Lasolvan solution 7.5mg / ml, 100ml

Acute and chronic diseases of the respiratory tract with the production of viscous sputum:

- acute and chronic bronchitis;

-pneumonia;

-chronic obstructive pulmonary disease;

- bronchial asthma with difficulty in sputum discharge;

- bronchiectasis.

Ingestion (1 ml = 25 drops).

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

Adults and children over 12 years old - 4 ml (100 drops) 3 times / day; children aged 6 to 12 years - 2 ml (50 drops) 2-3 times / day; children aged 2 to 6 years - 1 ml (25 drops) 3 times / day; children under 2 years old - 1 ml (25 drops) 2 times / day.

Inhalation

Adults and children over 6 years old - 1-2 inhalations of 2-3 ml of solution / day.

Children under the age of 6 years - 1-2 inhalations of 2 ml of solution / day.

LazolvanЃ solution for inhalation can be used using any modern inhalation equipment (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 a normal breathing mode. It is usually recommended to warm the inhalation solution to body temperature before inhalation. Patients with bronchial asthma are recommended to carry out inhalation after taking bronchodilators, in order to avoid nonspecific irritation of the respiratory tract and their spasm.

If the symptoms of the disease persist within 4-5 days from the start of using the drug, it is recommended to consult a doctor.

Solution for oral administration and inhalation

1 ml

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 mg

- Hypersensitivity to ambroxol or other components of the drug;

-pregnancy (I trimester).

- lactation period.

With care: II Ц III trimester of pregnancy; renal and / or hepatic impairment.

pharmachologic effect

Studies have shown that ambroxol, the active ingredient in LazolvanЃ, increases secretion in the respiratory tract. Enhances the production of pulmonary surfactant and stimulates ciliary activity. These effects lead to increased mucus flow and transport (mucociliary clearance). Enhancing mucociliary clearance improves sputum flow and relieves coughing.

In patients with COPD, long-term therapy with LazolvanЃ (for at least 2 months) led to a significant decrease in the number of exacerbations. There was a significant decrease in the duration of exacerbations and the number of days of antibiotic therapy.

Pharmacokinetics

Suction

All dosage forms of immediate release of Ambroxol are characterized by rapid and almost complete absorption with a linear dose dependence in the therapeutic range of concentrations. Cmax when taken orally is achieved after 1-2.5 hours.

Distribution

Vd is 552 liters. In the therapeutic concentration range, plasma protein binding is approximately 90%. The transition of ambroxol from blood to tissue with oral administration occurs quickly. The highest concentrations of the active ingredient of the drug are observed in the lungs.

Metabolism

Approximately 30% of a dose taken by mouth undergoes a 'first pass' effect through the liver. Studies on human liver microsomes have shown that the isoenzyme CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol to dibromantranilic acid. The remainder of ambroxol is metabolized in the liver, mainly by glucuronidation and by partial degradation to dibromantranilic acid (approximately 10% of the administered dose), as well as a small amount of additional metabolites.

Withdrawal

Terminal T1 / 2 of ambroxol is about 10 hours. The total clearance is within 660 ml / min, renal clearance accounts for approximately 8% of the total clearance. Using the method of introducing a radioactive label, it was calculated that after taking a single dose of the drug over the next 5 days, about 83% of the dose taken is excreted in the urine.

Pharmacokinetics in special patient groups

There was no clinically significant effect of age and gender on the pharmacokinetics of ambroxol, so there is no reason to select a dose for these signs.

Application during pregnancy and lactation

Ambroxol crosses 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 ambroxol after the 28th week of pregnancy has not found evidence of a negative effect of the drug on the fetus. However, the usual precautions must be followed when using the drug during pregnancy. It is especially not recommended to take LazolvanЃ in the first trimester of pregnancy. In the II and III trimesters of pregnancy, the use of the drug is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.

Ambroxol can be excreted in breast milk. Despite the fact that undesirable effects were not observed in breastfed children, it is not recommended to use LazolvanЃ solution for oral administration and inhalation during lactation.

Preclinical studies of ambroxol have not shown any negative effects on fertility.

Application for violations of liver function

Prescribe with caution in liver failure.

Application for impaired renal function

Prescribe with caution in renal failure.

Use in elderly patients

There was no clinically significant effect of age on the pharmacokinetics of ambroxol, so there is no reason to select a dose for these signs.

special instructions

It should not be used in combination with antitussives that impede the excretion of sputum.

The solution contains the preservative benzalkonium chloride, which, when inhaled, can cause bronchospasm in sensitive patients with increased airway reactivity.

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

Patients on a low sodium diet should take into account that LazolvanЃ 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.

There are isolated reports of severe skin lesions (Stevens-Johnson syndrome and toxic epidermal necrolysis) that coincided with the use of expectorant drugs such as ambroxol hydrochloride. In most cases, they are 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 develop fever, body pain, rhinitis, cough, and sore throat. With symptomatic treatment, it is possible to erroneously prescribe anti-cold remedies. With the development of new lesions of the skin and mucous membranes, the patient should stop treatment with ambroxol and immediately seek medical attention.

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

Influence on the ability to drive vehicles and 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 hazardous activities that require increased concentration of attention and speed of psychomotor reactions have not been conducted.

Overdose

Specific symptoms of an overdose in humans have not been described.

There have been reports of accidental overdose and / or medical error resulting in symptoms of known side effects of LazolvanЃ: nausea, dyspepsia, vomiting, diarrhea, abdominal pain.

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

Drug interactions

No clinically significant, adverse drug interactions have been reported.

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