Lazolvan - solution for oral administration and inhalation 100 ml, ambroxol, cough suppressant with phlegm

Transparent, colorless or slightly brownish solution. Pharmacological action Studies have shown that ambroxol - the active ingredient of Lazolvan ® - increases secretion in the respiratory tract.

It enhances the production of pulmonary surfactant and stimulates ciliary activity.

These effects lead to increased mucus flow and transport (mucociliary clearance).

Enhancing mucociliary clearance improves sputum flow and relieves coughing.

In patients with chronic obstructive pulmonary disease, long-term therapy with Lazolvan® (for at least 2 months) led to a significant decrease in the number of exacerbations.

There was a significant decrease in the duration of exacerbations and the number of days of antibiotic therapy.

Pharmacokinetics

All dosage forms of ambroxol immediate release are characterized by rapid and almost complete absorption with a linear dose dependence in the therapeutic range of concentrations.

The maximum plasma concentration (C max) when taken orally is achieved after 1 - 5 hours.

The volume of distribution is 552 liters.

In the therapeutic range of concentrations, plasma protein binding is approximately 90%.

The transition of Ambroxol from blood to tissue with oral administration occurs quickly.

The highest concentrations of the active ingredient of the drug are observed in the lungs.

Approximately 30% of the taken oral dose undergoes the effect of the primary passage through the liver.

Studies in human liver microsomes have shown that CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol to dibromantranilic acid.

The remainder of ambroxol is metabolized in the liver, mainly by glucuronidation and by partial degradation to dibromantranilic acid (approximately 10% of the administered dose), as well as a small amount of additional metabolites.

The terminal half-life of ambroxol is 10 hours.

The total clearance is in the range of 660 ml / min, renal clearance accounts for approximately 8% of the total clearance.

Using the method of radioactive labeling, it was calculated that after taking a single dose of the drug over the next 5 days, about 83% of the dose taken is excreted in the urine.

There was no clinically significant effect of age and gender on the pharmacokinetics of ambroxol, so there is no reason to select a dosage for these signs.

Name ENG

LAZOLVAN

Clinical and pharmacological group

Mucolytic and expectorant drug

ATX code

R05CB06

Dosage

ambroxol hydrochloride 7.5 mg

Structure

1 ml of solution contains:

active substance:

ambroxol hydrochloride 7.5 mg

Excipients: citric acid monohydrate 2 mg, sodium hydrogen phosphate

dihydrate 4.35 mg, sodium chloride 6.22 mg, benzalkonium chloride 225 μg, purified water

989.705 mg.

Indications

Acute and chronic diseases of the respiratory tract with the release of viscous sputum:

acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease,

bronchial asthma with difficulty in sputum discharge, bronchiectasis.

INN / Active ingredient

ambroxol hydrochloride

Contraindications

Hypersensitivity to ambroxol or other components of the drug,

pregnancy (I trimester), lactation period.

Use Lazolvan® with caution during pregnancy (II-III trimester), if

renal and / or hepatic failure.

Storage conditions and periods

At a temperature not exceeding 25 degrees, in the original packaging.

Expiration date: 5 years

Specifications

Category

Cough

,

Expectorants

Scope of the medicinal product

Ear, Throat, Nose

Release form

Solution

Manufacturer country

Italy

Package quantity, pcs

one

Scope of application

Virology

Minimum age from

No restrictions

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Volume, ml.

100 ml

Brand name

Sanofi

Components

measuring glass

The amount of the dosage form in the primary package

100 ml

Primary packaging type

Dropper bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Expectorant mucolytic agent

Anatomical and therapeutic characteristics

R05CB06 Ambroxol

Dosage form

Solution for oral administration and inhalation

Dosage (volume) of the substance in the preparation

7.5 mg

Expiration date in days

1825

Package weight, g

150

Mode of application

:

Inside.

Ingestion (1 ml = 25 drops).

Adults and children over 12 years old: 4 ml (= 100 drops) 3 times a day

Children from 6 to 12 years old: 2 ml (= 50 drops) 2-3 times a day

Children from 2 to 6 years old: 1 ml (= 25 drops) 3 times a day

Children under 2 years of age: 1 ml (= 25 drops) 2 times a day.

Drops can be diluted in water, tea, juice or milk.

You can apply the solution

regardless of food intake.