Ursodeoxycholic acid (Urdoxa) 500 mg – [50 tablets]

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.

Cystic fibrosis (cystic fibrosis)

According to clinical reports, there is long-term experience (up to 10 years and more) of treating children with hepatobiliary disease associated with cystic fibrosis with ursodeoxycholic acid. There is evidence that therapy with ursodeoxycholic acid is able to reduce the proliferation of bile ducts, slow down the development of lesions detected by histological examination, and even contribute to the reversal of hepatobiliary changes in the case if the therapy is started at early stages of cystic fibrosis. In order to optimize the effectiveness of treatment, therapy with ursodeoxycholic acid should be started as early as possible after the diagnosis of cystic fibrosis is made.

Cholesterol gallstones dissolution, biliary reflux gastritis, primary biliary cirrhosis without decompensation symptoms (symptomatic treatment), chronic hepatitis of various genesis, primary sclerosing cholangitis, cystic fibrosis, non-alcoholic steatohepatitis, alcoholic liver disease, biliary dyskinesia.

X-ray-positive (high calcium) gallstones; impaired gallbladder contractility; acute inflammatory diseases of the gallbladder and bile ducts; biliary tract occlusion (occlusion of common bile or bladder ducts), frequent episodes of biliary colic, hypersensitivity to the components of the drug or bile acids, children under 3 years of age (for this dosage form), decompensated liver cirrhosis and expressed hepatic and/or renal failure.

Pediatric population.

Unsuccessfully performed portoenterostomy or cases of failure to restore normal bile flow in children with biliary tract atresia.

In children under 3 years of age as well as in patients with difficulty in swallowing the tablets, it is recommended to use ursodeoxycholic acid in suspension.

Use in pregnancy and during breastfeeding

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.

Pregnancy

There are limited or no data on the use of ursodeoxycholic acid in pregnant women. Animal studies have shown reproductive toxicity in early pregnancy. During pregnancy, Urdox® 500 should not be used except when clearly necessary.

• For patients who can not swallow the preparation Urdox® 500, film-coated tablets 500 mg, or with body weight less than 47 kg it is recommended to use ursodeoxycholic acid in capsules or suspension.
• Tablets should be taken without chewing, with fluids. They should be taken regularly.
• Dissolving cholesterol gallstones
• The recommended dose is 10 mg of ursodeoxycholic acid per 1 kg of body weight per day, which corresponds to:
• Up to 60 kg 1 tablet
• 61-80 kg 1½ tablets
• 81-100 kg 2 tablets
• Over 100 kg 2½ tablets
• It usually takes 6-24 months to dissolve gallstones. If the size of the stones does not decrease after 12 months of treatment, treatment should be discontinued.
• The effectiveness of treatment should be evaluated every 6 months with ultrasound or radiography. In an interim follow-up evaluation, it should be assessed whether the stones have calcified since then. If stones have calcified, treatment should be discontinued.
• Treatment of biliary reflux gastritis
• Take 250 mg (½ tablet) every day in the evening before going to bed.
• The course of treatment from 10-14 days to 6 months, if necessary – up to 2 years.
• Symptomatic treatment of primary biliary cirrhosis
• The daily dose depends on body weight and varies from 11/2 to 31/2 tablets
• (14 ± 2 mg of ursodeoxycholic acid per 1 kg of body weight).
• During the first 3 months of treatment, the daily dose should be divided into several doses. After improvement of liver functional parameters, it is possible to switch to a single daily dose in the evening.
• Body weight (kg) Daily dose (mg/kg) Urdox® 500, film-coated tablets, 500 mg
• first 3 months thereafter
• morning noon evening evening (single dose)
• 47-62 12-16 1/2 1/2 1/2 11/2
• 63-78 13-16 1/2 1/2 1 2
• 79-93 13-16 1/2 1 1 21/2
• 94-109 14-16 1 1 1 3
• over 110 – 1 1 11/2 31/2
• Use of Urdox® 500 for the 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 ½ tablet daily, then the dose should be gradually increased (increasing the daily dose weekly by ½ tablet) until the recommended dosing regimen is achieved again.
• Symptomatic treatment of chronic hepatitis of different genesis
• Daily dose is 10-15 mg/kg in 2-3 intakes. Duration of treatment: 6-12 months or more.
• Primary sclerosing cholangitis
• The daily dose is 12-15 mg/kg; if necessary, the dose may be increased to 20 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 is 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 body weight) Urdox® 500, film-coated tablets, 500 mg
• morning noon evening
• 20 – 29 17 – 25 1/2 ˗ 1/2
• 30 – 39 19 – 25 1/2 1/2 1/2
• 40 – 49 20 – 25 1/2 1/2 1
• 50 – 59 21 – 25 1/2 1 1
• 60 – 69 22 – 25 1 1 1
• 70 – 79 22 – 25 1 1 1 1/2
• 80 – 89 22 – 25 1 1 1/2 1 1/2
• 90 – 99 23 – 25 1 1/2 1 1/2 1 1/2
• 100 – 109 23 – 25 1 1/2 1 1/2 2
• >110 1 1/2 2 2
• Nonalcoholic steatohepatitis
• The average daily dose is 10-15 mg/kg in 2 to 3 doses. The duration of therapy is
• 6-12 months or more.
• Alcoholic liver disease
• The average daily dose is 10-15 mg/kg in 2-3 doses. The duration of therapy is
• 6-12 months and longer.
• Biliary dyskinesia
• Average daily dose is 10 mg/kg in 2 intakes during 2 weeks to 2 months. If necessary, the course of treatment is recommended to be repeated.