Ursofalk (ursodeoxycholic acid) capsules 250 mg. №100

Description

Ursofalk (ursodeoxycholic acid) capsules 250 mg. №100

Composition 

active substance: ursodeoxycholic acid;

1 capsule contains 250 mg of ursodeoxycholic acid;

Excipients: corn starch, colloidal anhydrous silica, magnesium stearate, titanium dioxide (E 171), gelatin, purified water, sodium lauryl sulfate.

Dosage form

Capsules.

Main physical and chemical properties: white opaque hard gelatin capsules of size “0”, containing white compressed powder or granules.

Pharmacotherapeutic group

Drugs used to treat the liver and biliary tract. Means used in case of biliary pathology.

ATX code A05A A02.

Drugs used in case of liver disease, lipotropic substances.

ATX code A05B.

Pharmacological properties

A small amount of Ursofalk (ursodeoxycholic acid) capsules was found in human bile.

After oral administration, it reduces the saturation of bile with cholesterol, inhibiting its absorption in the intestine and reducing the secretion of cholesterol to bile. It is possible that due to the dispersion of cholesterol and the formation of liquid crystals there is a gradual dissolution of gallstones.

According to current knowledge, it is believed that the effect of ursodeoxycholic acid in liver disease and cholestasis is due to the relative replacement of lipophilic, detergent-like toxic bile acids with hydrophilic cytoprotective non-toxic ursodeoxycholic acid, improving the secretory capacity of hepatocytes.

Application for children

Cystic fibrosis

Information is available from clinical reports on the long-term use of ursodeoxycholic acid (for up to 10 years) in the treatment of children with hepatobiliary disorders associated with cystic fibrosis. There is evidence that the use of ursodeoxycholic acid can reduce proliferation in the bile ducts, stop the progression of histological changes and even eliminate hepatobiliary changes, provided that treatment is started in the early stages of cystic fibrosis. For better effectiveness, treatment with ursodeoxycholic acid should be started immediately after the diagnosis of cystic fibrosis.

Indications

Ursofalk (ursodeoxycholic acid) capsules is prescribed to dissolve cholesterol gallstones in the gallbladder. It is also used in the treatment of biliary reflux gastritis and primary biliary cirrhosis (if there are no signs of decompensation in the work of this organ). The drug is prescribed in the composition of complex therapy for chronic gastritis of various etiology, primary sclerosing cholangitis, cystic fibrosis, non-alcoholic steatohepatitis, biliary dyskinesia and toxic alcoholic liver damage.

Contraindications

Ursofalk (ursodeoxycholic acid) capsules is not prescribed if, during an X-ray examination, stones in the gallbladder with a high calcium content, a non-functioning gallbladder, acute inflammatory lesion of the gallbladder, as well as its ducts and intestines were found. It is contraindicated in case of decompensated cirrhosis of the liver, severe disorders in the functioning of the kidneys, liver and pancreas. Ursofalk is not prescribed for intolerance to usodeoxycholic acid, as well as for women at the stage of pregnancy and lactation.

Application during pregnancy and lactation

Ursofalk (ursodeoxycholic acid) capsules is contraindicated in pregnant and lactating women.

Method of administration and dosage

Ursofalk capsules and suspensions are intended for oral administration. If the patient was prescribed a single dose of the drug, then it is carried out in the evening. The capsules are swallowed whole, without chewing and drinking a sufficient amount of liquid. If the patient has difficulty swallowing capsules, then the drug is prescribed in the form of a suspension.
The doctor selects the duration of therapy and the dose of Ursofalk individually, taking into account the severity of the disease and the severity of the symptoms. In the treatment of acute and chronic liver diseases and cholelithiasis, the drug is prescribed at 10 or 15 mg per kg of the patient’s body weight. The duration of treatment is from 6 months to 2 years. During drug therapy, it is unacceptable to take breaks in treatment. If after 12 months of treatment of gallstone disease there is no decrease in calculi, then the drug is stopped.
In the treatment of biliary reflux gastritis or reflux esophagitis, the drug is taken at 250 mg 1 time per day, preferably in the evening. The duration of therapy is from 10 to 14 days.
In the treatment of biliary cirrhosis or sclerosing cholangitis, the drug is 10 or 15 mg per kg of body weight per day. If necessary, the daily dose can be increased to 20 mg per kg of body weight. The duration of treatment is from 6 months to 2 years.
In the treatment of toxic liver damage or acute alcohol poisoning, the drug is taken at 10 or 15 mg per kg of body weight. Duration of treatment is from 6 to 12 months.

Overdose

At the moment, no cases of Ursofalk overdose have been officially recorded.

Side effects

Side effects are very rare when taking Ursofalk. In patients with hypersensitivity to the drug, there is the development of pain in the epigastric region, calcification of stones in the gallbladder. In addition, some patients have mushy stools and allergic reactions.