Exhol (Ursodeoxycholic acid)

1 capsule contains:

active substance:

ursodeoxycholic acid 250 mg; 

Excipients:

colloidal silicon dioxide (Aerosil A -200 or A -300),

calcium hydrogen phosphate dihydrate,

magnesium stearate,

povidone (K-90 plasdon or collidon 90 F),

lactose monohydrate (milk sugar);

hard gelatin capsule composition:

case - titanium dioxide, gelatin;

cap - titanium dioxide, gelatin, indigo carmine.

Exhol - hepatoprotective agent, has a choleretic effect.

Reduces the synthesis of cholesterol in the liver, its absorption in the intestines and concentration in bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and secretion of bile.

Reduces the lithogenicity of bile, increases the content of bile acids in it; causes increased gastric and pancreatic secretion, enhances lipase activity, has a hypoglycemic effect. Causes partial or complete dissolution of cholesterol stones during enteral use, reduces the saturation of bile with cholesterol, which helps mobilize cholesterol from gallstones.

It has an immunomodulatory effect, affects the immunological reactions in the liver: reduces the expression of certain antigens on the hepatocyte membrane, affects the number of T-lymphocytes, the formation of interleukin -2, reduces the number of eosinophils.

• uncomplicated gallstone disease (biliary sludge, dissolution of cholesterol gallstones in the gallbladder with a functioning gallbladder, prevention of relapse of stone formation after cholecystectomy);
• chronic active hepatitis;
• toxic (including medicinal) liver damage;
• alcoholic liver disease;
• non-alcoholic steatohepatitis;
• primary biliary cirrhosis;
• primary sclerosing cholangitis;
• cystic fibrosis (cystic fibrosis) of the liver;
• biliary dyskinesia;
• biliary reflux gastritis and reflux esophagitis.

• hypersensitivity;
• X-ray positive (high in calcium) gallstones;
• non-functioning gall bladder;
• biliary gastric fistula;
• acute cholecystitis;
• acute cholangitis;
• decompensated liver cirrhosis;
• acute infectious diseases of the gallbladder, bile ducts and intestines;
• severe hepatic and / or renal failure;
• bile duct obstruction;
• empyema of the gallbladder;
• children under 3 years old.

With caution : children aged 3-4 years, as difficulty swallowing capsules.

Back pain, nausea, vomiting, diarrhea (may be dose-dependent), constipation, transient (transient) increased activity of hepatic transaminases, allergic reactions; rarely - calcification of gallstones, exacerbation of previously existing psoriasis, alopecia.

Antacids containing aluminum and ion-exchange resins (colestyramine) reduce the absorption of the drug.

Hypolipidemic drugs (especially clofibrate), estrogens, neomycin, or progestins increase bile saturation with cholesterol and may decrease the ability to dissolve cholesterol bile calculi.

Inside, without chewing, drinking plenty of water.

Diffuse liver diseases, cholelithiasis (cholesterol gallstones and biliary sludge): Exhol® is prescribed continuously for a long time (from several months to several years) in a daily dose of 10 mg / kg to 12-15 mg / kg ( 2–5 caps.). Duration of administration for dissolving stones - until complete dissolution, plus another 3 months for the prevention of relapse of stone formation. For diffuse liver diseases, the daily dose of Exhol® is divided into 2-3 doses, the capsules are taken with food. In gallstone disease, the entire daily dose is taken once at night.

Biliary reflux gastritis and reflux esophagitis: the drug is prescribed at 250 mg / day (1 caps.), Before bedtime. The course of treatment is from 10-14 days to 6 months, if necessary - up to 2 years.

After cholecystectomy, for the prevention of re-cholelithiasis: the recommended dose is 250 mg 2 times a day for several months.

Toxic, drug damage to the liver, alcoholic liver disease and atresia of the biliary tract: the daily dose is set at the rate of 10-15 mg / kg in 2-3 doses. The duration of therapy is 6-12 months or more.

Primary biliary cirrhosis: the drug is prescribed at a rate of 10-15 mg / kg / day (if necessary, up to 20 mg / kg) in 2-3 doses. The duration of therapy is from 6 months to several years.

Primary sclerosing cholangitis: 12–15 mg / kg / day (up to 20 mg / kg) in 2–3 doses. The duration of therapy is from 6 months to several years.

Non-alcoholic steatohepatitis: 13–15 mg / kg / day in 2–3 doses. The duration of therapy is from 6 months to several years.

Cystic fibrosis: the dose is set at the rate of 20-30 mg / kg / day (up to 20 mg / kg) in 2-3 doses. The duration of therapy is from 6 months to several years. For children over 3 years of age, the dose of the drug is prescribed individually, at the rate of 10-20 mg / kg / day.

No cases of overdose have been identified.

In case of an overdose, symptomatic treatment is performed.

For successful dissolution, it is necessary that the stones are purely cholesterol, no larger than 15–20 mm in size, the gallbladder is filled with stones no more than half and the bile ducts fully retain their function.

When prescribed for the purpose of dissolving gallstones, monitoring of the activity of hepatic transaminases and alkaline phosphatase, GGT, and bilirubin concentration is necessary. Cholecystography should be performed every 4 weeks in the first 3 months of treatment, then every 3 months. Monitoring the effectiveness of treatment is recommended every 6 months during an ultrasound during the 1st year of therapy.

While maintaining elevated rates, the drug should be discontinued. After the stones are completely dissolved, it is recommended to continue using them for at least 3 months, in order to facilitate the dissolution of stone residues, the sizes of which are too small for their detection and for the prevention of recurrence of stone formation. If partial dissolution of calculi has not occurred within 6-12 months after the start of therapy, it is unlikely that the treatment will be effective. Detection of non-visualizable gallbladder during treatment is evidence that complete dissolution of stones did not occur and treatment should be discontinued.

Capsules: Hard, Gelatin