Lazolvan solution for inhalation, dosage. Proper safety precautions for use

385 rub. Instructions for use:

Registration number:

P N016159/01

Trade name of the drug:

LAZOLVAN

International nonproprietary name:

ambroxol

Dosage form:

solution for oral administration and inhalation

Compound:

1 ml of solution contains:
active substance:
ambroxol hydrochloride 7.5 mg
Excipients: citric acid monohydrate 2 mg, sodium hydrogen phosphate dihydrate 4.35 mg, sodium chloride 6.22 mg, benzalkonium chloride 225 mcg, purified water 98.9705 g.

Description:

Clear, colorless or slightly brownish solution

Pharmacotherapeutic group:

Expectorant, mucolytic agent

ATX Code:

R05CB06

Pharmacological properties

Studies have shown that ambroxol, the active ingredient in Lazolvan, increases secretion in the inhalation tract. It enhances the production of pulmonary surfactant and stimulates ciliary activity. These effects lead to increased mucus flow and transport (mucociliary clearance). Increasing mucociliary clearance improves sputum discharge and relieves cough.

In patients with chronic obstructive pulmonary disease, long-term 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

All immediate-release dosage forms of ambroxol are characterized by rapid and almost complete absorption with a linear dose dependence in the therapeutic concentration range. The maximum plasma concentration (Cmax) after oral administration 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 transition of ambroxol from the blood to tissues when administered orally occurs quickly. The highest concentrations of the active component of the drug are observed in the lungs. Approximately 30% of an oral dose is subject to first pass effects through the liver. Studies on human liver microsomes have shown that CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol to dibromoantranilic acid. The remainder of ambroxol is metabolized in the liver. mainly by glucuronidation and by partial degradation to dibromanthranilic acid (approximately 10% of the administered dose), as well as a small number of additional metabolites. The terminal half-life of ambroxol is about 10 hours. The total clearance is within 660 ml/min, renal clearance accounts for approximately 83% of the total clearance.

No clinically significant effect of age and gender on the pharmacokinetics of ambroxol was found, so there is no basis for selecting the dosage based on these characteristics.

Indications for use

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 (first trimester), lactation period.

Use with caution

Lazolvan during pregnancy (II-III trimester), with renal and/or liver failure.

Use during pregnancy and breastfeeding

Ambroxol penetrates the placental barrier. Preclinical studies have not revealed direct or indirect adverse effects on pregnancy, embryonic/fetal, postnatal development and labor. Extensive clinical experience with the use of ambroxol after the 28th week of pregnancy has found no evidence of a negative effect of the drug on the fetus.

However, normal precautions must be taken when using the medicine during pregnancy. It is especially not recommended to take Lazolvan during the first trimester of pregnancy. In the 1st and 3rd trimesters of pregnancy, the use of the drug is possible only if the potential benefit to the mother outweighs the potential risk to the fetus.

Ambroxol can be excreted in breast milk. Despite. Since no undesirable effects were observed in breast-fed children, it is not recommended to use Lazolvan solution for oral administration and inhalation during lactation. Preclinical studies of ambroxol did not reveal any negative effects on fertility

Directions for use and dosage:

Inside.
Oral administration (1 ml = 25 drops).
Adults and children over 12 years old:
4 ml (= 100 drops) 3 times a day;
children from 6 to 12 years old:
2 ml (= 50 drops) 2-3 times a day;
children from 2 to 6 years old:
1 ml (= 25 drops) 3 times a day;
children under 2 years old:
1 ml (= 25 drops) 2 times a day.

Drops can be diluted in water, tea, juice or milk. The solution can be used regardless of meals.

