Лазолван®

General characteristics. Structure:

Active ingredient: 30 mg of Ambroxol of a hydrochloride.

Excipients - lactose, starch the corn dried-up, colloid silicon, magnesium stearate.

Pharmacological properties:

Pharmacodynamics. In researches it is shown that Ambroxol - active ingredient of Lazolvan - 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. At patients with a chronic obstructive pulmonary disease long therapy by Lzzolvan (for not less than 2 months) led to considerable decrease in number of aggravations reliable reduction of duration of aggravations and number of days of an antibioticotherapia Was noted. 

Pharmacokinetics. Bystry and almost full absorption with linear dependence on a dose in a therapeutic interval of concentration is characteristic of all dosage forms of Ambroxol of immediate release the Maximum concentration in plasma (Cmax) at oral administration is reached in 1 - 2.5 hour. Absolute bioavailability of tablets Lazolvan of 30 mg makes 79%.

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 accepted peroral dose are exposed to effect of primary passing through a liver. Researches on microsomes of a liver of the person showed that the isoenzyme of CYP3A4 is prevailing from Faure mine, responsible for metabolism of Ambroxol to dibromantranilovy acid. The rest of Ambroxol is metabolized and 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 period terminal to a floor you maintaining Ambroxol makes about 10 hours.

The general clearance is in limits of 660 ml/min., about 83% of the general clearance are the share of renal clearance clinically significant influence of age and a floor on Ambroxol pharmacokinetics 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. On 30 mg (1 tablet) 3 times a day. If necessary for strengthening of therapeutic effect it is possible to appoint 60 mg (2 tablets) 2 times a day. Drug is accepted, washing down with liquid. It is possible to take a pill 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:

It is not necessary to combine with the antibechics complicating removal of a phlegm. One tablet contains 162,5 mg of lactose. The maximum daily dose (4 tablets) contains 650 mg of lactose.

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 mucolytic means, such as Ambroxol. There are single messages on identification of a syndrome of Stephens-Johnson and a toxic epidermal necrolysis which matched on time about 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. For children 18 years perhaps use of other dosage forms of Lazolvan are younger (syrup, pastils, solution for intake and inhalations).

Use at pregnancy and during breastfeeding. Ambroxol gets through a placental barrier. Preclinical trials did not reveal direct or indirect adverse impact on pregnancy, embryonic/fetalis, post-natal development and on patrimonial activity. Extensive clinical experience of use of Ambroxol after the 28th week of pregnancy did not find the evidence of negative influence of drug on a fruit. Nevertheless it is necessary to observe usual precautionary measures when using medicine during pregnancy. Especially Lazolvan in the I trimester of pregnancy In II and III trimesters of pregnancy is not recommended to accept drug use perhaps only if the potential advantage for mother exceeds potential risk for a fruit.

Ambroxol can be excreted with breast milk. In spite of the fact 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 tablets. Preclinical trials of Ambroxol did not reveal negative impact on fertility.

Side effects:

Disturbances from digestive tract. Often (1,0 - 10,0%) - nausea; infrequently (0,1 - 1,0%) - dyspepsia, vomiting, diarrhea, abdominal pain.

Frustration of immune system, damage of skin and hypodermic fabrics. Seldom (0,01 - 0.1%) - rash, urticaria; a Quincke's disease *, anaphylactic reactions (including an acute anaphylaxis) *, an itch *, hypersensitivity *

* these side reactions were observed at broad use of drug; from 95% probability the frequency of these side reactions - infrequently (0,1%-1,0%), but is possible below; it is difficult to estimate exact frequency. as they were not noted at conduct of clinical trials.

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, children's age up to 18 years, deficit of lactase, a lactose intolerance, glyukozo-galaktozny malabsorption. 

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, dyspepsia, vomiting, abdominal pain. 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 tablets at a temperature not above 30 °C. A period of validity - 5 years. To store in the place, unavailable to children. Not to use after the period of validity specified on packaging.

Issue conditions:

Without recipe

Packaging:

Tablets of 30 mg in packagings on 20 and 50 pieces; on 10 pieces in the blister, 2 or 5 blisters in a cardboard pack with the application instruction.