Carbocisteine (Syrup) Instructions for Use

Instructions
Dosage forms

ATC Code

R05CB03 (Carbocisteine)

Active Substance

Carbocisteine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Mucolytic drug

Pharmacotherapeutic Group

Antitussives and cold remedies; expectorants, excluding combinations with antitussives; mucolytic agents

Pharmacological Action

Mucolytic agent. The action is due to the activation of sialyltransferase, 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

Open the list of ICD codes

ICD-10 code	Indication
H66	Suppurative and unspecified otitis media
J00	Acute nasopharyngitis (common cold)
J01	Acute sinusitis
J04.2	Acute laryngotracheitis
J20	Acute bronchitis
J31.0	Chronic rhinitis (including ozaena, atrophic and hypertrophic rhinitis)
J32	Chronic sinusitis
J37.1	Chronic laryngotracheitis
J42	Unspecified chronic bronchitis
J45	Asthma
J47	Bronchiectasis
Z51.4	Preparatory procedures for subsequent treatment or examination, not elsewhere classified

ICD-11 code	Indication
AA9Z	Unspecified suppurative otitis media
CA00	Acute nasopharyngitis
CA01	Acute rhinosinusitis
CA05.2	Acute laryngotracheitis
CA09.0	Chronic rhinitis
CA0A.Z	Chronic rhinosinusitis, unspecified
CA0G	Chronic laryngitis or laryngotracheitis
CA20.1Z	Chronic bronchitis, unspecified
CA23	Asthma
CA24	Bronchiectasis
CA42.Z	Acute bronchitis, unspecified
QB9A	Preparatory procedures for subsequent treatment

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer the syrup orally.

For adults, the initial daily dose is 2.25 g (15 ml of 150 mg/ml syrup three times daily).

After achieving the clinical effect (typically improved sputum expectoration), reduce the daily maintenance dose to 1.5 g (10 ml of 150 mg/ml syrup three times daily).

For children aged 5 to 12 years, administer 10 ml of syrup (150 mg/ml) three times daily.

For children aged 2 to 5 years, administer 5 ml of syrup (150 mg/ml) twice daily.

For children under 2 years, the dose is determined individually by a physician.

Adhere to a maximum treatment duration of 8 days without medical consultation.

Take the dose between meals.

Use the provided measuring device for accurate dosing.

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; gastric and duodenal ulcer in the acute stage; chronic glomerulonephritis (in the acute phase); cystitis; pregnancy; childhood – depending on the dosage form.

With caution: history of gastric and duodenal ulcer; breastfeeding period; elderly patients; concomitant 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 gastric and duodenal ulcer, and with concomitant use of drugs that increase the risk of gastrointestinal bleeding. If gastrointestinal bleeding develops, carbocisteine should be discontinued.

Effect on 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 glucocorticosteroids 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-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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Carbocisteine [Ivanovo Pharmaceutical Factory PJSC (Russia)]
Syrup 20 mg/1 ml: 90 ml, 100 ml, 115 ml, 125 ml, 150 ml, or 200 ml bottle or jar with or without a measuring cup/measuring syringe/measuring spoon/dropper pipette.
Syrup 50 mg/1 ml: 90 ml, 100 ml, 115 ml, 125 ml, 150 ml, or 200 ml bottle or jar with or without a measuring cup/measuring syringe/measuring spoon/dropper pipette.

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

Dosage Forms

	Carbocisteine	Syrup 20 mg/1 ml: 90 ml, 100 ml, 115 ml, 125 ml, 150 ml, or 200 ml bottle or jar with or without a measuring cup/measuring syringe/measuring spoon/dropper pipette.
		Syrup 50 mg/1 ml: 90 ml, 100 ml, 115 ml, 125 ml, 150 ml, or 200 ml bottle or jar with or without a measuring cup/measuring syringe/measuring spoon/dropper pipette.

Dosage Form, Packaging, and Composition

Syrup as a clear, colorless or light yellow liquid, with a strawberry odor.

	1 ml
Carbocisteine	20 mg

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

90 ml – jars* (1) – cardboard packs.
90 ml – bottles* (1) – cardboard packs.
100 ml – jars* (1) – cardboard packs.
100 ml – bottles* (1) – cardboard packs.
115 ml – jars* (1) – cardboard packs.
115 ml – bottles* (1) – cardboard packs.
125 ml – jars* (1) – cardboard packs.
125 ml – bottles* (1) – cardboard packs.
150 ml – jars* (1) – cardboard packs.
150 ml – bottles* (1) – cardboard packs.
200 ml – jars* (1) – cardboard packs.
200 ml – bottles* (1) – cardboard packs.

