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Choludexan-reb / Choludexan-reb

Indications for use:

- dissolution of cholesterol gallstones.
Cholesterol stones should not appear as shadows on an x-ray and should not exceed 15 mm in diameter. Despite the presence of stones, the function of the gallbladder should not be impaired; - treatment of gastritis with bile reflux;

- symptomatic treatment of primary biliary cirrhosis (PBC) in the absence of signs of decompensation.

Trade name: Choludexan-Reb

International nonproprietary name: Ursodeoxycholic acid

Dosage form: capsules

Compound:

The capsule contains:

Active substance: ursodeoxycholic acid 300 mg.

Excipients: corn starch, anhydrous colloidal silicon dioxide, magnesium stearate, purified water.

Composition of the capsule shell: titanium dioxide (E171), red iron oxide (E172), gelatin.

Pharmacotherapeutic group

Drugs for the treatment of diseases of the liver and biliary tract. Bile acid preparations.

ATX code: A05AA02.

Pharmacological properties

Pharmacodynamics

Small amounts of ursodeoxycholic acid have been found in human bile. After oral administration, the drug reduces the saturation of bile with cholesterol by inhibiting the absorption of cholesterol in the intestine and reducing the secretion of cholesterol in the bile. Presumably, as a result of cholesterol dispersion and the formation of liquid crystals, cholesterol stones gradually dissolve. According to generally accepted data, the effect of ursodeoxycholic acid on liver diseases and cholestatic diseases is achieved through an equal exchange of lipophilic, detergent-like toxic bile acids for hydrophilic, cytoprotective, non-toxic ursodeoxycholic acid, which leads to an improvement in the secretory ability of hepatocytes and immunoregulatory processes.

Ursodeoxycholic acid has a direct cytoprotective membrane-stabilizing effect on hepatocytes, cholangiocytes and epithelial cells of the gastrointestinal tract. Forms double molecules that interact with lipophilic membrane structures, integrate into cell membranes and stabilize them. Protects liver cells and bile duct cells from damaging factors, making them immune to the action of cytotoxic micelles.

It has immunomodulatory activity, reduces the severity of immunopathological reactions in the liver by reducing the expression of histocompatibility antigens HLA-1 on hepatocytes and HLA-2 on bile duct cells and reducing the effect of immunoglobulins (primarily IgM). Reduces the formation of cytotoxic T-lymphocytes.

By stimulating exocytosis in hepatocytes during cholestasis by activating Ca2+-dependent α-protein kinase, ursodeoxycholic acid reduces the concentration of bile acids toxic to hepatocytes and induces choleresis with a high content of bicarbonates, which leads to an increase in the passage of bile.

By reducing the synthesis of cholesterol in the liver, as well as its absorption in the intestine, ursodeoxycholic acid reduces the lithogenicity of bile, reduces the cholate-cholesterol index, promotes the dissolution of cholesterol stones and prevents the formation of new ones.

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 (no more than half filled with stones) and bile ducts fully retain their function.

Ursodeoxycholic acid significantly delays the progression of fibrosis in patients with primary biliary cirrhosis, cystic fibrosis and alcoholic steatohepatitis. Reduces the risk of developing varicose veins of the esophagus.

Regulates the processes of apoptosis (aging and cell death) that are disrupted in the pathology of the liver and other organs. The use of ursodeoxycholic acid inhibits the growth of colon cancer cells.

Pharmacokinetics

After taking the drug orally, ursodeoxycholic acid is absorbed in the small intestine by passive diffusion, and in the ileum by active transport. The maximum concentration in plasma is achieved within 30-60 minutes after administration, the level of adsorption is 60-80%.

With regular use of the drug, ursodeoxycholic acid becomes the main bile acid in the blood plasma, accounting for about 48% of the total amount of bile acids in the blood.

Ursodeoxycholic acid is excreted mainly in the feces. When used in large doses, the level of ursodeoxycholic acid excretion in urine increases, although this value remains insignificant (less than 1%), except in cases of severe cholestatic liver damage. The half-life of ursodeoxycholic acid is 3.5-5.8 days.

Indications for use

- dissolution of cholesterol gallstones. Cholesterol stones should not appear as shadows on an x-ray and should not exceed 15 mm in diameter. Despite the presence of stones, the function of the gallbladder should not be impaired;

- treatment of gastritis with bile reflux;

- symptomatic treatment of primary biliary cirrhosis (PBC) in the absence of signs of decompensation.

Directions for use and dosage

The capsule is swallowed whole, without chewing, with a sufficient amount of liquid (can be taken with food or a light snack).

