Lazolvan tablets 30mg №10×5

Name:
Lazolvan tablets 30 mg in a blister. in pack. No. 10×5
Description:
White or slightly yellowish, round, flat on both sides tablets with bevelled edges, with a dividing line on one side and engraving 67C on both sides of the dividing line, on the other side of the tablet there is a company logo. The main active ingredient Ambroxol Release form Tablets are white or slightly yellow in color, round, flat on both sides, with beveled edges, on one side there is a separating risk and engraving “67C” squeezed out on both sides of the separating risk, on the other side of the tablet is the company symbol. Dosage 30 mg Special instructions Should not be used in combination with antitussives that make it difficult to remove 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, the erroneous prescription of mucolytic agents such as ambroxol is possible. There are isolated reports of the detection of Stevens-Johnson syndrome and toxic epidermal necrolysis, coinciding in time with the appointment of the drug; however, there is no causal relationship with drug use. With the development of the above syndromes, it is recommended to stop treatment and immediately seek medical help. In case of impaired renal function, Lazolvan® should be used only on the advice of a doctor. For children and adolescents under the age of 18, it is possible to use other dosage forms of Lazolvan (syrup, lozenges, oral and inhalation solution). Influence on the ability to drive vehicles and control 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 and speed of psychomotor reactions have not been conducted. Pharmacodynamics: Preclinical studies have shown that ambroxol hydrochloride, the active ingredient in LASOLVAN, stimulates the secretion of the serous component of bronchial secretions. It also increases the secretion of surfactants by direct action on type II pneumocytes located in the alveoli and Clara cells in the bronchioles, and also stimulates the activity of the ciliated epithelium. The described effects cause a decrease in sputum viscosity and an improvement in mucociliary clearance. Improvement in mucociliary clearance has been demonstrated in clinical pharmacological studies. Increased secretion of the serous component of sputum and increased mucociliary clearance promote sputum discharge and relieve coughing. In patients with COPD who took LAZOLVAN 75 mg extended-release capsules for 6 months, a significant reduction in exacerbations was registered by the end of the 2nd month of treatment compared with placebo. In patients in the LAZOLVANA group, a significant decrease in the number of days of illness and a decrease in the number of days of taking antibacterial drugs were observed. Also, in the LAZOLVANA group, compared with placebo, there was a statistically significant improvement in the assessed symptoms, such as difficulty in expectorating sputum, cough, dyspnea, and auscultatory symptoms. The local anesthetic effect of ambroxol hydrochloride has been observed in studies conducted on a rabbit eye model and is likely due to blocking of sodium channels by the drug. Tests / and vitro showed that the drug reversibly and dose-dependently blocks neuronal sodium channels. Ambroxol hydrochloride has been found in vitro to have an anti-inflammatory effect. In in vitro tests, it significantly reduced the release of cytokines from circulating and tissue mononuclear and polymorphonuclear cells. Clinical studies in patients with sore throat have shown that ambroxol hydrochloride 20 mg lozenges significantly reduce pain and redness in the throat. These pharmacological properties support the additional observation from clinical efficacy studies that ambroxol inhalation provides rapid pain relief when used in the treatment of upper respiratory disease. The use of ambroxol hydrochloride increases the concentration in sputum and bronchial secretion of antibiotics such as amoxicillin, cefuroxime, erythromycin and doxycycline. To date, the clinical significance of this effect has not been proven. Pharmacokinetics Absorption Absorption of ambroxol hydrochloride from immediate release oral formulations is rapid and fairly complete with a linear relationship over the therapeutic range. The maximum concentration in blood plasma is reached 1-2.5 hours after oral administration of the immediate release dosage form and, on average, 6.5 hours after taking the prolonged-release dosage form. Absolute bioavailability after taking 30 mg tablets was 79%. Distribution The distribution of ambroxol hydrochloride from the blood to the tissues 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. In the therapeutic range, plasma protein binding is about 90%. Metabolism and excretion Approximately 30% of the oral dose is excreted as a result of first pass metabolism. Metabolism of ambroxol hydrochloride occurs predominantly in the liver by glucuronidation and partial cleavage to dibromanthranilic acid (approximately 10% of the dose). Studies of human liver microsomes have shown that CYP3A4 is responsible for the metabolism of ambroxol hydrochloride to dibromanthranilic acid. Within 3 days of oral administration, approximately 6% of the dose is found in the free form, and about 26% of the dose appears in the urine in the form of conjugates. The half-life of ambroxol hydrochloride from the body is 10 hours. The total clearance is in the range of 660 ml / min., The renal clearance provides approximately 8% of the total clearance. After 5 days, about 83% of the dose taken is excreted in the urine. Pharmacokinetics in special groups of patients In patients with impaired liver function, the excretion of ambroxol hydrochloride is reduced, which leads to an increase in its plasma level by 1.3-2 times. Due to the high therapeutic index of the drug, dose adjustment is not required. The pharmacokinetics of ambroxol is not clinically significantly dependent on age and gender, so dosage changes are not required. The bioavailability of ambroxol hydrochloride does not depend on food intake. Indications for use Secretolytic therapy for acute and chronic bronchopulmonary diseases associated with impaired formation and transport of sputum. Dosage and administration Children from 6 to 12 years old Usually ? tablets 2-3 times/day (corresponding