Lazolvan syrup 30 mg/5 ml. 100 ml.

Description

Lazolvan 100 ml Composition
active substance: ambroxol hydrochloride;

5 ml of syrup contains 15 mg of ambroxol hydrochloride;

excipients: sucralose, benzoic acid (E 210), hydroxyethyl cellulose, forest berry aroma (contains propylene glycol (E 1520)), vanilla aroma (contains propylene glycol (E 1520)), purified water.

Lazolvan 100 ml Dosage form
Syrup.

Basic physical and chemical properties: transparent or almost transparent, colorless or almost colorless, slightly viscous syrup with the taste of wild berries.

Lazolvan 100 ml Pharmacotherapeutic group
Drugs used for coughs and colds. Mucolytic agents. ATX code R05C B06.

Lazolvan 100 ml Pharmacodynamics
The local anesthetic effect of ambroxol hydrochloride, which may be explained by the sodium channel blocking properties, was observed in a rabbit eye model. In vitro studies have shown that ambroxol hydrochloride blocks neuronal sodium channels; binding was reversible and concentration dependent.

Ambroxol hydrochloride has been shown to be anti-inflammatory in vitro. Thus, ambroxol hydrochloride significantly reduces the release of cytokines from mononuclear and polymorphonuclear cells of blood and tissues.

As a result of clinical trials involving patients with pharyngitis, a significant reduction in pain and redness in the throat with the use of the drug has been demonstrated.

Due to the pharmacological properties of Ambroxol, pain quickly relieved in the treatment of diseases of the upper respiratory tract, was observed in the course of studies of the clinical efficacy of inhaled forms of Ambroxol.

After the use of ambroxol hydrochloride, the concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin and doxycycline) in bronchopulmonary secretions and in sputum increase. To date, no clinical significance has been found for this fact.

Pharmacokinetics

Absorption.

The absorption of ambroxol hydrochloride from oral forms of immediate release is rapid and fairly complete, with a linear dose dependence in the therapeutic range. Peak plasma levels are reached after 1 to 2.5 hours with oral administration of rapid-release dosage forms and an average of 6.5 hours with slow-release dosage forms.

Distribution.

When taken orally, the distribution of ambroxol hydrochloride from the blood to the tissues is rapid and pronounced, with a high concentration of the active substance in the lungs. The volume of distribution after oral administration is 552 liters. In the blood plasma in the therapeutic range, approximately 90% of the drug binds to proteins.

Metabolism and excretion.

Approximately 30% of the dose after oral administration is excreted through presystemic metabolism. Ambroxol hydrochloride is metabolized in the liver by glucuronidation and degradation into dibromantranilic acid (approximately 10% of the dose). Studies in human liver microsomes have shown that CYP3A4 is responsible for the metabolism of ambroxol hydrochloride to dibromantranilic acid.

After 3 days of taking ambroxol, hydrochloride is excreted in the urine, with about 6% of the dose being excreted unchanged, and about 26% of the dose in the form of conjugates of the compound.

The half-life of ambroxol hydrochloride is approximately 10 hours. The total clearance is approximately 660 ml / min, while the renal clearance is approximately 8% of the total. After 5 days, approximately 83% of the total dose is excreted in the urine.

Pharmacokinetics in special groups of patients.

In patients with impaired liver function, the excretion of ambroxol hydrochloride is reduced, which leads to a 1.3 – 2 times higher level in blood plasma. Since the therapeutic range of Ambroxol hydrochloride is wide enough, there is no need to change the dosage.

Age and gender have no clinically significant effect on the pharmacokinetics of ambroxol hydrochloride, and no dose adjustment is required.

Food intake does not affect the bioavailability of Ambroxol hydrochloride.

Indications
Secretolytic therapy for acute and chronic bronchopulmonary diseases, accompanied by impaired bronchial secretion and weakening of mucus movement.

Contraindications
Lazolvan® with wild berry flavor, syrup, 15 mg / 5 ml, should not be used in patients with known hypersensitivity to ambroxol hydrochloride or other components of the drug.

Lazolvan® with wild berry flavor should be used for children under 2 years of age as directed by a doctor.