Lazolvan - children's syrup 15 mg / 5ml 100 ml, ambroxol, cough remedy with sputum

Transparent or almost transparent, colorless or almost colorless, slightly viscous liquid with the smell of wild berries.

pharmachologic effect

Studies have shown that ambroxol, the active ingredient in 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 in 1-2.5 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 on human liver microsomes have shown that the isoenzyme 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. It was calculated using the radioactive label,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

active substance - ambroxol hydrochloride 15 mg

Structure

5 ml of syrup contains:

active substance - ambroxol hydrochloride 15 mg

excipients - benzoic acid 8.5 mg, hyetellose

(hydroxyethyl cellulose) 10 mg, potassium acesulfame 5 mg, liquid sorbitol

(non-crystallizing) 1750 mg, glycerol 85% 750 mg, forest berry flavor PHL-

132195 11 mg, vanilla flavor 201629 3 mg, purified water 3047.5 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.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

INN / Active ingredient

ambroxol hydrochloride

Contraindications

Hypersensitivity to ambroxol or other components of the drug,

pregnancy (I trimester), lactation period.

Lazolvan® syrup (15 mg / 5 ml) contains 10.5 g of sorbitol in terms of the maximum

recommended daily dose (30 ml).

Patients with rare hereditary

fructose intolerance should not take this medication.

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

renal and / or hepatic failure.

Specifications

Category

Cough

,

Expectorants

Scope of the medicinal product

Ear, Throat, Nose

Release form

Syrup

Manufacturer country

Spain

Package quantity, pcs

one

Minimum age from

No restrictions

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Volume, ml.

100 ml

Brand name

Boehringer ingelheim

Components

measuring glass

The amount of the dosage form in the primary package

100 ml

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Expectorant mucolytic agent

Anatomical and therapeutic characteristics

R05CB06 Ambroxol

Dosage form

Syrup

Expiration date in days

1095

Dosage (volume) of the substance in the preparation

ambroxol hydrochloride 15 mg

The target audience

Children

Package weight, g

one hundred

Mode of application

:

Inside.

The drug is prescribed for adults and children over 12 years of age: 10 ml 3 times a day

children from 6 to 12 years old: 5 ml 2-3 times a day

children from 2 to 6 years old: 2.5 ml 3 times a day

children under 2 years old: 2.5 ml 2 times a day.

Lazolvan® in syrup can be used regardless of the meal.

Information on technical characteristics, delivery set, country of manufacture