Exchol, 500 mg, film-coated tablets, 50 pcs.


Exchol, 500 mg, film-coated tablets, 50 pcs.

Capsules

Inside,

without chewing, drinking plenty of water.

Diffuse liver diseases, cholelithiasis (cholesterol gallstones and biliary sludge):

Exchol® is prescribed continuously for a long time (from several months to several years) at a daily dose of 10 to 12–15 mg/kg (2–5 caps.). The duration of treatment for dissolving stones is until complete dissolution, plus another 3 months to prevent recurrence of stone formation. For diffuse liver diseases, the daily dose of Exchol® is divided into 2-3 doses, the capsules are taken with food. For cholelithiasis, the entire daily dose is taken once at night.

Biliary reflux gastritis and reflux esophagitis:

the drug is prescribed 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, 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 atresia:

The daily dose is set at 10–15 mg/kg in 2–3 doses. 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 divided doses. The duration of therapy is from 6 months to several years.

Non-alcoholic steatohepatitis:

13–15 mg/kg/day in 2–3 divided 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 a rate of 10–20 mg/kg/day.

Film-coated tablets

Inside,

without chewing, drinking plenty of water.

Dissolution of cholesterol gallstones.

The recommended dose of Exchol® is 10 mg/kg/day.

The entire daily dose is taken once at night. The course of treatment is 6–12 months. To prevent the re-formation of stones, it is recommended to take the drug for several more months after the stones have dissolved.

Treatment of biliary reflux gastritis.

250 mg/day, before bedtime. The course of treatment is from 10–14 days to 6 months, if necessary – up to 2 years.

Symptomatic treatment of primary biliary cirrhosis.

The daily dose depends on body weight and is 10–15 mg/kg/day (if necessary, up to 20 mg/kg) in 2–3 doses in the first 3 months of treatment. After improvement of liver parameters, the daily dose can be used 1 time in the evening. The duration of treatment is not limited. In rare cases, clinical symptoms may initially worsen (increased itching). In this case, you should reduce the daily dose, and then gradually increase the dosage (increasing the daily dose weekly) until the recommended dosage regimen is achieved.

Chronic hepatitis of various origins, non-alcoholic steatohepatitis, alcoholic liver disease.

The drug Exchol® is prescribed in a daily dose of 10–15 mg/kg UDCA in 2–3 doses, continuously for a long time (6–12 months or more).

Primary sclerosing cholangitis and cystic fibrosis (cystic fibrosis)

Primary sclerosing cholangitis:

12–15 mg/kg/day (up to 20 mg/kg/day) in 2–3 divided doses. Duration of use - from 6 months to several years.

Cystic fibrosis (cystic fibrosis):

20–30 mg/kg per day in 2–3 divided doses. Duration of use - from 6 months to several years.

Biliary dyskinesia.

The average daily dose is 10 mg/kg in 2 divided doses for 2 weeks to 2 months.

If necessary, it is recommended to repeat the course of treatment. If it is impossible to comply with the dosage regimen, it is recommended to use the capsule dosage form, Exchol®, 250 mg.

For children over 3 years of age, UDCA is prescribed individually at a rate of 10–20 mg/kg/day.

Exchol tablet p/o film 500mg 50 pcs

Pharmacological group:

Hepatoprotective agent.
Pharmacodynamics:
Hepatoprotective agent, also has choleretic, cholelitholytic, hypolipidemic, hypocholesterolemic and some immunomodulatory effects. Having high polar properties, ursodeoxycholic acid (UDCA) forms non-toxic mixed micelles with apolar (toxic) bile acids, which reduces the ability of gastric reflux to damage cell membranes in biliary reflux gastritis and reflux esophagitis. In addition, UDCA forms double molecules that can be incorporated into cell membranes (hepatocytes, cholangiocytes, epithelial cells of the gastrointestinal tract (GIT)), stabilize them and make them immune to the action of cytotoxic micelles. By reducing the concentration of bile acids that are toxic to the liver cell and stimulating choleresis rich in bicarbonates, UDCA effectively promotes the resolution of intrahepatic cholestasis. Reduces the saturation of bile with cholesterol by inhibiting its absorption in the intestine, suppressing synthesis in the liver and reducing secretion into bile; increases the solubility of cholesterol in bile, forming liquid crystals with it; reduces the lithogenic index of bile. The result is the dissolution of cholesterol gallstones and the prevention of the formation of new stones. The immunostimulating effect is due to inhibition of the expression of HLA-1 antigens on the membranes of hepatocytes and HLA-2 on cholangiocytes, normalization of the natural killer activity of lymphocytes, etc. Significantly delays the progression of fibrosis in patients with primary biliary cirrhosis, cystic fibrosis and alcoholic steatohepatitis; reduces the risk of developing varicose veins of the esophagus. UDCA slows down the processes of premature aging and cell death (hepatocytes, cholangiocytes, etc.).

