Lazolvan Max - 10 capsules, ambroxol, means from cough with phlegm

Oblong hard gelatine capsules, consisting of a red opaque lid and an orange opaque body

on the lid there is a printed designation MUC 01" in white, on the body there is a symbol of Boehringer Ingelheim. Contents of the capsule: round, yellowish-white granules with a smooth, shiny surface, mixed with a small amount of powder.

Studies have shown that ambroxol, the active ingredient in Lazolvan® MAX, 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® MAX (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 immediate release ambroxol are characterized by rapid and almost complete absorption with a linear dose dependence in the therapeutic concentration range. The maximum plasma concentration (C max) when taking one prolonged-release capsule is achieved on average after 6.5 hours. The absolute bioavailability of Ambroxol 30 mg tablets is 79%. In the therapeutic range of concentrations, binding to blood plasma proteins is approximately 90%. Ambroxol 75 mg sustained-release capsules showed a relative bioavailability of 95% compared to 60 mg of ambroxol hydrochloride per day (30 mg twice daily) in tablet form (comparison was made after dose matching). The transition of ambroxol from blood to tissue with oral administration occurs quickly. The volume of distribution is 552 liters.

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.

Period

the terminal elimination half-life of ambroxol is about 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

Lasolvan

Clinical and pharmacological group

Mucolytic and expectorant drug

ATX code

R05CB06

Dosage

ambroxol hydrochloride 75 mg ambroxol hydrochloride 75 mg

Structure

1 capsule contains:

active substance - ambroxol hydrochloride 75 mg

excipients - crospovidone 12.55 mg, carnauba wax 18.31

mg, stearyl alcohol 110.94 mg, magnesium stearate 1.20 mg

composition of the capsule shell: gelatin 52.307 mg, purified water 9.135 mg, titanium

dioxide (E171) 1.008 mg, dye iron oxide red (E172) 0.150 mg, dye

iron oxide yellow (E172) 0.398 mg

ink composition: shellac, titanium dioxide.

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, children up to 6 years of age.

Lazolvan® syrup (30 mg / 5 ml) contains 5 g of sorbitol in terms of the maximum

recommended daily dose (20 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.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

Specifications

Category

Cough

,

Expectorants

Scope of the medicinal product

Ear, Throat, Nose

Release form

Capsules

Manufacturer country

Germany

Package quantity, pcs

ten

Scope of application

Virology

Minimum age from

18 years

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Boehringer ingelheim

The amount of the dosage form in the primary package

10 pieces.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Expectorant mucolytic agent

Anatomical and therapeutic characteristics

R05CB06 Ambroxol

Dosage form

Sustained-release capsules

Dosage (volume) of the substance in the preparation

In 1 caps .: Ambroxol hydrochloride 75 mg

Expiration date in days

1095

Package weight, g

ten

Mode of application

:

Inside.

1 capsule of prolonged action once a day.

Capsules should not be

open or chew.

Swallow whole with plenty of liquid.

"Remains of the capsule" that are sometimes present in the stool have already released active

substance while passing through the digestive tract, so they should not

attach importance.

The capsules can be used with or without food.

If the symptoms of the disease persist within 4-5 days from the start of admission

it is recommended to see a doctor.

Information on technical characteristics, delivery set, country of manufacture "