Lazolvan syrup 30mg/5ml bottle 100ml №1

Name:
Lazolvan syrup 30mg/5ml in vial 100ml in pack. No. 1
Description:
Transparent or almost transparent, colorless or almost colorless, slightly viscous syrup. The main active ingredient Ambroxol Release form Syrup Dosage 30 mg / 5 ml in a vial. 100ml Special instructions Do not use Lazolvan® syrup in combination with antitussives that make it difficult to remove sputum. Sorbitol, which is part of the syrup, can have a mild laxative effect. Lazolvan® syrup (30 mg/5 ml) contains 5 g of sorbitol in terms of the maximum recommended daily dose (20 ml), Lazolvan® syrup (15 mg/5 ml) contains 10.5 g of sorbitol in terms of the maximum recommended daily dose (30 ml ). Patients with rare hereditary fructose intolerance should not take this medicine. There have been isolated cases of severe skin lesions, for example, Stevens-Johnson syndrome and Lyell’s syndrome, coinciding in time with the appointment of ambroxol; however, the relationship with the drug has not been proven. 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 taken only as directed by a doctor. 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 In preclinical studies, it was shown that ambroxol hydrochloride, the active substance of Lazolvan, increases secretion in the respiratory tract, enhances the synthesis of pulmonary surfactant and stimulates ciliary activity. 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 sputum transport (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 addition, in patients with chronic bronchitis and/or chronic obstructive pulmonary disease (COPD), the number of exacerbations of the disease is reduced. 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. In vitro tests have shown 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 disorders. The simultaneous use of ambroxol hydrochloride with antibiotics (amoxicillin, cefuroxime, erythromycin and doxycycline) increases the concentration of antibiotics in the lung tissue. To date, the clinical significance of this effect has not been proven. Pharmacokinetics Absorption Absorption of oral immediate release forms is high and complete, the time to reach maximum plasma concentration is 1-2.5 hours after oral administration and 6.5 hours for slow release forms. The maximum bioavailability of 30 mg tablets approaches 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. Communication with blood plasma proteins – 90%, penetrates the blood-brain barrier, placental barrier, excreted in breast milk. Metabolism and biotransformation Approximately 30% of an oral dose is eliminated by first pass metabolism. Ambroxol is initially metabolized in the liver by conjugation, forming dibromanthranilic acid (approximately 10% of the dose), glucuronic conjugates and several minor metabolites. Studies of human liver microsomes have shown that CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol. With a three-day oral administration of ambroxol, approximately 6% of the dose is in the free form and 26% of the dose is converted into a conjugated form and excreted in the urine. Withdrawal The half-life is 10 hours. The total clearance is in the range of 660 ml / min., The renal clearance provides approximately 83% 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 case of severe renal impairment, accumulation of ambroxol metabolites formed in the liver may occur. 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 broad therapeutic effect of ambroxol, dose adjustment is not required. Studies have shown that the pharmacokinetics of ambroxol does not depend on age and gender and thus does not require dose changes. Eating does not affect the bioavailability of ambroxol hydrochloride. Preclinical safety data Ambroxol hydrochloride has a very low acute toxicity rate. In multiple oral dose trials of 150 mg/kg/day (mice, 4 weeks), 50 mg/kg/day (rats, 52 and 78 weeks), 40 mg/kg/day (rabbits, 26 weeks) and 10 mg /kg/day (dogs – 52 weeks) corresponded to the maximum doses leading to the development of observed adverse reactions (NOAELs). Toxicological studies did not reveal damage to target organs. Four-week toxicity studies with intravenous ambroxol hydrochloride in rats at 4, 16, and 64 mg/kg/day and in dogs at 45, 90, and 120 mg/kg/day (3 h/day infusions) showed no severe local or