Odeston tablets 200mg №10×5

NameOdeston. Forms of release Tablets. MNNHymecromon. FTG Choleretic agent. Basic properties Tablets are white or white with a yellowish tint, round, flat, with the letters “Ch” engraved on one side. Ingredients One tablet contains: Active ingredient Hymecromon 200 mg. Excipients Potato starch, gelatin, sodium lauryl sulfate, magnesium stearate. Pharmacotherapeutic groupMeans for the treatment of diseases of the liver and biliary tract. Other drugs for the treatment of diseases of the biliary tract. ATS code: А05АХ02 Pharmacological properties Pharmacodynamics Hymecromon is a derivative of coumarin. It acts spasmolytically on the smooth muscles of the bile ducts and the sphincter of Oddi, increases the secretion of bile and accelerates its excretion through the bile ducts. It reduces bile stasis and associated ailments, and also prevents the deposition of cholesterol and the formation of gallstones. Favorably affects the regeneration of hepatocytes damaged by cholestasis. Pharmacokinetics Absorption After oral administration, Hymecromone is well absorbed from the gastrointestinal tract, and its bioavailability is about 70-90%. Food does not affect the absorption of Hymecromon. In humans, after oral administration, the maximum concentration of hymecromon occurs after 1-2 hours. Hymecromon absorption is not dose dependent. Distribution After absorption into the blood, hymecromon is bound to plasma proteins. The mean volume of distribution of Hymecromon is 20.8 ± 1.4 L. The maximum plasma concentration of hymecromon ranged from 4.1 to 5.5 µg/ml. In a state of equilibrium concentration, the volume of distribution is 36.4 ± 2.11 liters. In the group of persons after cholecystectomy (with normal results of liver function tests), the parameters of the pharmacokinetics of hymecromon did not differ from those observed in healthy individuals. T0.5 absorption was 1.87 hours. Metabolism Hymecromon is metabolized mainly in the liver to hymecromon glucuronide and to hymecromon. Other coumarin derivatives are metabolized in a similar way. Intensive metabolism of hymecromon occurs during the first passage, and in humans this process does not depend on the dose in the range of applied therapeutic doses. A small amount of Hymecromone is also metabolized in the intestine and other tissues. In individuals with chronic liver injury, the rate of metabolism of hymecromone is slow, indicating the need to reduce the dose of hymecromone in these individuals. Withdrawal The half-life of hymecromon from the blood is on average 28 ± 2 minutes. Less than 0.8% of the administered dose is excreted more slowly, and the half-life of this fraction is from 70 to 359 minutes. The half-life of hymecromon in the body in persons with chronic hepatitis ranges from 3.77 to 4.33 hours, an average of 4 hours. Hymecromon is excreted in the urine in the form of metabolites. The main metabolite of hymecromone excreted in the urine is hymecromone glucuronide, which accounts for about 93 ± 4% of the administered dose. Hymecromone sulfate is excreted in the urine in smaller quantities. In the form of hymecromone sulfate, about 1.4 ± 0.3% of the administered dose is excreted in the urine. There are no data on the entry of Hymecromon into human milk and its penetration through the placenta. Indications for use As part of complex therapy for: – functional disorders of the gallbladder and biliary dyskinesia; – dyspeptic disorders (lack of appetite, nausea, constipation) associated with reduced bile secretion; – functional disorders of the biliary tract with uncomplicated cholelithiasis, after operations on the gallbladder and bile ducts. Method of application and dosage Dosage: Adults: 200-400 mg (1-2 tablets) 3 times a day orally 30 minutes before meals, swallowed whole with a little water. The daily dose is 1200 mg. Children over 7 years: 200 mg (1 tablet) 1 to 3 tablets daily by mouth 30 minutes before meals, swallowed whole with some water. Daily dose 600 mg. How to use: Inside 30 minutes before meals. Course of treatment: 2 weeks. Reception by patients with impaired renal and (or) hepatic function: The drug should not be used in patients with renal or hepatic insufficiency. Use in elderly patients: There is no need to change the dosage of the drug in elderly patients. If a dose is missed, the drug should be taken as soon as possible or, if the next dose is approaching, the missed dose should not be taken. Do not take a double dose at once. Side effects The following table summarizes the side effects of Hymecromone, according to the classification of the MedDRA system by frequency: very often (1/10), often (from 1/100 to < 1/10), infrequently (from 1/1000 to < 1/100) , rare (from 1/10000 to <1/1000), very rare (<1/10000), unknown (frequency cannot be estimated from the available data). Hymecromon is usually well tolerated. Nervous system disorders: rarely - headache. Gastrointestinal disorders: Not known Diarrhea, abdominal fullness or pressure, abdominal pain, flatulence, ulceration of the gastrointestinal mucosa Skin and subcutaneous tissue disorders: Rare: rash (including urticaria); unknown - anaphylactic reactions, including urticaria (rash), itching, shortness of breath, angioedema and hypotension, which can progress to anaphylactic shock. Reporting Suspected 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. Healthcare professionals are encouraged to report suspected adverse reactions through national adverse reaction reporting systems. In case of manifestation of the listed adverse reactions, as well as reactions not listed in the leaflet, stop taking the drug and consult a doctor. Contraindications - hypersensitivity to hymecromon or any other component of the drug, - obstruction of the bile ducts, - acute renal and / or liver failure, - patients with ulcerative colitis and Crohn's disease, - peptic ulcer of the stomach and 12 duodenal ulcers, - hemophilia, - children's age up to 7 years. Overdose Hymecromon is non-toxic, diarrhea occurs when using doses exceeding therapeutic ones. Treatment is symptomatic, gastric lavage, administration of activated charcoal or correction of fluid and electrolyte balance (in case of acidosis and loss of potassium). Precautions In case of symptoms of renal and / or hepatic insufficiency, the drug should be discontinued. The drug contains sodium in a small concentration: 1 Odeston tablet contains less than 1 mmol sodium (23 mg). Use in children This medicinal product is not intended for use in children under 7 years of age. Use in pregnant and breastfeeding women The safety of this medicinal product has not been established during pregnancy. Odeston can be used in acute conditions for short periods only if the expected therapeutic effect for the mother outweighs the potential risk to the fetus / child. The drug is not recommended for use during breastfeeding, if necessary, breastfeeding should be discontinued. Influence on the ability to drive vehicles and maintain moving mechanisms The drug is safe and does not affect the psychophysical abilities and the ability to service moving mechanisms, as well as drive a vehicle while driving. Interaction with other medicinal products Morphine weakens the effect of Hymecromon. When hymecromone and metoclopramide are taken together, the effect of both drugs decreases. Hymecromon enhances the effect of indirect anticoagulants. Conditions and shelf life The drug should be stored in its original packaging at temperatures up to 25°C. Keep out of the reach of children. 4 years. Do not use the drug after the expiration date. Holiday conditions Without a doctor's prescription. Packing: 10 tablets in a blister of PVC and aluminum foil (PCV/A1.). 2, 5 or 10 blisters, together with a leaflet, are enclosed in a cardboard box. Buy Odeston tablets 200mg No. 10x5 Price for Odeston tablets 200mg No. 10x5