, povidone, sodium starch glycolate (type A), magnesium stearate;
shell for 150 mg capsules: diamond blue (E 133), carmoisine (E 122), quinoline yellow (E 104), titanium dioxide (E 171), gelatin;
capsule shell for 300 mg capsules: diamond blue (E 133), titanium dioxide (E 171), gelatin.
Dosage form
Capsules.
Main physicochemical properties:
150 mg capsules: hard gelatin capsules with a brown cap and a blue body, containing white or almost white powder;
300 mg capsules: hard gelatin capsules with a blue cap and a white body, containing a white or almost white powder.
Pharmacotherapeutic group
Mucolytics. ATX code R05C B15.
Pharmacological properties
Pharmacodynamics
Erdosteine 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 drug helps to clear the respiratory tract of secretions and increases the efficiency of the mucociliary mechanism in removing mucus and mucopurulent secretions from the upper and lower respiratory tract.
Erdosteine also reduces the adhesive ability of Gram-positive and Gram-negative bacteria to the respiratory epithelium. As a result of this antibacterial anti-adhesive effect, which has been proven in in vitro studies, bacterial colonization of the respiratory tract may be reduced and the risk of bacterial superinfection may be reduced.
Erdosteine also acts as an acceptor of free oxygen radicals, prevents their formation locally and significantly reduces the level of 8-isoprostane as a marker of lipid peroxidation. The anti-inflammatory effect of erdosteine in vitro and in vivo was also indicated by a decrease in the synthesis of some pro-inflammatory cytokines (IL-6, IL-8).
Erdosteine prevents the inhibition of alpha-1-antitrypsin by tobacco smoke, thus preventing damage caused by smog or tobacco smoking.
Moreover, erdosteine increases the concentration of IgA in the airways of patients with chronic obstructive pulmonary disease (COPD) and prevents the inhibition of granulocytes caused by smoking. Erdosteine also increases the concentration of amoxicillin in bronchial secretions, and thus the therapeutic effect of the simultaneous use of these agents will be faster compared to the therapeutic effect of amoxicillin monotherapy. In patients with COPD, erdosteine therapy for 8 months reduced the frequency of exacerbations and improved the quality of life.
The effect of the drug is manifested approximately 3-4 days after the start of therapy. Erdosteine itself does not contain free SH-radicals, so it has a very slight effect on the digestive tract when used in recommended doses, and the profile of adverse events from the digestive tract when using it does not differ from that when using placebo.
Pharmacokinetics
Erdosteine is rapidly absorbed; metabolized by the liver to at least 3 active metabolites, the most abundant (in percentage) and active of which is
N-thiodiglycolylhomocysteine (metabolite 1, or M1). The main pharmacokinetic parameters (for M1): maximum concentration (Cmax) - 3.46 μg / ml; time to reach maximum concentration (Tmax) - 1.48 hours; area under the "concentration-time" curve (AUC) - 12.09 mg / l / h. The level of binding of erdosteine to blood plasma proteins is 64.5%. Elimination occurs through urine and feces, where only inorganic sulfates were detected.
The elimination half-life (for the product as a whole, i.e. for erdosteine and its metabolites) is more than 5 hours. Repeated administration and food intake do not alter the pharmacokinetic profile of the product. No signs of cumulation or enzyme induction were observed.
In cases of impaired liver function, an increase in Cmax and AUC values was observed.
In addition, in severe liver dysfunction, an increase in the half-life of the drug has been observed. In severe renal failure, there is a risk of accumulation of metabolites.
Indication
Reducing the viscosity and facilitating 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.
Prevention of recurrent episodes of infections and complications after surgical interventions, such as pneumonia or partial atelectasis of the lungs.
This drug is also indicated as concomitant therapy with antibiotics in case of bacterial respiratory tract infections.
Contraindication
Hypersensitivity to the active substance or to any of the excipients containing free SH groups.
You should stop using this medicine in the following cases:
– with renal failure (creatinine clearance < 25 ml/min);
– in homocystinuria (this drug is a source of homocysteine, and there are currently no data available on the use of erdosteine in cases of congenital disorders of amino acid metabolism, especially in patients who are forced to follow a methionine-free diet);
– with peptic ulcer disease in the active phase.
Interaction with other medicinal products and other types of interactions
No undesirable interactions with other drugs commonly used in respiratory tract infections and COPD, such as theophylline, bronchodilators, erythromycin, amoxicillin or sulfamethoprim, have been observed. Erdosteine potentiates the effect of some antibiotics (e.g. amoxicillin, clarithromycin) that may be used therapeutically. A synergistic effect of erdosteine has been demonstrated when used concomitantly with budesonide and salbutamol.
Application features
If classic symptoms of hypersensitivity appear, erdosteine therapy should be discontinued immediately.
The simultaneous use of antitussives is inappropriate and may cause accumulation of secretions in the bronchial tree, increasing the risk of developing superinfection or bronchospasm.
Use during pregnancy or breastfeeding
No cases of embryo/fetal malformations have been identified in studies, however, information on the use of erdosteine during pregnancy or breastfeeding is limited. Therefore, the drug should be used during pregnancy, especially during the first trimester, only if clearly needed, after assessing the benefit/risk to the fetus and mother.
Ability to influence reaction speed when driving vehicles or other mechanisms
No negative effects on the ability to drive, operate other mechanisms, or concentrate were observed.
Method of administration and doses
Mucitus is prescribed orally, regardless of meals.
For children aged 8 to 12 years, the recommended dose is 150 mg 2 times a day; for adults and children over 12 years old, 300 mg 2 times a day.
The course of treatment is determined by the doctor. In acute uncomplicated diseases, the drug is used for 5-10 days. The duration of treatment in chronic diseases is determined by the doctor.
No dosage adjustment is required for elderly patients.
Children
The drug is contraindicated in children under 8 years of age.
Overdose
No cases of overdose have been reported so far.
In case of overdose or accidental ingestion of this drug by a child, symptomatic therapy (gastric lavage and other supportive measures) is recommended.
Adverse reactions
Sometimes the use of erdosteine can cause undesirable reactions from the gastrointestinal tract, such as a burning sensation and pain in the stomach, nausea, vomiting and, rarely, diarrhea. In several cases, ageusia or dysgeusia were observed at the beginning of therapy. Hypersensitivity reactions, such as skin rashes or unexpected hyperpyrexia, erythema, Quincke's edema, occur rarely. From the nervous system, headache is possible.
Expiration date
2 years.
Storage conditions
Store in a place protected from light, at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
6 capsules in a strip, 2 or 5 strips in a cardboard box.
Vacation category
According to the recipe.
Producer
Macleods Pharmaceuticals Limited.
Location of the manufacturer and address of its place of business
Plot No. 25-27, Survey No. 366, Premier Industrial Estate, Kanchigam, Daman –396 210 (Phase II), India.
