Lasolvan Max, capsules 75 mg 10 pcs
€6.98 €6.11
Medications to relieve symptoms of colds and coughs.
Hypnotics. Mucolytics. Ambroxol.
ATC code R05CB06
Pharmacological action
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Pharmacokinetics
absorption. Absorption is high and almost complete, linearly dependent on the therapeutic dose. Maximum plasma concentration is reached within 6.5 hours. The relative bioavailability is 95%.
Distribution Distribution is rapid and extensive, with the highest concentrations in lung tissue. The volume of distribution is approximately 552 L. The binding to plasma proteins is approximately 90%.
Metabolism and excretion. Approximately 30% of the ingested dose is subjected to a “first pass” effect through the liver.
CYP3A4 is the main enzyme responsible for the metabolism of ambroxol, under the action of which, mainly in the liver, conjugates are formed.
The elimination half-life is 10 hours. Total clearance is within 660 ml/min, renal clearance is 83 % of total clearance. It is excreted by the kidneys: 26% in the form of conjugates, 6% – as free form.
The excretion of ambroxol is reduced with hepatic dysfunction, which leads to an increase in plasma levels by 1.3-2 times, but does not require dose adjustment.
Gender and age have no clinically significant effect on ambroxol pharmacokinetics and do not require dose adjustment.
Eating has no effect on the bioavailability of ambroxol hydrochloride.
Pharmacodynamics
The drug has secretolytic and expectorant action; stimulates serous cells of glands of mucous membrane of bronchi, increases the content of mucous secretion and secretion of surfactant in alveoli and bronchi; normalizes the disturbed ratio of serous and mucous components of sputum.
Activating hydrolyzing enzymes and increasing the release of lysosomes from Clara cells, reduces the viscosity of sputum. Increases motor activity of the cilia of the atomizing epithelium and increases mucociliary transport of sputum. Increasing secretion and mucociliary clearance improves sputum discharge and relieves coughing.
In patients with chronic obstructive pulmonary disease (COPD) the result of long-term treatment (6 months) was a significant reduction in exacerbations after 2 months of treatment. In addition, there was a decrease in disease symptoms such as difficult sputum discharge, cough, dyspnea, and auscultatory signs compared to placebo. It was also noted that the course of the disease and the need for antibiotic therapy were shorter compared to placebo.
The local anesthetic effect of ambroxol has been shown to be due to a dose-dependent blockade of neuronal sodium channels. Under the influence of ambroxol the release of cytokines from blood as well as from tissue mononuclears and polymorphonuclear cells is significantly reduced.
Clinical studies on patients with sore throat have shown a significant reduction in soreness and redness in the throat.
Indications
Active ingredient
Composition
Active ingredients:
ambroxol hydrochloride 75 mg;
Supplements:
crospovidone 12.55 mg,
carnauba wax 18.31 mg,
stearyl alcohol 110.94 mg,
Magnesium stearate 1.20 mg;
Capsule shell composition:
gelatin 52.307 mg, purified water 9.135 mg, titanium dioxide (E171) 1.008 mg, iron oxide red dye (E172) 0.150 mg, iron oxide yellow dye (E172) 0.398 mg;
The composition of the ink:
shellac, titanium dioxide.
How to take, the dosage
Adults:1 capsule once daily.
The capsule should be swallowed whole with plenty of liquid.
You may not open or chew the capsule!
The pellets inside the capsule release the active ingredient as they pass through the digestive system.
General Information.
It can be taken with a meal or on an empty stomach.
The course is 14 days for the treatment of acute respiratory conditions and for the initial treatment of chronic conditions.
If the condition does not improve with the current therapy of acute respiratory conditions, medical attention should be sought.
Interaction
No clinically significant adverse interactions with other drugs have been reported.
The combined use with anti-cough drugs leads to difficulty of sputum discharge on the background of cough suppression.
It increases penetration and concentration in the bronchial secretion of amoxicillin, cefuroxime and erythromycin.
Special Instructions
Very rare cases of severe skin lesions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with ambroxol hydrochloride. They are mainly due to the severity of the underlying disease and concomitant treatment.
In addition, in the early stages of Stevens-Johnson syndrome and toxic epidermal necrolysis, patients may show signs of the onset of nonspecific disease with the following symptoms: increased body temperature, full body pain, rhinitis, cough and sore throat.
The appearance of these signs can lead to unnecessary symptomatic treatment with cold medications. If skin lesions appear, the patient is immediately examined by a physician and ambroxol hydrochloride is discontinued.
Patients with decompensated renal insufficiency should use the drug only after consulting a physician.
Fertility, pregnancy and lactation
Ambroxol hydrochloride penetrates the placental barrier. Preclinical studies have shown no direct or indirect adverse effects on pregnancy, fetal development, labor and postnatal development.
The drug is not recommended for use during the first trimester of pregnancy. Use with caution in the II-III trimesters of pregnancy and lactation.
Ambroxol hydrochloride penetrates into breast milk, however, when prescribed in therapeutic doses, does not have adverse effects on the baby.
Preclinical studies have shown no direct or indirect adverse effects on fertility.
Specific effects of the drug on driving or potentially dangerous machinery
There are no reported cases of the drug affecting driving or operating ability in the post-marketing period. No studies have been conducted.
Contraindications
Side effects
Gastrointestinal disorders
Frequent (⥠1/100 – < 1/10):
Infrequent(⥠1/1,000 – < 1/100):
Rare (⥠1/10,000 – < 1/1,000):
Immune system disorders
Not known:
Skin and subcutaneous tissue disorders
Rare(⥠1/10,000 to < 1/1,000):
Not known:
Overdose
Symptoms: nausea, vomiting, diarrhea, dyspepsia.
Treatment: symptomatic therapy.
Similarities
Weight | 0.016 kg |
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Manufacturer | Sanofi Winthrop Industry, France |
Medication form | slow-release capsules |
Brand | Sanofi Winthrop Industry |
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