Ursodez, capsules 250 mg 120 pcs

Liver cirrhosis, Gallstone diseaseDissolution of small and medium cholesterol stones with functioning gallbladder, biliary reflux gastritis, primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment).

Chronic hepatitis of different genesis, primary sclerosing cholangitis, cystic fibrosis (cystic fibrosis), ialcoholic steatohepatitis, alcoholic liver disease, biliary dyskinesia.

Active ingredient

Ursodeoxycholic acid

How to take, the dosage

Oral.

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 should not be chewed), with a small amount of liquid.

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 stopped.

The effectiveness of treatment should be evaluated every 6 months with 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 discontinued.

In order to prevent recurrent cholelithiasis, it is recommended to take the drug for several months after stone dissolution.

The treatment of biliary reflux gastritis

1 capsule (250 mg) of Ursodez® daily in the evening 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 may be used once in the evening.

The duration of treatment course is not limited. Clinical symptoms may worsen in rare cases at the beginning of treatment (itching may become more frequent). In this case the daily dose should be reduced (to 250 mg) and then gradually increased (increasing the daily dose weekly) until the recommended dosing regimen is achieved.

In chronic hepatitis of various genesis, nonalcoholic 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.

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 in 2-3 times a day. Duration of use – from 6 months to several years. In cystic fibrosis (cystic fibrosis): 20-30 mg/kg per day in 2 to 3 doses. The duration of use is 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 intakes during 2 weeks to 2 months. If necessary the course of treatment should be repeated.

The dosing regimen is determined by the doctor.

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

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

Interaction

Colestiramine, colestipol and antacids containing aluminum hydroxide or smectite (aluminum oxide) reduce absorption of Ursodeoxycholic acid in the intestine and thus reduce its absorption and effectiveness. If the use of drugs containing at least one of these substances is still necessary, they should be taken at least 2 hours before taking Ursodez® .

Special Instructions

The drug Ursodez® should be administered under the supervision of a physician.
During the first 3 months of treatment liver functional parameters (transaminases, alkaline phosphatase and gamma-glutamyl transpeptidase) in serum every 4 weeks, and then every 3 months.

The monitoring of these parameters allows early detection of liver dysfunction. Also, this applies to patients in the later stages of primary biliary cirrhosis. In addition, this can quickly determine if a patient with primary biliary cirrhosis is responding to ongoing treatment.

When used to dissolve cholesterol gallstones:

In order to assess treatment progress and to detect signs of stone calcinosis in a timely manner, the gallbladder should be imaged (oral cholecystography) with obscuration examination in standing and supine positions (ultrasonography) 6-10 months after initiation. If it is impossible to visualize the gallbladder on X-rays or in cases of calcification of stones, poor gallbladder contractility or frequent attacks of colic, Ursodez® should not be used.

In treatment of patients in advanced stages of primary biliary cirrhosis: Extremely rare cases of decompensation of liver cirrhosis have been reported.
After discontinuation of therapy regression of decompensation manifestations was noted.

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

In patients with diarrhea, the drug dosage should be reduced. Treatment should be discontinued in persistent diarrhea.

Influence on driving and operating ability

There is no effect on driving and operating ability.

Contraindications

• X-ray-positive (with high calcium content) gallstones;
• Mephumecompromising gallbladder;
• Acute inflammatory diseases of the gallbladder and intestines.acute inflammatory diseases of the gallbladder, bile ducts and intestines;
• Liver cirrhosis in decompensation stage;
• Developed hepatic, renal, pancreatic dysfunction;
• High sensitivity to the drug components;
• Adults and children with body weight up to 34 kg;
• Children under 3 years for this dosage form.

With caution

To use with caution in the following conditions: with cholelithiasis, with cholestatic liver disease (see section “Special Indications”).

Side effects

Diarrhea, nausea, pain in the epigastric region and the right subcostal area, calcification of gallstones, increased activity of “liver” transaminases, allergic reactions.

Overdose

No cases of overdose were detected.

Pregnancy use

The drug is contraindicated during pregnancy and breastfeeding.

Similarities

Ursofalk, Ursosan, Urdoxa, Ursoliv, Exchol, Grinterol, Urcevel, Ursodeoxycholic acid