Ursosan (ursodeoxycholic acid) capsules 250 mg. №100

Description

Ursosan (ursodeoxycholic acid) capsules 250 mg. №100

Composition

active ingredient: ursodeoxycholic acid;

1 capsule contains 250 mg of ursodeoxycholic acid;

excipients: corn starch, pregelatinized starch, anhydrous colloidal silicon dioxide, magnesium stearate;

capsule composition: gelatin, titanium dioxide (E 171).

Dosage form

Capsules.

Basic physical and chemical properties: white gelatin capsules, size No. 0, containing a white or almost white powder; or white or almost white powder with lumps of mass; or a white or off-white powder compressed into a column that disintegrates when pressed.

Pharmacological group

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

ATX code A05A A02.

Medications used in liver diseases, lipotropic substances.

ATX code A05B.

Pharmacological properties

A small amount of ursodeoxycholic acid has been found in human bile.

After oral administration, it reduces the saturation of cholesterol bile, inhibiting its absorption in the intestine and reducing the secretion of cholesterol to bile. Perhaps due to the dispersion of cholesterol and the formation of liquid crystals, a gradual dissolution of gallstones occurs.

It is believed that the effect of ursodeoxycholic acid in liver diseases and cholestasis is due to the relative replacement of lipophilic, detergent-like toxic bile acids with hydrophilic cytoprotective non-toxic ursodeoxycholic acid, improvement in the secretory capacity of hepatocytes and immunoregulatory processes.

Indications

Ursosan capsules is used to treat patients with radiopaque cholesterol stones in the gallbladder. The size of the stones should not exceed 15 millimeters, and the gallbladder itself should maintain its normal functions. Also effective in treating heartburn and gastritis caused by bile reflux. It is applicable for primary biliary cirrhosis (if it is not in the stage of decompensation).
Ursodeoxycholic acid, which is the main active ingredient of the drug, actively affects the synthesis of cholesterol in the liver and its absorption in the intestine. In the process of interaction of ursodeoxycholinic acid with cholesterol, special liquid crystals are formed that dissolve cholesterol stones and reduce the lithogenicity of bile, and reduce the cholesterol index.
This acid is a non-toxic cytoprotector, and has the ability to replace toxic bile acids, improve the secretory capacity of hepatocytes, and stimulate immunoregulatory processes.

Contraindications

Contraindicated in case of a hypersensitive reaction of a person to ursodeoxycholic acid and to additional substances that make up the drug.
It is forbidden to use in case of obstruction of the bile ducts, impaired contractility in the gallbladder, or if acute inflammatory processes occur in it. It is also not prescribed if the patient has liver and kidney disorders.
Not effective for calcified stones, biliary colic.
For ulcerative and inflammatory diseases of the gastrointestinal tract, extrahepatic cholestasis, liver cirrhosis and hepatitis, it is used with extreme caution.

Application during pregnancy and lactation

For women in the third trimester of pregnancy, the drug is not prescribed. In the other two – if there are appropriate indications. In the course of treatment, it is necessary to choose reliable methods of preventing pregnancy. Lactation is stopped during treatment with this drug.

Method of administration and dosage

Take the capsules once a day, before going to bed. To dissolve stones in the gallbladder, the dose is taken at the rate of 10 mg of the drug per 1 kilogram of the patient’s weight (for primary biliary cirrhosis – 14 mg per 1 kg). For the onset of the effect, regular intake of this pharmaceutical preparation is required for six months to two years. If the admission has not shown any positive dynamics within one year, it is stopped. For control, it is necessary to monitor the size of gallstones using ultrasound at a frequency of at least once every six months. It is also necessary to regularly monitor that the stones do not calcify. For this, cholecystography is regularly performed.
To treat heartburn, it is enough to take 1 capsule at night for two weeks.
Treatment of biliary cirrhosis is carried out by dividing the daily dosage into 3 doses. However, if taking it has caused severe side effects, you can start taking it with 1 capsule at night, and then bring it up to the required volume.

Overdose

Overdose threatens the occurrence of severe diarrhea due to a strong outflow of bile. Treatment is aimed at restoring the water-salt balance. Until the restoration of the intestinal state is achieved, the drug is stopped.

Side effects

Pain in the liver, diarrhea, and calcification of gallstones (calculi) may develop. In the treatment of biliary cirrhosis, liver cirrhosis decompensation may occur. Hives were occasionally noted at the beginning of treatment.