Inhalations
Adults and children over 6 years old: 1-2 inhalations of 2-3 ml of solution per day
Children under 6 years of age: 1-2 inhalations of 2 ml of solution per day.
Lazolvan solution for inhalation can be used using any modern equipment for inhalation (except for steam inhalers). To achieve optimal hydration during inhalation, the drug is mixed with 0.9% sodium chloride solution in a 1:1 ratio. Since during inhalation therapy a deep breath can provoke a cough, inhalations should be carried out in normal breathing mode. Before inhalation, it is usually recommended to warm the inhalation solution to body temperature. Patients with bronchial asthma are recommended to carry out inhalation after taking bronchodilators to avoid nonspecific irritation of the respiratory tract and their spasm. If symptoms of the disease persist within 4-5 days from the start of treatment, it is recommended to consult a doctor

Side effect

Gastrointestinal disorders
Often (1.0-10.0%) - nausea, decreased sensitivity in the oral cavity or pharynx:
Uncommon (0.1-1.0%) - dyspepsia, vomiting, diarrhea, abdominal pain, dry mouth;
Rarely (0.01-0.1%) - dry throat.

Immune system disorders, skin and subcutaneous tissue disorders
Rarely (0.01-0.1%) - skin rash, urticaria; anaphylactic reactions (including anaphylactic shock)*, angioedema*, itching*, hypersensitivity*.

Nervous system disorders
Often (1.0-10.0%) - dysgeusia (impaired sense of taste).
*-these adverse reactions were observed with widespread use of the drug; with a 95% probability, the frequency of these adverse reactions is uncommon (0.1%-1.0%), but possibly lower; The exact frequency is difficult to estimate as they have not been reported in clinical studies.

Overdose

No specific symptoms of overdose have been described in humans. There have been reports of accidental overdose and/or medical error resulting in symptoms of known side effects of Pasolvan: nausea, dyspepsia, vomiting, diarrhea, abdominal pain. In this case, there may be a need for symptomatic therapy
Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug, symptomatic therapy.

Interaction with other drugs

No clinically significant, undesirable interactions with other drugs have been reported. Increases the penetration of amoxicillin, cefuroxime, and erythromycin into the bronchial secretions.

special instructions

It should not be combined with antitussives that make it difficult to remove sputum. The solution contains the preservative benzalkonium chloride, which, when inhaled, may cause bronchospasm in sensitive patients with increased respiratory tract reactivity.

Lazolvan solution for oral administration and inhalation is not recommended to be mixed with cromoglycic acid and alkaline solutions. An increase in the pH value of the solution above 6.3 may cause precipitation of ambroxol hydrochloride or the appearance of opalescence.

Patients on a hyposodium diet should take into account that Lazolvan solution for oral administration and inhalation contains 42.8 mg of sodium in the recommended daily dose (12 ml) for adults and children over 12 years of age.

In patients with severe skin lesions - Stevens-Johnson syndrome or toxic epidermal necrolysis - fever, body pain, rhinitis, cough and sore throat may appear in the early phase. During symptomatic treatment, erroneous prescription of mucolytic drugs, such as ambroxol hydrochloride, is possible. There are isolated reports of the detection of Stevens-Johnson syndrome and toxic epidermal necrolysis, which coincided with the prescription of the drug; however, there is no causal relationship with the drug.

If the above syndromes develop, it is recommended to stop treatment and immediately seek medical help. If renal function is impaired, Lazolvan should be used only on the recommendation of a doctor.

The effect of the drug on the ability to drive vehicles and machinery

There were no cases of the drug affecting the ability to drive vehicles and machinery. 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 conducted.

Release form

Solution for oral administration and inhalation 7.5 mg/ml. 100 ml in amber glass bottles with a polyethylene dropper and a polypropylene screw cap with first opening control. Each bottle is placed in a cardboard box with instructions for use and a measuring cup.

Storage conditions

In a place protected from light at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Best before date:

5 years.
Do not use after expiration date.

Conditions for dispensing from pharmacies:

Over the counter.

