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Carbocisteine, 2 % syrup for children

Drug formLiquid (for oral use)

ATC categoryPulmonology

ATC subcategoryMucolytic and expectorant agents

Brand nameCarbocisteine

Generic nameCarbocisteine

Composition

Each 5 ml of Carbocisteine 2% syrup for children contains:

active ingredient: carbocisteine-100mg;

excipients: sodium saccharin, propylene glycol, sucrose, methylparaben, aroma caramel, sodium hydroxide, color yellow E 110,water deionized.

Chemical name and CAS number

(2R)-2-amino-3-[(carboxymethyl)sulphanyl]propanoic acid , 2387-59-9.

Pharmacological group and ATC code

Mucolytic agent. ATC code: R05CB03.

Pharmacology

Pharmacodynamic properties
Carbocisteine (S-carboxymethyl L-cysteine) has been shown in normal and bronchitic animal models to affect the nature and amount of mucus glycoprotein which is secreted by the respiratory tract. An increase in the acid:neutral glycoprotein ratio of the mucus and a transformation of serous cells to mucus cells is known to be the initial response to irritation and will normally be followed by hypersecretion. The administration of Carbocisteine to animals exposed to irritants indicates that the glycoprotein that is secreted remains normal; administration after exposure indicates that return to the normal state is accelerated. Studies in humans have demonstrated that Carbocisteine reduces goblet cell hyperplasia. Carbocisteine can therefore be demonstrated to have a role in the management of disorders characterised by abnormal mucus.

Pharmacokinetic properties
Carbocisteineis rapidly absorbed from the gastrointestinal tract, peak plasma concentrations are reached after about hour(рН 7-9). Bioavailability is low, less than 10% ,probably, due to the metabolism in the gastrointestinal tract and “first pass” through the liver.
Carbocisteine is excreted primarily by the kidneys. The half-life is about 2 hours.

Uses

Violations of bronchial secretions (including acute bronchitis and acute exacerbations of chronic diseases of the bronchi and lungs).

Dosage and administration

The recommended dose for children 2-6 years is 2.5-5 ml syrup for children (half or one teaspoon), every 6 hours, for children 6-12 years 10 ml syrup for children (two teaspoons) every 8 hours.
Duration of treatment usually does not exceed 8-10 days.

Adverse effects

Immune System Disorders: there have been reports of anaphylactic reactions (rare).
Skin and Subcutaneous Tissue Disorders: there have been reports of skin rashes and allergic skin eruptions.
Gastrointestinal disorders: abdominal pain,nausea, diarrhea, gastrointestinal bleeding.
In case of such adverse effectsrecommended to reduce dose or stop taking the medication.

Precautions
Carbocisteine should be used with caution in patients with wet cough.
It should be used with caution in patients with gastric and duodenal ulcer. Carbocisteine shouldn’t be given with antitussive drugs and /or with drugs depressing bronchial secretions (including atropine – like drugs).
In the case of prescription of drug in patents having diabet , or in patents being on a diet with low sugar content, should be considered the sugar content (5.25 g per tablespoon).

Overdosage
Symptoms: Abdominal pain,nausea, diarrhea,
Treatment: appropriate symptomatic treatment is indicated.

Contraindications
  • Hypersensitivity to carbocisteine or to any of the excipientsin anamnesis.
  • Use in patients with active peptic ulceration.
  • Children under 12 years old.
  • Drug interactions

    Interaction with other medicins none stated.

    Pregnancy and breastfeeding

    Carbocisteineshould be used during pregnancy only when the potential benefits justify the possible risks to the fetus.
    Breastfeeding should be suspended during treatment with Carbocisteine.

    Identification

    A clear yellow colored, caramel flavored syrup.

    Prescription status

    To be dispensed without prescription.

    Presentation

    120 ml of syrup is filled into ambe glass bottles (inside package).
    The bottles are packed and inserted with the leaflet into cardboard boxes (outer package).

    Expiry date

    3 years.

    Storage conditions

    Store at a room temperature, out of the reach of children. Protect from light.