Ambroxol tablets 30mg №10×2

Name Ambroxol tab 30mg №20 The risk on the tablet has a functional purpose, for dividing into two halves equal in dosage. Composition Each tablet contains: active ingredient – ambroxol hydrochloride? 30 mg; Excipients ? lactose monohydrate, potato starch, calcium stearate, anhydrous colloidal silicon dioxide. Pharmacotherapeutic groupMeans used for coughs and colds. mucolytic agents. ATX code – R05CB06. Pharmacological properties Pharmacodynamics A mucolytic agent that increases the synthesis and secretion of surfactant and blocks its decay. It has a secretomotor, secretolytic and expectorant effect; stimulates the serous cells of the glands of the bronchial mucosa, increases the content of the mucous secretion and the release of a surfactant (surfactant) in the alveoli and bronchi; normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolyzing enzymes and increasing the release of lysosomes from Clark cells, it reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport. After oral administration, the effect occurs after 30 minutes and lasts for 6-12 hours. Pharmacokinetics Absorption Absorption of ambroxol hydrochloride from oral forms with immediate release is fast and fairly complete with a linear dependence in the therapeutic range. The maximum concentration in blood plasma is reached 1-2.5 hours after ingestion 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, 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 dose 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 sputum formation and excretion. Contraindications Hypersensitivity to the active substance, ambroxol hydrochloride, or any of the excipients listed in the Composition section. Ambroxol 30mg tablets are not suitable for children under 6 years of age due to the high content of the active ingredient. Dosing and Administration Inside, regardless of the meal, drinking enough liquid to swallow the tablet (for example, water, tea or fruit juice). Adults and adolescents from 12 years of age: in the first 2-3 days, 1 tablet (30 mg) 3 times a day. Then 1 tablet (30 mg) 2 times a day. For adults and adolescents over 12 years of age, to increase therapeutic efficacy, the dose can be increased to 2 tablets 2 times a day (equivalent to 120 mg ambroxol hydrochloride / day). Children aged 6 to 12 years: 1/2 tablet (15 mg) 2 to 3 times a day. The duration of treatment is determined by the doctor individually and depends on the severity of the disease. Side effects Side effects are classified by frequency of occurrence: very often (?1/10), often (?1/100, but <1/10), infrequently (?1/1000, but <1/100), rarely (?1/10 10,000 but <1/1000), very rare (<1/10,000), frequency unknown (cannot be estimated from available data). Immune system disorders: rarely - hypersensitivity reactions; the frequency is unknown - anaphylactic reactions, including anaphylactic shock, angioedema, itching. Respiratory, thoracic and mediastinal disorders: frequency unknown - shortness of breath (as a symptom of hypersensitivity). Gastrointestinal disorders: often - nausea, infrequently - vomiting, diarrhea, dyspepsia, abdominal pain; very rarely - salivation. Skin and subcutaneous tissue disorders: rarely - skin rash, urticaria; frequency unknown - severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epi-ermal necrolysis, acute generalized exanthematous pustulosis). Renal and urinary tract disorders: very rarely - dysuria. General disorders and reactions at the injection site: infrequently - fever, reactions from the mucous membranes. 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. Medical workers are encouraged to send information about any suspected adverse reactions and ineffectiveness of the medicinal product to the address: Republican Unitary Enterprise "Center for Expertise and Testing in Healthcare", per. Comradely, 2a, 220037, Republic of Belarus, e-mail: [email protected]. Interaction with other drugs Joint use with antitussive drugs leads to difficulty in sputum discharge against the background of a decrease in cough, therefore Ambroxol is not recommended to be combined with antitussive drugs that make it difficult to remove sputum. This combination should only be used after careful consideration by the physician of the benefit/risk ratio. Ambroxol increases the penetration of amoxicillin, cefuroxime, erythromycin and doxycycline into the bronchial secretion, the clinical significance of this has not been established. There are reports of the possibility of developing severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis when taking ambroxol. It is necessary to immediately stop the use of the drug if symptoms of a progressive skin reaction (including those associated with the development of blisters and lesions of the mucous membranes) appear. In case of impaired renal function or severe liver disease, the drug can be taken only after consulting a doctor. As with any drug that is metabolized in the liver and excreted by the kidneys, in the event of severe renal impairment, accumulation of ambroxol metabolites formed in the liver is expected. In patients with impaired motor function of the bronchi and the formation of a large amount of secretion (as, for example, in the syndrome of primary ciliary dyskinesia), Ambroxol is recommended to be used with caution due to the possible accumulation of sputum in the lumen of the respiratory tract. This medicinal product contains lactose and should therefore not be taken by patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption syndrome. Pregnancy and lactation Adequate and strictly controlled clinical studies on the safety of the use of ambroxol during pregnancy and lactation have not been conducted. Ambroxol crosses the placental barrier. Animal studies have not shown direct or indirect negative effects on pregnancy, embryo/fetal development, childbirth. Extensive clinical experience has shown the absence of any evidence of adverse effects on the fetus after the 28th week of pregnancy. However, the usual precautions regarding the use of medicines during pregnancy should be observed. Ambroxol is not recommended for use especially during the first trimester of pregnancy. Ambroxol passes into breast milk. Although no adverse effect of the drug on the child is expected, ambroxol is not recommended for mothers during breastfeeding. Influence on the ability to drive vehicles and work with other mechanisms There are no known cases of the effect of the drug on the ability to drive vehicles and work with other mechanisms. Relevant studies have not been conducted. OverdoseSymptoms: No specific symptoms of overdose are known. In case of accidental overdoses or medical errors, symptoms were observed that corresponded to side effects when taking the drug at the recommended doses. Treatment: symptomatic. Upakovka10 tablets in a blister pack of PVC film and aluminum foil. 2 or 5 blister packs, together with the leaflet, are placed in a pack of cardboard (No. 10x2, No. 10x5). Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25? Keep out of the reach of children. Shelf life 3 years. Do not use after the expiration date. Conditions for dispensing from pharmaciesWithout a prescription. Buy Ambroxol tablets 30mg No. 10x2 Price for Ambroxol tablets 30mg No. 10x2