Lazolvan syrup 30 mg/5 ml. 200 ml.

Description

Lazolvan Composition
active substance: ambroxol hydrochloride;

5 ml of syrup contains ambroxol hydrochloride 30 mg;

excipients: benzoic acid (E 210), hydroxyethyl cellulose, sucralose, strawberry-creamy aroma, vanilla aroma, purified water.

Lazolvan Dosage form
Syrup.

Basic physical and chemical properties: transparent or almost transparent, colorless or almost colorless, slightly viscous liquid with a fruity smell of strawberries and cream.

Lazolvan мPharmacotherapeutic group
Drugs used for coughs and colds. Mucolytic agents. ATX code R05C B06.

Lazolvan Pharmacodynamics
It has been preclinically proven that the active ingredient of Lazolvan® with strawberry-creamy taste, syrup, ambroxol hydrochloride, increases the proportion of serous bronchial secretions. Ambroxol enhances the release of pulmonary surfactant by direct action on type II pneumocytes in the alveoli and Clara cells in the bronchioles, and also stimulates ciliary activity, resulting in reduced sputum viscosity and improved excretion (mucociliary clearance). Improving mucociliary clearance has been proven during clinical and pharmacological studies.

The activation of secretion, a decrease in the viscosity of the secretion and an improvement in mucociliary clearance contribute to the excretion of mucus and facilitate the expectoration of sputum.

In patients with COPD who received ambroxol hydrochloride, 75 mg capsules for 6 months, there was a significant decrease in the number of exacerbations compared with placebo at the end of 2 months of treatment. Patients who were treated with ambroxol hydrochloride had significantly fewer days of illness and needed fewer days of antibiotic therapy. Compared with placebo, treatment with ambroxol hydrochloride, prolonged-release capsules showed a statistically significant improvement in the patient’s condition in terms of sputum production, cough, dyspnea and auscultatory data.

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 volume any

dose adjustment is not 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 strawberry-creamy flavor, syrup, should not be used in patients with hypersensitivity to ambroxol hydrochloride or other components of the drug.
Lazolvan® with strawberry-creamy flavor, syrup, should not be used in children under 2 years of age without a doctor’s prescription.