Pharmacokinetics:

UDCA is absorbed in the small intestine by passive diffusion (about 90%) and in the ileum by active transport. The maximum concentration in blood plasma (Cmax) after oral administration of 50 mg after 30, 60, 90 minutes is 3.8 mmol/l, 5.5 mmol/l and 3.7 mmol/l, respectively. Cmax is reached within 1-3 hours. The binding to plasma proteins is high - up to 96-99%. Penetrates through the placental barrier. When taken systematically, UDCA becomes the main bile acid in the blood serum and accounts for about 48% of the total amount of bile acids in the blood. The therapeutic effect of the drug depends on the concentration of UDCA in bile.

Metabolized in the liver (clearance during primary passage through the liver) into taurine and glycine conjugates. The resulting conjugates are secreted into bile. About 50-70% of the total dose of the drug is excreted in bile. A small amount of unabsorbed UDCA enters the large intestine, where it is broken down by bacteria (7-dehydroxylation); the resulting lithocholic acid is partially absorbed from the colon, but is sulfated in the liver and quickly excreted in the form of sulfolithocholylglycine or sulfolitocholyltaurine conjugate.

Exchol, 100 pcs., 250 mg, capsules

Capsules

Inside,

without chewing, drinking plenty of water.

Diffuse liver diseases, cholelithiasis (cholesterol gallstones and biliary sludge):

Exchol® is prescribed continuously for a long time (from several months to several years) at a daily dose of 10 to 12–15 mg/kg (2–5 caps.). The duration of treatment for dissolving stones is until complete dissolution, plus another 3 months to prevent recurrence of stone formation. For diffuse liver diseases, the daily dose of Exchol® is divided into 2-3 doses, the capsules are taken with food. For cholelithiasis, the entire daily dose is taken once at night.

Biliary reflux gastritis and reflux esophagitis:

the drug is prescribed 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, 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 atresia:

The daily dose is set at 10–15 mg/kg in 2–3 doses. 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 divided doses. The duration of therapy is from 6 months to several years.

Non-alcoholic steatohepatitis:

13–15 mg/kg/day in 2–3 divided 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 a rate of 10–20 mg/kg/day.

Film-coated tablets

Inside,

without chewing, drinking plenty of water.

Dissolution of cholesterol gallstones.

The recommended dose of Exchol® is 10 mg/kg/day.

The entire daily dose is taken once at night. The course of treatment is 6–12 months. To prevent the re-formation of stones, it is recommended to take the drug for several more months after the stones have dissolved.

Treatment of biliary reflux gastritis.

250 mg/day, before bedtime. The course of treatment is from 10–14 days to 6 months, if necessary – up to 2 years.

Symptomatic treatment of primary biliary cirrhosis.

The daily dose depends on body weight and is 10–15 mg/kg/day (if necessary, up to 20 mg/kg) in 2–3 doses in the first 3 months of treatment. After improvement of liver parameters, the daily dose can be used 1 time in the evening. The duration of treatment is not limited. In rare cases, clinical symptoms may initially worsen (increased itching). In this case, you should reduce the daily dose, and then gradually increase the dosage (increasing the daily dose weekly) until the recommended dosage regimen is achieved.

Chronic hepatitis of various origins, non-alcoholic steatohepatitis, alcoholic liver disease.

The drug Exchol® is prescribed in a daily dose of 10–15 mg/kg UDCA in 2–3 doses, continuously for a long time (6–12 months or more).

Primary sclerosing cholangitis and cystic fibrosis (cystic fibrosis)

Primary sclerosing cholangitis:

12–15 mg/kg/day (up to 20 mg/kg/day) in 2–3 divided doses. Duration of use - from 6 months to several years.

