Ursofalk
Active material: Ursodeozksiholevaya acid
When ATH: A05AA02
CCF: Preparation, a dissolution of cholesterol gallstones
ICD-10 codes (testimony): K74, K80
When CSF: 11.14
Manufacturer: Dr. FALK PHARMA GmbH (Germany)
Pharmaceutical form, composition and packaging
Capsules hard gelatin, size 0, white, opaque; contents of capsules – white powder or granules.
| 1 caps. | |
| ursodeoxycholic acid | 250 mg |
Excipients: magnesium stearate, corn starch, colloidal silicon dioxide, gelatin, sodium dodecyl sulfate, Titanium dioxide, Purified water.
10 PC. – blisters (1) – packs cardboard.
25 PC. – blisters (2) – packs cardboard.
25 PC. – blisters (4) – packs cardboard.
Oral suspension white, Homogeneous, containing small air bubbles, with lemon flavor.
| 5 ml (1 myern.l.) | |
| ursodeoxycholic acid | 250 mg |
Excipients: benzoic acid, avicel RC591, sodium chloride, sodium citrate, lemon acid, glycerol, propylene glycol, Xylitol, sodium cyclamate, Givaudan lemon flavor 87017, Purified water.
250 ml – vials of dark glass (1) complete with measuring spoon – cardboard boxes.
Pharmacological action
Gepatoprotektor. It has choleretic effect. It decreases cholesterol synthesis in the liver, its absorption in the intestine and a concentration in bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and excretion of bile. Reduces lithogenicity bile, it increases the content of bile acids. Causes increased gastric and pancreatic secretion, lipase activity intensifies. It has a hypoglycemic action.
It causes partial or complete dissolution of cholesterol stones ingestion, decreases the saturation of bile with cholesterol, which contributes to the mobilization of cholesterol gallstones.
It has immunomodulatory effects, affect immunological responses in the liver: reduces the expression of certain antigens on the membrane of hepatocytes, It affects the number of T-lymphocytes, interleukin-2, reduces the number of eosinophils.
Pharmacokinetics
The data on the pharmacokinetics Ursofalk not provided.
Testimony
- Dissolution of cholesterol gallstones;
- Biliary reflux gastritis;
- Primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment).
Dosage regimen
To Dissolution of cholesterol gallstones appointed 10 mg / kg body weight 1 time / day.
| Body Weight | Dose |
| to 60 kg | 2 capsules (2 measuring spoons) |
| to 80 kg | 3 capsules (3 measuring spoons) |
| to 100 kg | 4 capsules (4 measuring spoons) |
| above 100 kg | 5 capsules (5 measuring spoons) |
The capsules should be taken in the evening, before bedtime, liquid squeezed small amounts of liquid.
Length of treatment 6-12 Months. To prevent re cholelithiasis recommended taking the drug for several months after the dissolution of stones.
To Treatment of biliary reflux gastritis appointed 1 capsule (1 scoop) Ursofalka 1 time / day. A course of treatment – from 10-14 days before 6 Months, if necessary – to 2 years.
To symptomatic treatment of primary biliary cirrhosis daily dose depends on the body weight, and ranges from 2 to 6 capsules (scoops) (about 10-15 mg / kg body weight).
We recommend the following dosing regimen.
| Body Weight | Daily dose | morning | in the afternoon | in the evening |
| 34-50 kg | 2 capsules (2 measuring spoons) | 1 | – | 1 |
| 51-65 kg | 3 capsules (3 measuring spoons) | 1 | 1 | 1 |
| 66-85 kg | 4 capsules (4 measuring spoons) | 1 | 1 | 2 |
| 86-110 kg | 5 capsules (5 scoops) | 1 | 2 | 2 |
| above 110 kg | 6 capsules (6 scoops) | 2 | 2 | 2 |
Patients weighing less than 34 kg Ursofalk be used in slurry form.
Side effect
From the digestive system: diarrhea, nausea, epigastric pain and right upper quadrant, calcination gallstones, increase in liver transaminases.
In the treatment of primary biliary cirrhosis may be a transitory decompensated cirrhosis, which disappears after discontinuation of the drug.
Other: allergic reactions.
Contraindications
- Rentgenpolozhitelnye (high in calcium) gallstones;
- Non-functioning gall bladder;
- Acute inflammatory diseases of the gallbladder, bile ducts and intestines;
- Cirrhosis decompensated;
- Expressed by the human kidney;
- Expressed human liver;
- Expressed by the human pancreas;
- Pregnancy;
- Lactation (breast-feeding);
- Hypersensitivity to the drug.
Pregnancy and lactation
The drug is contraindicated in pregnancy and lactation (breast-feeding).
Cautions
–
Overdose
Data on drug overdose Ursofalk not provided.
Drug Interactions
Drug Interactions drug Ursofalk not described.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The drug should be stored out of reach of children at a temperature of 25 ° C. Shelf life of capsules – 5 years, suspension for oral – 4 year.
After opening the vial suspension should be used within 4 months.