Name and address of the legal entity in whose name the registration certificate was issued:

Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany

Manufacturer:

Instituto de' Angeli SRP., 50066 Reggello, Prulli, 103/S, Florence. Italy

Other drugs from the group Drugs used for respiratory diseases (expectorants, cough suppressants, antiasthmatic and bronchodilators, respiratory stimulants)

Name:

Lasolvan

Pharmacological
action:

Pharmacodynamics: Ambroxol hydrochloride, the active ingredient of lazolvan, increases the secretion of mucus in the respiratory tract. Ambroxol hydrochloride increases the synthesis of pulmonary surfactant and stimulates ciliary activity. These effects lead to improved mucus secretion and elimination (mucociliary clearance). Activation of fluid secretion and increased mucociliary clearance facilitate the removal of mucus and reduce cough.

Pharmacokinetics: Absorption of ambroxol is rapid and quite complete, with a linear dependence in the therapeutic range. The maximum concentration of the active substance in plasma is achieved after 30 minutes - 3 hours. In plasma, approximately 90% of the drug is bound to proteins. The distribution of ambroxol between the blood and tissues occurs quickly, and a high concentration of active substances is observed in the lungs. The plasma half-life is 7-12 hours; accumulation in tissues was not detected. Ambroxol is metabolized mainly in the liver by conjugation. About 90% of the drug is excreted by the kidneys.

Indications for
application:

Acute and chronic diseases of the respiratory tract, accompanied by the release of viscous sputum:
– acute and chronic bronchitis;
- pneumonia;
– chronic obstructive pulmonary disease;
– bronchial asthma with difficulty in sputum discharge;
– treatment of respiratory distress syndrome in premature and newborn babies;
– bronchiectasis.

Mode of application:

Inside, should be taken during meals with a small amount of liquid. Adults and children over 12 years of age are prescribed tablets: 30 mg 3 times a day in the first 2-3 days, then 30 mg 2 times or 15 mg 3 times a day; children 6-12 years old - 15 mg 2-3 times a day.

Oral solution(7.5 mg/ml) is prescribed to adults for the first 2-3 days - 4 ml, and then 2 ml 3 times a day or 4 ml 2 times a day; children under 2 years old - 1 ml 2 times a day, 2-5 years old - 1 ml 3 times a day, 5-12 years old - 2 ml 2-3 times a day.

Syrup(3 mg/ml) is prescribed for adults - in the first 2-3 days, 10 ml, and then 5 ml 3 times a day or 10 ml 2 times a day. In severe cases of the disease, the dose is not reduced throughout the entire course of treatment. Children 5-12 years old are prescribed 15 mg 2-3 times a day, 2-5 years old - 7.5 mg 3 times a day, up to 2 years old - 7.5 mg 2 times a day.

In the form of inhalations prescribed for adults and children over 5 years old - 15-22.5 mg, for children under 2 years old - 7.5 mg, for children from 2-5 years old - 15 mg 1-2 times a day. In cases where it is not possible to carry out more than one inhalation per day, tablets, solution or syrup are additionally administered orally.

Parenterally. The daily dose is 30 mg per 1 kg of body weight, divided into four administrations per day. The solution should be administered intravenously, slowly, over at least 5 minutes. The solution can also be prescribed intravenously. To do this, the Lazolvan solution should be diluted with a solution of glucose, levulose, saline or Ringer's solution.

Side effects:

The drug is generally well tolerated.

Allergic reactions: skin rash, urticaria, angioedema, in some cases - allergic contact dermatitis. Cases of acute severe reactions of the anaphylactic type (anaphylactic shock) have been reported extremely rarely.

With long-term use in high doses - heartburn, gastralgia, nausea, vomiting.

Contraindications:

Hypersensitivity;
- pregnancy (first trimester).
Carefully:
- II–III trimester of pregnancy;
- lactation period;
- renal and/or liver failure.

Interaction
other medicinal
by other means:

Compatible with drugs, inhibiting labor activity.
Combined use with antitussive drugs leads to difficulty in sputum discharge while reducing cough.
Increases the penetration of amoxicillin, cefuroxime, erythromycin and doxycycline into the bronchial secretions.

