Ursodez, 500 mg capsules 30 pcs

Liver cirrhosis, Gallstone disease

– dissolution of small and medium cholesterol stones with a 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);

– non-alcoholic steatohepatitis;

– alcoholic liver disease;

– biliary dyskinesia.

Active ingredient

Ursodeoxycholic acid

Composition

1 capsule ursodeoxycholic acid 500 mg

Associates:

croscarmellose sodium (primellose) – 16 mg,

hydroxypropyl methylcellulose (hypromellose) – 14 mg,

magnesium stearate – 5 mg.

Capsule shell composition:

Case: titanium dioxide – 2%, gelatin – up to 100%; lid: titanium dioxide – 1.7434%, sunset yellow dye – 0.4183%, gelatin – up to 100%.

How to take, the dosage

The drug is taken orally.

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 bedtime (capsules should not be chewed), with a small amount of fluid.

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 stopped.

Treatment of biliary reflux gastritis

The recommended dose is 1 capsule (250 mg) of Ursodez® daily in the evening before bedtime. The capsules should be swallowed with a small amount of 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 is 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 2-3 intakes, the first 3 months of treatment. After improvement of liver functional parameters, the daily dose can be used 1 time in the evening. The duration of 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, the daily dose should be reduced (to 250 mg) and then gradually increased (increasing the daily dose weekly) until the recommended dosage regimen is achieved.

Chronic hepatitis of various genesis, nonalcoholic steatohepatitis and alcoholic liver disease

The average daily dose is 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.

Primary sclerosing cholangitis, cystic fibrosis (cystic fibrosis)

In primary sclerosing cholangitis: 12-15 mg/kg/day (up to 20 mg/kg/day) in 2-3 doses. Duration of use – from 6 months to several years.

In cystic fibrosis (cystic fibrosis): 20-30 mg/kg/day in 2-3 doses. Duration of use – from 6 months to several years.

Dyskinesia of biliary tract

The average daily dose is 10 mg of ursodeoxycholic acid per 1 kg of body weight in 2 doses during 2 weeks to 2 months. If necessary the treatment course should be repeated. The dosage regimen is determined by the doctor.

Interaction

Colestyramine, 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 necessary, they should be taken at least 2 h before taking Ursodez®.

Ursodeoxycholic acid may enhance intestinal absorption of cyclosporine. Therefore, in patients taking cyclosporine, the blood concentration of cyclosporine should be checked and the dose of cyclosporine should be adjusted, if necessary.

In some cases Ursodez® may decrease absorption of ciprofloxacin.

Hypolipidemic drugs (especially clofibrate), estrogens, neomycin or gestagens increase bile cholesterol saturation and may decrease the ability to dissolve cholesterol bile concretions.

Special Instructions

The use of the drug Ursodez® should be under the supervision of a physician.

In the first 3 months of treatment, serum liver function parameters (transaminases, ALP and GGT) should be monitored every 4 weeks, and then every 3 months. Monitoring of these parameters allows to detect liver dysfunction at early stages. This also applies to patients in the later stages of primary biliary cirrhosis. In addition, this may quickly determine if a patient with primary biliary cirrhosis is responding to treatment.

Application to dissolve cholesterol gallstones

The gallbladder should be imaged (oral cholecystography) with observation of darkening in the standing and supine positions (ultrasound) 6-10 months after the start of treatment in order to assess treatment progress and to detect signs of calcification of the stones in time. If the gallbladder cannot be visualized on X-rays or in case of calcification of the stones, poor gallbladder contractility or frequent attacks of colic, Ursodez® should not be used.

Treatment of patients in advanced stages of primary biliary cirrhosis

There have been extremely rare cases of decompensation of liver cirrhosis. After discontinuation of therapy, regression of decompensation manifestations was noted.

Long therapy with ursodeoxycholic acid in high doses (28-30 mg/kg/day) may cause serious adverse events in patients with primary sclerosing cholangitis.

In patients with diarrhea, the drug dose 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 (high calcium) gallstones;

• non-functioning gallbladder;

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

• decompensated cirrhosis of the liver;

• disordered renal function;

• disordered liver function;

• expressed pancreatic dysfunction;

• adults and children up to 34 kg of body weight;

• children under 3 years of age (for this dosage form);

• hypersensitivity to the ingredients of the drug.

With caution the drug should be prescribed in cholelithiasis and cholestatic liver disease.

Side effects

Digestive system disorders: diarrhea, nausea, pain in the epigastric region and right subcostal area, calcification of gallstones, increased activity of liver transaminases.

In treatment of primary biliary cirrhosis, transient decompensation of liver cirrhosis may be observed, which disappears after discontinuation of the drug.

Other: allergic reactions.

Overdose

No cases of overdose have been identified. In case of overdose symptomatic treatment is administered.

Similarities

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