systemic effects. toxicity, including histopathology. All adverse reactions were reversible. Ambroxol hydrochloride, when tested at oral doses up to 3000 mg/kg/day in rats and up to 200 mg/kg/day in rabbits, showed neither embryotoxic nor teratogenic properties. The fertility of male and female rats did not change when the drug was administered at doses up to 500 mg/kg/day. NOAEL during perinatal and postnatal development was 50 mg/kg/day. At a dose of 500 mg/kg/day, ambroxol hydrochloride showed little toxicity to females and newborn offspring, which was manifested in a delay in body weight gain and a decrease in offspring size. Genotoxic studies in experiments in vitro (Ames test and analysis of chromosomal aberrations) and in vivo (micronuclear test in mice) did not show the mutagenic potential of ambrcosol hydrochloride. Ambroxol hydrochloride showed no tumorigenic potential in carcinogenicity studies in mice (50, 200, and 800 mg/kg/day) and rats (65, 250, and 1000 mg/kg/day) administered in admixture with feed for 105 and 116 weeks, respectively. Indications for use Reducing the viscosity and facilitating sputum discharge in colds and flu in adults/children over two years of age. Dosage and administration Syrup 15 mg/5 ml Children 6-12 years old: 5 ml (15 mg ambroxol hydrochloride) 2-3 times a day. The maximum dose is 45 mg ambroxol hydrochloride per day. After 2-3 days, if the patient feels better, LASOLVAN can be taken 2 times a day, i.e. every 12 hours. Children 2-5 years: 2.5 ml (7.5 mg ambroxol hydrochloride) 3 times a day (every 8 hours). The maximum dose is 22.5 mg ambroxol hydrochloride per day. After 2-3 days, if the patient feels better, LASOLVAN can be taken 2 times a day, i.e. every 12 hours. Children under 2 years of age: This medicinal product is contraindicated in children under 2 years of age. Syrup 30 mg/5 ml Adults: 10 ml (60 mg ambroxol hydrochloride) 2 times a day (every 12 hours). The maximum dose is 120 mg ambroxol hydrochloride per day. If the patient improves, the dose of LAZOLVAN can be halved. Children over 12 years: 5-7.5 ml (30-45 mg ambroxol hydrochloride) 2 times a day (every 12 hours). The maximum dose is 60-90 mg of ambroxol hydrochloride per day. Children 6-12 years old: 2.5 ml (15 mg ambroxol hydrochloride) 2-3 times a day. The maximum dose is 45 mg ambroxol hydrochloride per day. After 2-3 days, if the patient feels better, LASOLVAN can be taken 2 times a day, i.e. every 12 hours. Children 2-5 years: 1.25 ml (7.5 mg ambroxol hydrochloride) 3 times a day (every 8 hours). The maximum dose is 22.5 mg ambroxol hydrochloride per day. After 2-3 days, if the patient feels better, LASOLVAN can be taken 2 times a day, i.e. every 12 hours. Children under 2 years of age: This medicinal product is contraindicated in children under 2 years of age. Patients with impaired renal and hepatic function In patients with impaired renal function or severely impaired liver function, the drug should be taken only as prescribed by a physician and under medical supervision. Since the drug is metabolized in the liver and excreted by the kidneys, in case of severe renal insufficiency, the accumulation of ambroxol metabolites formed in the liver is expected. Skipping a dose If you forget to take LASOLVAN or take an insufficient amount, continue taking the drug further according to the dosing regimen. Do not double your dose to make up for a missed dose. It is recommended to drink a glass of water after each dose and drink more fluids throughout the day. LASOLVAN may be taken with or without food. If symptoms do not improve or worsen after 5 days of treatment, you should consult a doctor to reassess the clinical situation. 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. The use of LASOLVAN is not recommended, especially 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 reaction (sometimes associated with the development of blisters and lesions of the mucous membranes of the mouth, pharynx, nose, eyes, genitals) appear and immediately consult a doctor. 