Ursosan capsules 250mg №10×5

Name:
Ursosan.
Description:
Capsules: gelatin capsules size No. 0, capsule cap white, body white. The main active ingredient is Ursodeoxycholic acid. Release formCapsules. Dosage 250 mg. Special instructions Pharmacological group Means for the treatment of diseases of the liver and biliary tract. Means based on bile acids. ATX code: A05AA02. Action Ursodeoxycholic acid is a bile acid found in small amounts in human bile. Compared to other bile acids, it is non-toxic. When taken orally, it is absorbed in the small intestine and enters the liver through the blood stream. An increased concentration of ursodeoxycholic acid promotes the dissolution of cholesterol gallstones. The effect is manifested mainly due to a decrease in the concentration of cholesterol in bile, which is associated with inhibition of its secretion into bile and absorption in the intestine. Ursodeoxycholic acid has a beneficial effect on liver function, providing a hepatoprotective effect, which allows it to be successfully used in patients with various liver diseases, including those accompanied by bile stasis. Ursodeoxycholic acid also has a significant immunomodulatory effect. Indications for use For the dissolution of x-ray negative cholesterol gallstones no larger than 15 mm in diameter in patients with a functioning gallbladder, despite the presence of gallstone(s) in it(s). For the treatment of gastritis with bile reflux. For the symptomatic treatment of primary biliary cirrhosis in the absence of decompensated liver cirrhosis. For the treatment of hepatobiliary disorders in cystic fibrosis in children aged 6 to 18 years. Method of application and doses There are no age restrictions on the use of the drug. For patients who weigh less than 47 kg or who have difficulty swallowing capsules, ursodeoxycholic acid in the form of a suspension should be used. For the dissolution of cholesterol gallstones For the dissolution of gallstones in adults, the usual dose is 2 to 5 capsules per day, depending on the weight of the patient (10 mg/kg/day). Body weight Ursodeoxycholic acid Number of capsules up to 60 kg 500 2 up to 80 kg 750 3 up to 100 kg 1000 4 more than 100 kg 1250 5 Capsules should be taken regularly. The time needed for gallstones to dissolve is usually 6-24 months. If a decrease in the size of gallstones is not observed after 12 months of administration, therapy should not be continued. The success of the treatment should be checked every 6 months by ultrasound or X-ray. Additional studies need to be checked so that calcification of stones does not occur over time. If this happens, treatment should be discontinued. For the treatment of gastritis with bile reflux 250 mg 1 time per day with some liquid in the evening before bedtime. Usually for the treatment of gastritis with bile reflux, the drug is taken within 10-14 days. The duration of use depends on the condition of the patient. The doctor must decide on the duration of treatment in each case individually. For the symptomatic treatment of primary biliary cirrhosis (PBC) The daily dose depends on body weight and varies from 750 mg to 1,750 mg (14 ± 2 mg ursodeoxycholic acid/kg body weight). In the first 3 months of treatment, the drug should be taken by distributing the daily dose into 3 doses during the day. With improvement in liver function, the daily dose can be taken 1 time per day in the evening. Calculation of the daily number of capsules depending on the patient’s body weight and the recommended dose of the drug per 1 kg of body weight (mg / kg / day). Body weight (kg) Daily dose (mg/kg body weight) Distribution of drug intake First 3 months Later Morning Afternoon Evening Evening (1 time per day) 47-62 12-16 250 mg 250 mg 250 mg 750 mg 63-78 13 -16 250 mg 250 mg 500 mg 1,000 mg 79-93 13-16 250 mg 500 mg 500 mg 1,250 mg 94-109 14-16 500 mg 500 mg 500 mg 1,500 mg over 110,500 mg 500 mg 750 mg 1 750 mg Capsules should be swallowed whole with liquid. It is necessary to observe the regularity of reception. The use of the drug in primary biliary cirrhosis can be unlimited in time. In patients with primary biliary cirrhosis, in rare cases, clinical symptoms may worsen at the beginning of treatment, for example, itching may increase. If this happens, therapy should be continued, taking 250 mg per day, and then gradually increase the dose (increasing the daily dose by 250 mg weekly) until the prescribed dosing regimen is reached. Use in children Cholesterol gallstones and primary biliary cirrhosis are very rare in children. There are no