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

Excipients - acacia gum¹⁾ 850 mg, sorbitol²⁾ 307.4 mg, carión 83 [sorbitol, mannitol, hydrolyzed hydrogenated starch]²⁾ 614.8 mg, peppermint leaves 10 mg butter, eucalyptus leaflet oil 2 mg, sodium saccharinate 1.8 mg, paraffin liquid (purified mixture of liquid saturated hydrocarbons) 2.4 mg, purified water³⁾ 196.6 mg.

¹⁾ The amount is indicated with reference to an average solids content of 85%

²⁾ The amount is indicated with reference to the average solids content 70 %

³⁾ The amount is indicated with reference to the residual moisture content in the lozenge after drying

Description:Round pastilles are light-brown in color and smell of peppermint.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

In studies it is shown that ambroxol - active ingredient of Lazolvan - 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) resulted in a significant reduction in the number of exacerbations. There was a significant decrease in the duration of exacerbations and the number of days antibiotherapy.

Pharmacokinetics:

For all immediate-release ambroxol dosage forms, rapid and almost complete absorption with a linear dose-response in the therapeutic range of concentrations is characteristic. The maximum concentration in plasma (Cmah) with oral intake is achieved after 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 primary transmission through 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 rest of the ambroxol is metabolized in the liver, mainly by glucuronidation and by partial cleavage to dibromantranilic acid (approximately K)% 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 approximately 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 was no clinically significant effect of age and ion on the pharmacokinetics of ambroxol, so there is no reason to choose a dosage but these characteristics.

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, bronchoectatic disease.

Contraindications:

Hypersensitivity to ambroxol or other components of the drug, pregnancy (I trimester), lactation, children under 6 years. One Lazolvan lozenge contains 366 mg of sorbitol. The maximum recommended daily dose (120 mg) contains 2.9 g of sorbitol. Patients with rare hereditary intolerance fructose should not take this drug.

Carefully:II-III trimesters of pregnancy, renal and / or hepatic insufficiency.

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, the usual precautionary measures should be followed 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® lozenges are not recommended during lactation. Preclinical studies of ambroxol showed no adverse effects on fertility.

Dosing and Administration:

Inside. The lozenges slowly dissolve in the mouth.

Adults and children over 12 years of age: 30 mg (2 lozenges) 3 times a day.

If necessary, to increase the therapeutic effect, you can appoint 30 mg (2 lozenges) 4 times a day.

Children 6-12 years old: 1 lozenges 2 - 3 times a day.

Pastilles can be used regardless of the intake of food. If symptoms persist or worsen, please contact a specialist.

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.

Immune system disorders, skin and subcutaneous tissue damage

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 less frequently; the exact frequency is difficult to assess, since they were not noted during 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, dyspepsia, 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. Ambroxol increases penetration into the bronchial secret of amoxicillin, cefuroxime, erythromycin.

Special instructions:

Do not combine with antitussive agents. hampering the excretion of phlegm.

There are isolated reports of severe skin lesions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, coinciding with the appointment of expectorants such as ambroxol hydrochloride. In most cases, they can be explained by the severity of the underlying disease and / or concomitant therapy.

Patients with Stevens-Johnson syndrome or toxic epidermal necrolysis in the early phase may experience fever, body pain, rhinitis, cough and a sore throat. With symptomatic treatment, it is possible to erroneously prescribe anti-cold remedies.When new lesions of the skin and mucous membranes appear, it is recommended to stop ambroxol treatment and immediately seek medical help.

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

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:

Lozenges 15 mg.

Packaging:

For 10 pastilles in a blister of PVC / A1-foil. For 1, 2 or 4 blisters with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:Without recipe

Registration number:LP-001073

Date of registration:27.10.2011 / 03.08.2017

Expiration Date:Unlimited

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

Manufacturer: & nbsp

BOLDER ARZNEIMITTEL, GmbH & Co. KG. KG Germany

Representation: & nbspSanofi Russia, JSCSanofi Russia, JSCRussia

Information update date: & nbsp09.02.2018

Illustrated instructions

Instructions

Lazolvan® (Lasolvan®)