Description
Release form
Capsules.
Packing
100 pcs.
Pharmacological action of
Pharmacodynamics of
Having high polar properties, UDCA forms non-toxic mixed micelles with apolar (toxic) bile acids, which reduces the ability of refluxate to damage cell membranes during biliary reflux gastritis and reflux-reflux. In addition, UDCA forms binary molecules capable of being incorporated into cell membranes, stabilizing them and making them immune to cytotoxic micelles.
Reduces the saturation of bile with cholesterol by inhibiting its absorption in the intestine, inhibiting synthesis in the liver and lowering secretion into bile, increases the solubility of cholesterol in bile, forming liquid crystals with it, and decreases the lithogenic index of bile. The result is the dissolution of cholesterol gallstones and the prevention of the formation of new calculi.
The immunomodulatory effect is due to the inhibition of the expression of HLA antigens on the membranes of hepatocytes and cholangiocytes, the normalization of the natural killer activity of lymphocytes, etc. Reliably delays the progression of fibrosis in patients with primary biliary cirrhosis, cystic fibrosis and alcoholic steatohepatitis, and it reduces the risk of varicose vein hepatitis.
For successful dissolution of gallstones, it is necessary that the stones are purely cholesterol, their size does not exceed 15-20 mm, and the gallbladder (filled with stones no more than half) and bile ducts fully retain their function.
Pharmacokinetics
Absorbed in the jejunum due to passive diffusion, in the ileum – due to active transport. When administered in a single dose of 500 mg, the concentration in the blood serum after 30, 60 and 90 minutes is 3.8, 5.5 and 3.7 μmol / L, respectively.
With systematic administration, ursodeoxycholic acid (UDCA) becomes the main serum bile acid (48% of the total bile acid content). It is included in the system of enterohepatic circulation. The therapeutic efficacy of the drug depends on the concentration of UDCA in bile. During therapy, a dose-dependent increase in the proportion of UDCA in the bile acid pool up to 50-75% (with daily doses of 10-20 mg / kg). Penetrates through the placental barrier.
Indications
Dissolution of cholesterol gallbladder stones
biliary reflux gastritis
primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment).
Contraindications
Acute inflammatory disease of the gallbladder and bile ducts.
Blockage of the common bile duct or cystic duct.
Use during pregnancy and lactation
Published data on the use of the drug during pregnancy are available.
Currently, the use of the drug should be limited to the second and third trimesters of pregnancy.
There is no data on penetration into breast milk.
Composition
1 capsule contains:
Active ingredient:
ursodeoxycholic acid 250 mg.
Excipients:
magnesium stearate,
corn starch,
colloidal anhydrogenated silicon dioxide,
gelatin,
completed,
sodium sulfate,
titanium dioxide, srdlp.
Dosage and administration of
Dissolution of
cholesterol gallstones Approximately 10 mg per 1 kg of body weight daily, which corresponds to:
2 capsules (2 scoops) Ursofalk in patients weighing up to 60 kg
3 capsules (3 scoops Ursofalk in patients with body weight up to 80 kg
4 capsules (4 measured spoons) Ursofalk in patients with body weight up to 100 kg.
Capsules must be taken in the evening, before going to bed, without chewing and drinking a small amount of liquid. The 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.
Treatment of biliary reflux gastritis
1 capsule (1 scoop) Ursofalk daily. 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 ranges from 2 to 6 capsules (scoops) (approximately 10 to 15 mg of ursodeoxycholic acid per 1 kg of body weight).
The following regimen is recommended
Body weight 34-50 kg: 2 capsules (scoops, daily dose) in the morning – 1, in the afternoon -, in the evening – 1.
Body weight 51-65 kg: 3 capsules (measured spoons, daily dose ) in the morning – 1, in the afternoon – 1, in the evening – 1.
Body weight 66-85 kg: 4 capsules (measuring spoons, daily dose) in the morning – 1, in the afternoon – 1, in the evening – 2.
Body weight 86-110 kg: 5 capsules (scoops, daily dose) in the morning – 1, in the afternoon – 2, in the evening – 2.
Body weight over 110 kg : 6 capsules (scoops, daily dose) in the morning – 2, in the afternoon – 2, in the evening – 2.
Patients with body weight less than 34 kg should use Ursofalk in suspension.
Side effects
Diarrhea, nausea, epigastric pain and right hypochondrium calcification of gallstones increased activity of hepatic transaminases (AST, ALT).
Allergic reactions.
In the treatment of primary biliary cirrhosis, transient decompensation of cirrhosis of the liver may occur, which disappears after discontinuation of the drug.
Drug Interactions
Cholestyramine, colestipol and antacids containing aluminum hydroxide bind ursodeoxycholic acid in the intestine, inhibit its absorption and weaken its effectiveness (simultaneous administration is impractical).
Overdose
Overdose data not provided.
Storage Conditions
Store at 0 to 25 ° C.
Keep out of the reach and sight of children.
Shelf life
5 years.
Deystvuyushtee substance
Ursodezoksiholevaya Chisloth
Terms and conditions
prescription
dosage form
capsules
Possible Product Names
URSOFALK 0.25 N100 CAPSA
Ursofalk 250mg Caps. X100 (R)
Ursofalk 250mg No. 100 caps
Ursofalk caps 250mg N100
URSOFALK CAPS. 250MG N100
Dr. Falyk, Germany
