Lasolvan solution for inhalation 15 mg 2ml 100ml
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Active ingredients
Ambroxol
Release form
Solution
Composition
Active ingredient: ketoprofena losine salt. Auxiliary substances: glycerol, ethanol, methyl parahydroxybenzoate, mint flavor, menthol, sodium saccharin, brilliant green, sodium hydrogen phosphate, purified water. Concentration of active ingredient (mg): 16 mg
Pharmacological effect
Possesses sekretomotorny, sekretolitichesky and expectorant action; stimulates the serous cells of the glands of the mucous membrane of the bronchi, increases the content of mucous secretions and the release of surfactant (surfactant) in the 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 the motor activity of cilia of the ciliated epithelium, increases mucociliary transport of sputum. In an in vitro study, a local anesthetic effect was observed, which is explained by the ability of ambroxol to block sodium channels. This process is reversible and concentration dependent. Clinically, when inhaled, Ambroxol leads to rapid relief of pain and associated discomfort in the upper respiratory tract. In an in vitro study, it was also found that the release of cytokines from tissue mononuclear and polymorphonuclear blood cells is significantly reduced.
Pharmacokinetics
Absorption: Absorption - high, time to reach the maximum concentration - 1-2.5 hours after oral administration. 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. secondary metabolites. Studies on human liver microsomes have shown that CYP3A4 is a predominant isoform responsible for the metabolism of ambroxol hydrochloride.About 30% of the prescribed 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: Patients with impaired liver function excretion of ambroxol hydrochloride is reduced, which leads to an increase in its level in the blood plasma by 1.3-2 times, however, dosage adjustment is not required. 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
Indications
Acute and chronic diseases of the respiratory tract, accompanied by the release of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma with sputum obstruction, treatment of respiratory distress syndrome in premature and newborn children, bronchiectasis.
Contraindications
Hypersensitivity to ambroxol or other components of the drug.
Precautionary measures
It should not be combined with antitussive agents that impede the excretion of sputum. LAZOLVAN pills, 30 mg: one tablet contains 171 mg of lactose, which is 684 mg of lactose in the maximum recommended daily dose (120 mg). This drug should not be taken in patients with rare congenital intolerance to galactose, Lappa lactase deficiency, or with poor digestion of glucose-galactose. 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 the treatment with ambroxol hydrochloride should be discontinued as a precaution. In case of impaired renal function, LAZOLVAN can be taken only after consulting a doctor. As with other drugs undergoing metabolism in the liver, and then excreted by the kidneys, in the presence of severe renal failure, the accumulation of Ambroxol metabolites in the liver is possible.
Use during pregnancy and lactation
Ambroxol crosses the placental barrier. The safety of the drug during pregnancy has not been established. The use of LAZOLVANA during pregnancy is not recommended. Ambroxol is excreted in breast milk. The safety of the drug during lactation has not been established. LAZOLVAN is not recommended for use during breastfeeding.
Dosage and administration
Inside, it is necessary to accept during food intake, washing down with a small amount of liquid. Adults and children over 12 years old are prescribed pills: 30 mg 3 times a day for the first 2-3 days, then 30 mg 2 times or 15 mg 3 times a day. children 6-12 years old - 15 mg 2-3 times a day. The solution for oral administration (7. 5 mg ml) is prescribed to adults for the first 2-3 days - 4 ml, and then 2 ml 3 times a day or 4 ml 2 times a day. children under 2 years old - 1 ml 2 times a day, 2-5 years - 1 ml 3 times a day, 5-12 years - 2 ml 2-3 times a day. Syrup (3 mg ml) is prescribed for adults - in the first 2-3 days, 10 ml, and then 5 ml 3 times a day or 10 ml 2 times a day. In severe cases of the disease, the dose is not reduced during the entire course of treatment. Children of 5-12 years old should be prescribed 15 mg 2-3 times a day, 2-5 years - 7. 5 mg 3 times a day, up to 2 years - 7. 5 mg 2 times a day. In the form of inhalation prescribed for adults and children over 5 years of 15-22. 5 mg, for children under 2 years old - 7. 5 mg, for children from 2-5 years old - 15 mg 1-2 times a day. In the case when it is not possible to carry out more than one inhalation per day, additionally used pills, solution or syrup orally. Parenteral The daily dose is 30 mg per 1 kg of body weight, divided into four administrations per day. The solution should be administered intravenously, slowly, for at least 5 minutes. The solution can also be administered intravenously. To do this, the lasolvan solution should be diluted with a glucose solution, levulose, saline or Ringer's solution.
Side effects
Lasolvan is generally well tolerated. Minor gastrointestinal disturbances are possible (mainly heartburn, dyspepsia. Less commonly nausea and vomiting). Allergic reactions may occur in the form of a skin rash. In some cases, severe reactions of the anaphylactic type are possible, but their relationship with the intake of the drug has not been established.
Overdose
Symptoms of overdose in humans are not described. In case of accidental overdose and / or cases of medical errors, it was reported that the observed symptoms correspond to the known side effects of LAZOLVANA when taken in recommended doses. Possible: nausea, vomiting, diarrhea, dyspepsia. Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; reception of fat-containing products, symptomatic therapy.
Interaction with other drugs
No clinically significant, undesirable interactions with other drugs were reported. Ambroxol increases penetration into the bronchial secretion of amoxicillin, cefuroxime, erythromycin.