Lasolvan syrup 30mg / 5ml, 100 ml

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.

Inside, regardless of the meal.

Syrup 15 mg / 5 ml: adults and children over 12 years old - 10 ml 3 times a day; children from 6 to 12 years old - 5 ml 2-3 times a day; children from 2 to 6 years old - 2.5 ml 3 times a day; children under 2 years old - 2.5 ml 2 times a day.

Syrup 30 mg / 5 ml: adults and children over 12 years old - 5 ml 3 times a day. If necessary, to enhance the therapeutic effect, you can prescribe 10 ml 2 times a day. Children from 6 to 12 years old - 2.5 ml 2-3 times a day.

If the symptoms of the disease persist within 4Ц5 days from the start of taking the drug, it is recommended to consult a doctor.

The syrup is transparent or almost transparent, colorless or almost colorless, slightly viscous, with a strawberry smell.

5 ml

ambroxol hydrochloride 30 mg

Excipients: benzoic acid - 8.5 mg, hyetellose (hydroxyethyl cellulose) - 10 mg, potassium acesulfame - 5 mg, liquid sorbitol (non-crystallizing) - 1750 mg, glycerol 85% - 750 mg, strawberry-cream flavor PHL-132200 - 12 mg, vanilla flavor 201629 - 3 mg, purified water - 3031.5 mg.

- Hypersensitivity to ambroxol or other components of the drug;

-pregnancy (I trimester);

- lactation period;

-Children up to 6 years old (for syrup 30 mg / 5 ml).

Carefully:

II Ц III trimester of pregnancy;

lactation period;

renal and / or hepatic impairment.

pharmachologic effect

Studies have shown that ambroxol 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

Absorption and distribution

All dosage forms of immediate release ambroxol are characterized by rapid and almost complete absorption with a linear dose dependence in the therapeutic concentration range. Cmax in plasma after oral administration is achieved after 1-2.5 hours. In the therapeutic concentration range, binding to plasma proteins is approximately 90%.

Vd is 552 liters. 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 and excretion

Approximately 30% of the dose taken undergoes a 'first pass' effect through the liver. Studies in human liver microsomes have shown that 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.

The terminal T1 / 2 of ambroxol is 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.

Side effect

From the digestive system: often (1-10%) - nausea, decreased sensitivity in the mouth and pharynx; infrequently (0.1-1%) - dyspepsia, vomiting, diarrhea, abdominal pain, dry mouth; rarely (0.01-0.1%) - dry throat.

From the nervous system: often (1-10%) - dysgeusia (violation of taste).

Allergic reactions: rarely (0.01-0.1%) - rash, urticaria, anaphylactic reactions (including anaphylactic shock) , angioedema , pruritus , hypersensitivity .

* these adverse reactions were observed with widespread use of the drug; with a 95% probability, the frequency of these adverse reactions is infrequent (0.1-1%), but possibly lower; the exact frequency is difficult to estimate as they have not been observed in clinical trials.

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 28 weeks of gestation 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 intended 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 syrup during lactation.

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

Application for violations of liver function

Prescribe with caution to patients with hepatic impairment.

Application for impaired renal function

Use with caution in patients with renal insufficiency.

Application in children

The drug is contraindicated for use in children under 6 years of age.

special instructions

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

There are sporadic reports of severe skin lesions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, concurrent 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 cough 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.

LazolvanЃ syrup (30 mg / 5 ml) contains 5 g of sorbitol in terms of the maximum recommended daily dose (20 ml). Patients with rare hereditary fructose intolerance should not take this drug.

In case of impaired renal function, LazolvanЃ should be used only as directed by 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

The 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, diarrhea, vomiting, abdominal pain.

Treatment: artificial 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.