Lazolvan for inhalation inside a child. Name and address of the legal entity in whose name the registration certificate was issued

Lazolvan for inhalation, the instructions for use of which describe in detail its properties, is a high-quality German remedy. The effect of use is felt within half an hour after the procedure, and lasts - 10-12 hours.

Lazolvan (solution for oral administration and inhalation), the instructions for use of which recommend it for many diseases, is freely available in pharmacies. You can use it to treat yourself. However, if there is no improvement for 5 or more days, it is worth contacting a specialist for advice.

In contact with

Lazolvan for inhalation, instructions for use for which are contained in each package, is made using ambroxol. This main component has the following effect:

Secretory. It is a stimulation of contractions of the ciliated epithelium and peristalsis of the terminal branches of the bronchial tree. In parallel, there is an increase in the intensity of the secretion of the glands of the bronchi, it liquefies.
Leads to increased synthesis pulmonary surfactant. This material covers inner surface lung alveoli. Its presence determines the absence of their adhesion. The substance is synthesized from blood components.
Increases ciliary activity. Under the influence of ambroxol, the cilia lining the epithelium begin to move more actively. This helps clear mucus.

Thus, Lazolvan for inhalation, the instructions for use for which contain the full mechanism of action, accelerates mucociliary clearance. The result of this process is the removal of active biological agents. The remedy is recommended for pathologies of the respiratory organs, accompanied by the release of viscous sputum.

Instructions for use inhalation with Lazolvan and saline

For inhalation, pharmaceutical products, aromatic oils, extracts from plants are used. The procedure is special kind inhalation based therapy medicinal substances. To popular means applies Lazolvan - a solution for inhalation and oral administration.

Inhalations with Lazolvan are carried out according to the instructions for use in combination with saline in a nebulizer. For get well soon it is important to follow some guidelines.

Dosage for adults

To obtain a stable effect, it is necessary to make a course of procedures. The manufacturer stipulates in the instructions for use the following proportions for adults for inhalation with Lazolvan and saline:

optimally - 3-4 milliliters;
2-4 procedures must be done per day;
to achieve a therapeutic effect, combine with sodium chloride (0.9 percent concentration) in equal proportions.

Inhalations with Lazolvan and saline (dosage for adults is calculated for a day) are recommended to be done at a normal respiratory rate. The increased rhythm serves to increase the cough.

Proportions for children

Lazolvan for inhalation for children (instruction for use recommends it from the age of six) is used with sodium chloride at a concentration of 0.9 percent.

From the age of twelve, the dosage for children of inhalation with Lazolvan and saline increases to the amount required by an adult. Prior to this, the following proportions are recommended for children for inhalation with saline:

the daily amount of the drug - 2 ml or less;
given in equal proportions.

For inhalation in a nebulizer for children, the instructions for use recommend limiting themselves to 5–7 minutes of the procedure.

How to breed?

The components are mixed in equal amounts, but may vary as agreed with the doctor. In addition, it is important:

Inhalations with Lazolvan for children and adults are carried out with a warm liquid. According to the instructions for use, the solution should have a temperature of 20-30 degrees. Microwave use is not recommended. The best option- water bath.
Instructions for use are prohibited from combining with antitussive therapy. Inhalations with Lazolvan in this case can lead to bronchospasm.
In case of violations of the kidneys, the amount of the drug should be reduced. How to breed Lazolvan for inhalation in this case, you must check with your doctor. Certain patients will have to abandon such therapy completely.

How to do the procedure?

There are some rules to follow:

Use an inhaler. The most preferred inhalations with Lazolvan using a nebulizer.
Instructions for use for Lazolvan for inhalation advises not to carry out the procedure if the thermometer shows more than 37–37.5 degrees. The procedure should be postponed until the temperature normalizes.
Inhalation and exhalation is carried out freely, rhythmically, calmly. Clothing or posture should not restrict breathing.
Before the procedure, the patient must wash their hands.
Within an hour after the event, it is not recommended to eat, drink or smoke.
After each procedure, it is worth sterilizing the inhaler.
Therapy is carried out every 3-6 hours, not more often.

How to inhale with Lazolvan depends on the type of inhaler. Before the procedure, it is important to read the manufacturer's annotation. For inhalation by adults in a nebulizer, instructions for use for Lazolvan recommend a procedure duration of 7-15 minutes. Asthmatics should take a bronchodilator beforehand.

Can it be done without a nebulizer?

