Lazolvan Max capsules with prolonged release 75 mg. №10

Description

Lazolvan Max Composition
active substance: ambroxol hydrochloride

1 capsule contains 75 mg of ambroxol hydrochloride;

excipients: crospovidone, carnauba wax, stearyl alcohol, magnesium stearate;

capsule shell: gelatin, purified water, titanium dioxide (E 171), iron oxide red (E172), iron oxide yellow (E172) ink for capsule labeling: shellac, n-butyl alcohol, propylene glycol (E 1520), titanium dioxide (E 171).

Lazolvan Max Dosage form
Sustained-release capsules.

Basic physical and chemical properties: oblong hard gelatin capsules, consisting of an opaque orange body with the logo of the company Boehringer Ingelheim and a red opaque cap with the inscription “MUC01” in white.

Capsule content: round, yellowish-white pellets with a smooth shiny surface, mixed with a small amount of powder.

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

Lazolvan Max Pharmacodynamics
It has been preclinically proven that the active substance of Lazolvan Max capsules 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). Mucociliary improvement has been proven during clinical and pharmacological studies.

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

Patients with COPD who received ambroxol hydrochloride, sustained-release capsules, 75 mg for 6 months, showed 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, extended-release capsules, showed a statistically significant improvement in the patient’s condition in terms of sputum production, cough, dyspnea and auscultatory data.

Pharmacokinetics
Absorption. Absorption of ambroxol hydrochloride from oral forms of immediate release is rapid and complete, with a linear dose dependence in the therapeutic range. The maximum level in blood plasma is reached after 1-2.5 hours with oral administration of rapid-release dosage forms and, on average, after 6.5 hours with the use of slow-release forms.

Bioavailability after taking a 30 mg tablet is 79%.

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 expected volume of distribution for oral administration is 552 liters. In blood plasma in the therapeutic dose range, approximately 90% of the drug binds to proteins.

Indications
Secretolytic therapy for acute and chronic bronchopulmonary diseases associated with impaired bronchial secretion and weakening of mucus movement.

Contraindications
Lasolvan Max should not be used in patients with known hypersensitivity to ambroxol hydrochloride or to any other components of the drug.

Lasolvan Max is not intended for use in children under 12 years of age due to the amount of active ingredient contained in the capsule.