Universal reference book for medicines
Product name: URSODEZ ® (URSODEZ)

Active substance: ursodeoxycholic acid

Type: Hepatoprotector with choleretic and cholelitholytic action

Manufacturer: СЕВЕРНАЯ ЗВЕЗДА (Russia)
Composition, form of production and packaging
Capsules
hard gelatinous, size №0, opaque, white;
the contents of the capsules are white or almost white powder.
1 caps.

ursodeoxycholic acid 250 mg

Excipients: starch pregelatinized (starch 1500) - 73 mg, silicon dioxide colloid (aerosil) - 5 mg, magnesium stearate - 2 mg.

The composition of the capsule shell: body and lid: titanium dioxide - 2.1118%, gelatin - up to 100%.

10 pieces.
- packings cellular planimetric (4) - packs cardboard.
10 pieces.
- packings cellular planimetric (5) - packs cardboard.
10 pieces.
- packings cellular planimetric (6) - packs cardboard.
10 pieces.
- packings cellular planimetric (9) - packs cardboard.
10 pieces.
- packings cellular planimetric (10) - packs cardboard.
10 pieces.
- packings cellular planimetric (12) - packs cardboard.
40 pcs.
- polymer cans (1) - packs of cardboard.
40 pcs.
- vials polymeric (1) - packs cardboard.
50 pcs.
- polymer cans (1) - packs of cardboard.
50 pcs.
- vials polymeric (1) - packs cardboard.
60 pcs.
- polymer cans (1) - packs of cardboard.
60 pcs.
- vials polymeric (1) - packs cardboard.
100 pieces.
- polymer cans (1) - packs of cardboard.
100 pieces.
- vials polymeric (1) - packs cardboard.
120 pcs.
- polymer cans (1) - packs of cardboard.
120 pcs.
- vials polymeric (1) - packs cardboard.
Capsules hard gelatinous, size №00, opaque, with a white body and an orange lid;
the contents of the capsules are a granular powder and granules of white or almost white color.
1 caps.

ursodeoxycholic acid 500 mg

Excipients: croscarmellose sodium (impellosis) - 16 mg, hydroxypropylmethylcellulose (hypromellose) - 14 mg, magnesium stearate - 5 mg.

The composition of the capsule shell: body: titanium dioxide - 2%, gelatin - up to 100%;
lid: titanium dioxide - 1.7434%, dye sunset yellow - 0.4183%, gelatin - up to 100%.
10 pieces.
- packings of cellular contour (1) - packs cardboard.
10 pieces.
- packings cellular planimetric (3) - packs cardboard.
10 pieces.
- packings cellular planimetric (5) - packs cardboard.
30 pcs.
- polymer cans (1) - packs of cardboard.
30 pcs.
- vials polymeric (1) - packs cardboard.
50 pcs.
- polymer cans (1) - packs of cardboard.
50 pcs.
- vials polymeric (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

Hepatoprotector.
Has choleretic effect. Reduces the synthesis of cholesterol in the liver, its absorption in the intestine and concentration in the bile, increases the solubility of cholesterol in the bile excretory system, stimulates the formation and excretion of bile. Reduces the lithogenicity of bile, increases the content of bile acids. Causes an increase in gastric and pancreatic secretion, increases the activity of lipase. Has hypoglycemic effect.
Causes partial or complete dissolution of cholesterol stones when ingestion, reduces the saturation of bile with cholesterol, which promotes the mobilization of cholesterol from gallstones.

It has an immunomodulatory effect, affects immunological reactions in the liver: reduces the expression of certain antigens on the hepatocyte membrane, affects the number of T-lymphocytes, the formation of interleukin-2, reduces the number of eosinophils.

PHARMACOKINETICS

Suction

Ursodeoxycholic acid is absorbed from the small intestine due to passive diffusion (about 90%), and from the ileum through active transport.
After oral administration in a single dose of 500 mg C max in the blood serum after 30, 60, 90 minutes is 3.8 mmol / l, 5.5 mmol / l and 3.7 mmol / l, respectively.
Distribution

Binding to plasma proteins is high - up to 96-99%.
Penetrates through the placental barrier. With a systematic intake of ursodeoxycholic acid becomes the main bile acid in the blood serum (48% of the total amount of bile acids). The therapeutic effect of the drug depends on the concentration of ursodeoxycholic acid in the bile.
Metabolism and excretion

Metabolized in the liver (clearance at the "first passage" through the liver) with the formation of taurine and glycine conjugates.
The resulting conjugates are secreted into bile.
About 50-70% of the total dose of the drug is excreted by bile.
A small amount of unsweetened ursodeoxycholic acid enters the large intestine, where it undergoes cleavage by bacteria (7-dehydroxylation); the resulting lithocholic acid is partially absorbed from the colon, but is sulfated in the liver and is rapidly excreted as a sulfolithocholylglycine or sulfolithocholyltaurine conjugate.
INDICATIONS

- 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 various genesis;

- primary sclerosing cholangitis;

- Cystic fibrosis (cystic fibrosis);

- non-alcoholic steatohepatitis;

- alcoholic liver disease;

- biliary dyskinesia.