data on the efficacy and safety of the drug in this population. If necessary, the dose should be adjusted according to body weight. For children with cystic fibrosis aged 6 to 18 years, the dosage is 20 mg / kg / day and is divided into 2-3 doses, followed by an increase in dose to 30 mg / kg / day, if necessary. Body weight (kg) Daily dose (mg/kg) Ursosan®, capsules 250 mg Morning Afternoon Evening 20-29 17-25 1 – 1 30-39 19-25 1 1 1 40-49 20-25 1 1 2 50- 59 21-25 1 2 2 60-69 22-25 2 2 2 70-79 22-25 2 2 3 80-89 22-25 2 3 3 90-99 23-25 3 3 3 100-109 23-25 3 3 4 >110 3 4 4 Use during pregnancy and lactation There are no sufficient data on the use of ursodeoxycholic acid during pregnancy. Animal studies have shown reproductive toxicity in early pregnancy. Ursodeoxycholic acid should not be used by women during pregnancy. If it is necessary to use during pregnancy, it is necessary to evaluate the ratio of the benefits of treatment and the risk to the fetus. The decision can only be made by a doctor. Women of reproductive age can be treated only with reliable contraception. Patients of childbearing age taking a drug to dissolve gallstones should use effective non-hormonal methods of contraception, as hormonal oral contraceptives can promote the formation of gallstones. Before starting treatment, the possibility of pregnancy should be excluded. Limited data indicate that ursodeoxycholic acid passes into breast milk and is found in low amounts, and therefore the development of undesirable effects is unlikely. Influence on the ability to drive vehicles and other mechanisms The drug has no or little effect on the ability to drive vehicles and work with mechanisms. Precautions In the presence of variceal bleeding, hepatic encephalopathy, ascites, and if a liver transplant is necessary, patients should receive appropriate specific treatment. Monitoring the effectiveness of the use of ursodeoxycholic acid in the treatment of cholestatic liver diseases is based on the analysis of the biochemical parameters of cholestasis, as well as the detection of signs of liver cytolysis (increased activity of aspartate aminotransferase (ACT) and alanine aminotransferase (ALT), which often accompany the progression of cholestasis. During the first 3 months of therapy, the doctor should monitor liver function parameters ACT, ALT and γ-GTP every 4 weeks, then every 3 months.If diarrhea occurs, the dose of the drug should be reduced, and if diarrhea continues, the use of ursodeoxycholic acid should be discontinued. dissolution of gallstones, should use effective non-hormonal methods of contraception, since hormonal contraceptives can contribute to the formation of gallstones.In very rare cases, when treating patients with late stage primary biliary cirrhosis, decompensated cirrhosis, which was partially reversible after discontinuation of treatment. In patients with primary cirrhosis, clinical symptoms (eg, itching) may rarely worsen at the start of treatment. In this case, the dose should be reduced to 1 capsule of 250 mg per day, and then gradually increased to the recommended dose. With diarrhea, the dose should be reduced. In cases of persistent diarrhea, treatment should be discontinued. When used to dissolve cholesterol gallstones: in order to assess the therapeutic effect and to timely detect calcification of gallstones, depending on the size of the stone, it is necessary to visualize (using oral cholecystography) the general appearance and appearance of the blockage of the gallbladder in the standing position and lying on the back (ultrasound control ) 6-10 months after the start of treatment. If the gallbladder cannot be visualized on x-rays or in cases of calcification of stones, impaired contractility of the gallbladder, or frequent biliary colic, ursodeoxycholic acid preparations should not be taken. Use in persons over 65 years of age: Special studies have not been conducted. However, given the known data, no features are foreseen that could limit the use of ursodeoxycholic acid in the elderly. Interaction with other drugs Ursosan should not be used simultaneously with cholestyramine, colestipol or antacids containing aluminum hydroxide and / or smectite, since these drugs bind ursodeoxycholic acid in the intestine, thus preventing its absorption and reducing effectiveness. If the use of preparations containing one of these substances is necessary, they must be taken at least 2 hours before or 2 hours after taking Ursosan® capsules. Ursodeoxycholic acid may enhance the absorption of cyclosporine from the