The nebulizer turns liquid into an aerosol without heating. This contributes to the fact that tiny drops of the drug reach hard-to-reach areas of the mucosa. Instructions for the use of Lazovlan for inhalation in a nebulizer recommend this particular method due to its undeniable advantages. In the absence of the device, it is possible to use other inhalers that exclude steam heating.

Can it be used for dry cough?

Dry cough is not accompanied by sputum and has a paroxysmal character. Inhalations with Lazolvan with a dry cough alleviate the symptom and help the discharge to go away faster.

The cough becomes wet, and with sputum the body gets rid of active biological components. Inhalations with Lazolvan and saline (the dosage for children and adults is indicated above) can and should be used with a similar phenomenon.

During pregnancy

It is worth familiarizing yourself with how to take Lazolvan (solution for oral and inhalation), what restrictions exist on its use. Reasons to be careful are gestation and lactation. Exactly:

For inhalation during pregnancy, the first 3 months is prohibited due to possible negative consequences for the growth and development of the fetus.
Inhalations with Lazolvan during pregnancy are subsequently carried out with extreme caution. There are no studies confirming the harmlessness to the embryo.

The dosage of Lazolvan for inhalation for women during breastfeeding can be changed by a specialist. If an individual intolerance occurs in a baby or mother, treatment should be interrupted.

What's better?

On the pharmacy shelves a large number of analogues. For right choice it is necessary to have an understanding of their advantages and disadvantages.

Ambrobene

Ambrobene is a product for oral consumption and use in a nebulizer manufactured by a German company. At its core, the remedy is an analogue of Lazolvan for inhalation. Both have similar features:

active component. Both drugs are based on the effect of ambroxol.
Dosage. The amount of active ingredient is identical for both preparations.
Features of use. Ambrobene should be diluted similarly to the instructions on how to dilute Lazolvan with saline for inhalation. First you need to heat the liquid to a warm state.

However, there are many differences, in particular:

minor components are different, but this does not play a significant role for the patient;
have different age restrictions (Ambrobene is prescribed from the age of 12, and from 6);
Abrobene leads to the development of a reflex cough, has a less mild effect;
Ambrobene can serve as a provoking factor for the development of bronchospasm;
the taste of Ambrobene is more bitter and unpleasant;
Ambrobene costs half as much, but has large quantity possible side effects.

In search of information on what is better for inhalation - Lazolvan or Ambrobene, the scales tend to the first. However, the treatment is determined by the doctor, based on the parameters of the patient.

Often, experts recommend Lazolvan and Berodual for inhalation. Second medicine manufactured in Germany. It is completely different in composition and effect produced. The tool is recommended for:

disease prevention and symptom mitigation;
treatment of chronic obstructive pulmonary disease;
treatment (with/without emphysema).

Berodual stops bronchospasm, positively affects the functioning of the lungs, and relaxes their muscles. It is recommended in the presence of an allergic component, in the treatment of pneumonia. Which is better for inhalation, Berodual or Lazolvan, is incorrect to say. These are complementary, but not interchangeable medicines.

With complex paroxysmal cough(for example, false croup) resort to inhalation Lazolvan with Berodual. The benefits of this combination include:

Lazolvan and Berodual for inhalation together have double effect. In particular, Berodual expands the bronchi.
To facilitate coughing, Lasolvan and Berodual for inhalation can be prescribed (Lazolvan promotes sputum discharge).

Berodual is a powerful therapy for damage to the respiratory system. Inhalation through a nebulizer with Lazolvan (the dosage for adults and children is calculated exclusively by the doctor) together with Berodual has a significant healing effect even in emergency situations.

The composition of the medicinal product

active substance: ambroxol hydrochloride;

1 tablet contains ambroxol hydrochloride 30 mg

Excipients: lactose monohydrate, corn starch silicon dioxide colloidal magnesium stearate.

Dosage form

Tablets.

Round, white or slightly yellowish tablets, flat on both sides, with beveled edges on one side of the tablet - a notch and marking "67 °" on both sides of the notch, on the other side of the tablet the brand name is forced out.

Name and location of the manufacturer. Boehringer Ingelheim Ellas AE, Greece / Boehringer Ingelheim Ellas AE, Greece. 5th km Paiania-Markopoulo, Koropi Attiki 19400, Greece.

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Pharmacological group

Medications used for coughs and colds. mucolytic agents.

ATC code R05C B06.

It has been preclinically proven that the active ingredient Lazolvan tablets, ambroxol hydrochloride, increases the secretion of glands. respiratory tract. Ambroxol enhances the secretion of pulmonary surfactant by direct action on type II pneumocytes in the alveoli and Clara cells in the bronchioles, and also stimulates ciliary activity, thereby facilitating the secretion of mucus and its removal (mucociliary clearance). Improvement in mucociliary has been proven during clinical and pharmacological studies.

