Ursolysin

Common medication Ursolizin is often prescribed for diseases of the biliary system - pathologies of the liver and bile ducts.

Indications of the ursolysin

Ursolysin can be prescribed for the following medical purposes:

• for softening of radiologically negative biliary calculi of cholesterol origin, the size of which does not exceed 1.5 cm (with an efficient gallbladder);
• for the treatment of inflammatory processes in the stomach associated with the transfer of bile into it;
• for elimination of symptoms of primary biliary cirrhosis, if cirrhosis is in a compensated stage.

[1], [2], [3], [4], [5]

Release form

Ursolizin is produced in the form of capsules for internal use: blister plates contain 10 pieces of capsules, and a box of cardboard holds two blister plates.

Release Ursolizin possible in two dosage options:

• Ursolizin 150 mg, which contains 150 mg of the active ingredient ursodeoxycholic acid;
• Ursolizin 300 mg, which contains 300 mg of the active ingredient ursodeoxycholic acid.

Capsules are dense, white, with a white powdery substance inside.

[6], [7], [8]

Pharmacodynamics

The active ingredient of the drug Ursolysin is a bile acid present in the norm in the bile secretions of a person in the form of a small amount of cholic or chenodeoxycholic acid.

When you use capsules Ursolizin inside the drug reduces the cholesterol in the bile, prevents its absorption by the walls of the intestine, lowers the release of cholesterol in the bile environment.

It is generally accepted that bile calculi dissolve due to the dispersed decomposition of cholesterol and the formation of liquid crystal structures.

Presumably, the action of Ursolysin in hepatic and cholestatic pathologies is associated with a relative substitution of lipophilic toxic bile acids with a protective hydrophilic non-toxic acid. In addition, the productive capacity of liver cells improves, and immunoregulatory processes are normalized.

[9], [10], [11]

Pharmacokinetics

After internal use, Ursolysin is well absorbed into the intestinal cavity, thanks to passive and active transport. After the assimilation process, the active ingredient Ursolizin is conjugated in the liver with the participation of glycine and taurine, after which it leaves the body as bile.

The parameters of clearance during the primary hepatic passage can be almost 60%.

Under the influence of microorganisms of the intestine, incomplete degradation of the active ingredient Ursolysin is observed, with the formation of 7-ketolithocholic and lithocholic acid. The latter is considered toxic to the liver and leads to changes in the hepatic parenchyma in rodents. However, a relatively small amount of acid is sucked in people, which is sulphated by the liver and deactivated, and then leaves the body with bile secretions and feces.

The biological duration of half-life of the active ingredient Ursolizin can range from 3.5 to 5.8 days.

[12], [13], [14], [15], [16], [17]

Dosing and administration

Ursolizin is prescribed exclusively by a doctor. Patients weighing up to 47 kg, or those who have difficulty in swallowing capsular preparations, the doctor can prescribe other medication-analogues in the form of a suspension.

• In the presence of gallstones of cholesterol origin, 10 mg of Ursolysin is prescribed per kg of weight of the patient. Capsules are swallowed whole, daily at night, regularly. Duration of admission, as a rule, is from six months to a year. If after 12 months of treatment a positive result was not found, Ursolizin is discontinued. The quality of treatment should be checked once every six months, using ultrasound and radiography methods. At the same time, the probability of calcification of concrements is estimated. If signs of calcification are found, therapy is discontinued.
• In the inflammatory process in the stomach with reflux casting of bile, 1 capsule of Ursolysin is prescribed for the night, for two weeks. The treatment plan can be changed to the discretion of the doctor.
• In primary biliary cirrhosis, the daily amount of Ursolysin should be 12-16 mg per kg of the patient's weight. During the first three months of therapy Ursolizin is taken three times a day. After the improvement of the patient's condition, they switch to the usual method - once a day at night.

Capsules are swallowed whole, with water. It is advisable to take a daily intake at the same time.

At primary biliary cirrhosis at the beginning it can be observed the aggravation of clinical symptoms - for example, itching. With this development of events, the treatment continues, limiting the administration of Ursolizin 1 time per day. After stabilizing the patient's condition, the amount of the drug is gradually increased (weekly add one capsule until the required dosage is reached).

[25], [26], [27], [28], [29]

Use of the ursolysin during pregnancy

At the moment, information on the use of Ursolizin by pregnant patients has not been received sufficiently. Given this, it is preferable to avoid the use of this medication during the period of gestation.

It is recommended to all patients of childbearing age before starting treatment to start taking contraceptives in order to avoid negative consequences in case of pregnancy. Contraceptive means should be non-hormonal, or with a minimum content of estrogens.

In the absence of the necessary information, it is not recommended to take Ursolysin during breastfeeding.

Contraindications

Do not prescribe Ursolysin:

• with a tendency to an allergic response of the body to the ingredients of the drug;
• with exacerbation of the inflammatory process in the bile excretory system;
• with obstruction of the bile duct.

Do not choose Ursolysin in the presence of calcification in the gallbladder, with impaired contractile function of the gallbladder, with frequent hepatic colic.

[18], [19], [20], [21]

Side effects of the ursolysin

Treatment with Ursolysin can be accompanied by some undesirable phenomena:

• diarrhea, semi-liquid excrement;
• pain in the abdomen or in the liver;
• formation of calcifications;
• the transition of biliary cirrhosis to a transient stage of decompensation;
• allergic reactions in the form of urticaria.

[22], [23], [24]

Overdose

When taking irrationally large amounts of Ursolysin, diarrhea can develop. Other signs of an overdose are unlikely, because with increased intake of Ursolizin in the intestine its absorption is reduced, and the excess of the drug is excreted with calories.

When there is diarrhea, the dose of Ursolizin is revised and adjusted. With persistent diarrhea, Ursolizin is discontinued.

Special measures for overdose do not apply. It is recommended to monitor the stability of the water-electrolyte balance.

[30], [31]

Interactions with other drugs

You can not take Ursolizin in conjunction with such drugs as Kolestyramin, Kolestypol, as well as with anti-acid agents with the presence of aluminum salts in the composition. If you can not avoid combining these medicines, you need to maintain a break between taking them in 120 minutes.

Ursolysin is able to accelerate the assimilation of Cyclosporine, which requires additional control of its level in the bloodstream, with possible dosage adjustment.

In some patients, Ursolysin may impair the absorption of ciprofloxacin.

Estrogen-containing drugs, as well as medications that reduce the cholesterol content in the bloodstream (eg, Clofibrate) can increase the likelihood of formation of biliary calculi and minimize the effect of Ursolysin (if the drug is used to dissolve these stones).

[32], [33], [34], [35]

Storage conditions

It is possible to store Ursolysin at room temperature conditions - up to + 25 ° C. It is necessary to monitor the lack of access of children to storage facilities for medicines.

[36], [37]

Shelf life

Ursolysin is suitable for use for three years from the production date.

[38]