Exchol, 250 mg capsules 100 pcs

Pharmgroup:

Hepatoprotective agent.

Pharmic action:

Exchol is a hepatoprotective agent and has choleretic effect.

Reduces cholesterol synthesis in the liver, its absorption in the intestine and its concentration in the bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and excretion of bile. It decreases lithogenicity of bile and increases the content of bile acids in it; it causes intensification of gastric and pancreatic secretion, increases lipase activity, and has hypoglycemic effect.

Causes partial or complete dissolution of cholesterol stones when enteral administration, reduces the saturation of bile with cholesterol, which promotes the mobilization of cholesterol from gallstones.

It has immunomodulatory effects, affects immunological reactions in the liver: decreases the expression of some antigens on the membrane of hepatocytes, affects the number of T-lymphocytes, interleukin -2 formation, decreases the number of eosinophils.

Pharmacokinetics:

Absorption from the small intestine is high (about 90%). Passes through the placental barrier. Maximum concentration (Cmax) when ingested 50 mg in 30, 60, 90 min is 3.8, 5.5, 3.7 mmol/l, respectively. Time of reaching maximum concentration (TCmax) is 1-3 hours. Binding to plasma proteins is high.

It is metabolized in the liver (clearance during “primary passage” through the liver) into taurine and glycine conjugates. The resulting conjugates are secreted into the bile. It is 50-70% excreted through the intestine. A small amount of unabsorbed ursodeoxycholic acid enters the large intestine, where it undergoes cleavage by bacteria (7-dehydroxylation); the resulting lithocholic acid is partially absorbed from the colon, but is sulfated in the liver and rapidly excreted as sulfolithocholylglycine or sulfolithocholyltaurine conjugate.

Indications

Primary biliary cirrhosis with no signs of decompensation (symptomatic therapy), dissolution of small and medium cholesterol stones with functioning gallbladder, biliary reflux-gastritis.

Active ingredient

Composition

1 capsule contains:

the 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 collidon 90 F),

lactose monohydrate (milk sugar);

composition of the hard gelatin capsule:

casing – titanium dioxide,

gelatin;

p> cap – titanium dioxide,

gelatin,

indigo carmine.

How to take, the dosage

Exchol is taken orally.

For dissolution of cholesterol gallstones, the average daily dose is 10 mg/kg. The course of treatment is 6-12 months. To prevent recurrent stone formation, it is recommended to continue taking the drug for several months after the stones have been dissolved.

In biliary reflux gastritis the dose is 250 mg once a day. The course of treatment is from 10 -14 days to 6 months, if necessary – up to 2 years.

The symptomatic therapy of primary biliary cirrhosis: daily dose is 10-15 mg/kg. Capsules are taken in the evening, without chewing, with a small amount of water. Patients with body weight less than 34 kg are recommended to take the drug in the form of suspension.

Interaction

Antacids containing Al3+ and ion exchange resins (colestyramine) reduce absorption.

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

Special Instructions

For successful dissolution, it is necessary that the stones are pure cholesterol stones, their size does not exceed 15-20 mm, the gallbladder is not more than half filled with stones and the biliary tract fully preserved its function.

When prescribed for the dissolution of gallstones, it is necessary to monitor the activity of “hepatic” transaminases and alkaline phosphatase (ALP), gamma-glutamintransferase (GGT), bilirubin concentration. Cholecystography should be performed every 4 weeks during the first 3 months of treatment, and then – every 3 months. Control of treatment efficacy should be carried out every 6 months during ultrasound investigation during the first year of therapy.

If elevated values persist, the drug should be discontinued. After complete dissolution of the concrements, it is recommended to continue use for at least 3 months in order to promote dissolution of residual concrements, the size of which is too small to be detected.

If partial dissolution of the concrements has not occurred within 6-12 months after initiation of therapy, it is unlikely that treatment will be effective.

Detection of an unvisualized gallbladder during treatment is an indication that complete dissolution of the concrements has not occurred and treatment should be discontinued.

Contraindications

Side effects

Overdose

No cases of overdose have been identified.

In case of overdose symptomatic treatment is administered.

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