Activation of fluid secretion and increased mucociliary clearance facilitate mucus clearance and relieve coughing.

The local anesthetic effect of ambroxol hydrochloride was observed in a rabbit eye model, which may be due to sodium channel blocking properties. Research in vitro showed that ambroxol hydrochloride blocks neuronal sodium channels; binding was reversible and concentration dependent.

Ambroxol hydrochloride has shown anti-inflammatory in vitro. Thus, ambroxol hydrochloride significantly reduces the release of cytokines from mononuclear and polymorphonuclear blood cells and tissues.

As a result clinical trials with the involvement of patients with pharyngitis, a significant reduction in pain and redness in the throat with the use of the drug has been proven.

Thanks to pharmacological property ambroxol rapidly alleviated pain in the treatment of upper respiratory diseases, observed in studies clinical efficacy inhaled forms of ambroxol.

The use of ambroxol hydrochloride increases the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin and doxycycline) in bronchopulmonary secretions and sputum.

Absorption. Absorption of ambroxol hydrochloride from oral immediate release formulations is rapid and complete, with linear dependence dose within the therapeutic range. Max level in blood plasma is achieved after 1-2.5 hours with oral administration of fast-release dosage forms and an average of 6.5 hours with the use of slow-release forms.

Distribution. When administered orally, the distribution of ambroxol hydrochloride from the blood to the tissues is fast and pronounced, with a high concentration of the active substance in the lungs. The expected volume of distribution after oral administration is 552 liters. In plasma, in the therapeutic dose range, approximately 90% of the drug binds to proteins.

Metabolism and excretion. Approximately 30% of the dose after oral administration is excreted by first pass metabolism. Ambroxol hydrochloride is metabolized in the liver by glucuronidation and cleavage to dibromanthranilic acid (approximately 10% of the dose). Studies in human liver microsomes have shown that CYP3A4 is responsible for the metabolism of ambroxol hydrochloride to dibromomanthranilic acid.

After 3 days of administration, about 6% of the dose is excreted in the urine unchanged, about 26% of the dose is excreted in conjugated form.

The plasma half-life is about 10:00. The total clearance is approximately 660 ml / min. Renal clearance is approximately 8% of the total. After 5 days, approximately 83% of the total dose is excreted in the urine.

Pharmacokinetics in special groups of patients. In patients with impaired liver function, the excretion of ambroxol hydrochloride is reduced, resulting in 1.3-2 times higher plasma levels. Since the therapeutic range of ambroxol hydrochloride is quite wide, there is no need to change the dosage.

Age and gender do not have a clinically significant effect on the pharmacokinetics of ambroxol hydrochloride, so any dose adjustment is not required.

Indications.

Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with impaired bronchial secretion and weakening the progress of mucus.

Contraindications.

Lazolvan should not be used in patients with hypersensitivity to ambroxol hydrochloride or other components of the drug.

Lazolvan 30 mg tablets is not intended for use in children under 6 years of age due to dosage. For children under 6 years of age, it is recommended to use Lazolvan, syrup 15 mg / 5 ml, or Lazolvan, solution for inhalation and oral administration, 15 mg / 2 ml.

Appropriate safety precautions for use

Only a few reports have been reported of severe GI skin lesions: Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome) associated with the use of expectorants such as ambroxol hydrochloride. Basically, they could be explained by the severity of the underlying disease in patients and the simultaneous use of another drug.

Also on initial stage Stevens-Johnson syndrome or Lyell's syndrome patients may have non-specific, flu-like symptoms such as fever, aches, rhinitis, cough, and sore throat. Mistakenly, with such non-specific, similar signs of the onset of influenza symptoms, symptomatic treatment with cough and cold drugs can be used. Therefore, if new lesions of the skin or mucous membranes appear, you should immediately seek medical advice. medical care and stop treatment with ambroxol hydrochloride.

Lazolvan tablets contain 684 mg of lactose in the maximum recommended daily dose (120 mg).

Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency, or malabsorption of glucose and galactose should not take this medicine.

Since Ambroxol may increase mucus secretion, Lazolvan tablets should be used with caution in cases of impaired bronchial motility and increased mucus secretion (for example, with this rare disease as primary ciliary dyskinesia).

Patients with impaired renal function or severe liver failure should take Lazolvan tablets only after consulting a doctor. When using Ambroxol, like any active substance that is metabolized in the liver and then excreted by the kidneys, there is an accumulation of metabolites formed in the liver in patients with severe renal insufficiency.