intestine. In patients taking cyclosporine, the doctor should check the concentration of this substance in the blood and, if necessary, adjust the dose of cyclosporine. In some cases, ursodeoxycholic acid may reduce the absorption of ciprofloxacin. In a clinical study in healthy volunteers, the combined use of ursodeoxycholic acid (500 mg/day) and rosuvastatin (20 mg/day) resulted in a slight increase in plasma concentrations of rosuvastatin. The clinical significance of this interaction, as well as the significance of interactions with other statins, is unknown. Ursodeoxycholic acid has been shown to reduce the peak plasma concentration (Cmax) and area under the curve (AUC) of the calcium antagonist nitrendipine in healthy volunteers. Careful monitoring of the result of the combined use of nitrendipine and ursodeoxycholic acid is recommended. An increase in the dose of nitrendipine may be required. In addition, a decrease in the therapeutic effect of dapsone has been reported. These findings, as well as in vitro data, suggest that ursodeoxycholic acid has the potential to induce cytochrome P450 3A enzymes. However, in an interaction study with budesonide, which is a cytochrome P450 3A substrate, no such effect was observed. With the simultaneous use of drugs that are metabolized with the participation of this enzyme, care must be taken and it should be borne in mind that dose adjustment may be required. Estrogen hormones, as well as cholesterol-lowering drugs such as clofibrate, increase cholesterol secretion by the liver and thus can promote gallstone formation, causing an effect opposite to that of the ursodeoxycholic acid used to dissolve them. Contraindications – with hypersensitivity to ursodeoxycholic acid or other components of the drug; – with decompensated cirrhosis of the liver; – with acute inflammation of the gallbladder and biliary tract; – with obstruction of the bile ducts (blockage of the common bile or cystic duct); – if the gallbladder is not visualized by X-ray methods; – in the presence of calcified stones; – in violation of the contractility of the gallbladder; – in case of frequent attacks of biliary colic; – with severe functional disorders of the kidneys and liver. Children and adolescents: – Unfortunate result of portoenterostomy or lack of adequate biliary outflow in children with biliary atresia. Composition Active substance: ursodeoxycholic acid 250 mg in one capsule. Excipients: corn starch, pregelatinized corn starch, anhydrous colloidal silicon dioxide, magnesium stearate. Capsule composition: gelatin, titanium dioxide. Overdose Overdose is unlikely because the absorption of ursodeoxycholic acid decreases with increasing dose, and it is mainly excreted in the feces. Overdose may cause diarrhea. If diarrhea occurs, the dose should be reduced, and if diarrhea persists, the use of ursodeoxycholic acid should be discontinued. The effects of diarrhea should be treated symptomatically with fluid and electrolyte balance maintained. Long-term use of high doses of ursodeoxycholic acid (28-30 mg/kg/day) in patients with primary sclerosing cholangitis (off-label use) was associated with a higher incidence of serious side effects. Side effects Undesirable reactions are presented in accordance with the classification of organ systems and the frequency of occurrence: very often (≥1 / 10), often (≥1 / 100 to < 1/10), infrequently (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to <1/1,000), very rare (< 1/10,000), frequency unknown (cannot be estimated from the available data. Gastrointestinal disorders In clinical studies, the presence of pasty stools or very rarely in the treatment of primary biliary cirrhosis, severe abdominal pain with localization in the right hypochondrium was noted.On the part of the liver and gallbladder Very rarely, during the treatment with ursodeoxycholic acid, calcification of gallstones is possible.During the treatment of late stages of primary biliary cirrhosis, decompensation of cirrhosis of the liver was very rarely observed , which partially regressed after discontinuation of treatment.On the part of the skin and subcutaneous tissue Allergic reactions are very rarely possible, including rash, urticaria. If you experience any unusual reactions, stop taking the drug and talk to your doctor. Storage conditions In a dry, dark place at a temperature of 15-25 °C. Shelf life 4 years. Warnings Do not take the drug after the expiry date stated on the package. Keep the drug out of the reach of children. 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