Ursofalk, capsules 250mg, 50pcs

Composition

Active ingredient:

ursodeoxycholic acid 250 mg.

Auxiliary substances:

magnesium stearate,

corn starch,

colloidal anhydrous silicon dioxide,

gelatin,

dodelyl,

sodium sulfate,

titanium dioxide,

purified water.

Pharmacological action

Pharmacodynamics

Having high polar properties, UDCA forms non-toxic mixed micelles with apolar (toxic) bile acids, which reduces the ability of refluktate to damage cell membranes in biliary reflux gastritis and reflux esophagitis. In addition, UDCA forms double molecules that can be incorporated into cell membranes, stabilize them, and make them immune to the action of cytotoxic micelles.

Reduces the saturation of bile with cholesterol by inhibiting its absorption in the intestine, suppressing synthesis in the liver and reducing secretion in bile; increases the solubility of cholesterol in bile, forming liquid crystals with it; reduces the litogenic index of bile. The result is the dissolution of cholesterol gallstones and the prevention of the formation of new stones.

The immunomodulatory effect is caused by inhibition of HLA-antigen expression on the membranes of hepatocytes and cholangiocytes, normalization of the natural killer activity of lymphocytes, etc. Significantly delays the progression of fibrosis in patients with primary biliary cirrhosis, cystic fibrosis and alcoholic steatohepatitis, reduces the risk of esophageal varicose veins.

For successful dissolution of gallstones, it is necessary that the stones are pure 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

It is absorbed in the jejunum due to passive diffusion, in the ileum – due to active transport. When taken orally 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 mmol/l, respectively.

When taken systematically, ursodeoxycholic acid (UDCA) becomes the main bile acid in the blood serum (48% of the total bile acid content).

It is included in the enterohepatic circulation system.

The therapeutic efficacy of the drug depends on the concentration of UDCA in the bile. During therapy, there is a dose-dependent increase in the proportion of UDCA in the bile acid pool to 50-75% (at daily doses of 10-20 mg / kg). Penetrates the placental barrier.

Indications

• Dissolution of cholesterol gallstones;
• biliary reflux gastritis;
• primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment).

Contraindications

Acute inflammatory diseases of the gallbladder and bile ducts.

Blockage of the common bile duct or cystic duct.

Side effects

Diarrhea, nausea, pain in the epigastric region and right hypochondrium; calcification of gallstones; increased activity of hepatic transaminases (AST, ALT).

Allergic reactions.

In the treatment of primary biliary cirrhosis, temporary decompensation of liver cirrhosis may occur, which disappears after discontinuation of the drug.

Interaction

Cholestyramine, colestipol and antacids containing aluminum hydroxide bind ursodeoxycholic acid in the intestine, prevent its absorption and weaken its effectiveness (simultaneous use is not advisable).

How to take, course of use and dosage

Dissolving cholesterol gallstones

Approximately 10 mg per 1 kg of body weight daily, which corresponds to:

• 2 capsules (2 scoops) of Ursofalk in patients weighing up to 60 kg;
• 3 capsules (3 scoops) of Ursofalk in patients weighing up to 80 kg;
• 4 capsules (4 scoops) of Ursofalk in patients weighing up to 100 kg.

Capsules should be taken in the evening, before going to bed, without chewing and with a small amount of liquid. The duration of treatment is 6-12 months. To prevent recurrent cholelithiasis, it is recommended to take the drug for several months after the dissolution of the stones.

Treatment of biliary reflux gastritis

1 capsule (1 scoop) of 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 (measuring spoons) (approximately 10 to 15 mg of ursodeoxycholic acid per 1 kg of body weight).

The following application mode is recommended

• Body weight 34-50 kg: 2 capsules (measuring spoons, daily dose); in the morning-1, in the afternoon – -, in the evening-1.
• Body weight 51-65 kg: 3 capsules (measuring 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 (measuring spoons, daily dose); in the morning-1, in the afternoon-2, in the evening-2.
• Body weight over 110 kg: 6 capsules (measuring spoons, daily dose); in the morning-2, in the afternoon-2, in the evening-2.

Patients with a body weight of less than 34 kg should use Ursofalk in suspension.

Overdose

No overdose data was provided.

Form of production

Capsules

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

5 years

Active ingredient

Ursodeoxycholic acid

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Description

For adults as prescribed by a doctor, For pregnant women, For Children as prescribed by a doctor

Indications

Liver damage, Alcoholism, Cholelithiasis, Hepatitis, Reflux Esophagitis, Biliary Dyskinesia, Cirrhosis of the liver