DOSING MODE

The drug is taken orally.

Dissolution of cholesteric gallstones

The recommended (approximate) dose is 10 mg ursodeoxycholic acid per 1 kg of body weight per day.
The drug should be taken daily in the evening, before going to bed (capsules are not chewed), squeezed with a small amount of liquid.
To dissolve gallstones, it usually takes 6-24 months.
If after 12 months of treatment the size of the stones does not decrease, then the treatment should be stopped.
The effectiveness of treatment should be evaluated every 6 months with ultrasound or radiography.
During the interim survey, it should be assessed whether stone calcification has occurred during the past period. In the case of calcification of stones, treatment should be discontinued.
For the prevention of repeated cholelithiasis, the use of the drug is recommended for several months after the dissolution of the stones.

Treatment of biliary reflux gastritis

The recommended dose is 1 caps.
(250 mg) of Ursodez ® every evening before bedtime. Capsules should be washed down 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

The daily dose depends on the body weight and is from 1 to 3 caps.
(500 mg) or from 2 to 6 caps. (250 mg) (approximately 10 to 15 mg of ursodeoxycholic acid per 1 kg of body weight) in 2-3 doses, the first 3 months of treatment. After improving the functional parameters of the liver, the daily dose can be applied 1 time in the evening. The duration of the course of treatment is not limited. In rare cases, clinical symptoms may worsen at the beginning of treatment (itching may occur). In this case, you should reduce the daily dose (up to 250 mg), and then gradually increase it (weekly increasing the daily dose) until the recommended dosage regimen is reached.
Chronic hepatitis of various genesis, non-alcoholic steatohepatitis and alcoholic liver disease

The average daily dose is from 10 to 15 mg ursodeoxycholic acid per 1 kg of body weight in 2-3 divided doses.
The duration of therapy is 6-12 months or more.
Primary sclerosing cholangitis, cystic fibrosis (cystic fibrosis)

With the 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.
With cystic fibrosis (cystic fibrosis): 20-30 mg / kg / day in 2-3 divided doses.
Duration of use - from 6 months to several years.
Biliary dyskinesia

The average daily dose is 10 mg ursodeoxycholic acid per 1 kg of body weight in 2 divided doses for 2 weeks to 2 months.
If necessary, the course of treatment should be repeated. Dosage regimen is set by the doctor.
Calculation of the daily number of capsules depending on the patient's body weight and the recommended dose of the drug per 1 kg of body weight

Body weight, kg 10 mg / kg / day 12 mg / kg / day 15 mg / kg / day 20 mg / kg / day 30 mg / kg / day

34-35 1 caps.
250 mg 2 caps. 250 mg or 1 caps. 500 mg 2 caps. 250 mg or 1 caps. 500 mg 3 caps. 250 mg 4 caps. 250 mg or 2 caps. 500 mg each
36-40 2 caps.
250 mg or 1 caps. 500 mg 2 caps. 250 mg or 1 caps. 500 mg 2 caps. 250 mg or 1 caps. 500 mg 3 caps. 250 mg 5 caps. 250 mg each
41-45 2 caps.
250 mg or 1 caps. 500 mg 2 caps. 250 mg or 1 caps. 500 mg 3 caps. 250 mg 4 caps. 250 mg or 2 caps. 500 mg 5 caps. 250 mg each
45-50 2 caps.
250 mg or 1 caps. 500 mg 2 caps. 250 mg or 1 caps. 500 mg 3 caps. 250 mg 4 caps. 250 mg or 2 caps. on 500 mg of 6 caps. 250 mg or 3 caps. 500 mg each
51-55 2 caps.
250 mg or 1 caps. 500 mg 3 caps. 250 mg 3 caps. 250 mg 4 caps. 250 mg or 2 caps. 500 mg of 7 caps. 250 mg each
56-60 2 caps.
250 mg or 1 caps. 500 mg 3 caps. 250 mg 4 caps. 250 mg or 2 caps. 500 mg 5 caps. 250 mg 7 caps. 250 mg each
61-65 3 caps.
250 mg 3 caps. 250 mg 4 caps. 250 mg or 2 caps. 500 mg 5 caps. 250 mg 8 caps. 250 mg or 4 caps. 500 mg each
66-70 3 caps.
250 mg 3 caps. 250 mg 4 caps. 250 mg or 2 caps. on 500 mg of 6 caps. 250 mg or 3 caps. 500 mg 8 caps. 250 mg or 4 caps. 500 mg each
71-75 3 caps.
250 mg 4 caps. 250 mg or 2 caps. 500 mg 5 caps. 250 mg 6 caps. 250 mg or 3 caps. 500 mg 9 caps. 250 mg each
76-80 3 caps.
250 mg 4 caps. 250 mg or 2 caps. 500 mg 5 caps. 250 mg 6 caps. 250 mg or 3 caps. 500 mg 10 caps. 250 mg or 5 caps. 500 mg each
81-85 3 caps.
250 mg 4 caps. 250 mg or 2 caps. 500 mg 5 caps. 250 mg 7 caps. 250 mg 10 caps. 250 mg or 5 caps. 500 mg each
86-90 4 caps.
250 mg or 2 caps. 500 mg of 4 caps. 250 mg or 2 caps. 500 mg 5 caps. 250 mg 7 caps. on 250 mg of 11 caps. 250 mg each
91-95 4 caps.
250 mg or 2 caps. 500 mg 5 caps. 250 mg 6 caps. 250 mg or 3 caps. 500 mg 8 caps. 250 mg or 4 caps. on 500 mg of 11 caps. 250 mg each
96-100 4 caps.
250 mg or 2 caps. 500 mg 5 caps. 250 mg 6 caps. 250 mg or 3 caps. 500 mg 8 caps. 250 mg or 4 caps. 500 mg of 12 caps. 250 mg or 5 caps. 500 mg each
101-105 4 caps.
250 mg or 2 caps. 500 mg 5 caps. 250 mg 6 caps. 250 mg or 3 caps. on 500 mg of 8 kapp. 250 mg or 4 caps. on 500 mg of 13 caps. 250 mg each
105-110 4 caps.
250 mg or 2 caps. 500 mg 5 caps. 250 mg 7 caps. 250 mg 9 caps. on 250 mg of 13 caps. 250 mg each
For children from 3 years - individually (at the rate of 10-20 mg / kg / day).

