Ursodeoxycholic acid (Ursodez) 500 mg – [30 capsules]

Hepatoprotective drug, has a choleretic effect. Reduces cholesterol synthesis in the liver, its absorption in the intestine and its concentration in bile, increases cholesterol solubility in the biliary system, stimulates bile formation and excretion. It decreases 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, reduces bile saturation with cholesterol, 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.

Dissolution of cholesterol gallstones, biliary reflux gastritis, primary biliary cirrhosis with no signs of decompensation, 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, obstruction of biliary tracts (blockage of common bile duct or vesicular duct), frequent episodes of gall cramps; acute inflammatory diseases of gallbladder and bile ducts; decompensated liver cirrhosis; marked hepatic and/or renal insufficiency, 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 Ursodez® in suspension, since there may be difficulties in swallowing the capsules.

USE DURING PREGNANCY AND BREASTFEEDING, EFFECT ON FERTILITY

According to animal studies, ursodeoxycholic acid has no effect on fertility. There are no data on the effect of treatment with ursodeoxycholic acid on fertility in humans.

 

• Inside.
• Dissolution of cholesterol gallstones.
• The recommended (approximate) dose is 10 mg of ursodeoxycholic acid per 1 kg of body weight per day. The drug should be taken daily in the evening, before going to bed (capsules are not chewed), with a small amount of fluid.
• It usually takes 6-24 months to dissolve gallstones. If after 12 months of treatment the stones have not decreased in size, the treatment should be stopped.
• The effectiveness of treatment should be evaluated every 6 months by ultrasound or radiography. In an interim evaluation, it should be assessed whether the stones have calcified since then. If stones have calcified, treatment should be stopped.
• To prevent recurrent cholelithiasis, administration of the drug for several months after stone dissolution is recommended.
• Treatment of biliary reflux gastritis
• 1 capsule (250 mg) of Ursodez* every night before going to bed 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 1 to 3 capsules (500 mg) or 2 to 6 capsules (250 mg) (about 10 to 15 mg of ursodeoxycholic acid per 1 kg of body weight) in 2 to 3 times, the first 3 months of treatment. After improvement of liver functional parameters, the daily dose can be used once in the evening. The duration of the treatment course is not limited. In rare cases at the beginning of treatment clinical symptoms may worsen (itching may become more frequent). In this case daily dose should be reduced (to 250 mg) and then it should be gradually increased (increasing daily dose weekly) until the recommended dosage regimen is achieved.
• In chronic hepatitis of various genesis, nonalcoholic steatohepatitis and alcoholic liver disease
• Average daily dose is from 10 to 15 mg of ursodeoxycholic acid per 1 kg of body weight in 2-3 doses. The duration of therapy is 6-12 months or more.
• In primary sclerosing cholangitis, cystic fibrosis (cystic fibrosis)
• In primary sclerosing cholangitis: 12-15 mg/kg/day (up to 20 mg/kg) of body weight during 2-3 times a day. Duration of use – from 6 months to several months.
• In cystic fibrosis (cystic fibrosis): 20-30 mg/kg per day in 2-3 doses. Duration of use – from 6 months to several years.
• In biliary dyskinesia
• The average daily dose is 10 mg of ursodeoxycholic acid per 1 kg of body weight in 2 doses for 2 weeks to 2 months. If necessary, the treatment course should be repeated.
• Dosing regimen is determined by the doctor.
• For children over 3 years of age.
• Individually (at the rate of 10-20 mg/kg per day).