Mucosol (Capsules, Syrup) Instructions for Use

ATC Code

R05CB03 (Carbocisteine)

Active Substance

Carbocisteine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Mucolytic drug

Pharmacotherapeutic Group

Mucolytic agent

Pharmacological Action

Mucolytic agent. The action is due to the activation of sialyl transferase, an enzyme of the goblet cells of the bronchial mucosa.

It normalizes the quantitative ratio of acidic and neutral sialomucins in the bronchial secretion. It reduces the viscosity of bronchial secretion and discharge from the paranasal sinuses, facilitates the discharge of sputum and mucus, and reduces cough.

It promotes regeneration of the mucous membrane, normalizes its structure, and activates the activity of the ciliated epithelium.

It restores the secretion of immunoglobulin IgA (specific protection) and the number of sulfhydryl groups of mucus components (nonspecific protection), and improves mucociliary clearance.

Pharmacokinetics

After oral administration, Carbocisteine is rapidly absorbed. Bioavailability is low (less than 10% of the administered dose).

C_max in blood serum and in the respiratory tract mucosa is reached 2-3 hours after administration and is maintained in the mucosa for 8 hours.

It is metabolized in the liver. It is excreted mainly by the kidneys, partially unchanged (30-60%), partially as metabolites. T_1/2 is about 2 hours.

Indications

Acute and chronic bronchopulmonary diseases and diseases of the ENT organs, accompanied by the formation of viscous, difficult-to-discharge sputum (tracheitis, bronchitis, tracheobronchitis, bronchial asthma, bronchiectasis) and mucus (inflammatory diseases of the middle ear, nose and its paranasal sinuses – rhinitis, otitis media, sinusitis); preparation of the patient for bronchoscopy or bronchography.

ICD codes

Dosage Regimen

Administer orally. For adults, the initial daily dose is 2.25 g divided into three doses of 750 mg each.

After achieving the clinical effect, reduce the daily dose to a maintenance level of 1.5 g divided into two or three doses.

For pediatric patients, adjust the dose strictly according to age and available formulation. For children aged 5 to 12 years, administer 250 mg three times daily.

For children aged 2 to 5 years, the typical dose is 100 mg to 200 mg three times daily, using an age-appropriate formulation.

For children under 2 years of age, dosing is based on 25 mg/kg to 30 mg/kg of body weight per day, divided into two or three doses.

Take capsules with a full glass of water. Administer syrup using the provided measuring device for accuracy.

The duration of self-treatment without medical supervision should not exceed 8 days.

If symptoms persist beyond this period, discontinue use and consult a physician.

Adverse Reactions

From the digestive system: nausea, vomiting, diarrhea, epigastric pain, gastrointestinal bleeding.

From the immune system: allergic skin rash and anaphylactic reactions, including urticaria, angioedema, itching, exanthema, fixed drug eruption.

From the skin and subcutaneous tissues: bullous dermatitis, Stevens-Johnson syndrome.

General reactions: dizziness, weakness, malaise.

Contraindications

Hypersensitivity to carbocisteine; peptic ulcer of the stomach and duodenum in the acute stage; chronic glomerulonephritis (in the acute phase); cystitis; pregnancy; childhood – depending on the dosage form.

With caution: history of peptic ulcer of the stomach and duodenum; breastfeeding period; elderly patients; simultaneous use of drugs that increase the risk of gastrointestinal bleeding.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy.

If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Renal Impairment

Contraindicated in chronic glomerulonephritis in the acute phase.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the carbocisteine drug leaflets regarding contraindications for the use of specific carbocisteine dosage forms in children of different ages.

Geriatric Use

Should be used with caution in elderly patients.

Special Precautions

Caution should be exercised when using carbocisteine in elderly patients, with a history of peptic ulcer of the stomach and duodenum, and with simultaneous use of drugs that increase the risk of gastrointestinal bleeding.

If gastrointestinal bleeding develops, carbocisteine should be discontinued.

Influence on the ability to drive vehicles and mechanisms

During treatment with carbocisteine, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities due to the possibility of dizziness and weakness.

Drug Interactions

Carbocisteine enhances the effectiveness of therapy with corticosteroids and antibacterial drugs in the treatment of infectious and inflammatory diseases of the upper and lower respiratory tracts.

Carbocisteine potentiates the bronchodilator effect of theophylline.

The effect of carbocisteine is weakened by antitussive and m-cholinoblocking agents.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.