Use during pregnancy or lactation

Pregnancy. Ambroxol hydrochloride crosses the placental barrier. Animal studies have not revealed direct or indirect harmful effects on pregnancy, embryo/fetal development, parturition or postnatal development.

As a result clinical research the use of the drug after the 28th week of pregnancy, not a single harmful influence to the fruit.

However, it is necessary to observe the usual measures regarding the use of drugs during pregnancy. In particular, in the first trimester of pregnancy, it is not recommended to use Lazolvan tablets.

Breastfeeding. Ambroxol hydrochloride penetrates into breast milk. Lazolvan tablets are not recommended for use during breastfeeding.

Fertility. Preclinical studies do not indicate direct or indirect harmful effect for fertility.

The ability to influence the reaction rate when driving vehicles or operating other mechanisms

There is no data on the effect on the reaction rate when driving vehicles or operating other mechanisms. Relevant studies have not been conducted.

Children.

Applied to children over the age of 6 who cannot tolerate syrup or solution for inhalation and oral administration.

Method of application and dose.

children aged 6 to 12 as a rule, the dose is 1/2 tablet 2-3 times a day (equivalent to 30-45 mg ambroxol hydrochloride / day);

adults and children over 12 years old the usual dose is 1 tablet 3 times a day for the first 2-3 days (equivalent to 90 mg ambroxol hydrochloride/day). Continue treatment with 1 tablet 2 times a day (equivalent to 60 mg ambroxol hydrochloride/day).

If necessary therapeutic effect for adults and children over 12 years of age can be enhanced by the use of 2 tablets 2 times a day (equivalent to 120 mg ambroxol hydrochloride / day).

Tablets should be swallowed whole with enough fluids (such as water, tea, or fruit juice) after meals.

In general, there are no restrictions on the duration of use, but long-term therapy should be monitored.

Lazolvan tablets should not be used for longer than 4-5 days without consulting a doctor.

Overdose

To date, there are no reports of cases of overdose in humans. Symptoms known from rare reports of overdose and / or cases of erroneous use of drugs correspond to the known side effects of Lazolvan at recommended doses and require symptomatic treatment.

Update: October 2018

Solution for inhalation Lazolvan is a popular mucolytic drug that can also be taken orally. Therapy with Lazolvan softens dry cough, promotes productive sputum discharge, accelerates recovery in acute course bronchopulmonary diseases and shortens periods of exacerbation of chronic pathologies.

Farmgroup: Expectorant and mucolytic drug.

Composition, physical and chemical properties, price

Dosage form: solution intended for inhalation and internal use.
Base substance: 7.5 mg ambroxol hydrochloride;
Auxiliary components: 2 mg monohydrate citric acid, 4.35 mg sodium hydrophosphate dihydrate, 6.22 mg sodium chloride, 225 mcg benzalkonium chloride, 98.9705 gr. purified water.
Physiochemical properties: Clear solution, light brown or colorless, 100 ml.
Packing: tinted glass bottles with a polyethylene dropper and a measuring cup.
Price: 350-400 rubles.

pharmachologic effect

Ambroxol hydrochloride activates secretory function respiratory tract, increases the production of surfactant (a substance that lines the alveoli) and stimulates the mobility of cilia epithelial cells in the bronchi. These effects can significantly improve the flow and transport of mucus through the bronchi - sputum discharge improves and the cough becomes less painful and more productive.

In the course of long-term observations, it has been proven that long-term therapy with Lazolvan in patients with COPD leads to a decrease in the number of exacerbations, a decrease in the duration acute period and the use of antibiotics.

Pharmacokinetics

At internal application absorption is almost complete and differs in a linear dependence on the dose taken in the therapeutic concentration range. Active substance reaches its maximum concentration in the blood one and a half to two hours after ingestion. At the maximum concentration, it binds to plasma proteins by 90%. It quickly passes from the blood into tissues and is found in the highest concentration in the lung tissue.

A third of the dose taken is subject to the so-called primary passage through the liver tissue. The CYP3A4 isoform is involved in the metabolism of ambroxol hydrochloride to dibromanthranilic acid. Two-thirds of the dose taken is metabolized in the liver by partial cleavage to the metabolite of dibromanthranilic acid and by glucuronidation. The half-life of the body after 10 hours.

The total clearance is 660 ml / min. After taking a single dose, about 83% is excreted in the urine over the next 5 days. Gender and age do not affect the pharmacokinetics of the active substance.

