Carbocisteine (Syrup) Instructions for Use
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).
Cmax 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. T1/2 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
| 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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
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.
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 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.
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
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 |
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 (1) – cardboard packs.
200 ml – bottles (1) – cardboard packs.
250 ml – bottles (1) – cardboard packs.
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.
![Carbocisteine [Syrup] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Carbocisteine [Syrup] 2")