Pregnancy:

Preclinical trials and extensive clinical experience no undesirable consequences of treatment with the drug during pregnancy were identified. However, general rules for prescribing medications should be followed, especially in the first trimester. Lazolvan passes into breast milk, but in therapeutic doses does not have a negative effect on the child.

If it is necessary to use Lazolvan in the II–III trimesters of pregnancy, the potential therapy for the mother and the possible risk to the fetus should be assessed

Overdose:

Symptoms: possible - nausea, vomiting, diarrhea, dyspepsia, gastralgia.
Treatment: induction of vomiting, gastric lavage in the first 1–2 hours after taking the drug; intake of fat-containing foods, symptomatic therapy.

Release form:

Solution for intravenous administration, 2 ml in ampoules. 10 ampoules per pack.
Pills 10 pieces per pack.
Syrup in bottles of 100 ml.
Oral solution in bottles of 100 ml.

Storage conditions:

Store at room temperature (not higher than 25°C for solution and not higher than 30°C for other forms of release) out of the reach of children. Protect from direct sunlight, heat and frost.

Best before date:
tablets - 5 years;
syrup 15 mg/5 ml - 3 years;
syrup 30 mg/5 ml - 5 years;
solution – 5 years.

Conditions for dispensing from pharmacies – on prescription.

International and chemical name: ambroxol: trans-4-[(2-amino-3,5-dibromo-benzyl (amino)) cyclohexanol hydrochloride].

Physicochemical characteristics: transparent, colorless solution, practically free of impurities.

2 ml of solution for intravenous administration contains 15 mg of the active substance (ambroxol hydrochloride), as well as the following excipients: citric acid, disodium hydrogen phosphate dihydrate, sodium chloride, benzalkonium chloride, water for injection.

One tablet contains:
active substance- ambroxol hydrochloride 30 mg;
Excipients- lactose, dried corn starch, colloidal silicon, magnesium stearate.

5ml syrup contains: active substance - ambroxol hydrochloride 15 or 30 mg; excipients: - hydroxyethylcellulose, sorbitol, glycerin, benzoic acid, propylene glycol, raspberry flavor, tartaric acid, purified water.

The drug "Lazolvan" (solution for oral administration and inhalation) is a slightly brown or colorless transparent liquid. The active ingredient is ambroxol hydrochloride. The medication belongs to the group of expectorants and mucolytics.

Mechanism of action

The medicine "Lazolvan" (solution for oral administration and inhalation) helps to liquefy sputum. This effect is achieved by stimulating serous cells in the bronchial mucosa. Thanks to the action of the medication, the motor activity of the cilia in the ciliated epithelium is normalized and their clumping is prevented. Therapeutic effectiveness is observed half an hour after use. The effect of the medication lasts for six to twelve hours (in accordance with the dosage).

Indications

The drug "Lazolvan" (solution for oral administration and inhalation) is recommended for pathologies in the respiratory system complicated by the formation of difficult-to-remove viscous sputum. Indications include bronchial asthma, pneumonia. Medicine is prescribed for COPD, bronchitis in acute or chronic form.

How to take Lazolvan?

The solution for oral use can be diluted in fruit juice, tea, water or milk. Take the medicine with meals. Adults are prescribed 100 drops three times, patients over 6 years old - 50 drops. 2-3 times, from two to six years - three times 25 drops, up to two years - 25 drops. twice a day. For inhalations, patients over the age of six are recommended to take 2-3 ml per procedure. Patients under 6 years old - 2 ml. The frequency of inhalations is 1-2 per day. To effectively carry out the procedure, the air humidity in the respirator must be optimal. To do this, the medication is mixed with saline solution 1:1. It is recommended to warm the mixture to body temperature. The drug can be used with any modern inhaler, except for evaporating devices.

From this medical article you can familiarize yourself with the drug Lazolvan. The instructions for use will explain in what cases the medicine can be taken, what it helps with, what are the indications for use, contraindications and side effects. The annotation presents the forms of release of the drug and its composition.