* may be supplied with a measuring cup/measuring syringe/measuring spoon/dropper pipette

Syrup as a clear, colorless or from light yellow to yellow liquid, with a slight characteristic odor.

	1 ml
Carbocisteine	50 mg

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

* may be supplied with a measuring cup/measuring syringe/measuring spoon/dropper pipette

Carbocisteine [Elius, LLC (Russia)]
Syrup 20 mg/ml: 150 ml, 200 ml, or 250 ml bottle.
Syrup 50 mg/ml: 150 ml, 200 ml, or 250 ml bottle.

Marketing Authorization Holder

Elius, LLC (Russia)

Manufactured By

Vertex, JSC (Russia)

Dosage Forms

	Carbocisteine	Syrup 20 mg/ml: 150 ml, 200 ml, or 250 ml bottle.
		Syrup 50 mg/ml: 150 ml, 200 ml, or 250 ml bottle.

Dosage Form, Packaging, and Composition

Syrup as a clear, colorless or light yellow liquid, with a strawberry odor.

	1 ml
Carbocisteine	20 mg

Excipients: sucrose – 700 mg, flavor “Strawberry with natural extract RX9711” – 1 mg, methylparahydroxybenzoate (methylparaben) – 1.5 mg, sodium hydroxide – to pH 6.1-6.3, purified water – up to 1 ml.

150 ml – bottles – cardboard packs.
200 ml – bottles – cardboard packs.
250 ml – bottles – cardboard packs.

Syrup as a clear, colorless or from light yellow to yellow liquid, with a slight characteristic odor.

	1 ml
Carbocisteine	50 mg

Excipients: sucrose – 400 mg, methylparahydroxybenzoate (methylparaben) – 1.5 mg, sodium hydroxide – to pH 6.1-6.3, purified water – up to 1 ml.

150 ml – bottles – cardboard packs.
200 ml – bottles – cardboard packs.
250 ml – bottles – cardboard packs.

Carbocisteine-Teva [Elius, LLC (Russia)]
Syrup 20 mg/ml
Syrup 50 mg/ml

Marketing Authorization Holder

Elius, LLC (Russia)

Manufactured By

Vertex, JSC (Russia)

Dosage Forms

	Carbocisteine-Teva	Syrup 20 mg/ml
		Syrup 50 mg/ml

Dosage Form, Packaging, and Composition

Syrup

	1 ml
Carbocisteine	20 mg

150 ml – bottles – cardboard packs – Over-the-Counter
200 ml – bottles – cardboard packs – Over-the-Counter
250 ml – bottles – cardboard packs – Over-the-Counter

Syrup

	1 ml
Carbocisteine	50 mg

150 ml – bottles – cardboard packs – Over-the-Counter
200 ml – bottles – cardboard packs – Over-the-Counter
250 ml – bottles – cardboard packs – Over-the-Counter

Carbocisteine-Vertex [Vertex, JSC (Russia)]
Syrup 20 mg/ml: 150 ml, 200 ml, or 250 ml bottle.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Carbocisteine-Vertex

Syrup 20 mg/ml: 150 ml, 200 ml, or 250 ml bottle.

Dosage Form, Packaging, and Composition

Syrup as a clear, colorless liquid, with a strawberry odor.

	1 ml
Carbocisteine	20 mg

150 ml – bottles (1) – cardboard packs.
200 ml – bottles (1) – cardboard packs.
250 ml – bottles (1) – cardboard packs.

Carbocisteine-Vertex [Vertex, JSC (Russia)]
Syrup 50 mg/ml: 150 ml, 200 ml, or 250 ml bottle.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Carbocisteine-Vertex

Syrup 50 mg/ml: 150 ml, 200 ml, or 250 ml bottle.

Dosage Form, Packaging, and Composition

Syrup as a clear light yellow with a brownish tint liquid, with a caramel odor.

	1 ml
Carbocisteine	50 mg

Excipients: sucrose – 400 mg, flavor “Caramel-cream 761” – 2 mg, methylparahydroxybenzoate (methylparaben) – 1.5 mg, sodium hydroxide – to pH 6.1-6.3, purified water – up to 1 ml.

150 ml – bottles (1) – cardboard packs.
200 ml – bottles (1) – cardboard packs.
250 ml – bottles (1) – cardboard packs.

Medixlife (Author)

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