Biliary dyskinesia treatment

Active substance:

Content

Pharmacological groups

Nosological classification (ICD-10)

Description of the dosage form

White or almost white solid opaque gelatin capsules No. 0. Capsules contents: white or almost white granulate.

pharmachologic effect

Pharmacodynamics

Hepatoprotective drug, also has choleretic, cholelitholytic, hypocholesterolemic, hypolipidemic, immunomodulating action.

It is embedded in the hepatocyte membrane, stabilizes its structure and protects the hepatocyte from the damaging action of bile salts, thus reducing their cytotoxic effect. When cholestasis activates Ca 2+ -dependent α-protease and stimulates exocytosis, reduces the concentration of toxic bile acids (chenodesoxycholic, lithocholic, deoxycholic), whose concentrations in patients with chronic liver diseases are elevated.

Competitively reduces the absorption of lipophilic bile acids in the intestine, increases their fractional circulation during enterohepatic circulation, induces choleresis, stimulates the passage of bile and the excretion of toxic bile acids through the intestines.

Shields non-polar bile acids (chenodeoxycholic), due to which mixed (non-toxic) micelles are formed.

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

Increases the solubility of Xc in the biliary 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, enhances the activity of lipase, and has a hypoglycemic effect.

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

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

Pharmacokinetics

UDCA is absorbed in the small intestine due to passive diffusion (about 90%), and in the ileum via active transport. Cmax in the blood plasma when administered orally in a dose of 50 mg after 30, 60, 90 min – 3.8, 5.5 and 3.7 mmol / l, respectively. Cmax achieved in 1-3 hours

Communication with plasma proteins is high – up to 96–99%. It penetrates the placental barrier. When systematically taking the drug UDCA becomes the main bile acid in serum and accounts for about 48% of the total amount of bile acids in the blood. The therapeutic effect of the drug depends on the concentration of UDCA in the bile.

Metabolized in the liver (clearance during the first passage through the liver) in the taurine and glycine conjugates. The resulting conjugates are secreted into the bile.

About 50–70% of the total dose of the drug is excreted in the bile. A small amount of non-absorbed UDCA enters the colon, where it is broken down by bacteria (7-dehydroxylation); The formed lithocholic acid is partially absorbed from the colon, but is sulfated in the liver and rapidly excreted as a sulfolithocholyl glycine or sulfolithocholyl taurin conjugate.

Indications of drug uroksa ®

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

dissolving cholesterol gallstones;

primary sclerosing cholangitis;

alcoholic liver disease;

cystic fibrosis (cystic fibrosis);

chronic hepatitis of various origins;

biliary dyskinesia.

Contraindications

hypersensitivity to the drug;

X-ray (high calcium) gallstones;

nonfunctioning gallbladder;

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

cirrhosis of the liver in the stage of decompensation;

Biliary dyskinesia treatment

severe impaired renal function, liver, pancreas.

UDCA has no age limit for use, however, children under 3 years old are not recommended to use the drug in this dosage form.

Carefully: in children from 3 to 4 years old,

Use during pregnancy and lactation

In experimental animal studies, no mutagenic and carcinogenic effects of UDCA were found. UDCA use during pregnancy is possible only when the expected benefit to the mother outweighs the potential risk to the fetus (there are no adequate well-controlled studies of the use of UDCA in pregnant women).

Biliary dyskinesia treatment

If necessary, the use of the drug during lactation should decide on the termination of breastfeeding. Data on the allocation of UDCA with breast milk is currently not available.

Side effects

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

UDCA can increase the absorption of cyclosporine from the intestine. Therefore, in patients taking cyclosporine, it is necessary to check the concentration of cyclosporine in the blood and adjust the dose of cyclosporine if necessary.

In some cases, the drug Urdoksa ® may reduce the absorption of ciprofloxacin.

Lipid-lowering drugs (especially clofibrate), estrogens, neomycin, or progestins increase cholesterol saturation of bile and may decrease the ability to dissolve cholesterol biliary calculi.

You should inform the doctor about all the drugs taken.

Dosage and administration

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 caps. – approximately (14 ± 2) mg UDCA per 1 kg. In the first 3 months of treatment, the dose of Urdox ® should be divided into several doses throughout the day. After improvement of liver indices, the daily dose of the drug can be taken 1 time in the evening.

The following mode of application is recommended (see table 1).

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

Dissolution of cholesterol gallstones

The recommended dose is 10 mg UDCA per 1 kg / day (see table 2).

Urdox® preparation should 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 caps Urdox® preparation daily 1 time a 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.

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 ranges 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, treatment is recommended to repeat.

For children over 3 years old, the drug is prescribed individually, at the rate of 10–20 mg / kg / day.

Overdose

Cases of overdose of UDCA are unknown.

special instructions

Urdox’s ® drug should be administered under the supervision of a physician.

When using the drug 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 be filled with no more than half of the stones, the pervasiveness of the cystic and general The bile duct must be maintained. With prolonged (more than 1 month) administration of the drug every 4 weeks for 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 ultrasound of the biliary tract. After complete dissolution of the stones, it is recommended to continue using the drug for at least 3 months in order to facilitate the dissolution of the remains of stones, whose dimensions are too small to detect them and to prevent recurrence of stone formation.

In patients with primary biliary cirrhosis in rare cases, clinical symptoms may worsen at the beginning of treatment, for example, itching may intensify. In this case, the treatment should be continued, taking 1 caps. daily, then the dosage should be increased (increasing the daily dosage weekly by 1 capsule) until the recommended dosing regimen is again reached.

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

When disposing of unused product packaging special precautions are required.

Biliary dyskinesia treatment

Influence on ability to drive vehicles and work with mechanisms. Impact on the ability to drive and work with the mechanisms was not identified.

Release form

Capsules, 250 mg. 10 caps. in a blister strip packaging of PVC film and aluminum printed lacquered foil.

50 or 100 caps. in a polymer can or polymer can with a lid for drugs. The lid of the jar can be made of yellow plastic.

On each can stick a label made of paper writing or label or self-adhesive label.

1 jar or 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 blister packs are placed in a cardboard box.

Manufacturer

1. JSC Pharmaceutical enterprise Obolensky . 142279, Russia, Moscow region, Serpukhov district, p. Obolensk, bld. 7–8, 39.

2. ZAO “Farmproekt”. 192236, Russia, St. Petersburg, ul. Sofia, 14, lit. BUT.

Legal entity in the name of which a registration certificate / organization that claims is issued: Pharmaceutical Enterprise Obolenskoe JSC. 142279, Russia, Moscow region, Serpukhov district, p. Obolensk, bld. 7–8.

Tel / Fax: (495) 646-28-68.

Pharmacy sales terms

Storage conditions of the drug Urdox ®

Keep out of the reach of children.

Shelf Life Urdox ®

Do not use after the expiration date printed on the package.

Like this post? Please share to your friends:
Leave a Reply