Carbocisteine ??syrup 50mg / ml, 150ml Vertex

- Acute and chronic bronchopulmonary diseases and diseases of the ENT organs accompanied by the formation of viscous difficult to separate sputum (tracheitis bronchitis tracheobronchitis bronchial asthma bronchiectasis) and mucus (inflammatory diseases of the middle ear of the nose and its paranasal sinuses - rhinitis otitis media sinusitis);

- preparation of the patient for bronchoscopy or bronchography.

Inside.

Carbocisteine ??20 mg / ml :

One teaspoon of syrup (5 ml) contains 100 mg of carbocysteine.

Children aged 2-5 years: take 2 times a day, one teaspoon of syrup (200 mg per day);

Children over 5 years of age: Take one teaspoon 3 times a day (300 mg per day).

Carbocisteine ??50 mg / ml :

One tablespoon of syrup (15 ml) contains 750 mg of carbocisteine.

Adults : Take 3 times a day, one tablespoon (2250 mg per day).

The duration of treatment with the drug Carbocisteine ??should not exceed 8 days without consulting a doctor.

Dosage 50 mg / ml

active substance: carbocisteine ??- 50.0 mg;

excipients: sucrose - 400.0 mg, flavor 'Caramel cream 761' - 2.0 mg, methyl parahydroxybenzoate (methylparaben) - 1.5 mg, sodium hydroxide - up to pH 6.10 - 6.30, purified water - up to 1.0 ml.

- Hypersensitivity to carbocisteine ??or other components of the drug;

- peptic ulcer of the stomach and duodenum in the acute stage;

- chronic glomerulonephritis (in the exacerbation phase);

- cystitis;

- pregnancy;

- children's age up to 2 years (for syrup 20 mg / ml) and up to 15 years (for syrup 50 mg / ml);

- sucrase / isomaltase deficiency; fructose intolerance; glucose-galactose malabsorption.

Carefully:

- History of gastric ulcer and duodenal ulcer (see the section 'Special instructions');

- the period of breastfeeding;

- elderly patients (see the section 'Special instructions');

- concomitant use of drugs that increase the risk of gastrointestinal bleeding (see section 'Special instructions').

Trade name of the drug

Carbocisteine

International non-proprietary name

Carbocisteine

Dosage form

syrup

Composition

1 ml of syrup contains:

Dosage 20 mg / ml

active substance: carbocisteine ??- 20.0 mg;

excipients: sucrose - 700.0 mg, flavoring 'Strawberry with natural extract RX9711 - 1.0 mg, methyl parahydroxybenzoate (methylparaben) - 1.5 mg, sodium hydroxide - up to pH 6.10 - 6.30, purified water - up to 1.0 ml.

Dosage 50 mg / ml

active substance: carbocisteine ??- 50.0 mg;

excipients: sucrose - 400.0 mg, flavor 'Caramel cream 761' - 2.0 mg, methyl parahydroxybenzoate (methylparaben) - 1.5 mg, sodium hydroxide - up to pH 6.10 - 6.30, purified water - up to 1.0 ml.

Description

Transparent, colorless liquid with a strawberry odor (dosage 20 mg / ml) or transparent, light yellow with a brownish tinge liquid with a caramel odor (dosage 50 mg / ml).

Pharmacotherapeutic group

Expectorant mucolytic agent

ATX code

R05CB03

Pharmacodynamics:

Carbocisteine, being a mucolytic, has an effect on the gel phase of endobrochial secretions, breaking the disulfide bridges of glycoproteins and thus decreasing the viscosity and increasing the elasticity of the secretion. Carbocisteine ??activates sial transferase - an enzyme of the goblet cells of the bronchial mucosa normalizes the quantitative ratio of acidic and neutral sialomucins promotes regeneration of the mucous membrane normalizes its structure activates the activity of the ciliated epithelium restores the secretion of immunologically active IgA (specific protection) improves mucociliary clearance. The effect is dose-dependent.

Pharmacokinetics:

Suction

Carbocisteine ??is rapidly and almost completely absorbed after oral administration, reaching a maximum concentration in the blood plasma and the mucous membrane of the respiratory tract after 2 hours. Bioavailability is low (less than 10% of the dose taken) as a result of possible rapid passage through the liver.

Metabolism

The half-life is about 2 hours.

Withdrawal

Excretion is carried out mainly by the kidneys. Part of the drug is excreted by the kidneys unchanged (30-60%), the rest is excreted in the form of metabolites.

