Lasolvan tablets 30mg, No. 20

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 with liquid.

30 mg (1 tab.) 3 times a day. If necessary, to enhance the therapeutic effect, you can prescribe 60 mg (2 tab.) 2 times a day.

You can take the tablets with or without food.

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

In 1 tablet:

Ambroxol hydrochloride 30 mg

Excipients: lactose monohydrate - 171 mg, dried corn starch - 36 mg, colloidal silicon dioxide - 1.8 mg, magnesium stearate - 1.2 mg.

- Hypersensitivity to ambroxol or other components of the drug;

-pregnancy (I trimester);

- lactation period;

-Children up to 18 years old;

- lactase deficiency;

-lactose intolerance;

-glucose-galactose malabsorption.

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

pharmachologic effect

Mucolytic and expectorant drug.

Studies have shown that ambroxol increases secretion in the respiratory tract. It 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 is achieved after 1-2.5 hours. The absolute bioavailability of LasolvanЃ 30 mg tablets is 79%.

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 and excretion

Approximately 30% of the administered oral dose 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.

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 radioactive labeling, 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.

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; infrequently (0.1-1%) - dyspepsia, vomiting, diarrhea, abdominal pain.

From the side of the immune system, from the skin and subcutaneous tissues: rarely (0.01-0.1%) - rash, urticaria; angioedema, anaphylactic reactions (including anaphylactic shock), 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 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 medication 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 children receiving breastfeeding, it is not recommended to use LazolvanЃ 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

For children under 6 years old, it is possible to use other dosage forms of the drug LazolvanЃ (syrup 15 mg / ml, solution for oral administration and inhalation).

special instructions

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

One tablet contains 162.5 mg of lactose. The maximum daily dose (4 tab.) Contains 650 mg of lactose.

Patients with severe skin lesions (Stevens-Johnson syndrome or toxic epidermal necrolysis) may develop fever, body pain, rhinitis, cough, and inflammation of the pharynx in the early phase. With symptomatic treatment, it is possible that mucolytic agents such as ambroxol are mistakenly prescribed. There are isolated reports of the detection of Stevens-Johnson syndrome and toxic epidermal necrolysis, which coincided with the appointment of the drug; however, there is no causal relationship with the drug intake. With the development of the above syndromes, it is recommended to stop treatment and immediately seek medical attention.

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

Use in pediatrics

For children under 6 years old, it is possible to use other dosage forms of the drug LazolvanЃ (syrup 15 mg / ml, solution for oral administration and inhalation).

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 are reports of accidental overdose and / or medical error, as a result of which symptoms of known side effects of LasolvanЃ were observed: nausea, dyspepsia, 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.