Ekurohol - instructions for use, dose, side effects, contraindications

Hard gelatin capsules №0. The case of white color is opaque, the lid of light gray color is opaque. The contents of the capsules are a mixture of powder and granules of white or almost white color. It is allowed to compact the contents of the capsules into lumps that are easily destroyed when pressed.

Pharmacotherapeutic group:hepatoprotective agent

ATX: & nbsp

A.05.A.A Preparations of bile acids

Pharmacodynamics:

Hepatoprotective agent, has a cholagogue effect. Reduces the synthesis of cholesterol in the liver, its absorption in the intestine and concentration in the bile, increases the solubility of cholesterol in the bile excretory system, stimulates the formation and excretion of bile. Reduces the lithogenicity of bile, increases the content of bile acids.Causes an increase in gastric and pancreatic secretion, increases the activity of lipase. Has hypoglycemic effect. Causes partial or complete dissolution of cholesterol stones when ingested, reduces the saturation of bile with cholesterol, which promotes the mobilization of cholesterol from gallstones. It has an immunomodulatory effect, affects 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.

Pharmacokinetics:

After oral administration ursodeoxycholic acid quickly absorbed in the jejunum and in the proximal part of the ileum due to passive diffusion, and in the distal part of the ileum - due to active transport. About 60-80% is absorbed.

After absorption, bile acid is almost completely conjugated in the liver with glycine and taurine and is excreted with bile. At the first passage through the liver, up to 60% is metabolized.

Depending on the daily dose, type of disease or liver condition, more or less ursodeoxycholic acid accumulates in the bile.At the same time, a relative decrease in the content of other more lipophilic bile acids is observed.

Under the influence of intestinal bacteria ursodeoxycholic acid partially destroyed with the formation of 7-keto-lithocholic and lithocholic acids. Lithocholic acid is hepatotoxic, in some animal species it causes damage to the liver parenchyma. In man, it is absorbed only in a small amount, sulfated in the liver and, thus, detoxified before excretion into bile and excretion with feces. The half-life of ursodeoxycholic acid is 3.5-5.8 days.

Indications:

- Dissolution of small and medium cholesterol stones with a functioning gallbladder;

- prevention of recurrence of stone formation after cholecystectomy;

- biliary reflux gastritis and reflux esophagitis;

- primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment);

- chronic hepatitis of various genesis;

- acute hepatitis;

- primary sclerosing cholangitis;

- cystic fibrosis of the liver;

- toxic (including medicinal) liver damage;

- nonalcoholic steatohepatitis;

- alcoholic liver disease;

- biliary dyskinesia.

Contraindications:

- Hypersensitivity to the components of the drug;

- X-ray positive (high in calcium) gallstones;

- non-functioning gallbladder;

- acute inflammatory diseases of the gallbladder, bile ducts and intestines, Crohn's disease;

- cirrhosis of the liver in the stage of decompensation;

- marked violations of the kidneys, liver, pancreas;

- complete obstruction of the biliary tract;

- bile-gastrointestinal fistula;

- frequent biliary colic;

- lactation period;

- Children under 3 years of age (not recommended for use in this dosage form).

Ursodeoxycholic acid has no age limitation in use, but it is recommended to use the drug in the form of a suspension for children under 3 years of age. there may be difficulty in swallowing the capsules.

Carefully:DAt the age of 3 years (may be difficult if swallowed capsules).

Pregnancy and lactation:The drug can be used during pregnancy only in those cases when the potential benefit of its use for the mother exceeds the possible risk to the fetus.

Data on the isolation of ursodeoxycholic acid with breast milk are absent.If ursodeoxycholic acid is needed during lactation, breastfeeding should be stopped.

Dosing and Administration:

Inside.

Children and adults with a body weight of less than 34 kg it is recommended to use the drug in the form of a suspension.

Dissolution of cholesteric gallstones:

The recommended dose is 10 mg / kg / day, which corresponds to:

Body weight, kg	Number of capsules, pcs.
up to 60	2
61-80	3
81-100	4
Over 100	5

The drug should be taken daily in the evening, before going to bed (capsules are not chewed), squeezed with a small amount of liquid. The duration of treatment is 6-12 months. For the prevention of repeated cholelithiasis, the use of the drug is recommended for several months after the dissolution of the stones.

Treatment of biliary reflux gastritis:

1 capsule of the drug every evening, before going to bed (capsules are not chewed), with a small amount of water. The course of treatment - from 10-14 days to 6 months, if necessary - up to 2 years.

Symptomatic treatment of primary biliary cirrhosis:

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

In the first 3 months of treatment, the 250 mg capsule preparation should be divided into several doses during the day.After improving liver function, the daily dose of the drug can be taken 1 time in the evening.

