Лазолван®

General characteristics. Structure:

Active ingredient: 15 mg of Ambroxol of a hydrochloride in 5 ml of syrup.

Excipients - hydroxyethylcellulose, sorbitol, глицерол, the benzoic acid, propylene glycol, crimson fragrance, the tartaric acid, water purified.

Pharmacological properties:

Pharmacodynamics. In researches it is shown that Ambroxol - active ingredient of Laeolvan - increases secretion in respiratory tracts. It strengthens products of pulmonary surfactant and stimulates tsiliarny activity. These effects lead to strengthening of current and transport of slime (mukotsiliarny clearance). Strengthening of mukotsiliarny clearance improves otkhozhdeny phlegms and facilitates cough.

Pharmacokinetics. Bystry and almost full absorption with linear dependence on a dose in a therapeutic interval of concentration is characteristic of Ambroxol. The maximum content in plasma at oral administration is reached in 1 - 2,5 hour. The volume of distribution makes 552 l. In a therapeutic interval of concentration linkng with proteins of plasma makes about 90%. Transition of Ambroxol in fabric at oral administration comes from blood quickly. The highest concentration of active component of drug are observed in lungs.

About 30% of the entered peroral dose are exposed to effect of primary passing through a liver. Researches on microsomes of a liver of the person showed that CYP3A4 is the prevailing isoform responsible for metabolism of Ambroxol to dibromantranilovy acid. The rest of Ambroxol is metabolized in a liver, mainly, by a glyukuronidation and by partial splitting to dibromantranilovy acid (about 10% of the entered dose), and also a small amount of additional metabolites the Terminal elimination half-life of Ambroxol makes 10 hours.

The general clearance is in limits of 660 ml/min., about 8% of the general clearance are the share of renal clearance. Clinically significant influence of age and a floor on фа a rma to Ambroxol kinetics therefore there are no bases for selection of a dosage for these signs is not revealed.

Indications to use:

Acute and chronic respiratory diseases with allocation of a viscous phlegm: acute and chronic bronchitis, pneumonia, a chronic obstructive pulmonary disease, bronchial asthma with difficulty of an otkhozhdeniye of a phlegm, a bronchoectatic disease.

Route of administration and doses:

Inside. Drug is appointed to adults and children 12 years are more senior: on 10 ml 3 times a day;

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

- to children from 2 to 6 years: on 2,5 ml 3 times a day:

- to children up to 2 years: on 2,5 ml 2 times a day.

Lazolvan in syrup it is possible to apply irrespective of meal. In case of preservation of symptoms of a disease within 4-5 days from the beginning of reception it is recommended to see a doctor.

Features of use:

Pregnancy and period of a lactation. Ambroxol gets through a placental barrier. Experiments on animals did not reveal direct or indirect adverse impact on pregnancy, embryonic, prenatal and post-natal development and on childbirth. Comprehensive clinical trials after the 28th week of pregnancy did not find the evidence of otritsatepny influence of drug on a fruit. Nevertheless, it is necessary to observe usual precautionary measures when using medicine during pregnancy. Especially Lazolvan in the first trimester of pregnancy is not recommended to accept. Ambroxol can be excreted with women's milk. Despite the fact that. that undesirable effects at the children receiving feeding by a breast were not observed, in the period of a lactation Lazolvan is not recommended to use syrup.

It is not necessary to combine with the antibechics complicating removal of a phlegm. The sorbitol which is a part of syrup can render easy laxative effect. Patients with severe defeats have skin - Stephens-Johnson's syndrome or a toxic epidermal necrolysis - in an early phase temperature, body pain, rhinitis, cough and an inflammation of a throat can appear. At a symptomatic treatment perhaps wrong purpose of mukholitichesky means, such as Ambroxol a hydrochloride there are single messages on identification of a syndrome of Stephens-Johnson and a toxic epidermal necrolysis which matched on time purpose of drug: however relationship of cause and effect with administration of drug is absent. At development of above-mentioned syndromes it is recommended to stop treatment and to ask immediately for medical care.

At a renal failure Lazolvan it is necessary to apply only according to the recommendation of the doctor.

Influence of drug on ability to manage vehicles and mechanisms. Cases of influence of drug on ability to manage vehicles and mechanisms were not revealed. Researches on influence of drug on ability to manage vehicles and to be engaged in other potentially dangerous types of activity demanding the increased concentration vnimaniya1 and speed of psychomotor reactions were not conducted.

Side effects:

Disturbances from digestive tract Often (1,0 - 10,0%) - nausea; Infrequently (0,1 - 1,0%) - heartburn, dyspepsia, vomiting, diarrhea, pains in an upper part of a stomach; dryness in a mouth and in a throat *, decrease in sensitivity in an oral cavity or глотки*.

Frustration of immune system, damage of skin and hypodermic fabrics.  Seldom (0,01 - 0,1%) - skin rash, a small tortoiseshell, anaphylactic reactions (including an acute anaphylaxis) *, a Quincke's disease *, an itch * and others allergic реакции*.

Frustration from a nervous system. Dysgeusia * (disturbance of flavoring feelings).

Interaction with other medicines:

About clinically significant, undesirable interactions with other medicines it was not reported. Increases penetration into a bronchial secret of amoxicillin, a tsefuroksim, erythromycin.

Contraindications:

Hypersensitivity to Ambroxol or other components of drug, pregnancy (the I trimester), the lactation period.

Syrup Lzeolvan (15 mg / 5 ml) contains 10.5 g of sorbitol in terms of the maximum recommended daily dose (30 ml) Patients with rare hereditary intolerance of fructose should not accept this drug.

With care to apply Lazolvan during pregnancy (the II-III trimester), at a renal and/or liver failure.

Overdose:

Specific symptoms of overdose at the person are not described. There are messages on accidental overdose and/or a medical mistake as a result of which symptoms of the known side effects of drug Lazolvan were observed: nausea, heartburn, dyspepsia, vomiting, pains in an upper part of a stomach. At the same time need for symptomatic therapy is possible.

Treatment: artificial vomiting, a gastric lavage in the first 1 - 2 hour after administration of drug: symptomatic therapy.

Storage conditions:

To store at a temperature not above 30 °C. To store in the place, unavailable to children. Period of validity 3 years.

Issue conditions:

Without recipe

Packaging:

Syrup of 15 mg / 5мл. On 100 ml in glass bottles of amber or brown glass with the screwed cap from polyethylene or aluminum with control of the first opening. The bottle is placed in a cardboard pack together with the instruction on use and a measured glass