Universal reference book for medicines
Product name: LAZOLVAN ® (LASOLVAN ® )

Active substance: ambroxol

Type: Mucolytic and expectorant

Manufacturer: BOEHRINGER INGELHEIM INTERNATIONAL (Germany) manufactured and packaged BOLDER ARZNEIMITTEL (Germany), issuing quality control BOEHRINGER INGELHEIM PHARMA (Germany)
? Pastilles are light brown in color, round, with the smell of peppermint.
1 loaf

Ambroxol hydrochloride 15 mg

Auxiliary substances: acacia gum * - 850 mg, sorbitol ** - 370.4 mg, caryon 83 (sorbitol, mannitol, hydrolyzed hydrogenated starch) ** - 614.8 mg, peppermint leaf oil - 10 mg, leafy eucalyptus leaf oil - 2 mg, sodium saccharinate - 1.8 mg, paraffin liquid (purified mixture of liquid saturated hydrocarbons) - 2.4 mg, purified water *** - 196.6 mg.

10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (4) - packs of cardboard.
* the amount is indicated with reference to the average solids content of 85%

** the amount is indicated with reference to the average solids content of 70%

*** the amount is indicated with reference to the residual moisture content in the lozenge after drying



INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Ambroxol is an active ingredient of Lazolvan.
Has a secreto-motor, secretolitic and expectorant action. It stimulates serous cells of the glands of the bronchial mucosa.Ambroxol enhances the production of pulmonary surfactant, stimulates ciliary activity and normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolysing enzymes and enhancing the release of lysosomes from Clara cells, it reduces the viscosity of sputum. Ambroxol increases the current and transport of mucus (mucociliary clearance). Strengthening mucociliary clearance improves sputum discharge and facilitates coughing.
PHARMACOKINETICS

Ambroxol is characterized by rapid and almost complete absorption with a linear dose dependence in the therapeutic range of concentrations.
C max for oral administration is achieved after 1-2.5 hours. V d after oral administration is 552 liters. In the therapeutic concentration range, binding to plasma proteins is approximately 90%.
The transfer of ambroxol from the blood to the tissue with oral administration occurs rapidly.
The highest concentrations of the active component of the drug are observed in the lungs. Approximately 30% of the orally administered dose is subjected to primary metabolism. Studies on human liver microsomes showed that CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol to dibromoanthranilic acid. The rest of the ambroxol is metabolized in the liver, mainly by glucuronidation and by partial digestion to dibromantropyl acid (approximately 10% of the administered dose), as well as a small number of additional metabolites. The terminal T 1/2 ambroxol is 10 hours. The total clearance is within 660 ml / min, the renal clearance accounts for approximately 8% of the total clearance.
There is no clinically significant effect of age and sex on the pharmacokinetics of ambroxol, so there is no reason for any dosage change in these features.

In patients with hepatic insufficiency, excretion of ambroxol is slowed, which leads to an increase in the level of ambroxol in plasma by a factor of 1.3-2.
Due to the wide therapeutic range of ambroxol, a dose reduction is not required.
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 of sputum discharge;

bronchoectatic disease.

DOSING MODE

Inside.
The lozenges slowly dissolve in the mouth. Adults and children over 12 years - 2 lozenges 3 times / day. Children 6-12 years: 1 lozenge 2-3 times / day.
Pastilles can be used regardless of food intake.
If symptoms persist or worsen, please contact a specialist.
SIDE EFFECT

Lazolvan, as a rule, is well tolerated.

From the GI tract: often (1.6-10%) - nausea, decreased sensitivity in the oral cavity or esophagus;
infrequently (0.1-1%) - heartburn, indigestion, vomiting, diarrhea, pain in the upper abdomen; dryness of the mucous membrane of the mouth and throat.
Immune system disorders, skin and subcutaneous tissue damage: seldom (0.01-0.1%) - rash, urticaria;
angioedema, anaphylactic reactions (including anaphylactic shock) *, itching * and other allergic reactions *.
Disorders from the nervous system: often (1-10%) - dysgeusia (a violation of taste sensations).

* Only isolated reports of these adverse reactions were noted with a wide application of the drug, but the association with the use of Lazolvan was not proven;
the frequency of these rare phenomena is difficult to assess.
CONTRAINDICATIONS

- Pregnancy (I trimester);

- lactation period;

- children's age till 6 years;

- Hypersensitivity to ambroxol or other components of the drug.

Lazolvan lozenges (15 mg) contain 3.2 g of sorbitol in terms of the maximum recommended daily dose (90 mg).
Patients with a rare hereditary intolerance to fructose should not take this drug.
With caution: II-III trimesters of pregnancy, renal and / or hepatic insufficiency.

PREGNANCY AND LACTATION

Ambroxol penetrates the placental barrier.
In animal studies, there was no adverse effect on pregnancy, embryonic / fetal, postnatal development, and delivery. The extensive clinical experience of using ambroxol after the 28th week of pregnancy indicates that there is no adverse effect
to the fetus.
In the first trimester contraindicated, use in the II and III trimesters of pregnancy - with caution.
Ambroxol can excrete with human milk.
Despite the fact that undesirable effects in children receiving breastfeeding were not observed, it is not recommended to use Lazolvan lozenges during lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER

Carefully.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Carefully.

APPLICATION FOR CHILDREN

Contraindicated in children under 6 years.

Children 6-12 years: 1 lozenge 2-3 times / day.

SPECIAL INSTRUCTIONS

Do not combine with antitussive drugs that make it difficult to withdraw phlegm.

In patients with severe skin lesions - Stevens-Johnson syndrome or toxic epidermal necrolysis - temperature, body pain, rhinitis, cough and sore throat may appear in the early phase.
With symptomatic treatment, it is possible to erroneously administer mucolytic agents, such as ambroxol. There are isolated reports of detection, Stevens-Johnson syndrome and toxic epidermal necrolysis, coinciding with the appointment of the drug; but there is no causal relationship with taking the drug.
With the development of the above syndromes, it is recommended to stop treatment and immediately seek medical help.

In case of impaired renal function, Lazolvan should be used only on the advice of a doctor.

Impact on the ability to drive vehicles and manage mechanisms

There were no cases of drug effects on the ability to drive vehicles and mechanisms.
Studies on the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions have not been carried out.
OVERDOSE

Specific symptoms of an overdose in humans are not described.
There are reports of a random overdose and / or medical error that resulted in symptoms of known side effects of Lazolvan,
such as nausea, diarrhea, heartburn, indigestion, vomiting, pain in the upper abdomen.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug, symptomatic therapy.

DRUG INTERACTION

Clinically significant, undesirable interactions with other drugs have not been reported.

Ambroxol increases penetration into the bronchial secret of amoxicillin, cefuroxime, erythromycin.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

Store at a temperature not exceeding 30 ° C.
Keep out of the reach of children. Shelf life - 3 years.
The information is provided for your information, do not self-medicate, it is dangerous for your health.

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