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 impairment of kidney function, accumulation of ambroxol metabolites formed in the liver may occur. In patients with impaired bronchial motility and copious bronchial secretions (as, for example, in the rare syndrome of primary ciliary dyskinesia), LASOLVAN should be used with caution due to the risk of difficult discharge of large amounts of sputum and bronchial obstruction. Lazolvan syrup contains sorbitol (E-420). Sorbitol is a source of fructose. Patients with hereditary fructose intolerance should not use this medicine. An additive effect should be taken into account when using sorbitol or fructose from other sources. The content of sorbitol in medicinal products may affect the bioavailability of other medicinal products used simultaneously. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect. When prescribing to children aged 2 to 6 years, the risk / benefit ratio should be considered. LASOLVAN syrup 30 mg/5 ml: 1.2 g of sorbitol is contained in 5 ml of syrup, which is 4.9 g of sorbitol in the maximum recommended daily dose (20 ml). LASOLVAN syrup 15 mg/5 ml: 1.2 g of sorbitol is contained in 5 ml of syrup, which is 7.4 g of sorbitol in the maximum recommended daily dose (30 ml). Interaction with other drugs: Combined use with antitussive drugs leads to difficulty in sputum discharge against the background of a decrease in cough, therefore, it is recommended with caution, after a thorough assessment of the benefit / risk ratio. Increases the penetration and concentration in the bronchial secretion of amoxicillin, cefuroxime and erythromycin. The clinical significance of this has not been established. Contraindications Hypersensitivity to ambroxol or other components of the drug. Rare hereditary intolerance to any component of the drug (see section “Precautions”). Children under the age of 2 years. CompositionSyrup 15 mg / 5 ml: 5 ml of syrup contains the active substance – ambroxol hydrochloride 15 mg; excipients – benzoic acid (E210), hydroxyethylcellulose, acesulfame potassium (E950), non-crystallizing liquid sorbitol (E420), 85% glycerin (E422), PHL-132195 flavor “Wild berries”, flavor “Vanilla” 201629, purified water. Syrup 30 mg / 5 ml: 5 ml of syrup contains the active substance – ambroxol hydrochloride 30 mg; excipients – benzoic acid (E210), hydroxyethyl cellulose, acesulfame potassium (E950), non-crystallizing liquid sorbitol (E420), 85% glycerin (E422), PHL-132200 strawberry and cream flavor, Vanilla flavor 201629, purified water. Overdose Symptoms of overdose in humans are not described. In case of accidental overdoses and/or cases of medical error, the observed symptoms have been reported to be consistent with the known side effects of LAZOLVAN when used at the recommended doses. Possible: nausea, vomiting, diarrhea, dyspepsia. Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug, symptomatic therapy. Side effect Criteria for assessing the frequency of adverse drug reactions are classified according to the international dictionary of adverse reactions divided by system-organ classes (MedDRA system): 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). Frequent adverse reactions are: taste perversion, pharyngeal hypoesthesia, nausea, oral cavity hypoesthesia. Immune system disorders: rarely: hypersensitivity reactions; frequency unknown: anaphylactic reactions, including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissue, mucous or submucosal tissue), itching. Nervous system disorders: often: taste perversion. Respiratory, thoracic and mediastinal disorders: often: hypoesthesia of the pharynx; very rarely: rhinorrhea; frequency unknown: shortness of breath (as a symptom of an allergic reaction). From the gastrointestinal tract: often: nausea, hypoesthesia of the oral cavity; infrequently: vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth; rarely: dry throat; very rarely: constipation, hypersalivation. Skin and subcutaneous tissue disorders: rarely: rash, urticaria; frequency unknown: severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis). From the side of the kidneys and urinary tract: very rarely - dysuria. General disorders and reactions at the injection site: infrequently: fever, reactions from the mucous membrane. Reporting adverse 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 conditions Syrup 15 mg / 5 ml should be stored at a temperature not exceeding 30 ° C, do not freeze. Store syrup 30 mg/5 ml at a temperature not exceeding 30°C, do not freeze. Keep out of the reach of children. Buy Lazolvan syrup 30mg/5ml in a 100ml vial No. 1