Cystic fibrosis (cystic fibrosis):

20–30 mg/kg per day in 2–3 divided doses. Duration of use - from 6 months to several years.

Biliary dyskinesia.

The average daily dose is 10 mg/kg in 2 divided doses for 2 weeks to 2 months.

If necessary, it is recommended to repeat the course of treatment. If it is impossible to comply with the dosage regimen, it is recommended to use the capsule dosage form, Exchol®, 250 mg.

For children over 3 years of age, UDCA is prescribed individually at a rate of 10–20 mg/kg/day.

Exhol® (Exhol®)

Children and adults weighing less than 47 kg are recommended to use ursodeoxycholic acid in the form of a suspension.

Dissolution of cholesterol gallstones

The recommended dose is 10 mg of ursodeoxycholic acid per 1 kg of body weight per day, which corresponds to:

Body mass Capsules
Up to 60 kg 2
61-80 kg 3
81-100 kg 4
Over 100 kg 5

The drug must be taken daily in the evening, before bed (the capsules are not chewed), with a small amount of liquid.

Duration of treatment is 6-12 months. To prevent recurrent cholelithiasis, it is recommended to take the drug for several months after the stones have dissolved.

Treatment of biliary reflux gastritis

1 capsule of Exchol® daily in the evening before bed, without chewing and with a small amount of water.

The course of treatment is from 10-14 days to 6 months, if necessary - up to 2 years.

Treatment of primary biliary cirrhosis

The daily dose depends on body weight and ranges from 3 to 7 capsules (approximately 14 ± 2 mg ursodeoxycholic acid per 1 kg of body weight).

In the first 3 months of treatment, taking Exchol® capsules 250 mg should be divided into several doses throughout the day. After improvement of liver parameters, the daily dose of the drug can be taken once in the evening.

The following mode of application is recommended:

250 mg capsules

Body weight (kg) Exchol® capsules 250 mg
first 3 months of treatment Subsequently
morning day evening evening

(1 per day)

47-62 1 1 1 3
63-78 1 1 2 4
79-93 1 2 2 5
94-109 2 2 2 6
over 110 2 2 3 7

Capsules should be taken regularly, without chewing, with a small amount of liquid.

The use of ursodeoxycholic acid for the treatment of primary biliary cirrhosis can be continued indefinitely.

In patients with primary biliary cirrhosis, in rare cases, clinical symptoms may worsen at the beginning of treatment, for example, itching may become more frequent. In this case, treatment should be continued, taking one capsule daily, then the dosage should be gradually increased, increasing the daily dose by one capsule weekly, until the recommended dosage regimen is achieved again.

Symptomatic treatment of chronic hepatitis of various origins -

daily dose 10-15 mg/kg in 2-3 doses. Duration of treatment is 6-12 months or more.

Primary sclerosing cholangitis -

daily dose 12-15 mg/kg; if necessary, the dose can be increased to 20-30 mg/kg in 2-3 doses. The duration of therapy ranges from 6 months to several years (see section: “Special instructions”).

Cystic fibrosis (cystic fibrosis)

- daily dose 20 mg/kg/day in 2-3 divided doses, with a further increase to 30 mg/kg/day if necessary.

Body weight
(kg)
Daily dose (mg/kg body weight) Exchol® capsules 250 mg
morning day evening
20-29 17-25 1 1
30-39 19-25 1 1 1
40-49 20-25 1 1 2
50-59 21-25 1 2 2
60-69 22-25 2 2 2
70-79 22-25 2 2 3
80-89 22-25 2 3 3
90-99 23-25 3 3 3
100-109 23-25 3 3 4
>110 3 4 4

Non-alcoholic steatohepatitis

- average daily dose 10-15 mg/kg in 2-3 doses. The duration of therapy ranges from 6-12 months or more.

Alcoholic liver disease

- average daily dose 10-15 mg/kg in 2-3 doses. The duration of therapy ranges from 6-12 months or more.

Biliary dyskinesia -

the average daily dose is 10 mg/kg in 2 divided doses for 2 weeks to 2 months. If necessary, it is recommended to repeat the course of treatment.

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