SIDE EFFECT

On the part of the digestive system: diarrhea, nausea, pain in the epigastric region and right hypochondrium, calcification of gallstones, increased activity of hepatic transaminases.

In the treatment of primary biliary cirrhosis, transient decompensation of liver cirrhosis can occur, which disappears after drug withdrawal.

Other: allergic reactions.

CONTRAINDICATIONS

- X-ray positive (high in calcium) gallstones;

- non-functioning gallbladder;

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

- cirrhosis of the liver in the stage of decompensation;

- severe renal dysfunction;

- pronounced violations of the liver function;

- pronounced impairment of pancreatic function;

- adults and children weighing up to 34 kg;

- Children under 3 years of age (for this dosage form);

- Hypersensitivity to the components of the drug.

With caution should prescribe the drug for cholelithiasis, cholestatic liver diseases.

PREGNANCY AND LACTATION

The drug is contraindicated in pregnancy and lactation (breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER

The drug is contraindicated in severe impairment of kidney function.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

The drug is contraindicated in severe violations of liver function, liver cirrhosis in the decompensation stage.

With caution should prescribe the drug for cholestatic liver diseases.

APPLICATION FOR CHILDREN

The use of the drug in the form of capsules is contraindicated in children under 3 years of age.

The drug is not prescribed for children weighing up to 34 kg.

SPECIAL INSTRUCTIONS

Use of the drug Ursodez ® should be carried out under the supervision of a doctor.

During the first 3 months of treatment, liver function tests (transaminases, amphoteric and GGT) in the blood serum should be monitored every 4 weeks, and then every 3 months.
Control of these parameters allows us to identify violations of liver function in the early stages. This also applies to patients in the late stages of primary biliary cirrhosis. In addition, it is possible to quickly determine whether the patient reacts with primary biliary cirrhosis for ongoing treatment.
Application for the dissolution of cholesteric gallstones

In order to assess the progress in treatment, as well as for the timely detection of signs of calcification of stones, the gallbladder should be visualized (oral cholecystography) with examination of blackouts in standing and lying on the back (US) 6-10 months after the start of treatment.
If the gallbladder can not be visualized on X-rays or in case of calcification of stones, weak contractility of the gallbladder or frequent attacks of colic, Ursoce ® should not be used.
Treatment of patients in advanced stages of primary biliary cirrhosis

Very rarely there were cases of decompensation of liver cirrhosis.
After discontinuation of therapy, regression of manifestations of decompensation was noted.
Long-term therapy with ursodeoxycholic acid in high doses (28-30 mg / kg / day) can lead to the development of serious side effects in patients with primary sclerosing cholangitis.

Patients with diarrhea should reduce the dose of the drug.
With persistent diarrhea, treatment should be discontinued.
Impact on the ability to drive vehicles and manage mechanisms

Influence on ability to drive vehicles and mechanisms is not revealed.

OVERDOSE

Cases of an overdose have not been revealed.
In case of an overdose, symptomatic treatment is performed.
DRUG INTERACTION

Colestramine, colestipol and antacids containing aluminum hydroxide or smectite (aluminum oxide), reduce the absorption of ursodeoxycholic acid in the intestine and, thus, reduce its absorption and efficiency.
If the use of drugs containing at least one of these substances is necessary, they must be taken at least 2 hours prior to taking Ursodez ® .
Ursodeoxycholic acid can increase the absorption of cyclosporine from the intestine.
Therefore, in patients taking cyclosporine, you should check the concentration of cyclosporine in the blood and adjust the dose of cyclosporine, if necessary.
In some cases, ursodez ® can reduce the absorption of ciprofloxacin.

Lipid-lowering drugs (especially clofibrate), estrogens, neomycin or gestagens increase the saturation of bile with cholesterol and may reduce the ability to dissolve cholesterol bile stones.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 ° C.
Shelf life of capsules 250 mg - 5 years, capsules 500 mg - 3 years.
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