Ursodeoxycholic acid 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 the bile, increases the solubility of cholesterol in the biliary system,

stimulates the formation and excretion of bile. It reduces bile lithogenicity and increases bile acids content; it causes intensification of gastric and pancreatic secretion, increases lipase activity and has hypoglycemic effect. Causes partial or complete dissolution of cholesterol stones in enteral administration, decreases bile cholesterol saturation, which promotes 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.

Cholesterol gallstones dissolution, biliary reflux gastritis, primary biliary cirrhosis without decompensation symptoms, chronic hepatitis of various genesis, primary sclerosing cholangitis, cystic fibrosis, nonalcoholic steatohepatitis, alcoholic liver disease, biliary dyskinesia.

X-ray-positive (high calcium) gallstones; impaired gallbladder contractility, biliary tract occlusion (occlusion of common bile duct or vesicular duct), frequent episodes of gall cramps; acute inflammatory diseases of gallbladder, bile ducts and bowels; decompensated liver cirrhosis; marked liver and/or kidney failure, hypersensitivity to the drug components or other bile acids.

Pediatric population.

Unsuccessfully performed portoenterostomy or cases of absence of restoration of normal bile flow in children with biliary tract atresia.

Ursodeoxycholic acid has no age restrictions for use, but in children under 3 years of age, it is recommended to use ursodeoxycholic acid in suspension, as there may be difficulties in swallowing the capsules.

 

• Children and adults with a body weight less than 47 kg are recommended to use the drug Ursodeoxycholic acid in suspension.
• Dissolution of cholesterol gallstones
• The recommended dose is 10 mg of ursodeoxycholic acid per 1 kg of body weight per day, which corresponds to:
• Body weight Capsules.
• Up to 60 kg 2
• 61 – 80 kg 3
• 81 – 100 kg 4
• Above 100 kg 5
• The drug should be taken daily in the evening, before going to bed (capsules are not chewed), with 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
• 1 capsule of ursodeoxycholic acid daily in the evening before going to bed, without chewing and with a small amount of water.
• The course of treatment – from 10-14 days to 6 months, if necessary – up to 2 years.
• Treatment of primary biliary cirrhosis
• Daily dose depends on body weight and is from 3 to 7 capsules (about 14 ± 2 mg of ursodeoxycholic acid per 1 kg of body weight).
• During the first 3 months of treatment the drug intake of Ursodeoxycholic acid capsules 250 mg should be divided into several intakes during the day. After improvement of hepatic parameters daily dose of the drug can be taken once in the evening.
• The following regimen of administration is recommended:
• Capsules of 250 mg
• Body weight Ursodeoxycholic acid capsules 250 mg
• The first 3 months of treatment Afterwards
• Morning Afternoon Evening
• (1 time a day)
• 42 – 62 kg 1 1 1 3
• 1 1 2 4
• 79 – 93 kg 1 2 2 5
• 94 – 109 kg 2 2 2 6
• Over 110 kg 2 2 3 7
• The capsules should be taken regularly without chewing, 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 one capsule daily, then the dosage should be gradually increased, increasing the daily dose weekly by one capsule, until the recommended dosage regimen is reached again. Symptomatic treatment of chronic hepatitis of different genesis – daily dose 10-15 mg/kg in 2-3 doses. Duration of treatment – 6-12 months or more.
• Primary sclerosing cholangitis – daily dose is 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 (see sect.: “Cautions”).
• Cystic fibrosis (cystic fibrosis) – daily dose 20 mg/kg/day in 2-3 doses, with further increase to 30 mg/kg/day if necessary.
• Weight
• body weight
• (kg) Daily dose (mg/kg body weight) Ursodeoxycholic acid 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
• Non-alcoholic steatohepatitis – average daily dose is 10-15 mg/kg in 2-3 doses. Duration of therapy is 6-12 months or more. Alcoholic liver disease – average daily dose is 10-15 mg/kg in 2-3 doses. The duration of therapy is 6-12 months or more.
• Biliary dyskinesia is an average daily dose of 10 mg/kg in 2 doses for 2 weeks to 2 months. If necessary, it is recommended to repeat the treatment course.