Exhol capsules 250mg, 50pcs

Composition

1 capsule contains:

Active ingredient:

ursodeoxycholic acid 250 mg;

excipients:

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

calcium hydrophosphate dihydrate,

magnesium stearate,

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

lactose monohydrate (milk sugar);

composition of solid gelatin capsule:

body – titanium dioxide, gelatin;

lid-titanium dioxide, gelatin, indigo carmine.

Pharmacological action

Exhol is a hepatoprotective agent that 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 excretion of bile.

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

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

Indications

• uncomplicated cholelithiasis (biliary sludge, the dissolution of cholesterol gallstones in the gallbladder with a functioning gallbladder, prevention of stone recurrence after cholecystectomy);
• chronic active hepatitis;
• toxic (including drugs) liver disease;
• alcoholic liver disease;
• nonalcoholic steatohepatitis;
• primary biliary cirrhosis;
• primary sclerosing cholangitis;
• cystic fibrosis (cystic fibrosis) of the liver;
• biliary dyskinesia;
• biliary reflux gastritis and reflux esophagitis.

Contraindications

• hypersensitivity;
• roentgenologically (high in calcium) gallstones;
• non-functioning gall bladder;
• chronic gastric fistula;
• acute cholecystitis,
• acute cholangitis;
• cirrhosis of the liver in the stage of decompensation;
• acute infectious diseases of the gallbladder, bile ducts and intestines;
• severe hepatic and/or renal failure;
• obstruction of the biliary tract;
• empyema of the gall bladder;
• children’s age up to 3 years.

Caution: children aged 3-4 years, as it may be difficult to swallow capsules.

Side effects

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

Interaction

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 reduce the ability to dissolve cholesterol bile stones.

How to take, course of use and dosage

Inside, without chewing, with a sufficient amount of water.

Diffuse liver diseases, gallstone disease (cholesterol gallstones and biliary sludge):  the drug 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 capsules). The duration of use for stone dissolution is up to complete dissolution, plus another 3 months to prevent relapses of stone formation. In diffuse liver diseases, the daily dose of Exhol® is divided into 2-3 doses, capsules are taken with food. In cholelithiasis, the entire daily dose is taken once a night.

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

After cholecystectomy, to prevent recurrent cholelithiasis:  the recommended dose is 250 mg 2 times a day for several months.

Toxic, drug-induced liver damage, alcoholic liver disease and biliary tract atresia:  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 the 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 divided 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.

Overdose

No cases of overdose were detected.

In case of overdose, symptomatic treatment is performed.

Special instructions

For successful dissolution, it is necessary that the stones are pure cholesterol, no more than 15-20 mm in size, the gallbladder is filled with stones no more than half, and the biliary tract completely retains its function.

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

If elevated indicators persist, the drug should be discontinued. After the calculus is completely dissolved, it is recommended to continue the application for at least 3 months, in order to promote the dissolution of calculus residues, the size of which is too small for their detection and to prevent the recurrence of stone formation. If there is no partial dissolution of the calculi within 6-12 months after the start of therapy, it is unlikely that the treatment will be effective. Detection of an unvisualized gallbladder during treatment is an indication that complete dissolution of the calculi has not occurred and treatment should be discontinued.

Form of production

Capsules:  solid, gelatinous

Storage conditions

Store in a dry place protected from light at a temperature not exceeding 25 ° C. Keep out of reach of children.

Shelf

life is 3 years.

Active ingredient

Ursodeoxycholic acid

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Description

Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Biliary dyskinesia, Cholelithiasis, Hepatitis, Reflux esophagitis, Liver damage, Alcoholism, Cirrhosis of the liver