Urdoksa - instructions for use, analogs, reviews and release forms (capsules or tablets 250 mg) of hepatoprotector medication for the treatment of hepatitis, fibrosis and cirrhosis, gallstones in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Urdoksa. Comments of visitors of the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Urdoksy in their practice are presented. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Urdoksy in the presence of existing structural analogues. Use for the treatment of hepatitis, fibrosis and cirrhosis of the liver, the dissolution of gallstones in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Urdoksa - hepatoprotective drug, also has choleretic, cholelitholitic, hypocholesterolemic, immunomodulating effect.

It is embedded in the membrane of the hepatocyte, stabilizes its structure and protects the hepatocyte from damaging effects of bile salts, thus reducing their cytotoxic effect. In cholestasis activates Ca2-dependent protease and alpha-stimulated exocytosis, reduces the concentration of toxic bile acids (chenodeoxycholic, lithocholic, deoxycholic and others), whose concentrations in patients with chronic liver disease increased.

Competitive reduces the absorption of lipophilic bile acids in the intestine, increases their "Fractional" turnover under enterohepatic circulation cholepoiesis induces, promotes the passage of bile and excretion of toxic bile acids across the gut.

It screens nonpolar bile acids (chenodeoxycholic), due to which mixed (non-toxic) micelles are formed.

Reduces the saturation of bile with cholesterol by reducing the synthesis and secretion of cholesterol in the liver and inhibiting its absorption in the intestine.

Increases the solubility of cholesterol in the bile excretory system, stimulates the formation and secretion of bile. It reduces the lithogenicity of bile, increases the concentration of bile acids in it, causes an increase in gastric and pancreatic secretion, increases lipase activity, and has a hypoglycemic effect.

Causes partial or complete dissolution of cholesterol gallstones, reduces the saturation of bile with cholesterol, which contributes to its mobilization from gallstones.

It has an immunomodulatory effect, affects immunological reactions in the liver: reduces the expression of certain histocompatibility antigens - HLA-1 on the membrane of hepatocytes and HLA-2 on cholangiocytes, affects the number of T-lymphocytes, the formation of interleukin 2, reduces the number of eosinophils, suppresses immunocompetent Ig (in first of all IgM).

Composition

Ursodeoxycholic acid + auxiliary substances.

Pharmacokinetics

Ursodeoxycholic acid is absorbed in the small intestine due to passive diffusion (about 90%), and in the ileum through active transport. Binding to plasma proteins is high - up to 96-99%. Penetrates through the placental barrier.In the systemic drug reception becomes ursodeoxycholic acid in the serum and the primary bile acid is about 48% of the total bile acids in the blood. The therapeutic effect of the drug depends on the concentration of ursodeoxycholic acid in the bile. Metabolised in the liver (clearance at the "first passage" through the liver) into Taurine and Glycine conjugates. The resulting conjugates are secreted into bile. About 50-70% of the total dose of the drug is excreted with bile. A small number nevsosavsheysya ursodeoxycholic acid enters the colon, where bacteria undergoes cleavage (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

• primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment);
• dissolution of small and medium cholesterol stones of the gallbladder;
• biliary reflux-gastritis;
• primary sclerosing cholangitis;
• alcoholic liver disease;
• non-alcoholic steatohepatitis;
• cystic fibrosis (cystic fibrosis);
• chronic hepatitis of various genesis;
• biliary dyskinesia.

Forms of release

Capsules 250 mg (sometimes mistakenly called pills).

Instructions for use and dosage

Urdox capsules are taken orally, without chewing, squeezed with a small amount of water, before meals or at night, depending on the dosage regimen.

Symptomatic treatment of primary biliary cirrhosis

The daily dose depends on the body weight and is from 3 to 7 capsules (about 14 mg ursodeoxycholic acid per 1 kg of body weight). In the first 3 months of treatment, taking Urdox should be divided into several doses during the day. After improving liver function, the daily dose of the drug can be taken 1 time, in the evening.

Urdox should be taken regularly. Duration of therapy - for unlimited time.

Dissolution of gallstones cholesterol stones

The recommended dose is 10 mg ursodeoxycholic acid per 1 kg of body weight per day.

Drug Urdoksa must be taken daily in the evening, before going to bed. The duration of therapy is 6-12 months. For the prevention of recurrent cholelithiasis, the use of the drug is recommended for several months afterdissolution of stones.

Treatment of biliary reflux gastritis

1 capsule of the drug Urdoks daily 1 time per day before bedtime. The course of treatment is 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 may be increased to 20-30 mg / kg in 2-3 doses. The duration of therapy is 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 is 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 is from 6-12 months or more.