Indications

Drops Lazolvan for inhalation and internal reception prescribed for chronic acute pathologies respiratory tract, which are accompanied by a cough with sputum difficult to separate:

bronchitis acute and chronic;
COPD;
pneumonia;
bronchial asthma;
bronchiectasis disease.

Contraindications

The drug should not be used in the following groups of patients:

with hypersensitivity to ambroxol and auxiliary components of the solution;
in the 1st trimester of pregnancy;
during lactation.

special instructions

It is used with caution in the 2-3 trimesters of pregnancy, as well as in liver and kidney failure. The preservative benzalconine chloride, which is contained in the solution, when inhaled, can lead to bronchospasm in patients with high airway reactivity - this should be taken into account during the procedure.

Influences on the reaction rate at internal and inhalation use Lazolvan was not noted.

Dosage

Inhalations

The instructions for use of Lazolvan for inhalation for children indicate the following scheme:

children under 6 l: 1-2 inhalations per day, for which 2 ml of solution is used;
children from 6 liters, as well as adults: 1-2 inhalations per day, for which 2-3 ml of solution is used.

Lazolvan is suitable for use for inhalation with any modern inhalers, except for steam ones. To obtain a working solution of Lazolvan for children for inhalation, the drug is mixed with 0.9% p-m sodium chloride in a ratio of one to one. In the same way, the drug is prepared for use by adults.

Inhalations are carried out in the mode of normal breathing, since deep breath may provoke a coughing fit. The solution (a mixture of saline and Lazolvan) should be slightly warmed up before inhalation. Patients who have bronchial asthma, inhalation should be carried out after taking bronchodilator drugs.

Internal reception

1 ml of Lazolvan's solution is 25 drops. The drug can be dissolved in water, juice, tea, milk and used regardless of the meal:

children under 2 l: 25 drops (equal to 1 ml) twice a day;
children 2-6 liters: 25 drops (equal to 1 ml) three times a day;
children 6-12 l: 50 drops (equal to 2 ml) three to two times a day;
children from 12 liters and adults: 100 drops (equal to 4 ml) three times a day.

If the symptoms persist for more than 4-5 days during the treatment with Lazolvan, the drug is canceled and a doctor is consulted.

Pregnancy, lactation period

The active substance penetrates well into the placental circulation. In the course of preclinical studies of direct or indirect negative influence on the course of pregnancy and fetal development has not been identified. In women who took Lazolvan after 23 weeks of pregnancy, no negative impact during pregnancy, childbirth and fetal development. Ambroxol is also excreted in mother's milk.

Like any other drug, Lazolvan is prescribed with caution both during pregnancy and during the entire period of breastfeeding.

Side effects

Often on the part of the gastrointestinal tract, nausea and a decrease in sensitivity in the pharynx and oral cavity are noted, less often - dry throat, vomiting, diarrhea and pain in the epigastric region. From the side nervous system dysgeusia is often noted, in which there is a violation taste sensations. allergic reactions can be expressed skin rash, itching, anaphylactic phenomena.

Overdose

drug interaction

No clinically significant adverse effect on the effectiveness of other drugs was noted. At simultaneous application with cefuroxime, amoxicillin and erythromycin, there is an increase in the effect of the latter due to better penetration into the bronchial secret.

Lazolvan should not be combined with antitussives that make it difficult to remove sputum.

Analogues

Solutions for inhalation with a similar composition:

Amprobene;
Ambroxol;
Ambrohexal;
Bronchorus.

Lazolvan is a "brand" German drug based on ambroxol, which is taken for infectious and inflammatory diseases of the respiratory tract to facilitate the evacuation of sputum. It has secretomotor (sputum removal), mucolytic (sputum thinning) and expectorant action. The success of lazolvan in the noble cause of clearing the branched "root system" of the bronchial tree from mucus is based on several of its qualitative functional characteristics. So, the drug induces the activity of serous bronchial cells, which produce not a viscous, but a liquid secret, which helps to remove sputum from the respiratory tract. At the same time, lazolvan increases mucus secretion and production of endogenous surfactant (a surfactant that performs protective functions and preventing the collapse of the pulmonary vesicles). At the same time, the action of lazolvan is aimed at normalizing the ratio of the serous and mucous components of sputum. The viscosity of the latter decreases due to the activation of hydrolyzing enzymes by lazolvan and stimulation of the release of lysosomes ( cell structures specialized in splitting various substances) from large neurons spinal cord- Clark cells. The secretomotor action of lazolvan is realized through the activation of cilia hairs of the ciliated epithelium and, accordingly, mucus transport (mucociliary clearance). The cough becomes productive and fully performs the function of clearing the airways of mucus.