The following application mode is recommended:

250 mg capsules

Body weight, kg	Daily dose (capsules, pieces)	In the morning	In the afternoon	In the evening
47-62	3	1	1	1
63-78	4	1	1	2
79-93	5	1	2	2
94-109	6	2	2	2
Over 109	7	2	2	3

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

The use of the drug for the treatment of primary biliary cirrhosis can be continued for an unlimited time. In patients with primary biliary cirrhosis, in rare cases, clinical symptoms may worsen at the beginning of treatment, for example, itching may increase. In this case, the treatment should continue, taking 1 capsule daily, then gradually increase the dosage (increasing the daily dose weekly by 1 capsule) until the recommended dosage regimen is again achieved.

Primary sclerosing cholangitis:

12-15 mg / kg / day (up to 20 mg) for 6-24 months (up to several years).

Cystic Fibrosis:

Up to 20-30 mg / kg / day for 6-24 months or more.

Chronic hepatitis of various genesis, non-alcoholic steatohepatitis, alcoholic liver disease:

The daily dose is 12-15 mg / kg (2-5 capsules in 2-3 doses, the duration of therapy is 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.

Children over 3 years old the drug is administered individually, based on a calculation of 20 mg / kg / day.

Side effects:

The incidence of adverse reactions listed below was determined according to the following (World Health Organization classification): Often (≥1/10), often (≥1/100 - <1/10), infrequently (≥1/1 000 - <1/100), rarely (≥1/10 000 - <1/1 000), rarely (<1/10 000), frequency unknown (the evaluation can not be carried out on the basis of available data).

From the gastrointestinal tract: often - Unformed stool or diarrhea; in the treatment of primary biliary cirrhosis rarely - Acute pain in the right upper abdomen.

From the liver and biliary tract: rarely calcification of gallstones.

In the treatment of advanced stages of primary biliary cirrhosis rarely - Decompensation of liver cirrhosis, which disappears after the drug is discontinued.

From the skin and subcutaneous tissues: rarely - hives.

If any of the side effects listed here are aggravated, or if you notice other side effects not listed in the description, you should inform your doctor.

Overdose:

In case of an overdose, diarrhea may occur. In case of an overdose, symptomatic treatment is performed.

Interaction:

Colestramine, colestipol and antacids, containing aluminum hydroxide or smectite (aluminum oxide), reduce the absorption of ursodeoxycholic acid in the intestine and thus reduce its absorption and efficacy. If the use of drugs containing at least one of these substances is still necessary, they should be taken at least 2 hours prior to taking the drug.

Ursodeoxycholic acid can enhance the absorption of cyclosporine from the intestine. Therefore, in patients receiving ciclosporin, the doctor should check the concentration of cyclosporine in the blood and, if necessary, adjust its dose.

In some cases, the drug may reduce the absorption of ciprofloxacin.

Lipid-lowering drugs (especially clofibrate), estrogens, Neomycin or progestins increase the saturation of bile with cholesterol and may reduce the ability of the drug to dissolve cholesterol bile calculi.

Special instructions:

The drug should be administered under the supervision of a doctor.

During the first 3 months of treatment, liver function tests should be monitored: transaminases, alkaline phosphatase and gamma-glutamyl transpeptidases in serum every 4 weeks, and then every 3 months. Control of these parameters allows us to identify violations of liver function in the early stages. This also applies to patients in the late stages of primary biliary cirrhosis. In addition, it is possible to quickly determine if the patient is responding to primary biliary cirrhosis for ongoing treatment.

When using the drug to dissolve cholesterol gallstones:

In order to assess the progress in treatment and in order to detect signs of calcification of stones in time, depending on their size, the gallbladder should be visualized (oral cholecystography) with examination of blackouts in standing and lying on the back (US) 6-10 months after the beginning treatment.

If the gallbladder can not be visualized on X-rays or in cases of calcification of stones, weak contractility of the gallbladder or frequent attacks of colic, the drug should not be used.

In the treatment of patients in the late stages of primary biliary cirrhosis:

Very rarely there were cases of decompensation of liver cirrhosis. After the cessation of therapy, a partial reverse development of manifestations of decompensation was noted.

Patients with diarrhea should reduce the dosage of the drug. With persistent diarrhea, treatment should be discontinued.

Effect on the ability to drive transp. cf. and fur:

Influences on ability to drive vehicles and employment by other potentially dangerous kinds of activity have not been revealed.

Form release / dosage:

Capsules, 250 mg.

Packaging:

For 5, 6, 10 capsules in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

10, 20, 30, 40, 50 or 100 capsules in cans of polyethylene terephthalate for medicinal products sealed with caps screwed on with first opening control or with a "push-turn" system of polypropylene or polyethylene or polypropylene cans for drugs sealed with lids pulled from control of the first opening from polyethylene or cans of polypropylene for medicines sealed with lids pulled with the control of the first opening of high pressure polyethylene.

One jar or 1, 2, 3, 4, 5 or 10 contour mesh packages together with the instruction for use are placed in a cardboard package (bundle).

It is allowed to bundle 2 or 3 cardboard packages (packs) into a group package (shipping container) from cardboard for consumer packaging.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003801

Date of registration:19.08.2016

Expiration Date:19.08.2021

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Representation: & nbspOZONE LLC OZONE LLC Russia

Information update date: & nbsp10.10.2016

Illustrated instructions

Instructions

Ekurohol (Ekurokhol)