Urdox capsules 250mg №100

Indications and usage

- primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment);

- dissolution of cholesterol gall bladder stones;

- biliary reflux gastritis;

- primary sclerosing cholangitis;

- alcoholic liver disease;

- non-alcoholic steatohepatitis;

- cystic fibrosis (cystic fibrosis);

- chronic hepatitis of various genesis;

- biliary dyskinesia.

Urdox Capsules^® accept inside, without chewing, washing down with a small amount of water.

Symptomatic treatment of primary biliary cirrhosis

The daily dose depends on body weight and ranges from 3 to 7 capsules (approximately 14 ± 2 mg of ursodeoxycholic acid per 1 kg of body weight). In the first 3 months of treatment, taking the drug Urdox^® should be divided into several receptions throughout the day. After improvement of liver indices, the daily dose of the drug can be taken 1 time in the evening.

Urdox preparation^® should be taken regularly. The duration of therapy - for an unlimited time.

Dissolution of cholesterol gallstones

The recommended dose is 10 mg of ursodeoxycholic acid per 1 kg of body weight / day, which corresponds to:

Drug urdox^® must be taken daily in the evening, before bedtime. The duration of therapy is 6-12 months. For the prevention of re-cholelithiasis, it is recommended to take the drug for several months after the stones dissolve.

Treatment of biliary reflux gastritis

1 capsule of drug urdoksa^® daily 1 time / day before bedtime. The course of treatment from 10-14 days to 6 months, if necessary up to 2 years.

Primary sclerosing cholangitis

The daily dose is 12-15 mg / kg; if necessary, the dose can be increased to 20-30 mg / kg in 2-3 doses. The duration of therapy ranges from 6 months to several years.

Alcoholic liver disease

The average daily dose is 10-15 mg / kg in 2-3 doses. The duration of therapy ranges from 6-12 months or more.

Non-alcoholic steatohepatitis

The average daily dose is 10-15 mg / kg in 2-3 doses. The duration of therapy ranges from 6-12 months or more.

Cystic fibrosis (cystic fibrosis)

The daily dose is 12-15 mg / kg; if necessary, the dose can be increased to 20-30 mg / kg in 2-3 doses.The duration of therapy is from 6 months to several years or for life.

Chronic hepatitis of various origins

The daily dose is 10-15 mg / kg in 2-3 doses. The duration of therapy is 6-12 months or more.

Biliary dyskinesia

The average daily dose is 10 mg / kg in 2 doses. The duration of therapy is from 2 weeks to 2 months. If necessary, the treatment is recommended to repeat.

Children over 3 years old the drug is prescribed individually at the rate of 10-20 mg / kg / day.

Adverse reactions

The frequency of adverse reactions is given in accordance with the following scale: very often (> 10%); often (> 1% and <10%); infrequently (> 0.1% and <1%); rarely (> 0.01% and <0.1%); very rarely (<0.01%).

From the gastrointestinal tract: often - diarrhea; rarely - nausea, vomiting, transient increase in liver enzymes; very rarely - calcification of gallstones. In the treatment of advanced stages of primary biliary cirrhosis is very rare - decompensation of cirrhosis of the liver, which disappears after discontinuation of the drug.

From the skin: very rarely - hives.

If any of the adverse events listed in the instructions are aggravated or any other adverse effects that are not listed in the instructions, inform your doctor.

- X-ray (high calcium) gallstones;

- non-functioning gallbladder;

- acute inflammatory diseases of the gallbladder, bile ducts and intestines;

- liver cirrhosis in the stage of decompensation;

- pronounced dysfunction of the kidneys, liver, pancreas;

- hypersensitivity to the drug.

Ursodeoxycholic acid has no age restrictions in use, however, children under 3 years old are not recommended to use the drug in this dosage form.

Carefully used in children aged 3 to 4 years, because difficulty in swallowing capsules.

Pregnancy and Breastfeeding

AT experimental studies No mutagenic and carcinogenic effect of ursodeoxycholic acid was detected in animals. The use of the drug during pregnancy is possible only when the expected benefit to the mother outweighs the potential risk to the fetus (there were no adequate, strictly controlled studies of the use of ursodeoxycholic acid in pregnant women).

If necessary, the use of the drug during lactation should decide on the termination of breastfeeding. Data on the allocation of ursodeoxycholic acid in breast milk are currently not available.

Contraindications: severe liver dysfunction, cirrhosis in the stage of decompensation.

Contraindication: severe renal dysfunction.

Use in children

Ursodeoxycholic acid has no age restrictions in use, however, children under 3 years old are not recommended to use the drug in this dosage form.

Carefully used in children aged 3 to 4 years, because difficulty in swallowing capsules.

Children over 3 years old Ursodeoxycholic acid is prescribed individually at the rate of 10-20 mg / kg / day.

Special notes

Urdox medication^® should be carried out under the supervision of a physician.

When taking the drug in order to dissolve gallstones, the following conditions must be met: the stones must be cholesterol (X-ray negative), their size must not exceed 15-20 mm, the gallbladder must remain functional and must be filled with not more than half of the stones; common bile duct should be maintained. With prolonged (more than 1 month) taking the drug every 4 weeks in the first 3 months of treatment, then every 3 months it is necessary to conduct a biochemical blood test to determine the activity of hepatic transaminases. Monitoring the effectiveness of treatment should be carried out every 6 months according to the ultrasound scan