This whole cascade of necessary and useful features Lazolvan begins to be implemented half an hour after taking it and retains its activity for 6-12 hours. The drug is available in four dosage forms: solution for oral or inhalation, lozenges, tablets and syrup. Read more about the dosing regimen of lazolvan depending on dosage form and age of the patient can be found in the instructions for use enclosed in the secondary packaging along with the drug. Doses of lazolvan for adult patients will also be given here. Oral solution is added to any drink (tea, coffee, milk, juice, water) 4 ml (100 drops) and drunk 3 times a day. The same solution, but for inhalation, should be dosed in 2-3 ml and do 1-2 similar procedures in a day. Pastilles are absorbed three times a day, two pieces at a time. Tablets should be taken at 30 mg 3 times a day (or, for the fastest achievement of clinical significant effect- 60 mg twice a day). The syrup is taken 2 teaspoons (10 ml) three times a day.

Lazolvan can also be used independently without a medical prescription (fortunately, the over-the-counter procedure for its implementation from pharmacies allows you to do this without problems), however, it is not recommended to take it for more than 4-5 days without control by a person in a white coat.

Pharmacology

Ambroxol is an active ingredient in Lazolvan. It has a secretomotor, secretolytic and expectorant action. It stimulates the 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 hydrolyzing enzymes and increasing the release of lysosomes from Clara cells, it reduces the viscosity of sputum. Ambroxol enhances the current and transport of mucus (mucociliary clearance). Increased mucociliary clearance improves sputum discharge and relieves cough.

Pharmacokinetics

Ambroxol is characterized by rapid and almost complete absorption with a linear dose dependence in the therapeutic concentration range. C max when taken orally is achieved after 1-2.5 hours. V d after oral administration is 552 liters. In the therapeutic concentration range, plasma protein binding is approximately 90%.

The transition of ambroxol from the blood to the tissues when administered orally occurs quickly. The highest concentrations active component the drug is observed in the lungs. Approximately 30% of an orally administered dose undergoes primary metabolism. Studies in human liver microsomes have shown that CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol to dibromanthranilic acid. The rest of ambroxol is metabolized in the liver, mainly by glucuronidation and by partial cleavage to dibromanthrapilic acid (approximately 10% of the administered dose), as well as a small number of additional metabolites. The terminal T 1/2 of ambroxol is 10 hours. The total clearance is within 660 ml / min, renal clearance accounts for approximately 8% of the total clearance.

There was no clinically significant effect of age and gender on the pharmacokinetics of ambroxol, so there is no reason for any change in dosage on these grounds.

In patients with liver failure the excretion of ambroxol is slowed down, which leads to an increase in the plasma level of ambroxol by 1.3-2 times. Due to the wide therapeutic range of ambroxol, dose reduction is not required.

Release form

Pastilles light brown, round, with the smell of peppermint.

Excipients: acacia gum * - 850 mg, sorbitol ** - 307.4 mg, carion 83 (sorbitol, mannitol, hydrolyzed hydrogenated starch) ** - 614.8 mg, peppermint leaf oil - 10 mg, eucalyptus rod-shaped leaf oil - 2 mg, sodium saccharinate - 1.8 mg, liquid paraffin (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.

* Amount indicated with reference to an average solids content of 85%.
** Amount indicated with reference to an average solids content of 70%.
*** Amount indicated with reference to the residual moisture content of the lozenge after drying.

Dosage

inside. The lozenges slowly dissolve in the mouth. Adults and children over 12 years old - 2 lozenges 3 times / day. Children 6-12 years old: 1 lozenge 2-3 times / day.

Pastilles can be used regardless of the meal. If the symptoms of the disease persist or worsen, you should consult a specialist.

Overdose

Specific symptoms of overdose in humans are not described. There are reports of accidental overdose and/or medical error, as a result of which symptoms of known side effects of the drug Lazolvan were observed,
such as nausea, diarrhea, heartburn, dyspepsia, vomiting, pain in the upper abdomen.

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

Interaction

No clinically significant, undesirable interactions with other medicinal products have been reported.

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

Side effects

Lazolvan is generally well tolerated.

From the gastrointestinal tract: often (1.6-10%) - nausea, decreased sensitivity in the mouth or esophagus; infrequently (0.1-1%) - heartburn, dyspepsia, vomiting, diarrhea, pain in the upper abdomen; dryness of the mucous membrane of the mouth and throat *.