In the article, doctors and consumers can only leave real reviews about Lazolvan, from which you can find out whether the medicine helped in the treatment of bronchitis, pneumonia and cough in adults and children. The instructions list analogues of Lazolvan, prices of the drug in pharmacies, as well as its use during pregnancy.

Lazolvan is a mucolytic expectorant drug. Instructions for use: syrup for children and solution for inhalation recommends taking it for the treatment of chronic and acute respiratory diseases, which are accompanied by coughing and viscous sputum (pneumonia, bronchial asthma, bronchiectasis, chronic and acute bronchitis).

Release form and composition

Lazolvan is produced in the following dosage forms:

1. Lozenges: round, light brown, with the smell of peppermint (in blisters of 10 pieces, 1, 2 or 4 blisters in a cardboard box).
2. Tablets: round, slightly yellowish or white, flat on both sides, with beveled edges, on one side there is a separating line and the inscription “67C” embossed on both sides of it, on the other - the company symbol (in blisters of 10 pcs., 2 or 5 blisters in a cardboard box).
3. Syrup: almost colorless or colorless, almost transparent or transparent, with the smell of wild berries (15 mg/5 ml each) or strawberry smell (30 mg/5 ml each), slightly viscous (in dark glass bottles of 100, 200 or 250 ml per complete with or without a measuring cup, 1 bottle in a cardboard box).
4. Solution for oral administration and inhalation: transparent, slightly brownish or colorless (in dark glass bottles of 100 ml, complete with a dosing cup or beaker, 1 bottle in a cardboard box).

The composition of 1 Lazolvan lozenge includes: the active substance ambroxol – 15 mg (in the form of hydrochloride) and auxiliary components.

1 tablet contains: active substance ambroxol – 30 mg (in the form of hydrochloride).

The composition of 5 ml of Lazolvan syrup includes: active substance: ambroxol - 15 or 30 mg (in the form of hydrochloride).

The composition of 1 ml of solution for oral administration and inhalation includes: active substance ambroxol - 7.5 mg (in the form of hydrochloride).

Pharmacological properties

The drug Lazolvan has a mucolytic effect; the instructions for use also indicate that the syrup and other forms of the drug activate the removal of sputum from the body by stimulating the motor activity of the epithelial cilia of the bronchi and the activity of the serous cells of the bronchial mucosa.

The therapeutic effect of Lazolvan appears after half an hour and can last for 6-12 hours.

What does Lazolvan help with?

Indications for use of syrup, solution for inhalation, tablets, lozenges include:

• bronchiectasis;
• chronic obstructive pulmonary disease;
• acute and chronic bronchitis;
• bronchial asthma with difficulty in sputum discharge;
• pneumonia.

Instructions for use

Lazolvan is used orally (syrup, tablets, lozenges) or inhalation (solution). The drug can be taken orally regardless of the time of meal. Lozenges should be slowly dissolved in the mouth, tablets should be taken with liquid, the solution can be diluted in juice, tea, milk or water.

As a rule, Lazolvan is prescribed orally according to the following scheme:

• Lozenges: adults and children over 12 years old – 3 times a day, 2 lozenges; children 6-12 years old – 2-3 times a day, 1 lozenge.
• Tablets: 3 times a day, 1 tablet; To enhance the therapeutic effect, it is possible to increase the daily dose (2 times a day, 2 tablets).
• Syrup 15 mg/5 ml: adults and children over 12 years old – 3 times a day, 10 ml; children 6-12 years old – 2-3 times a day, 5 ml; children 2-6 years old – 3 times a day, 2.5 ml; children under 2 years old – 2.5 ml 2 times a day.
• Syrup 30 mg/5 ml: adults and children over 12 years old – 3 times a day, 5 ml; children 6-12 years old – 2-3 times a day, 2.5 ml.
• Oral solution (1 ml = 25 drops): adults and children over 12 years old – 3 times a day, 100 drops; children 6-12 years old – 2-3 times a day, 50 drops; children 2-6 years old – 3 times a day, 25 drops; children under 2 years old – 2 times a day, 25 drops.

