Instructions for use Langes oral solution 50 mg/ml, 60 ml container with dosing syringe No. 1
Composition
active ingredient: carbocysteine;
1 ml of the drug contains 50 mg of carbocysteine;
excipients: sodium saccharin, methyl parahydroxybenzoate (E 218), raspberry flavor, sodium hydroxide, carmellose sodium, purified water.
Dosage form
Oral solution.
Main physicochemical properties: transparent solution of light yellow color with a characteristic raspberry odor.
Pharmacotherapeutic group
Mucolytics. Carbocysteine. ATX code R05C B03.
Pharmacological properties
Pharmacodynamics.
Carbocysteine affects the gel phase of respiratory tract mucus: by breaking disulfide bridges of glycoproteins, it causes liquefaction of excessively viscous bronchial secretion, which promotes sputum excretion.
The mucoregulatory effect of carbocysteine is associated with the activation of sialic transferase, an enzyme of the goblet cells of the bronchial mucosa. Carbocysteine normalizes the quantitative ratio of acidic and neutral sialomucins of the bronchial secretion, restores its viscosity and elasticity. Activates the activity of the ciliated epithelium and improves mucociliary clearance. Promotes the regeneration of the respiratory tract mucosa, normalizes its structure, reduces goblet cell hyperplasia and, as a result, reduces mucus production. Restores the secretion of immunologically active IgA (specific protection) and the number of sulfhydryl groups of mucus components (nonspecific protection). It exhibits an anti-inflammatory effect due to the kinin-inhibiting activity of sialomucins, which leads to a decrease in edema and bronchial obstruction.
Pharmacokinetics.
After oral administration, the drug is rapidly absorbed from the gastrointestinal tract. The maximum concentration in the blood plasma is reached after 2 hours. The bioavailability of carbocysteine is low (about 10% of the dose taken) due to intensive metabolism in the gastrointestinal tract and the effect of the first passage through the liver. The half-life is about 2 hours. Carbocysteine and its metabolites are excreted mainly in the urine.
Indication
Treatment of symptoms of disorders of bronchial secretion and sputum discharge, especially in acute bronchopulmonary diseases, such as acute bronchitis; in exacerbations of chronic diseases of the respiratory system.
Contraindication
Hypersensitivity to carbocysteine or to any of the components of the drug (especially to methyl parahydroxybenzoate or to other salts of parahydroxybenzoate);
peptic ulcer of the stomach and duodenum during the exacerbation period;
I trimester of pregnancy due to insufficient data on teratogenic and embryotoxic effects;
children's age up to 2 years.
Interaction with other medicinal products and other types of interactions
During treatment with the drug, antitussives and agents that suppress bronchial secretion should not be used. Increases the effectiveness of glucocorticoid (mutually) and antibacterial therapy.
Application features
Productive cough is a fundamental defense mechanism of the bronchopulmonary system and should generally not be suppressed. It is irrational to combine drugs that modify bronchial secretion with cough suppressants (anticoptives) and/or substances that reduce secretion (e.g., the atropine group).
The use of mucolytic agents may lead to impaired bronchial patency in children under 2 years of age due to the limited ability to clear the respiratory tract of bronchial secretions due to age-related anatomical and physiological characteristics. Any mucolytic agents should not be used in children under 2 years of age.
Treatment should be reviewed in case of lack of effect or worsening of symptoms.
In the presence of a productive cough with purulent sputum, high fever, or chronic bronchial or pulmonary disease, the clinical situation should be reviewed.
Do not exceed the recommended doses of the drug.
The drug should be used with caution in patients with a history of gastric or duodenal peptic ulcer.
This medicinal product contains sodium, i.e. 2 ml of solution contains 0.67 mmol (or 15.5 mg) of sodium and 15 ml of solution contains 5.07 mmol (or 116.6 mg). This should be taken into consideration by patients on a controlled sodium diet.
The medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
Use during pregnancy or breastfeeding
The use of the drug in the first trimester of pregnancy is contraindicated. In the second and third trimesters of pregnancy or during breastfeeding, the drug should be used only under the supervision of a physician if the potential benefit to the mother outweighs the potential risk to the fetus/child.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
The drug is administered orally. The dosage of the drug depending on the patient's age is given in the table.
| Age | Release form |
| 2-5 years | Container 60 ml | 2 ml 2 times a day |
| 5-15 years | Container 60 ml | 2 ml 3 times a day |
| Children aged 15 and over and adults | Container 200 ml | 15 ml 3 times a day |
The maximum single dose for children under 15 years of age should not exceed 100 mg (2 ml).
The duration of treatment should not exceed 8-10 days.
The duration of use of carbocysteine in children should be as short as possible, no more than 5 days.
Adults and children over 15 years of age should be given the solution in 200 ml containers, children aged 2 to 15 years – in 60 ml containers. For accurate dosing, use a measuring cup when using the solution in 200 ml containers, and a dosing syringe in 60 ml containers.
Children
The drug should be used in children over 2 years of age. Treatment of children should be carried out under the supervision of a physician.
Overdose
Overdose may cause stomach pain, nausea, and diarrhea.
Treatment is symptomatic. In case of overdose, it is recommended to consult a doctor.
Side effects
On the part of the respiratory system, thoracic organs and mediastinum: risk of bronchial obstruction in children under 2 years of age (see sections "Contraindications" and "Peculiarities of use").
Gastrointestinal: indigestion, nausea, vomiting, stomach pain, diarrhea.
From the side of the central nervous system: dizziness, weakness, malaise.
Allergic reactions: in rare cases - itching, urticaria, exanthema, angioedema, erythematous skin rashes (may be delayed in time).
Several cases of fixed drug-related rash have been reported.
In case of adverse reactions, it is recommended to reduce the dose or discontinue the drug and be sure to consult a doctor.
Expiration date
2 years.
Do not use the drug after the expiration date indicated on the package.
The shelf life of the solution after opening the container is 12 months.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
60 ml or 200 ml of solution in brown polyethylene terephthalate containers, sealed with polyethylene or aluminum caps.
60 ml container with dosing syringe or 200 ml container with measuring cup in a cardboard pack.
Vacation category
Without a prescription.
Producer
Joint Ukrainian-Spanish enterprise "Sperco Ukraine".