Disorders immune system, lesions of the skin and subcutaneous tissues: rarely (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 (violation of taste sensations).

* only single reports of data are marked adverse reactions at wide application the drug, however, the relationship with taking the drug Lazolvan has not been proven; the frequency of these rare events is difficult to estimate.

Indications

Sharp and chronic diseases 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

pregnancy (I trimester);
lactation period;
children's age up to 6 years;
hypersensitivity to ambroxol or other components of the drug.

Pastilles Lazolvan (15 mg) contain 3.2 g of sorbitol in terms of the maximum recommended daily dose(90 mg). Patients with rare hereditary fructose intolerance should not take this drug.

Carefully: II-III trimesters pregnancy, renal and / or liver failure.

Application features

Use during pregnancy and lactation

Ambroxol crosses the placental barrier. In animal studies, no adverse effects on pregnancy, embryonic/fetal, postnatal development and childbirth have been identified. Extensive clinical experience the use of ambroxol after the 28th week of pregnancy indicates the absence of a negative effect
to the fruit. In the first trimester is contraindicated, use in the II and III trimesters pregnancy - with caution.

Ambroxol can be excreted from women's milk. Although unwanted effects in children receiving breastfeeding, were not observed during lactation, it is not recommended to use Lazolvan lozenges.

Application for violations of liver function

Carefully.

Application for violations of kidney function

Carefully.

Use in children

Contraindicated in children under 6 years of age.

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

special instructions

It should not be combined with antitussives that make it difficult to remove sputum.

Patients with severe skin lesions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may develop fever, body pain, rhinitis, cough, and sore throat in the early phase. At symptomatic treatment erroneous prescription of mucolytic agents such as ambroxol is possible. There are isolated reports of the detection of Stevens-Johnson syndrome and toxic epidermal necrolysis, coinciding in time with the appointment of the drug; however, there is no causal relationship with drug use.

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.

Influence on the ability to drive vehicles and control mechanisms

There were no cases of the effect of the drug 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 dangerous species activities requiring increased concentration attention and speed of psychomotor reactions were not carried out.

If the child has coughing, and sputum is separated with difficulty, drugs are used that belong to the group of mucolytics. Ambroxol preparations are very popular among them. One of them is a German medicine called Lazolvan, which is praised for its effective action at various diseases respiratory tract.

For childhood it comes in the form of a syrup to make it easy to swallow the medication. Is it possible to give such a syrup to infants, at what dose is it used in children, and with what analogues can it be replaced?

Release form

Syrup Lazolvan is an almost transparent and slightly viscous liquid that smells like wild berries or strawberries. Such a solution is almost colorless and is sold in 100 and 200 ml bottles. In each cardboard box, a 5 ml measuring cup is attached to a glass bottle in order to accurately measure the desired dose of the drug.

In addition to syrup, Lasolvan is also produced in other forms: a solution with which inhalations are made (this drug can also be taken orally), lozenges, tablets and long-acting capsules (they are called Lasolvan Max). The nasal spray Lazolvan Rino is separately produced, but it has a different active substance.

Compound

The main component of Lazolvan, thanks to which the syrup has therapeutic effect, ambroxol acts. This substance in the form of hydrochloride is contained in 5 milliliters of the drug at a dose of 15 mg or 30 mg. Additionally, the drug includes benzoic acid, purified water, gietellose, glycerol, liquid sorbitol and acesulfame potassium.

For a pleasant aroma, the formulation with a lower dose contains wild berry and vanilla flavors, while the higher concentration formulation contains vanilla and creamy strawberry flavors.

Operating principle

Ambroxol has a mucolytic effect, since this substance stimulates the formation of enzymes that affect the viscosity of mucus produced in the bronchi. The drug activates the secretory function of the cells of the mucous membrane of the respiratory tract, resulting in an increase in sputum volume. In addition, ambroxol affects the production of surfactant and increases the activity of the ciliated epithelium.

The result of this action is an easier expectoration of sputum and the transformation of dry unproductive cough into wet.

Absorption of ambroxol from oral syrup is very fast. 1.5-2 hours after ingestion, its concentration in the blood becomes maximum, after which the active substance passes into the tissues (mainly in the lung tissue). The effect of the drug becomes noticeable 30 minutes after ingestion and lasts up to 10 hours.

Indications

Lazolvan is used for those pathologies respiratory system, a symptom of which is the formation of very viscous sputum.

The medicine is in demand

With pneumonia.
At acute inflammation bronchi.
With bronchial asthma.
With bronchiectasis.
With chronic bronchitis.
With other chronic pulmonary pathologies.