Cystic fibrosis (cystic fibrosis)

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

Chronic hepatitis of different genesis

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

Biliary dyskinesia

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

Children older than 3 years of age, the drug is administered individually at a rate of 10-20 mg / kg per day.

Side effect

• diarrhea;
• nausea, vomiting;
• transient increase in hepatic enzyme activity;
• acute pain in the right upper abdomen;
• calcification of gallstones;
• decompensation of liver cirrhosis, which disappears after drug withdrawal
• hives.

If any of the undesirable effects specified in the instruction are aggravated or any other undesirable phenomena not indicated in the instruction appear, the patient should inform the doctor about it.

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;
• marked violations of the kidneys, liver, pancreas;
• children under 3 years;
• hypersensitivity to the components of the drug.

Application in pregnancy and lactation

In experimental studies on animals, there was no mutagenic and carcinogenic effect of the drug Urdoks.The use of the drug in pregnancy is possible only if the expected benefit for the mother exceeds the potential risk for the fetus (adequate strictly controlled studies of the use of ursodeoxycholic acid in pregnant women have not been performed).

If you need to use the drug during lactation, you should decide whether to stop breastfeeding. Data on the isolation of ursodeoxycholic acid with breast milk are currently not available.

Use in children

The drug Urdoksa has no age restrictions in use, but children under the age of 3 years are not recommended to use the drug in this dosage form.

Use with caution in children aged 3 to 4 years, t. possible difficulty in swallowing capsules.

Children over 3 years of ursodeoxycholic acid are prescribed individually at a rate of 10-20 mg / kg per day.

special instructions

The use of the drug Urdoksa should be carried out under the supervision of a doctor.

When applying the drug for the purpose of dissolution of gallstones, the following conditions must be observed: the stones must be cholesteric (X-ray negative), their size should not exceed 15-20 mm,the gallbladder should remain functional and should be filled with stones no more than half, the permeability of the cystic and common bile duct should be preserved. For prolonged (more than 1 month) use of the drug every 4 weeks in the first 3 months of treatment, further - every 3 months it is necessary to conduct a biochemical blood test to determine the activity of hepatic transaminases. Control of the effectiveness of treatment should be carried out every 6 months according to ultrasound of bile ducts. After completely dissolving the stones, it is recommended to continue the use of the preparation for at least 3 months in order to facilitate the dissolution of stone remains, the sizes of which are too small for their detection and for the prevention of stone recurrence.

In patients with primary biliary cirrhosis, in rare cases, clinical symptoms may worsen at the beginning of treatment, for example, itching may worsen. In this case, the treatment should continue, taking 1 capsule daily, then you should increase the dose (increasing the daily dose weekly by 1 capsule) until the recommended dosage regimen is again achieved.

In case of unwanted or severe reactions, the patient should immediately inform the attending physician about them and, in no case, continue the use of the drug without his recommendation.

Impact on the ability to drive vehicles and manage mechanisms

Effects on the ability to drive vehicles and work with mechanisms were not identified.

Drug Interactions

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 should be taken at least 2 hours before taking Urdox.

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, the drug Urdoksa 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.

The patient should inform the doctor about all the medications he is taking.

Analogues of the drug Urdoksa

Structural analogs for the active substance:

• Grinterol;
• Livedoksa;
• Urso 100;
• Ursodeoxycholic acid;
• Ursodez;
• Ursodex;
• Ursuliv;
• Ursolit;
• Ursomik;
• Ursoprim;
• Ursor;
• Ursosan;
• Ursofalk;
• Holudexan;
• Exxhol.

Analogues for the pharmacological group (hepatoprotectors):

• Alpha lipoic acid;
• Antraliv;
• Berlition;
• Bondjigar;
• Brentzialle forte;
• Vitanorm;
• Gepa Merz;
• Gepabene;
• Hepatosan;
• Heptor;
• Heptral;
• Heptrog;
• Glutargin;
• Dipan;
• Covechol;
• Karsil;
• Karsil Forte;
• Laennek;
• Legalon;
• Liv.52;
• Liv.52 K;
• Liventziale;
• Livolife Forte;
• Lipoic acid;
• Methionine;
• Moliksan;
• Octolipen;
• Ornilatex;
• Ornitsetil;
• Polythion;
• Progepar;
• Resalute Pro;
• Remaxol;
• Sibektan;
• Silegon;
• Silibinin;
• Sylimar;
• Silymarin;
• Sirepard;
• Thioctic acid;
• Thiolipone;
• Tiotriazolin;
• Phosphogliv;
• Phosphogliv Forte;
• Phosphontsiale;
• Hepabos;
• Betaine citrate Bofur;
• Erbisol;
• Eslidine;
• Essentiale N;
• Essentiale forte N;
• Essential phospholipids;
• Essencigliv;
• Essley forte;
• The Essler;
• Essliver forte.

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