Lasolvan (Ambroxol) 30 mg

indications for Lasolvan (Ambroxol)

Structure Lasolvan:

1 tablet contains:
active substance - ambroxol hydrochloride 30 mg;
auxiliary substances - lactose monohydrate 171 mg, dried corn starch 36 mg, colloidal silicon dioxide 1.8 mg, magnesium stearate 1.2 mg.

Description Lasolvan:

Tablets - round, white or slightly yellow tablets, flat on both sides, with beveled edges, on one side there is a dividing line and engraving "67C", squeezed out on both sides of the dividing marks, on the other side of the tablet the company symbol.
Ambroxol

Pharmaco-therapeutic group Lasolvan:

Expectorant, mucolytic agent

Pharmacological properties Lasolvan:

Pharmacological action
Studies have shown that ambroxol - the active ingredient in Lasolvan® - increases the 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 chronic obstructive pulmonary disease, long-term therapy with Lasolvan® (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 Lasolvan:

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. The maximum plasma concentration (Cmax) when taken orally is achieved in 1-2.5 hours. The absolute bioavailability of Lasolvan® 30 mg tablets
is 79%. The volume of distribution is 552 liters. In the therapeutic range of concentrations, plasma protein binding is approximately 90%.
Lasolvan

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.
Approximately 30% of the taken oral dose undergoes the effect of the primary passage through the liver. Studies on human liver microsomes have shown that the CYP3A4 isoenzyme 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 half-life of ambroxol is about 10 hours. The total clearance is in the range of 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 dosage for these signs.

Overdose Lasolvan:

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 Lasolvan® were observed: nausea, dyspepsia, vomiting, abdominal pain. In this case, the need for symptomatic therapy is possible.
Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug, symptomatic therapy.

Indications for use Lasolvan:

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.

Mode of application Lasolvan:

Inside.

Children from 6 to 12 years old: 15 mg (½ tablet) 2-3 times a day.
Adults and children over 12 years old: 30 mg (1 tablet) 3 times a day.
If necessary, to enhance the therapeutic effect, you can prescribe 60 mg (2 tablets) 2 times a day.
The drug Lasolvan is taken with liquid.
You can take the tablets with or without food.
If the symptoms of the disease persist within 4-5 days from the start of admission, it is recommended to consult a doctor.

Contraindications Lasolvan:

Hypersensitivity to ambroxol or other components of the drug, pregnancy (I trimester), lactation period, children under 6 years of age, lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
Use Lasolvan® with caution during pregnancy (II – III trimester), with renal and / or hepatic failure.
Application during pregnancy and during 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 ambroxol after the 28th week of pregnancy has not found evidence of a negative effect of the drug on the fetus.
However, you must follow the usual precautions when using the medication during pregnancy.
It is especially not recommended to take Lasolvan® in the first trimester of pregnancy.
In the II and III 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 the fact that undesirable effects have not been observed in children receiving breastfeeding, it is not recommended to use Lasolvan® tablets during lactation.
Preclinical studies of ambroxol have not shown a negative effect on fertility.

Side effects Lasolvan:

Disorders from the gastrointestinal tract
Often (1.0 - 10.0%) - nausea;
Infrequently (0.1 - 1.0%) - dyspepsia, vomiting, diarrhea, abdominal pain.
Disorders of the immune system, skin and subcutaneous tissue damage
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 - 1.0%), but possibly lower; the exact frequency is difficult to estimate as it has not been observed in clinical trials.

special instructions Ambroxol:

Should not be combined with antitussives that impede the excretion of sputum.

One tablet contains 162.5 mg of lactose. The maximum daily dose (4 tablets) 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 sore throat in the early phase. With symptomatic treatment, it is possible to erroneously prescribe mucolytic agents such as ambroxol. There are isolated reports of the detection of Stevens-Johnson syndrome and toxic epidermal necrolysis that 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, Lasolvan® should be used only on the recommendation of a doctor.

For children under 6 years of age, it is possible to use other dosage forms of Lasolvan® (syrup 15 mg / ml, solution for oral administration and inhalation).
The effect of the drug Ambroxol 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 an increased concentration of attention and speed of psychomotor reactions have not been conducted. Lasolvan (Ambroxol)