Ursochol

The lipotropic agent Ursochol contains ursodeoxycholic acid, which is actively used in hepatobiliary diseases.

Indications Ursohola

The encapsulated lipotropic drug Ursochol is prescribed to eliminate bile stones of cholesterol etiology that are not determined by radiographic methods (provided that the function of bile secretion is preserved).

In addition, Ursohol is appropriate as a drug for the complex therapy of reflux inflammation in the stomach with bile reflux, primary biliary cirrhosis in a compensatory state, and hepatobiliary disorders in cystic fibrosis in childhood.

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Release form

Ursochol is produced in capsule form of 250 mg, with the active ingredient ursodeoxycholic acid.

The honeycomb packaging contains 10 capsules. The cardboard pack may include five or ten honeycomb packages with the drug.

Pharmacodynamics

The active ingredient Ursochol can be found in trace amounts in human bile.

When capsules are taken internally, the cholesterol saturation of bile secretions is reduced by inhibiting the absorption of cholesterol by the intestine and reducing the release of cholesterol into the bile formation and excretion system. Probably, as a result of the dispersion processes and the formation of liquid crystalline forms, a slow dissolution of bile stones is observed.

It is believed that the effect of Ursohol in liver and cholestatic diseases is associated with incomplete replacement of lipophilic toxic bile acids with hydrophilic non-toxic acids, as well as with facilitating the secretion of liver cells and regulating immune defense.

Pharmacokinetics

After oral administration, the active ingredient Ursochol is absorbed within a short time in the small intestine, in the ascending ileum by passive transport and in the terminal ileum by active transport.

The absorption rate can typically be estimated at 60-80%.

After the end of absorption, bile acid undergoes almost absolute liver conjugation, with the participation of amino acids taurine and glycine. The next stage is the removal of the acid with the flow of bile.

Indicative values for initial liver passage clearance may be around 60%.

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Dosing and administration

Ursochol is prescribed by a doctor if there are appropriate indications. The dosage and duration of therapy depend mainly on the patient's weight and the characteristics of the disease.

• To get rid of gallstones, the dosage is determined at the rate of 10 mg Ursochol per kg of the patient's weight. The required number of capsules is swallowed whole, every evening, before bed, regularly. The duration of treatment can be from six months to a year. If, after 12 months of therapy, a positive effect of the dynamics is not detected, then the use of Ursochol is discontinued. It is important to monitor the dynamics of treatment once every six months, using ultrasound diagnostics and radiography. At the same time, the probability of calcification of stones should be assessed. If signs of calcification were detected, the course of treatment is completed.
• In case of inflammation of the mucous tissues of the stomach with reflux of bile, it is enough to take 1 capsule of Ursohol at night, for 10-14 days. The treatment regimen can be adjusted at the discretion of the attending physician.
• In the primary form of biliary cirrhosis, the daily dose of Ursohol should be 12-16 mg per kg of the patient's weight. During the initial three months of therapy, Ursohol is taken three times a day. After the patient's condition has stabilized, they switch to the standard dose - once a day, at night.

The capsules are swallowed whole, with liquid. They are taken daily at the same time.

In the primary form of biliary cirrhosis, a worsening of clinical symptoms may initially be observed, such as itching. With such signs, therapy is continued, limiting the intake of Ursochol to once a day. After the patient's condition has normalized, the number of capsules is gradually increased (one capsule is added weekly until the required therapeutic dosage is reached).

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Use Ursohola during pregnancy

There is currently no reliable data on the effect of Ursohol on the course of pregnancy and on the development of the fetus.

Experiments conducted on animals have proven the teratogenic activity of Ursohol in the first months of pregnancy. For this reason, Ursohol cannot be recommended for the treatment of pregnant and lactating patients.

If treatment is prescribed to a woman of childbearing age, she should take measures to prevent pregnancy during the therapy period. It is preferable to use non-hormonal oral contraceptives.

Contraindications

Ursochol is not prescribed for the following diseases and conditions:

• in case of hypersensitivity to any substance in the composition of Ursohol;
• in the acute period of inflammatory diseases affecting the biliary system;
• in case of obstruction of the bile ducts;
• for frequently diagnosed hepatic colic;
• in the presence of radiologically contrasting gallstones;
• in case of disruptions in the contractile ability of the gallbladder;
• in case of unfavorable completion of portoenterostomy, or in case of obstruction of bile outflow in pediatric patients with biliary atresia.

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Side effects Ursohola

Most often, Ursohol treatment occurs without any side effects. However, some patients may experience undesirable symptoms, such as:

• diarrhea, or the passage of pasty feces;
• severe pain in the right hypochondrium;
• calcification of bile stones;
• transition of compensated primary biliary cirrhosis to decompensated (with relative regression after completion of the course of Ursochol therapy);
• allergy (skin rash).

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Overdose

The main, if not the only, sign of an overdose of Ursohol is considered to be the appearance of diarrhea. Other symptoms are practically reduced to zero, since with diarrhea the absorption of Ursohol is disrupted, and most of the drug is excreted with feces.

If diarrhea occurs, the dosage is reduced or the medication is discontinued completely.

If necessary, additional symptomatic medications may be prescribed, as well as correction of the water balance in the body.

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Interactions with other drugs

It is not recommended to use Ursohol in combination with such drugs as Cholestyramine or Cholestipol, anti-acid medications, which contain aluminum compounds. The above drugs envelop the constituent ingredients of Ursohol inside the intestine, which provokes a deterioration in absorption and a decrease in the effect. If it is not possible to avoid the above combination, then it is permissible to wait 180 minutes between taking the listed drugs.

Ursochol can enhance the quality of absorption of Cyclosporine. Therefore, in those persons who are treated with Cyclosporine, it is necessary to check the content of this drug in the bloodstream, and, if necessary, adjust it.

In some patients, Ursochol may slow down the absorption of Ciprofloxacin.

The combination of Ursochol and medications whose metabolism involves cytochrome P450 3A4 should be carried out under constant observation and control (dosage adjustments may often be required).

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Storage conditions

It is optimal to store Ursohol at a temperature range from +18°C to +25°C.

Children should not have access to places where medicines are stored.

Shelf life

Ursochol can be stored for up to 2 years, subject to the basic rules for storing medications.