Ursofalk oral suspension 250mg / 5ml fl (ursodeoxycholic acid)

Latin name

Ursofal

Release form

Suspension for oral release srdldprrdard46pr1676r1446prrd46r4176r1446prrd461641 Suspension for oral administration

Packing

Bottle 250 ml.

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 in biliary reflux gastritis and 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 to 50-75% (with daily doses of 10-20 mg / kg). Penetrates through the placental barrier.

Indications

Dissolution of gallbladder cholesterol stones

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.

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.

Compound

Active with hydrochloric acid srdlkd.

Excipients:

benzoic acid,

avicel RC 591,

sodium chloride,

sodium citrate,

citric acid,

glycerin,

propylene glycol,

xylitol, srdlklgp lemon, srdlklgp 87 gld

Dosage and administration

10 mg / kg body weight 1 time / day is prescribed to dissolve cholesterol gallstones.

Duration of treatment 6-12 months

For the prevention of re-cholelithiasis, it is recommended to take the drug for several months after dissolving the stones

For the treatment of biliary reflux gastritis, 1 measured spoon of Ursofalk is prescribed 1 time / day.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 scoops (approximately 10-15 mg / kg body weight).

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, transient decompensation of cirrhosis of the liver may occur, which disappears after discontinuation of the drug.

Drug interaction

Cholestyramine, colestipol and antacids containing aluminum hydroxide bind ursodeoxycholic acid in the intestine, interfere with its absorption and weaken effectiveness (simultaneous administration is impractical).

Overdose

Overdose data not provided.

Storage Conditions

Do they store at 0 to 25 WITH.

Shelf life

4 years.

Deystvuyushtee substance

Ursodezoksiholevaya Chisloth

Terms and conditions

prescription

Dosage form

suspension for oral administration

Possible product names

URSOFALK 0.25 / 5ML 250ML SUSP

URSOFALK 0.25 / 5ML. 250ML. SUSP.

Ursofalk 250mg / 5ml Suspension d / v. Inside 250ml Fl. X1 B (R)

URSOFALK SUSP. D / PR. INSIDE 250ML / 5ML 250ML

URSOFALK SUSP. D / RECEPTION INSIDE 250MG / 5ML FL. 250ML No. 1



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