Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..
PHARMACHOLOGIC EFFECT
Mucolytic agent with expectorant action. Stimulates the serous cells of the glands of the bronchial mucosa, increasing the content of mucous secretions and, thus, changes the disturbed ratio of serous and mucous components of sputum. This activates the hydrolyzing enzymes, and increases the release of lysosomes from Clara cells, which leads to a decrease in the viscosity of sputum. Ambroxol increases the content of surfactant in the lungs, which is associated with increased synthesis and secretion in the alveolar pneumocytes, as well as with disruption of its disintegration. Increases mucociliary transport of phlegm. Slightly suppresses cough.
PHARMACOKINETICS
After ingestion, ambroxol is almost completely absorbed from the digestive tract. Cmax in the blood plasma is achieved in about 0.5-3 hours. Does not cumulate.Binding to plasma proteins is about 90%.
After oral administration and parenteral administration, ambroxol is rapidly distributed in the body tissues, the highest concentration is determined in the lungs.
Penetrates through the BBB and placental barrier, excreted in breast milk.
Metabolised in the liver by conjugation with the formation of pharmacologically inactive metabolites.
T 1/2 is 7-12 hours. It is excreted mainly by kidneys in the form of metabolites - 90%, in unchanged form - 5%.
T 1/2 increases with chronic renal failure of severe severity.
INDICATIONS
Acute and chronic diseases of the respiratory tract, accompanied by the release of viscous sputum (chronic bronchitis with bronchial obstruction syndrome, bronchial asthma, bronchiectatic disease). Respiratory distress syndrome in newborns and premature infants.
DOSING MODE
Inside adults and children over 12 years - 30 mg 2-3 times / day.
The dosage regimen for children under 12 years of age is presented in the following table.
Age Single dose Frequency of admission
5-12 years 15 mg 2-3 times / day
2-5 years 7.5 mg 3 times / day
up to 2 years 7.5 mg 2 times / day
In the form of inhalations for adults and children older than 5 years - 15-22.5 mg 1-2 times / day.
Adults parenteral (in / m, in / in) - 15 mg, in severe cases - 30 mg 2-3 times / day.
Children v / m - 1.2-1.6 mg / kg 3 times / day; in / in - 1.2-1.6 mg / kg / day.
Children under the age of 2 years in the / in - 15 mg / day, the frequency of administration - 2 times / day.
Children from 2 to 5 years in the / in - 22.5 mg / day, the frequency of administration - 3 times / day.
Children older than 5 years - 30-45 mg / day, the frequency of administration - 2-3 times / day.
To treat respiratory distress syndrome in preterm and newborn children, ambroxol is administered iv or IM at a dose of 10 mg / kg / day, the frequency of administration is 3-4 times / day, if necessary, the dose can be gradually increased to 30 mg / kg / day.
SIDE EFFECT
On the part of the digestive system: rarely - nausea, vomiting, diarrhea, abdominal pain.
Allergic reactions: skin rash, hives, angioedema.
Other: rarely - weakness, headache.
CONTRAINDICATIONS
Peptic ulcer of the stomach and duodenum, convulsive syndrome of various etiologies, I trimester of pregnancy, hypersensitivity to ambroxol.
PREGNANCY AND LACTATION
Ambroxol is contraindicated in the first trimester of pregnancy. If it is necessary to use in the II and III trimesters, one should evaluate the potential benefit of therapy for the mother and the possible risk to the fetus.
If you need to use ambroksola during lactation, you should decide whether to stop breastfeeding.
APPLICATION FOR CHILDREN
The application is possible according to the dosing regimen.
APPLICATION IN ELDERLY PATIENTS
The application is possible according to the dosing regimen.
SPECIAL INSTRUCTIONS
Patients suffering from bronchial asthma can use bronchodilators to avoid nonspecific irritation of the airways and their spasm before inhaling ambroxol.
DRUG INTERACTION
With simultaneous use with antitussive drugs, it is difficult to separate sputum from a cough reduction; with amoxicillin, doxycycline, cefuroxime, erythromycin - increasing their penetration into the bronchial secretion.
Ambroxol is compatible with drugs that inhibit labor.
