Lazolvan solution for inhalation 15 mg/2 ml. 100 ml.

Description

Lazolvan for inhalation Storage
active substance: ambroxol hydrochloride;

2 ml of solution for inhalation and oral administration contain ambroxol hydrochloride 15 mg;

excipients: citric acid, monohydrate; sodium hydrogen phosphate, dihydrate; sodium chloride; benzalkonium chloride; purified water.

Lazolvan for inhalation Dosage form
Solution for inhalation and oral administration.

Main physical and chemical properties: clear, colorless or slightly brown solution.

Lazolvan for inhalation Pharmacotherapeutic group
Remedies used for coughs and colds. Mucolytics.

ATX code R05C B06.

Lazolvan for inhalation Pharmacological properties

Pharmacodynamics

Ambroxol hydrochloride, substituted by benzylamine, is a metabolite of bromhexine. It differs from bromhexine by the absence of a methyl group and the presence of a hydroxyl group in the para-trans position of the cyclohexyl ring.

Studies prove its secretolytic and secretomotor effect in the bronchial tract.

When administered orally, the effect occurs in an average of 30 minutes and lasts 6 to 12 hours, depending on the individual dose.

It has been clinically proven that ambroxol hydrochloride increases the proportion of the serous component of bronchial secretions. Ambroxol enhances mucus removal by reducing viscosity and activating the ciliary epithelium.

Ambroxol activates the surfactant system by directly affecting type II pneumocytes in the alveoli and Clara cells in the small airway. It enhances the formation and excretion of surfactant material in the alveoli and bronchial tree of the fetus and adult body. These effects have been demonstrated in various species on cell cultures and in vivo.

In addition, the antioxidant effects of ambroxol have been demonstrated in various preclinical studies.

Pharmacokinetics

Absorption

Ambroxol is almost completely absorbed after oral administration. Tmax after oral administration is 1 – 3 hours. The absolute bioavailability of ambroxol when administered orally is reduced by approximately 1/3 due to presystemic metabolism.

Distribution

Approximately 85% (80-90%) of the drug is bound to plasma proteins. In lung tissue, ambroxol reaches a higher concentration than in blood plasma when administered parenterally. Ambroxol may enter the cerebrospinal fluid, the placental barrier and be excreted in breast milk.

Biotransformation

The formation of metabolites capable of penetrating the kidneys (eg, dibromanthranilic acid, glucuronide) occurs in the liver.

Breeding

Almost 90% of the drug is excreted by the kidneys in the form of metabolites formed in the liver. Less than 10% of ambroxol is excreted unchanged by the kidneys. Due to the high degree of protein binding, large volume of distribution and slow redistribution of the drug from tissues into the blood during dialysis or forced diuresis, significant excretion of ambroxol is unlikely.

The terminal half-life from blood plasma is 7 to 12 hours. The plasma half-life of ambroxol and its metabolites is approximately 22 hours.

Patients with impaired liver and kidney function

In patients with severe hepatic disorders, the clearance of ambroxol is reduced by 20 – 40%. Accumulation of ambroxol metabolites may occur in patients with severe renal impairment.

Indication
Secretolytic therapy for acute and chronic bronchopulmonary diseases associated with impaired bronchial secretion and impaired mucus.

Contraindication
Lasolvan®, a solution for inhalation and oral administration, should not be used in patients with hypersensitivity to ambroxol hydrochloride or other components of the drug.