At what age are they prescribed?

Lasolvan in the form of a syrup, from 5 milliliters of which the patient receives 15 mg of ambroxol, is allowed for children of any age. At the same time, it is prescribed to children of the first year of life in a limited way, since coughing up a large amount of sputum in infants is difficult. The drug, in which the active substance is represented by a dosage of 30 mg / 5 ml, is contraindicated up to 6 years.

Contraindications

Lazolvan syrup should not be given to children with intolerance to ambroxol or any other component of the drug. The drug is also contraindicated in hereditary fructose intolerance. For adults, the drug is not prescribed during pregnancy (in the first trimester) and breastfeeding. If a child has a liver or kidney failure, give the syrup should be with extreme caution.

Side effects

Taking Lazolvan can cause nausea, change in taste, thinning of the stool, drying out of the oral mucosa, allergic rash, liquefaction of the stool, vomiting and other negative symptoms. If they appear in a child during treatment, you should immediately consult a doctor.

Instructions for use

The syrup is taken orally, regardless of the diet. The medication is dosed with a measuring cup and, if necessary, washed down with water.

The dosage of the drug depends on age:

Child under 2 years old give a medicine with a concentration of 15 mg / 5 ml twice a day, 2.5 ml each.
Children 2-6 years old a medication is also prescribed containing 15 mg of the active compound in 5 ml. At this age, a single dose is also 2.5 ml, but the remedy is taken three times.
Child 6-12 years old you can give both a syrup with a concentration of ambroxol 15 mg / 5 ml (this drug is taken in 5 ml) and a medicine with an active ingredient content of 30 mg / 5 ml (such a syrup is given in 2.5 ml per dose). The drug is taken twice a day, but sometimes the doctor prescribes a triple dose.
Teenagers 12 years old and older Lazolvan in the form of a syrup is given three times a day, 5 ml each (if it is a drug with a concentration of 30 mg / 5 ml) or 10 ml each (if a drug with more than low content ambroxol).

The duration of treatment with syrup is determined for each small patient separately, since it depends both on the diagnosis and on the response of the child's body to therapy. If after 4-5 days from the start of treatment with Lazolvan the course of the disease remains unchanged, you should consult a doctor.

Overdose

Accidentally overdose of syrup leads to nausea, abdominal pain, diarrhea and other signs of dyspepsia. If an overdose is detected immediately, you should wash the stomach, and then call a doctor. If the syrup in a too high dose was taken more than 2 hours ago, you need to focus on the child's well-being and, if it worsens, consult a doctor for symptomatic treatment.

Interaction with other drugs

Lazolvan in syrup should not be combined with antitussive drugs, because due to oppression cough reflex mucus cannot be expelled from the respiratory tract normally.
Studies have shown that treatment with Lazolvan contributes to the entry into the secretion of the bronchi of some antibacterial agents such as cefuroxime and amoxicillin.

Terms of sale

To buy Lazolvan in the form of a syrup, it is not necessary to obtain a prescription from a doctor, but a pediatrician's consultation when treating a child with this remedy is desirable. For 100 ml of syrup containing ambroxol at a dose of 15 mg / 5 ml, you need to pay about 200-220 rubles. average price a bottle with 100 ml of a drug with a higher concentration of the active ingredient (30 mg) is 260-280 rubles.

Storage conditions and shelf life

Keep the syrup at home in a place hidden from small children, where the temperature will not exceed +25 degrees. To medicinal properties the drug has not changed, such a place should be protected from moisture and sunlight. The shelf life of this form of Lazolvan is 3 years.

Reviews

Most of reviews of parents about the treatment of their children with Lazolvan syrup are positive. According to the mothers, the drug begins to act very quickly and brings relief both with a dry cough and with a wet one. The use of such a medicine accelerates the excretion of sputum and contributes to a faster recovery from any pulmonary pathologies.

The sweet taste of the drug is liked by most babies and only occasionally causes a protest in a sick child. The advantages of the drug are also called ease of dosing and long shelf life.

The syrup is tolerated, as noted by mothers, mostly well. Any side effects from taking such a remedy are rarely detected, although occasionally they occur. As for the shortcomings, parents often complain about the high cost of Lazolvan, which is why they often choose the more affordable drug Ambroxol.

Analogues

Any other drug containing the same active compound is capable of replacing Lazolvan syrup. The range of such funds is quite large and includes such drugs:

AmbroGEXAL

Flavamed

Such a medication is produced in Germany in tablet form and in solution.