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Active ingredients
Ambroxol
Release form
Pills
Composition
Active ingredient: Ambroxol (ambroxol). Concentration of active ingredient (mg): 30
Pharmacological effect
Absorption: Absorption - high, the time to reach maximum concentration - 1-2.5 hours after oral administration. Distribution: The distribution of ambroxol hydrochloride from the blood into the tissue is rapid and pronounced, with the highest concentration of the active substance found in the lungs. The volume of distribution after oral administration is 552 liters. Communication with plasma proteins - 90%, penetrates the blood-brain barrier, placental barrier, excreted in breast milk. Metabolism and excretion Metabolism - in the liver due to conjugation, forms dibromantranilic acid (approximately 10% of the dose), glucuronic conjugates and several minor metabolites. Studies of human liver microsomes have shown that Surzr4 is a predominant isoform responsible for the metabolism of ambroxol. About 30% of the administered oral dose is excreted as a result of presystemic metabolism. The half-life is 10 hours. Total clearance is in the range of 660 ml / min, renal clearance provides about 8% of the total clearance. Pharmacokinetics in special groups of patients due to the fact that the drug is metabolized in the liver and excreted by the kidneys, in the case of severe renal dysfunction, accumulation of ambroxol metabolites in the liver can occur. In patients with impaired liver function, the elimination of ambroxol hydrochloride is reduced, which leads to an increase in its plasma levels by 1.3-2 times. Studies have shown that the pharmacokinetics of Ambroxol does not depend on age and gender, and thus does not require a change in dosage. Eating does not affect the bioavailability of ambroxol hydrochloride.
Pharmacokinetics
Homeopathic medicine, the action of which is due to its constituent components.
Indications
Acute and chronic bronchitis. pneumonia. COPD bronchial asthma with sputum obstruction bronchiectasis.
Contraindications
1 trimester of pregnancy. lactation period. children and adolescents up to 18 years.lactose deficiency, lactose intolerance, glucose-galactose malabsorption. Hypersensitivity to Ambroxol or other components of the drug.
Precautionary measures
Several cases of severe skin damage have been reported, including Stevens-Johnson syndrome and toxic epidermal necrolysis associated with taking mucolytic agents like ambroxol hydrochloride. These cases can be explained, as a rule, by the severity of the concomitant disease or by the simultaneous use of other drugs. In addition, at an early stage of Stevens-Johnson syndrome and toxic epidermal necrolysis, patients may show signs of the onset of a nonspecific disease resembling the flu: fever, body ache, rhinitis, cough and sore throat. The appearance of these symptoms can lead to unnecessary symptomatic treatment with anti-cold drugs. Therefore, in the event of damage to the skin or mucous membrane, immediately consult a doctor, and treatment of ambroxol with hydrochloride should be stopped as a precautionary measure. In case of impaired renal function or severe impaired liver function, Lasolvan should be taken only after consulting a doctor. Due to the fact that the drug is metabolized in the liver and excreted by the kidneys, in the case of severe renal dysfunction, accumulation of ambroxol metabolites can occur in the liver. When prescribing to children aged 2 to 6 years, the risk / benefit ratio should be considered. For patients with impaired motor motility of the bronchi and abundant bronchial secretions (such as, for example, in rare primary ciliary dyskinesia syndrome), Lasolvan should be used with caution because of the risk of large sputum and bronchial obstruction. Lazolvan syrup 30 mg / 5 ml: 5 ml of syrup contains 1.2 g of sorbitol, which is 4.9 g of sorbitol in the maximum recommended daily dose (20 ml). Patients with rare hereditary fructose intolerance should not take this drug. Lazolvan syrup 15 mg / 5 ml: 5 ml of syrup contains 1.2 g of sorbitol, which is 7.4 g of sorbitol in the maximum recommended daily dose (30 ml).Patients with rare hereditary fructose intolerance should not take this drug. It can also have a mild laxative effect.
Use during pregnancy and lactation
Ambroxol penetrates the placental barrier. Preclinical studies have not revealed a direct or indirect adverse effect on pregnancy, fetal / fetal, postnatal development and on labor. Clinical experience with Ambroxol after 28 weeks of gestation did not reveal evidence of a negative effect of the drug on the fetus. However, you must follow the usual precautions when using the drug during pregnancy. 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 in the case when the intended benefit to the mother outweighs the potential risk to the fetus. Ambroxol may be excreted in breast milk. Despite the fact that adverse effects in breastfed babies have not been observed, it is not recommended to use Lasolvan syrup during lactation. Preclinical studies of ambroxol did not reveal a negative impact on fertility.
Dosage and administration
Tablets are taken with a liquid. You can take pills regardless of the meal.
Side effects
Nausea. dyspepsia, vomiting, diarrhea, abdominal pain, rash, urticaria. angioedema, anaphylactic reactions (including anaphylactic shock), pruritus, hypersensitivity.
Overdose
The specific symptoms of overdose in humans are not described. There are reports of an accidental overdose and / or medical error, which resulted in symptoms of known side effects of the drug Lasolvan: nausea, dyspepsia, diarrhea, vomiting, abdominal pain. Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug, symptomatic therapy.
Interaction with other drugs
No clinically significant undesirable interactions with other drugs have been reported. Ambroxol increases penetration into the bronchial secretion of amoxicillin, cefuroxime, erythromycin.
special instructions
Since the preparation contains natural plant components, during storage a slight turbidity and weakening of smell and taste may be observed, which does not reduce the effectiveness of the preparation. The drug should be stopped immediately if there are signs of liver damage (jaundice, dark urine, pain in the right hypochondrium, nausea, lack of appetite, weakness). If there is no improvement in the condition within 1 month while taking the drug, the patient should consult a doctor. Influence on the ability to control the mechanisms and the car: during the period of use of the drug, care should be taken when performing potentially dangerous activities that require increased attention and speed of psychomotor reactions. The preparation contains ethyl alcohol (ethanol) 43% by weight. Remens (Remens) - drops contain in a single dose (10 drops) 0.17 g of alcohol. The maximum daily dose (8 times a day, 10 drops) contains 1.35 g of ethanol (ethanol).