Instructions for inhalation

Inhalation Lazolvan is usually prescribed: adults and children over 6 years old - 1-2 inhalations of 2-3 ml of solution per day; children under 6 years old – 1-2 inhalations of 2 ml of solution per day.

For inhalation, you can use any modern equipment designed for this (except for steam inhalers). To ensure optimal hydration during inhalation, Lazolvan should be mixed with a 0.9% sodium chloride solution in a 1:1 ratio.

Since during inhalation therapy a deep breath can lead to the development of a cough, inhalations must be carried out while maintaining a normal breathing rhythm. Before the procedure, it is recommended to warm the inhalation solution to body temperature.

Patients with bronchial asthma are recommended to carry out inhalation after taking bronchodilator drugs, which will help avoid nonspecific irritation of the respiratory tract and their spasm. If symptoms of the disease persist for 4-5 days from the start of taking Lazolvan, it is recommended to consult a doctor.

Contraindications

• manifestation of sensitivity to any of the components;
• pregnancy (first term);
• breastfeeding period.

Lazolvan should be used with caution in pregnant women in the second and third trimesters, as well as in those with renal and/or liver failure.

Side effects

• skin rash;
• angioedema;
• anaphylactic reactions (including anaphylactic shock);
• nausea, vomiting;
• heartburn;
• diarrhea;
• hives;
• dyspepsia.

Children, pregnancy and breastfeeding

Lazolvan penetrates the placental barrier. Experimental studies on animals did not reveal direct or indirect adverse effects on pregnancy, embryonic, prenatal and postnatal development and childbirth. Clinical studies during 28 weeks of pregnancy found no evidence of a negative effect of the drug on the fetus.

However, the usual precautions should be taken when using the drug during pregnancy. It is especially not recommended to take Lazolvan in the 1st trimester of pregnancy. Ambroxol can be excreted in human milk. Therefore, it is not recommended to prescribe the medication to nursing mothers. However, an adverse effect in newborns is unlikely.

For children and adolescents under 18 years of age, it is advisable to use other dosage forms of the drug (syrup, lozenges, solution for oral administration and inhalation).

special instructions

In patients with severe skin lesions in the early phase, cough and inflammation of the pharynx, fever, rhinitis, and body pain may occur.

There are isolated reports of the detection of toxic epidermal necrolysis and Stevens-Johnson syndrome, which coincided with the use of the drug. However, there is no cause-and-effect relationship with taking Lazolvan. If the above syndromes occur, it is advisable to stop therapy and seek medical help.

No cases of the drug affecting the ability to drive vehicles and machinery have been identified.

Drug interactions

There are no data on undesirable clinically significant interactions of Lazolvan with other drugs. The drug increases the penetration of drugs such as cefuroxime, amoxicillin and erythromycin into the bronchial secretions.

Analogues of the drug Lazolvan

Analogues in structure:

1. Suprima coffee
2. Fervex for cough.
3. Ambrobene.
4. Medox.
5. Remebrox.
6. Flavamed.
7. Bronchorus.
8. Deflegmin.
9. AmbroHEXAL.
10. Ambrosan.
11. Ambrosol.
12. Bronchoxol.
13. Mucobron.
14. Neo-Bronchol.
15. Halixol.
16. Ambrolan.
17. Bronchovern drops.
18. Ambroxol.
19. Lazolangin.

Vacation conditions and price

The average price of the drug Lazolvan (syrup) in Moscow is 177 rubles. Lozenges are sold for 144 rubles. In Kyiv you can buy syrup for 88 hryvnia, in Kazakhstan - for 1320 tenge. In Minsk, pharmacies offer medicine for 7-8 bel. rubles Dispensed from pharmacies with a prescription.