Description
Release form
Hard gelatin capsules, size 0, white, opaque capsule contents – white or almost white powder.
Pharmacological action
Hepatoprotector. It has a choleretic effect. Reduces the synthesis of cholesterol in the liver, its absorption in the intestine and concentration in bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and excretion of bile. Reduces the lithogenicity of bile, increases the content of bile acids in it. It causes an increase in gastric and pancreatic secretion, enhances lipase activity. It has a hypoglycemic effect.
Causes partial or complete dissolution of cholesterol stones when taken orally, reduces the saturation of bile with cholesterol, which helps mobilize cholesterol from gallstones.
It has an immunomodulatory effect, affects the immunological reaction 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.
Indications
dissolution of gallbladder cholesterol stones
– biliary reflux gastritis
– primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment).
Contraindications
– X-ray positive (high calcium) gallstones
– non-functioning gallbladder
– acute inflammatory diseases of the gallbladder, bile ducts and intestines
– cirrhosis of the liver at the stage of decompensation
dysfunctions – severe
– severe pancreatic dysfunction
– pregnancy
– lactation (breastfeeding)
– adults and children weighing up to 34 kg
– increased sensitivity to the drug.
Special instructions
In case of gallstone disease, the effectiveness of treatment is monitored every 6 months by X-ray and ultrasound examination of the biliary tract in order to prevent relapse of cholelithiasis.
In case of cholestatic liver diseases, transaminase activity should be periodically determined, alkaline phosphatase and gamma-glutamyl transpeptidase in serum.
Influence on the ability to drive vehicles and control mechanisms
There is no data on the effect of ursodeoxycholic acid on the ability to drive vehicles and work with mechanisms.
Composition
1 caps.
ursodeoxycholic acid 250 mg
Excipients: pregelatinized starch (1500 starch) – 73 mg, colloidal silicon dioxide (aerosil) – 5 mg, magnesium stearate – 2 mg.
Capsule shell composition: titanium dioxide, gelatin.
Dosage and administration
To dissolve cholesterol gallstones, a dose of 10 mg / kg of body weight is prescribed 1 time / day.
Body weight Number of capsules
up to 60 kg2
61-80 kg3
81-100 kg4
over 100 kg5
The drug must be taken daily in the evening, at bedtime (do not chew the capsules) with a small amount of liquid.
Duration of treatment is 6-12 months. For the prevention of re-cholelithiasis, the drug is recommended for several months after the dissolution of the stones.
1 capsule is prescribed for the treatment of biliary reflux gastritis. Ursodez daily in the evening before going to bed, washed down with not a lot of water. The course of treatment is from 10-14 days to 6 months, if necessary – up to 2 years.
For the symptomatic treatment of primary biliary cirrhosis, the daily dose depends on body weight and ranges from 2 to 6 capsules (approximately 10-15 mg / kg body weight).
The following dosing regimen is recommended.
Body weight Daily dose (caps.) in the morning in the evening
34-50 kg21-1
51-65 kg3111
66-85 kg4112
86-110 kg5122
over 110 kg6222
Side effects 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 cirrhosis of the liver may occur, which disappears after discontinuation of the drug.
Other: allergic reactions.
Drug Interactions
Colestyramine, 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 effectiveness. If the use of drugs containing at least one of these substances is nevertheless necessary, they must be taken at least 2 hours before taking Ursodez.
Ursodeoxycholic acid may enhance absorption of cyclosporine from the intestines. Therefore, in patients taking cyclosporine, the doctor should check the concentration of cyclosporin in the blood and adjust the dose of cyclosporine if necessary.
In some cases, ursodez may decrease the absorption of ciprofloxacin.
Hypolipidemic drugs (especially clofibrate), estrogens, neomycin, or gestagens increase bile saturation with cholesterol and may decrease the ability to dissolve cholesterol bile calculi.
Overdose
No overdose has been detected. In case of overdose, symptomatic treatment is performed.
Storage conditions
The product should be stored out of reach of children, in a dry, dark place at a temperature not exceeding 25 ° C.
Shelf life
5 years.
Pharmacy terms
prescription
Dosage form
capsules
Possible product names
URSODEZ 0.25 N50 CAPS
Ursodez 250mg Caps. X50 (blisters) (R)
Ursodez 250mg 50
Ursodez caps 250mg N50 (pack contact N10x5)
Ursodez caps. 250mg N50 Russia
Northern Star, Russia
