Lazolvan - instructions for use, dose, side effects, contraindications

Tablet - round, white or slightly yellow tablets, flat on both sides, with beveled edges on one side - "67C" risk isolation and engraved, embossed on both sides of the dividing risks, on the other side of the tablet of the company symbol.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

In studies it is shown that ambroxol - Active ingredient in Mucosal^® - increases secretion in the respiratory tract. It increases the production of pulmonary surfactant and stimulates ciliary activity. These effects lead to increased current and transport of mucus (mucociliary clearance). Strengthening mucociliary clearance improves sputum discharge and facilitates coughing. In patients with chronic obstructive pulmonary disease, prolonged therapy with Lazolvan^®(for at least 2 months) led to a significant reduction in the number of exacerbations. There was a significant decrease in the duration of exacerbations and the number of days of antibiotic therapy.

Pharmacokinetics:

For all immediate-release ambroxol dosage forms, rapid and almost complete absorption with a linear dose dependence in the therapeutic range of concentrations. The maximum concentration in plasma (Cmah) with oral intake is achieved through 1 - 2,5 hours. The volume of distribution 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 oral dose taken is exposed to the effect of a primary pass through the liver. Studies on microsomes of the human liver showed that the isoenzyme CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol to dibromoanthranilic acid. The remainder of ambroxol is metabolized in the liver, mainly by glucuronidation and by partial cleavage to dibromantranilic acid (approximately 10% of the administered dose), as well as a small number of additional metabolites. The terminal half-life of ambroxol is 10 hours. The total clearance is within 660 ml / min, the renal clearance accounts for about 8% of the total clearance. With the radioactive label method, it was estimated that after taking a single dose of the drug for the next 5 days, about 83% of the dose taken is excreted in the urine.

There is no clinically significant effect of age and sex on the pharmacokinetics of ambroxol, so there is no reason to select a dosage for these features.

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.

Contraindications:

Hypersensitivity to ambroxol or other components of the drug, pregnancy (I trimester), lactation period, children under 6 years of age, lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Carefully:

Carefully Use Lazolvan® during pregnancy (II-III trimester), with kidney and / or liver failure.

Pregnancy and lactation:

Ambroxol penetrates the placental barrier. Preclinical studies showed no direct or indirect adverse effects on pregnancy, fetal / fetal, postnatal development, and on generic activities.

The extensive clinical experience of the use of ambroxol after the 28th week of pregnancy found no evidence of a negative effect of the drug on the fetus.

However, it is necessary to observe the usual precautions when using the medication during pregnancy.Especially it is not recommended to take Lazolvan in the first trimester of pregnancy. In the II and III trimesters of pregnancy, the drug can be used only if the potential benefit to the mother exceeds the potential risk to the fetus.

Ambroxol can be excreted in breast milk. Despite the fact that undesirable effects in children receiving breastfeeding were not observed, lazolvan syrup is not recommended during lactation. Preclinical studies of ambroxol showed no adverse effects on fertility.

Dosing and Administration:

Inside.

Children from 6 to 12 years: 15 mg (1/2 tablet) 2-3 times a day.

Adults and children over 12 years: 30 mg (1 tablet) 3 times a day.

If necessary, 60 mg (2 tablets) can be administered twice a day to enhance the therapeutic effect. The drug is taken with a liquid.

You can take the pill regardless of the meal.

If the symptoms persist for 4-5 days after the start of treatment, it is recommended that you consult a doctor.

Side effects:

Disorders from the gastrointestinal tract

Often (1,0 - 10,0%) - nausea, decreased sensitivity in the oral cavity or pharynx;

Infrequent (0,1 - 1,0%) - dyspepsia, vomiting, diarrhea, abdominal pain, dry mouth;

Rarely (0.01 - 0.1%) - dryness in the throat.

Disorders of the immune system, lesions of the rut and subcutaneous tissues

Rare (0.01 - 0.1%) - rash, hives; anaphylactic reactions (including anaphylactic shock) *, angioedema, * itching *, hypersensitivity *.

Disorders from the nervous system

Often (1,0 - 10,0%) - dysgeusia (a violation of taste sensations).

* - these adverse reactions were observed with a wide application of the drug; with 95% probability, the incidence of these adverse reactions is infrequent (0.1% -1.0%), but possibly lower; the exact frequency is difficult to assess, as they were not noted in clinical trials.

Overdose:

Specific symptoms of an overdose in humans are not described.

There are reports of accidental overdose and / or medical error, which resulted in symptoms of known side effects of Lazolvan: nausea, indigestion, diarrhea, vomiting, abdominal pain. In this case, the need for symptomatic therapy.

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

Interaction:

Clinically significant, undesirable interactions with other drugs have not been reported. Increases the penetration into the bronchial secret of amoxicillin, cefuroxime, erythromycin.

Special instructions:

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

One tablet contains 162.5 mg of lactose. The maximum daily dose (4 tablets) contains 650 mg of lactose.

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 designate mucolytic agents, such as ambroxol. There are isolated reports of the detection of 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 physician.

For children younger than 6 years, the use of other medicinal forms Lazolvan® (syrup 15 mg / ml, solution for ingestion and inhalation) is possible.

Effect on the ability to drive transp. cf. and fur:

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.

Form release / dosage:

Tablets 30 mg.

Packaging:

For 10 tablets in a contour mesh package (blister) of PVC / A1 foil. For 2 or 5 blisters with instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N014992 / 01

Date of registration:16.05.2008

The owner of the registration certificate:SANOFI RUSSIA, CJSCSANOFI RUSSIA, CJSC

Manufacturer: & nbsp

BOEHRINGER INGELHEIM ELLAS, A.E. Greece

Representation: & nbspSanofi Russia, JSCSanofi Russia, JSCRussia

Information update date: & nbsp09.02.2018

Illustrated instructions

Instructions

Lazolvan® (Lasolvan®)