Composition, form of production and packaging
Suspension for ingestion of white color, homogeneous, containing small air bubbles, with the aroma of lemon.
5 ml (1 measuring cup)
ursodeoxycholic acid 250 mg
Auxiliary substances: benzoic acid 7.5 mg, xylitol 1600 mg, glycerol 500 mg, microcrystalline cellulose 100 mg, propylene glycol 50 mg, sodium citrate 25 mg, sodium cyclamate 25 mg, citric acid anhydrous 12.5 mg sodium chloride - 3 mg, flavoring lemon (Givaudan PHL-134488) - 1.5 mg, purified water - 2875.5 mg.
250 ml - bottles of dark glass (1) complete with a measuring cup - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2012.
PHARMACHOLOGIC EFFECT
Hepatoprotector. Has choleretic 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 ingestion, 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
Data on the pharmacokinetics of Ursofalk is not available.
INDICATIONS
- dissolution of gallstones cholesterol stones;
- Biliary reflux-gastritis;
- primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment).
DOSING MODE
Children and adults weighing less than 34 kg are advised to use Ursofalk in the form of a suspension.
To dissolve cholesterol gallstones , a dose of 10 mg / kg of body weight is prescribed 1 time / day.
Capsules
Body weight Number of capsules
up to 60 kg 2
61-80 kg 3
81-100 kg 4
more than 100 kg 5
Suspension for oral administration
Body weight Number of measuring spoons Corresponding (ml)
5-7 kg 0.25 1.25
8-12 kg 0.5 2.50
13-18 kg 0.75 3.75
19-25 kg 1 5.00
26-35 kg 1.5 7.50
36-50 kg 2 10.00
51-65 kg 2.5 12.50
66-80 kg 3 15.00
81-100 kg 4 20.00
more than 100 kg 5 25.00
The drug should be taken daily in the evening, before going to bed (capsules are not chewed), squeezed with a small amount of liquid.
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.
For the treatment of biliary reflux gastritis, 1 caps is prescribed. (1 measuring spoon) Ursofalka daily in the evening before going to bed, drinking with a lot of water.The course of treatment - from 10-14 days to 6 months, if necessary - up to 2 years.
For symptomatic treatment of primary biliary cirrhosis, the daily dose depends on the body weight and is from 2 to 6 capsules (measuring spoons) (about 10-15 mg / kg body weight).
The following dosing regimen is recommended.
Capsules
Body weight Daily dose in the morning in the afternoon
34-50 kg 2 caps. 1 caps. - 1 caps.
51-65 kg 3 caps. 1 caps. 1 caps. 1 caps.
66-85 kg 4 caps. 1 caps. 1 caps. 2 caps.
86-110 kg 5 caps. 1 caps. 2 caps. 2 caps.
more than 110 kg 6 caps. 2 caps. 2 caps. 2 caps.
Suspension for oral administration
Body weight Daily dose in the morning in the afternoon
Number of measured. spoons . (ml) (measuring spoons) ( measuring spoons) ( measuring spoons)
5-7 kg 0.25 1.25 - - 0.25
8-12 kg 0.5 2.50 - 0.25 0.25
13-18 kg 0.75 3.75 0.25 0.25 0.25
19-25 kg 1 5.00 0.5 1 0.5
26-35 kg 1.5 7.50 0.5 0.5 0.5
36-50 kg 2 10.00 1 - 1
51-65 kg 3 15.00 1 1 1
66-80 kg 4 20.00 1 1 2
81-100 kg 5 25.00 1 2 2
more than 100 kg 6 30.00 2 2 2
SIDE EFFECT
On the part of the digestive system: diarrhea, nausea, pain in the epigastric region and right hypochondrium, calcification of gallstones, increased activity of hepatic transaminases.
In the treatment of primary biliary cirrhosis, transient decompensation of liver cirrhosis can occur, which disappears after drug withdrawal.
Other: allergic reactions.
CONTRAINDICATIONS
- X-ray positive (high in calcium) gallstones;
- non-functioning gallbladder;
- acute inflammatory diseases of the gallbladder, bile ducts and intestines;
- cirrhosis of the liver in the stage of decompensation;
- severe renal dysfunction;
- pronounced violations of the liver function;
- pronounced impairment of pancreatic function;
- Pregnancy;
- the period of lactation (breastfeeding);
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
The drug is contraindicated in pregnancy and lactation (breastfeeding).
APPLICATION FOR FUNCTIONS OF THE LIVER
The drug is contraindicated in severe impairment of kidney function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
The drug is contraindicated in severe violations of liver function, liver cirrhosis in the decompensation stage.
SPECIAL INSTRUCTIONS
In cholelithiasis, treatment effectiveness is monitored every 6 months by performing X-ray and ultrasound examination of the biliary tract to prevent relapse of cholelithiasis.
When cholestatic liver diseases should periodically determine the activity of transaminases, alkaline phosphatase and gamma-glutamyltranspeptidase in the blood serum.
OVERDOSE
Cases of an overdose have not been revealed. In case of an overdose, symptomatic treatment is performed.
DRUG 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 must be taken at least 2 hours before taking Ursofalk.
Ursodeoxycholic acid can enhance the absorption of cyclosporine from the intestine. Therefore, in patients taking ciclosporin, the doctor should check the concentration of cyclosporine in the blood and adjust the dose of cyclosporine, if necessary.
In some cases, Ursofalk can 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 to dissolve cholesterol bile stones.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of up to 25 В° C. The shelf life of the capsules is 5 years, the suspension for oral administration is 4 years.
After opening the vial, the suspension should be used within 4 months.
