Ursodeoxycholic acid (Ursomax) 250 mg – [50 capsules]

Hepatoprotective drug, has a choleretic effect. Reduces the synthesis of cholesterol in the liver, its absorption in the intestine and its concentration in bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and excretion of bile. Reduces lithogenicity of bile and increases the content of bile acids in it. Causes increase in gastric and pancreatic secretion, increases lipase activity. It has a hypoglycemic effect. Causes partial or complete dissolution of cholesterol stones when ingested, reduces the saturation of bile with cholesterol, which promotes the mobilization of cholesterol from gallstones. It has an immunomodulatory effect, affects immunological reactions in the liver: it reduces the expression of some antigens on the membrane of hepatocytes, affects the number of T-lymphocytes, interleukin-2 formation, reduces the number of eosinophils.

Pediatric population.

Cystic fibrosis (cystic fibrosis).

According to clinical reports, there is a long history (up to 10 years or more) of treatment with ursodeoxycholic acid in pediatric patients with hepatobiliary disease associated with cystic fibrosis (CFAHD). There is evidence that therapy with ursodeoxycholic acid can decrease bile duct proliferation, slow down the development of lesions detected by histological examination, and even promote reversal of hepatobiliary changes if therapy is started at early stages of CFAHD. In order to optimize the effectiveness of treatment, ursodeoxycholic acid therapy should be started as early as possible after the diagnosis of CFAHD.

– Dissolution of small and medium-sized cholesterol stones in a functioning gallbladder;

– Biliary reflux gastritis and reflux esophagitis;

– Primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment);

– Chronic hepatitis of different genesis;

– Primary sclerosing cholangitis;

– Cystic fibrosis;

– Nonalcoholic steatohepatitis;

– alcoholic liver disease;

– biliary dyskinesia.

Contraindications .

– Hypersensitivity to the components of the drug and other bile acids;

– X-ray-positive (high in calcium) gallstones;

– impairment of the contractility of the gallbladder;

– Acute inflammatory diseases of the gallbladder, bile ducts, and intestines;

– cirrhosis of the liver in the stage of decompensation;

– Severe hepatic and/or renal insufficiency;

– biliary tract occlusion (occlusion of common bile duct or vesicular duct);

– Frequent episodes of biliary colic;

– unsuccessfully performed portoenterostomy or cases of absence of restoration of normal bile flow in children with biliary tract atresia;

– Children under 3 years of age (not recommended for use in this dosage form).

Ursodeoxycholic acid has no age restrictions for use, but children under 3 years of age are recommended to use the drug in the form of suspension, since there may be difficulties in swallowing the capsules.

 

• Inside. Children and adults with body weight less than 47 kg are recommended to use the drug in the form of suspension.
• Dissolution of cholesterol gallstones:
• The recommended dose is 10 mg/kg/day, which corresponds to:
• Body weight, kg Number of capsules, pcs.
• up to 60 2
• 61-80 3
• 81-100 4
• Over 100 5
• The drug should be taken every day in the evening before going to bed (capsules are not chewed), drinking plenty of fluids. Duration of treatment – 6-12 months. For the prevention of recurrent cholelithiasis is recommended to take the drug for several months after the dissolution of stones.
• Treatment of biliary reflux gastritis and reflux esophagitis:
• 1 capsule of the drug daily in the evening before going to bed (capsules are not chewed), with a small amount of water. The course of treatment – from 10-14 days to 6 months, if necessary – up to 2 years.
• Symptomatic treatment of primary biliary cirrhosis:
• Daily dose depends on body weight and is from 3 to 7 capsules (about 14±2 mg/kg ursodeoxycholic acid per 1 kg of body weight). During the first 3 months of treatment, the use of the drug in 250 mg capsules should be divided into several intakes during the day. After improvement of hepatic parameters the daily dose of the drug can be taken 1 time in the evening. The following mode of administration is recommended:
• 250 mg capsules
• Body weight, kg Daily dose
• (Capsules, units) Morning Afternoon Evening
• 47-62 3 1 1 1
• 63-78 4 1 1 2
• 79-93 5 1 2 2
• 94-109 6 2 2 2
• Above 109 7 2 2 3
• Capsules should be taken regularly without chewing and with small amount of liquid.
• Administration of the drug for treatment of primary biliary cirrhosis may be continued indefinitely. In patients with primary biliary cirrhosis, in rare cases, clinical symptoms may worsen at the beginning of treatment, for example, itching may become more frequent. In this case, treatment should be continued by taking 1 capsule daily, then the dosage should be gradually increased (increasing daily dose weekly by 1 capsule) until the recommended dosage regimen is reached again.
• Symptomatic treatment of chronic hepatitis of various genesis, non-alcoholic steatohepatitis; alcoholic liver disease – daily dose 10-15 mg/kg in 2-3 doses. Duration of treatment – 6-12 months or more.
• Primary sclerosing cholangitis – daily dose 12-15 mg/kg; if necessary, the dose may be increased to 20-30 mg/kg in 2-3 doses. Duration of therapy ranges from 6 months to several years.
• Cystic fibrosis (as part of complex therapy) – daily dose 20 mg/kg/day in 2-3 doses, with further increase to 30 mg/kg/day if necessary.
• Body weight, kg Daily dose, mg/kg morning noon evening
• 20-29 17-25 250 mg
• 30-39 19-25 250 mg 250 mg
• 40-49 20-25 250 mg 250 mg 500 mg
• 50-59 21-25 250 mg 500 mg
• 60-69 22-25 500 mg 500 mg
• 70-79 22-25 500 mg 500 mg 750 mg
• 80-89 22-25 500 mg 750 mg 750 mg
• 90-99 23-25 750 mg 750 mg 750 mg
• 100-109 23-25 750 mg 750 mg 1000 mg
• >110
• 750 mg 1000 mg 1000 mg
• Biliary dyskinesia – average daily dose 10 mg/kg in 2 doses for 2 weeks to 2 months. If necessary, it is recommended to repeat the course of treatment.
• Children over 3 years old are prescribed the drug individually, based on the rate of 20 mg/kg/day.