to 2-3 x 15 mg ambroxol hydrochloride per day). Adults and children over 12 years of age Usually 1 tablet 3 times/day (corresponding to 3 to 30 mg ambroxol hydrochloride per day) for the first 2 to 3 days, then 1 tablet 2 times/day (corresponding to 2 to 30 mg ambroxol hydrochloride in a day). For adults and children over 12 years of age, the therapeutic effect can be increased by increasing the dose to 2 tablets twice a day (corresponding to 120 mg of ambroxol hydrochloride per day). In case of impaired renal function or severe impaired liver function, LASOLVAN should be taken only after consulting a doctor. In patients with impaired liver function, the excretion of ambroxol hydrochloride is reduced, which leads to an increase in its plasma level by 1.3-2 times. Due to the high therapeutic index of the drug, dose adjustment is not required. The pharmacokinetics of ambroxol is not clinically significantly dependent on age and gender, so a change in dosage in elderly patients is not required. LASOLVAN tablets 30 mg should not be taken for more than 4-5 days without consulting a doctor. If you miss the next dose, you should take it as soon as you remember about it. If it’s almost time for the next dose, don’t take the missed dose and continue as usual. Do not take a double dose to make up for a forgotten individual dose. Directions for use LASOLVAN tablets 30 mg can be taken with or without food; Tablets should be swallowed whole and washed down with a sufficient amount of liquid (for example, water or fruit juice). Use during pregnancy and lactation Pregnancy Ambroxol hydrochloride crosses the placental barrier. Animal studies have not shown direct or indirect negative effects on pregnancy, embryonic/fetal development, childbirth or postnatal development. Extensive clinical experience with the use of the drug after the 28th week of pregnancy did not reveal any evidence of a negative effect on the fetus. However, the usual precautions regarding the use of any drug during pregnancy are recommended. In particular, the use of LASOLVAN is not recommended during the first trimester of pregnancy. Breastfeeding Period Ambroxol has been shown in animal studies to be excreted in breast milk. Use during breastfeeding is not recommended. Fertility Animal studies have shown no direct or indirect adverse effects on fertility. Precautions There have been reports of the development of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis in patients taking ambroxol. It is necessary to immediately stop using the drug if symptoms of a progressive skin rash appear (sometimes with the formation of blisters or damage to the mucous membranes of the mouth, pharynx, nose, eyes, genitals) and urgently consult a doctor. In patients with impaired bronchial motility and profuse sputum secretion (as, for example, in the rare syndrome of primary ciliary dyskinesia), LAZOLVAN tablets 30 mg should be used with caution due to the risk of sputum accumulation. 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 case of severe renal impairment, accumulation of ambroxol metabolites formed in the liver may occur. One tablet contains 171 mg of lactose, which is 684 mg of lactose in the maximum recommended daily dose. LAZOLVAN 30 mg tablets should not be taken in patients with rare hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. Interaction with other drugs Simultaneous use of LAZOLVAN tablets 30 mg and drugs that suppress cough can lead to a dangerous accumulation of sputum in the respiratory tract due to a weakening of the cough reflex. This combination should only be used after a careful assessment of the risks and benefits. Contraindications The drug LAZOLVAN tablets 30 mg is contraindicated in patients with known hypersensitivity to ambroxol hydrochloride or to any of the excipients. LASOLVAN 30 mg tablets should not be given to children under 6 years of age. Children under the age of 6 years may be prescribed LASOLVAN syrup and / or LASOLVAN solution for inhalation. Composition 1 tablet contains: active ingredient: ambroxol hydrochloride 30 mg; excipients: dried corn starch, anhydrous colloidal silicon dioxide, lactose monohydrate, magnesium stearate. Overdose No specific symptoms characteristic of an overdose in humans have been described. In case of accidental overdoses or cases of medical errors, the observed symptoms correspond to adverse reactions that occur when taken at recommended doses and may require symptomatic therapy. Side effect Criteria for assessing the frequency of adverse drug reactions: very often (? 1/10); often (?1/100, <1/10); infrequently (?1/1000, <1/100); rarely (?1/10000, <1/1000); very rarely (<1/10000); frequency unknown (cannot be determined from the available data). Immune system disorders Rare: hypersensitivity reactions. Frequency unknown: anaphylactic reactions, including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissue, mucous membrane or submucosa), itching. Gastrointestinal disorders Common: nausea. Uncommon: Vomiting, diarrhea, dyspepsia, abdominal pain. Very rare: salivation. Respiratory, thoracic and mediastinal disorders Not known: dyspnea (as a symptom of an allergic reaction). Skin and subcutaneous tissue disorders Rare: rash, urticaria. Frequency unknown: severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis). General disorders and injection site reactions Uncommon: fever, mucosal reactions. It is important to report suspected adverse reactions after registration of a medicinal product in order to ensure continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are encouraged to report any suspected adverse drug reactions through national adverse drug reaction and drug failure reporting systems. The patient, if he experiences any adverse reactions, is advised to consult a doctor. This recommendation applies to any possible adverse reactions, including those not listed in the instructions for use of the drug. You can also report adverse reactions to the adverse drug reactions (actions) information database, including reports of drug failures. By reporting adverse reactions, you help to get more information about the safety of the drug. Storage conditionsStore at a temperature not exceeding 30 °C. Keep out of the reach of children. Buy Lazolvan tablets 30mg No. 10x5