There are no age restrictions for taking Choludexan-Reb capsules at a dosage of 300 mg, but for patients weighing less than 47 kg or who have difficulty swallowing capsules, it is recommended to prescribe ursodeoxycholic acid in the form of an oral suspension.

To dissolve cholesterol gallstones - approximately 10 mg ursodeoxycholic acid / kg body weight.

Capsules should be swallowed whole with water, 1 time per day in the evening before bed. Capsules must be taken regularly.

The time required for gallstones to dissolve is usually 6-24 months. If a reduction in the size of gallstones is not observed after 12 months of use, therapy should not be continued.

The success of treatment should be checked every 6 months using ultrasound or x-ray. With the help of additional studies, it is necessary to check whether the calcification of stones has occurred over time. If this happens, treatment should be stopped.

Gastritis with bile reflux - prescribe 300 mg of the drug at bedtime. The course of treatment is usually 10-14 days. The duration of treatment depends on the patient's condition. The doctor must decide on the duration of treatment in each case individually.

For the symptomatic treatment of primary biliary cirrhosis (PBC), the daily dose depends on body weight and is determined at the rate of 14±2 mg of ursodeoxycholic acid per kg of body weight.

Use in the elderly: There is no data on the need for dose adjustment in people of this age category. However, precautions must be taken during treatment.

Children: Although there are no fundamental age restrictions for the use of ursodeoxycholic acid, capsules are not recommended for use in children weighing less than 47 kg and/or under 6 years of age due to possible difficulties with swallowing. If the child weighs less than 47 kg or has difficulty swallowing, it is recommended to use ursodeoxycholic acid in the form of a suspension.

Side effect

The side effect frequency parameters used below are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (from ≥1/10000 to <1/1000), very rare (<1/10000).

Gastrointestinal Disorders: Reports of pasty stools or diarrhea are very common in clinical trials.

Very rarely, during treatment of primary biliary cirrhosis, severe pain occurred in the abdominal area on the right side.

Liver and biliary disorders: Calcification of stones may very rarely occur during treatment with ursodeoxycholic acid.

During the treatment of late stages of primary biliary cirrhosis, decompensation of liver cirrhosis was very rarely observed, which disappears after discontinuation of the drug.

Hypersensitivity reactions: In very rare cases, an allergic rash (urticaria) may occur.

Contraindications

- hypersensitivity to the active substance or other ingredients included in this medicinal product;

- X-ray positive (high calcium content) gallstones;

- non-functioning gallbladder;

- obstruction of the bile ducts, frequent biliary colic;

- acute inflammatory diseases of the gallbladder, bile ducts and intestines;

— liver cirrhosis in the stage of decompensation;

- severe liver and/or kidney failure;

- pancreatitis;

- first trimester of pregnancy;

- children under 6 years of age.

Precautionary measures

Before starting treatment, females must ensure that they are not pregnant. Taking the drug Choludexan-Reb should be carried out under the supervision of a doctor.

Use during pregnancy and lactation

The drug is contraindicated in the first trimester of pregnancy. Use in the second and third trimesters of pregnancy is possible only if the benefit to the mother outweighs the potential risk to the fetus (there have been no adequate, strictly controlled studies of the use of ursodeoxycholic acid in pregnant women).

There are currently no data on the excretion of ursodeoxycholic acid in breast milk. If it is necessary to prescribe a drug during lactation, the issue of stopping breastfeeding should be decided. The decision to use Choludexan-Reb is made by the doctor.

Use in pediatrics

Due to the fact that Choludexan-Reb is available in the form of capsules of 300 mg, the drug is not used in children under 6 years of age (less than 20 kg of weight).

Overdose

In case of overdose, diarrhea may occur. In general, overdose is unlikely because the absorption of ursodeoxycholic acid decreases with increasing doses and it is mainly excreted in the feces.

Storage conditions and shelf life

Store at a temperature not exceeding 25°C.

Keep out of the reach of children!

3 years from the date of production. Do not use after the expiration date.

Package

10 capsules each in a blister pack made of PVC/PVDC and flexible packaging based on aluminum foil. 2, 4 or 6 blister packs along with an insert in a cardboard pack.

Manufacturer information

Foreign production and trading unitary enterprise "Reb-Pharma", 223216, Republic of Belarus, Minsk region, Chervensky district, urban settlement. Smilovichi, st. Sadovaya, 1, tel./fax: (+375) 17 240 26 35, e-mail, https://www.rebpharma.by.

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Choludexan-reb / ​​Choludexan-reb

Indications for use:

Choludexan-reb / Choludexan-reb