Indications:

- Acute and chronic bronchopulmonary diseases and diseases of the ENT organs accompanied by the formation of viscous difficult to separate sputum (tracheitis bronchitis tracheobronchitis bronchial asthma bronchiectasis) and mucus (inflammatory diseases of the middle ear of the nose and its paranasal sinuses - rhinitis otitis media sinusitis);

- preparation of the patient for bronchoscopy or bronchography.

Contraindications:

- Hypersensitivity to carbocisteine ??or other components of the drug;

- peptic ulcer of the stomach and duodenum in the acute stage;

- chronic glomerulonephritis (in the exacerbation phase);

- cystitis;

- pregnancy;

- children's age up to 2 years (for syrup 20 mg / ml) and up to 15 years (for syrup 50 mg / ml);

- sucrase / isomaltase deficiency; fructose intolerance; glucose-galactose malabsorption.

Carefully:

- History of gastric ulcer and duodenal ulcer (see the section 'Special instructions');

- the period of breastfeeding;

- elderly patients (see the section 'Special instructions');

- concomitant use of drugs that increase the risk of gastrointestinal bleeding (see section 'Special instructions').

Pregnancy and lactation:

Pregnancy

Due to insufficient clinical data, the use of the drug Carbocisteine ??during pregnancy is contraindicated.

Breastfeeding period

It is not known whether carbocisteine ??is excreted in breast milk. During breastfeeding, the drug Carbocisteine ??is used with caution.

Method of administration and dosage:

Inside.

Carbocisteine ??20 mg / ml :

One teaspoon of syrup (5 ml) contains 100 mg of carbocysteine.

Children aged 2-5 years: take 2 times a day, one teaspoon of syrup (200 mg per day);

Children over 5 years of age: Take one teaspoon 3 times a day (300 mg per day).

Carbocisteine ??50 mg / ml :

One tablespoon of syrup (15 ml) contains 750 mg of carbocisteine.

Adults : Take 3 times a day, one tablespoon (2250 mg per day).

The duration of treatment with the drug Carbocisteine ??should not exceed 8 days without consulting a doctor.

Side effects:

Gastrointestinal disturbances: nausea diarrhea epigastric pain gastrointestinal bleeding vomiting.

Immune system disorders: allergic skin rash and anaphylactic reactions including urticaria angioedema pruritus exanthema fixed drug rash.

Disorders of the skin and subcutaneous tissues: isolated cases of bullous dermatitis such as Stevens-Johnson syndrome and erythema multiforme.

General disorders and reactions at the injection site: dizziness, weakness, malaise.

Overdose:

Symptoms

Skin reactions gastrointestinal disturbances.

Treatment

Gastric lavage and specific supportive therapy are recommended. There is no specific antidote.

Interaction:

The interaction of carbocysteine ??and food products as well as substances used for laboratory research has not been identified.

Carbocisteine ??increases the effectiveness of glucocorticosteroid and antibacterial therapy for infectious and inflammatory diseases of the upper and lower respiratory tract.

Potentiates the bronchodilator effect of theophylline.

The action of carbocisteine ??is weakened by antitussives and m-anticholinergics.

Special instructions:

Caution should be exercised when using the drug Carbocisteine ??in elderly patients with a history of gastric ulcer and duodenal ulcer while taking drugs that increase the risk of gastrointestinal bleeding (see section 'With caution'). With the development of gastrointestinal bleeding, you should stop taking the drug.

When prescribing the drug Carbocisteine ??to patients with diabetes mellitus or patients on a low-carbohydrate diet, it should be taken into account that 1 teaspoon (5 ml) of 20 mg / ml syrup contains 35 g of sucrose and 13 mg of sodium; 1 tablespoon of syrup (15 ml) 50 mg / ml contains 6 g of sucrose and 97 mg of sodium. When patients follow a salt-free or low-salt diet, the sodium content of the preparation should be taken into account.

Since the drug Carbocisteine ??contains sucrose, its use is not recommended in patients with sucrase / isomaltase deficiency, fructose intolerance, glucose / galactose malabsorption syndrome.

Impact on the ability to drive vehicles. Wed and fur .:

During the period of drug treatment, care should be taken when driving vehicles and when engaging in other potentially hazardous activities due to the possibility of dizziness and weakness.

Release form / dosage:

Syrup 20 mg / ml and 50 mg / ml.

Packaging:

150 ml 200 ml or 250 ml in dark bottles made of polyethylene terephthalate with a screw cap with a first opening control made of polypropylene.

Each bottle, along with instructions for use, is placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ? C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Vacation conditions

Without recipe

Manufacturer

Joint Stock Company 'VERTEX' (JSC 'VERTEX'), St. Petersburg, Road to Kamenka, 62, lit. A, Russia