Ursodez (Ursodeoxycholic acid)

Chronic hepatitis of various origins, primary sclerosing cholangitis, cystic fibrosis (cystic fibrosis), non-alcoholic steatohepatitis, alcoholic liver disease, biliary dyskinesia.

• X-ray positive (high calcium) gallstones;
• Mefumcciating gallbladder;
• Acute inflammatory diseases of the gallbladder, bile ducts and intestines;
• Cirrhosis of the liver in the stage of decompensation;
• Severe dysfunction of the liver, kidneys, pancreas;
• Hypersensitivity to the components of the drug;
• Adults and children weighing up to 34 kg;
• Children's age up to 3 years for this dosage form.

Use with caution in the following conditions: in case of gallstone disease, in case of cholestatic liver diseases (see section "Special Instructions").

Dissolution of cholesterol gallstones

The recommended (approximate) dose is 10 mg of ursodeoxycholic acid per 1 kg of body weight per day. The drug must be taken daily in the evening, before bedtime (capsules do not chew), washed down with a small amount of liquid.

It usually takes 6-24 months to dissolve gallstones. If after 12 months of treatment the size of the stones does not decrease, then treatment should be discontinued.

Treatment efficacy should be evaluated every 6 months with ultrasound or radiography. During the interim examination, it should be assessed whether calcification of stones has occurred over the past period. In case of calcification of stones, treatment should be discontinued.

For the prevention of re-cholelithiasis, the drug is recommended for several months after the dissolution of the stones.

Treatment of biliary reflux gastritis

1 capsule (250 mg) of Ursodez® daily in the evening before bedtime with a little water.

The course of treatment is 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 ranges from 1 to 3 capsules (500 mg) or 2 to 6 capsules (250 mg) (approximately 10 to 15 mg of ursodeoxycholic acid per 1 kg of body weight) in 2 to 3 doses, the first 3 months of treatment. After improving the functional parameters of the liver, the daily dose can be applied once in the evening.

The duration of treatment is not limited. In rare cases, clinical symptoms may worsen at the beginning of treatment (itching becomes more frequent). In this case, the daily dose should be reduced (to 250 mg), and then gradually increase it (increasing the daily dose weekly) until the recommended dosage regimen is reached.

In chronic hepatitis of various origins, non-alcoholic steatohepatitis and alcoholic liver disease

The 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.

With primary sclerosing cholangitis, cystic fibrosis (cystic fibrosis)

With primary sclerosing cholangitis: 12-15 mg / ct / day (up to 20 mg / kg) of body weight per day in 2-3 doses. Duration of use - from 6 months to several years. With cystic fibrosis (cystic fibrosis): 20-30 mg / kg per day in 2 to 3 doses. Duration of use - from 6 months to several years.

With biliary dyskinesia

The average daily dose is 10 mg of ursodeoxycholic acid per 1 kg of body weight in 2 divided doses for 2 weeks to 2 months. If necessary, the treatment should be repeated.

The dosage regimen is determined by the doctor.

Table. 
Calculation of the daily number of capsules depending on the patient’s body weight and the recommended dose of the drug pa 1 kg body weight

For children from 3 years old 
Individually (at the rate of 10-20 mg / kg per day).

Monitoring these parameters allows you to identify violations of the liver in the early stages. Also, this applies to patients in the later stages of primary biliary cirrhosis. In addition, one can quickly determine if a patient with primary biliary cirrhosis responds to treatment.

When used to dissolve cholesterol gallstones:

In order to assess the progress in treatment and for the timely detection of signs of calcification of stones, the gallbladder should be visualized (oral cholecystography) with examination of the blackouts in the "standing" and "lying on the back" positions (ultrasound) 6-10 months after the start of the study. If the gallbladder cannot be visualized on x-rays or in cases of calcification of stones, weak contractility of the gallbladder or frequent bouts of colic, the drug Ursodez® should not be used.

When treating patients in the late stages of primary biliary cirrhosis: Very rarely, there have been cases of decompensation of liver cirrhosis. 
After discontinuation of therapy, a regression of manifestations of decompensation was noted.

Long-term therapy with high doses of Ursodeoxycholic acid (28-30 mg / kg / day) can lead to the development of serious side effects in patients with primary sclerosing cholangitis.

In patients with diarrhea, the dosage of the drug should be reduced. With persistent diarrhea, treatment should be discontinued.

Influence on the ability to drive vehicles and control mechanisms

Influence on the ability to drive vehicles, mechanisms not identified.