Description
Latin name
URSOFALK
Release form
Hard gelatin capsules, size 0, opaque, white, capsule contents – powder or white granules.
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.
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: it 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 cholesterol stones of the gallbladder
– biliary reflux gastritis
– primary biliary cirrhosis of the liver with no signs of decompensation (symptomatic treatment)
– chronic hepatitis of various genesis
– malignant sclerosis – primary sclerosis steatohepatitis
– alcoholic liver disease
– biliary dyskinesia.
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
dysfunction – severe
– severe pancreatic dysfunction
– pregnancy
– lactation (breastfeeding)
– hypersensitivity to drug components .
Special instructions
Ursofalk is administered under medical supervision.
During the first 3 months of treatment, liver function indicators should be monitored: the activity of transaminases, alkaline phosphatase and GGT in the blood serum every 4 weeks, and then every 3 months. Monitoring these parameters allows you to identify violations of the liver in the early stages. This also applies to patients in the late stages of primary biliary cirrhosis. In addition, it should be possible to determine more quickly if a patient with primary biliary cirrhosis is responding to treatment.
When used to dissolve cholesterol gallstones
In order to in order to evaluate progress in treatment and for the timely detection of signs of calcification of stones depending on the size of the stones, the gallbladder should be visualized (oral cholecystography) with examination of the blackouts in the standing and lying on the back (ultrasound) 6-10 months after the start of treatment.
If the gallbladder cannot be visualized on x-rays or in cases of calcification of stones, weak contractility of the gallbladder, or frequent bouts of colic, Ursofalk should not be used.
When treating patients in the later stages of primary biliary cirrhosis
, there have been very rare cases of decompensation of liver cirrhosis. After discontinuation of therapy, a partial reverse development of manifestations of decompensation was noted.
In patients with diarrhea, the dose should be reduced. With persistent diarrhea, treatment should be discontinued.
Influence on the ability to drive vehicles and control mechanisms
No influence on the ability to drive vehicles and moving mechanisms was detected.
Composition
1 caps. – ursodeoxycholic acid 250 mg.
Excipients:
corn starch – 73 mg,
silicon dioxide colloidal – 5 mg,
magnesium stearate – 2 mg,
titanium dioxide – 1.94 mg,
gelatin – 80.51 mg,
sodium lauryl sulfate – 0.2 mg pure, 0.2 mg water 14.55 mg.
Dosage and administration
The drug is taken once a day (at night) by mouth. The capsule is swallowed without opening the shell, washed down with water. The average daily dose of Ursofalk is calculated on the patient s body weight and is 10 mg / kg / day. If the dosage exceeds the average, you can divide the daily dose into 2 to 3 doses. It is recommended to take the drug for a long time – from several months to 2 years, without interruption in treatment.
To dissolve stones in the gallbladder before starting treatment, make sure that they are cholesterol (they are not visible on the x-ray), no larger than 20 mm in size, fill the gallbladder no more than half, while maintaining the patency of the bile ducts. Like its analogues, Ursofalk is not recommended to be used simultaneously with agents that increase cholesterol in bile (clofibrate, estrogens, etc.). Antacids worsen the absorption of the drug.
In case of gallstone disease, the duration of dissolution of the stones is from 6 to 24 months, but if after 12 months from the start of taking positive dynamics, Ursofalk can be canceled, since further treatment is not practical for them.
To monitor the effectiveness of treatment, the liver and bile ducts should be examined every six months using ultrasound and radiology. With biliary reflux gastritis and reflux esophagitis, the average course of administration lasts 10 to 14 days. With cystic fibrosis, the daily dose of Ursofalk reaches 20-30 mg / kg / day, with primary biliary cirrhosis up to 15-20 mg / kg / day.
Side effects
Determination of the frequency of adverse reactions: very often (? 1/10), often (? 1 / 100- <1/10), infrequently (? 1 / 1000- <1/100), rarely (? 1/10 000- <1/1000), very rarely (<1/10 000). From the digestive system: often in clinical trials – loose stools or diarrhea is very rare in the treatment of primary biliary cirrhosis – acute pain in the upper right abdomen. On the part of the liver and biliary tract: very rarely – calcification of gallstones, in the treatment of developed stages of primary biliary cirrhosis – decompensation of cirrhosis of the liver, which disappears after drug withdrawal. From the skin and subcutaneous tissues: very rarely – urticaria. If any of the following adverse reactions worsen, or any other adverse reactions occur, the patient should inform the doctor. 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 should be taken at least 2 hours before taking Ursofalk. Ursodeoxycholic acid may enhance absorption of cyclosporine from the intestines. Therefore, in patients receiving cyclosporine, the doctor should check the concentration of cyclosporin in the blood and adjust the dose of cyclosporin if necessary. In some cases, Ursofalk may decrease the absorption of ciprofloxacin. Hypolipidemic drugs (especially clofibrate), estrogens, neomycin, or progestins 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 the reach of children at 25 ° C. Shelf life 5 years. drugstore conditions drugstore Dosage form capsules Possible product names Ursofalk tablets 500 mg 50 pcs
