Citobronho (Syrup) Instructions for Use

Marketing Authorization Holder

MBNPK Cytomed, JSC (Russia)

ATC Code

R05CB03 (Carbocisteine)

Active Substance

Carbocisteine (Rec.INN registered by WHO)

Dosage Forms

	Citobronho	Syrup 20 mg/ml: 60 ml or 125 ml bottle
		Syrup 50 mg/ml: 60 ml or 125 ml bottle

Dosage Form, Packaging, and Composition

Syrup transparent colorless or light yellow.

Excipients: sucrose, methylparahydroxybenzoate (methylparaben) (E218), sodium hydroxide, purified water.

60 ml – dark glass bottles (1) – cardboard packs.
125 ml – dark glass bottles (1) – cardboard packs.

Syrup transparent colorless or light yellow.

Excipients: sucrose, methylparahydroxybenzoate (methylparaben) (E218), sodium hydroxide, purified water.

60 ml – dark glass bottles (1) – cardboard packs.
125 ml – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Mucolytic drug

Pharmacotherapeutic Group

Mucolytic expectorant

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 the 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), 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. Select the appropriate syrup strength based on patient age. Use the provided measuring device for accurate dosing.

For adults and adolescents over 15 years, use the 50 mg/ml syrup. Take 15 ml (750 mg) three times daily. After achieving the clinical effect, reduce the dose to 10 ml (500 mg) three times daily.

For children aged 6 to 15 years, use the 20 mg/ml syrup. Take 15 ml (300 mg) three times daily. After achieving the clinical effect, reduce the dose to 10 ml (200 mg) three times daily.

For children aged 2 to 6 years, use the 20 mg/ml syrup. Take 5 ml (100 mg) three times daily. After achieving the clinical effect, reduce the dose to 2.5 ml (50 mg) three times daily.

For children aged 1 to 2 years, use the 20 mg/ml syrup. Take 2.5 ml (50 mg) three times daily. After achieving the clinical effect, reduce the dose to 1.25 ml (25 mg) three times daily.

Do not administer the 50 mg/ml syrup to children under 6 years of age. Do not administer the 20 mg/ml syrup to children under 1 year of age.

The duration of treatment should not exceed 8 days without consulting a physician. If symptoms persist or worsen, seek medical advice.

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

Use in Renal Impairment

Contraindicated in chronic glomerulonephritis in the acute phase.

Pediatric Use

Can be used in children 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.

Effect 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 tract.

Carbocisteine potentiates the bronchodilator effect of theophylline.

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