Livodeksa - hepatoprotector with choleretic, cholelitholytic, hypocholesterolemic, hypolipidemic and immunomodulatory effects.
Release form and composition
Livodeksa is produced in the form of tablets: round, biconvex, film-coated brown-red color, with a risk on one side; on the break - white core (10 pieces in blisters, in a cardboard bundle of 1, 5 or 10 blisters).
Active ingredient - ursodeoxycholic acid: in 1 tablet - 150 or 300 mg.
Auxiliary components: sodium carboxymethyl starch, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone K-30, purified talc, sodium lauryl sulfate, starch, lactose.
The composition of the shell: hypromellose (E5 premium), titanium dioxide, macrogol 6000, iron dyes yellow oxide and iron red oxide.
Indications for use
- Biliary reflux gastritis and reflux esophagitis;
- Primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment);
- Cystic fibrosis (cystic fibrosis);
- Chronic hepatitis of various genesis;
- Biliary dyskinesia;
- Primary sclerosing cholangitis;
- Non-alcoholic steatohepatitis;
- Alcoholic liver disease;
- Small and medium cholesterol stones with a functioning gallbladder (for the purpose of dissolution).
The use of Livodeksy strictly contraindicated in the following cases:
- Cirrhosis of the liver in the stage of decompensation;
- Non-functioning gallbladder;
- X-ray positive (i.e. high calcium) gallstones;
- Severe dysfunction of the pancreas, kidneys and liver;
- Acute inflammatory bowel disease, bile duct and gallbladder;
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- Children's age up to 3 years;
- Hypersensitivity to the drug.
With extreme caution, the drug should be used in the treatment of children aged 3-4 years, because they may have difficulty swallowing pills.
Dosing and Administration
Livodeksu take inside, swallowing pills whole and squeezed water. If necessary, they can be divided in half.
The average daily dose depending on the evidence:
- Dissolution of cholesterol gallstones - 10-15 mg / kg. In this case, the drug should be taken immediately before bedtime. The course of treatment is 6-12 months. For the prevention of re-formation of stones, it is recommended to continue taking the drug for a few months after the dissolution of the stones;
- Symptomatic treatment of primary biliary cirrhosis - 10-15 mg / kg, if necessary, increase the dose to 20 mg / kg. Treatment can last from 6 months to several years. In this case, the drug should be taken during a meal with a sufficient amount of liquid;
- Biliary reflux gastritis and reflux esophagitis - 10 mg / mg, the drug should be taken at bedtime. The duration of treatment is from 10 days to 6 months, in some cases up to 2 years;
- Chronic hepatitis of various genesis, primary non-alcoholic steatohepatitis, alcoholic liver disease - 10-15 mg / kg in 2-3 doses for 6-12 months, if necessary, longer;
- Primary sclerosing cholangitis, cystic fibrosis - 12-15 mg / kg in 2-3 doses, if necessary, increase the dose to 20-30 mg / kg. Treatment lasts from 6 months to several years;
- Biliary dyskinesia - 10 mg / kg for 2 doses. The duration of therapy is 2-8 weeks. If necessary, conduct repeated courses.
The dose for children is determined individually at the rate of 10-20 mg / kg per day.
The calculation of the daily number of tablets Livodeksa depending on the weight of the patient when prescribing a dose of 10 mg / kg per day (for Livodeks 150 mg / Livodeks 300 mg):
- 34-50 kg - 3 tab. / 1,5 tabl .;
- 51-65 kg - 4 tabl./2 tabl .;
- 66-85 kg - 5 tab. / 2.5 tabl .;
- 86-100 kg - 6 tabl./3 tabl .;
- > 100 kg - 7 tabl./4 tabl.
The calculation of the daily number of tablets Livodeksa depending on the weight of the patient when prescribing a dose of 15 mg / kg per day (for Livodeks 150 mg / Livodeks 300 mg):
- 34-50 kg - 5 tab. / 2 tab .;
- 51-65 kg - 6 tabl./3 tabl .;
- 66-85 kg - 7 tabl. / 3,5 tabl .;
- 86-100 kg - 8 tab. / 4,5 tabl .;
- > 100 kg - 9 tab. / 6 tab.
The calculation of the daily number of tablets Livodeksa 300 mg, depending on the weight of the patient when prescribing a dose of 20 mg / kg:
- 34-50 kg - 3 tablets;
- 51-65 kg - 4 tablets;
- 66-85 kg - 5 tablets;
- 86-100 kg - 6 tablets;
- > 100 kg - 7 tablets.
The calculation of the daily number of tablets Livodeksa 300 mg, depending on the weight of the patient when prescribing a dose of 30 mg / kg:
- 34-50 kg - 5 tablets;
- 51-65 kg - 6 tablets;
- 66-85 kg - 7 tablets;
- 86-100 kg - 8 tablets;
- > 100 kg - 9 tablets.
When taking the drug may be observed side effects of the digestive system, such as abdominal pain, nausea, diarrhea, increased activity of hepatic transaminases, calcification of gallstones; in the treatment of primary biliary cirrhosis may develop transient decompensation of cirrhosis of the liver (passes after discontinuation of the drug).
The prerequisites for successful dissolution of stones are: the content of stones - cholesterol, size - no more than 15-20 mm, full preservation of the function of the biliary tract, fullness of the gall bladder with stones - no more than half.
When prescribing Livodexes for the purpose of dissolving gallstones, it is necessary to control the activity of hepatic transaminases, alkaline phosphatase and gamma glutamyltransferase, as well as the concentration of bilirubin. If elevated rates persist, the drug should be withdrawn.
In the first 3 months of treatment, cholecystography should be performed every 4 weeks, then every 3 months. After 6 and 12 months during the ultrasound study, the effectiveness of therapy is evaluated. After complete dissolution of the stones, it is recommended to continue taking Livodexes for at least 3 more months in order to dissolve the remnants of stones that are not detected because of their too small size.
If within 6-12 months of treatment the partial dissolution of the stones did not occur, further treatment is likely to be ineffective.
If a non-visualized gallbladder is detected during therapy, this indicates that the concrements did not completely dissolve. Treatment in this case should be stopped.
Cancel the drug is also necessary in case of violation of the contractility of the gallbladder, calcification of gallstones, frequent attacks of biliary colic.
Data on the effect of ursodeoxycholic acid on the reaction rate and ability to concentrate attention are not available.
Antacids containing ion exchange resins and aluminum can interfere with the absorption of ursodeoxycholic acid, therefore, it is not recommended to administer these drugs simultaneously with it.
Estrogens, oral contraceptives containing gestagen, neomycin and lipid-lowering drugs increase the saturation of bile with cholesterol, which may decrease the ability of ursodeoxycholic acid to dissolve cholesterol gallstones.
Ursodeoxycholic acid can increase the absorption of cyclosporine from the intestine, therefore, if such a combination is necessary, the concentration of cyclosporine in the blood should be monitored and, if necessary, its dose should be adjusted.
Terms and conditions of storage
To store in the unavailable to children, protected from moisture and light a place at a temperature up to 25 ° C.
Shelf life - 2 years.