Description
Latin name
URSODEZ
Release form
Gelatin capsules, size 00, opaque, with a white body and an orange cap, the contents of the capsules are granular powder and granules of white or almost white color.
Pharmacological action of
hepatoprotective, choleretic, cholelitholytic.
Indications
– sleep disorders, including due to a disturbance in the rhythm of sleep-wakefulness, such as desynchronosis (a sharp change in time zones).
Contraindications
x-ray (high calcium) gallstones
– non-functioning gallbladder
– acute inflammatory diseases of the gallbladder, biliary ducts and intestines
– cirrhosis of the liver at the stage of decompensation
– severe impaired renal function
– severe impaired liver function
– severe impaired pancreatic function
– adults and children weighing up to 34 kg
– children under 3 years of age (for given dosage form)
– hypersensitivity to the components of the drug.
Precautions should be prescribed a drug for gallstone disease, cholestatic liver disease.
Special instructions
The use of Ursodez ® should be carried out under medical supervision.
During the first 3 months of treatment, the functional parameters of the liver (transaminases, alkaline phosphatase and GGT) in the blood serum should be monitored every 4 weeks, and then every 3 months. Monitoring these parameters allows you to identify violations of the liver in the early stages. This also applies to patients in the late stages of primary biliary cirrhosis. In addition, this way you can quickly determine whether a patient with primary biliary cirrhosis responds to treatment.
Application for the dissolution of cholesterol gallstones
In order to assess progress in treatment, as well as for timely detection of signs of calcification of stones, the gallbladder should be visualized (oral cholecystography) with examination of the blackouts in the standing and lying on the back (ultrasound) after 6-10 month after the start of treatment. If the gallbladder cannot be visualized on x-rays or in case of calcification of stones, weak contractility of the gallbladder or frequent bouts of colic, the drug Ursodez ® should not be used.
Treatment of patients in the later stages of primary biliary cirrhosis
Cases of decompensation of liver cirrhosis have been extremely rare. After discontinuation of therapy, a regression of manifestations of decompensation was noted.
Long-term therapy with high doses of ursodeoxycholic acid (28-30 mg / kg / day) can lead to serious side effects in patients with primary sclerosing cholangitis.
In patients with diarrhea, the dose should be reduced. With persistent diarrhea, treatment should be discontinued.
Influence on the ability to drive vehicles and drive machinery
Influence on the ability to drive vehicles and machinery has not been identified.
Composition
1 caps.
ursodeoxycholic acid 500 mg
Excipients: croscarmellose sodium (primellose) – 16 mg, hydroxypropylmethyl cellulose (hypromellose) – 14 mg, magnesium stearate – 5 mg.
Composition of the capsule shell: case: titanium dioxide – 2%, gelatin – up to 100% cap: titanium dioxide – 1.7434%, sunset sunset yellow colorant – 0.4183%, gelatin – up to 100%.
Dosage and administration of
The drug is taken orally.
Dissolution of cholesterol gallstones
The recommended (approximate) dose is 10 mg of ursodeoxycholic acid per 1 kg of body weight per day. The drug must be taken daily in the evening, before bedtime (capsules do not chew), washed down with a small amount of liquid.
It usually takes 6-24 months to dissolve gallstones. If after 12 months of treatment the size of the stones does not decrease, then treatment should be discontinued.
Treatment efficacy should be evaluated every 6 months with ultrasound or radiography. During the interim examination, it should be assessed whether calcification of stones has occurred over the past period. In case of calcification of stones, treatment should be discontinued.
To prevent re-cholelithiasis, it is recommended to take the drug for several months after the stones dissolve.
Treatment of biliary reflux gastritis
Recommended dose – 1 caps. (250 mg) of Ursodez ® daily in the evening before bedtime. Capsules should be washed down with a small amount of water.
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 ranges from 1 to 3 caps. (500 mg) or 2 to 6 caps. (250 mg) (from about 10 to 15 mg of ursodeoxycholic acid per 1 kg of body weight) in 2-3 doses, the first 3 months of treatment. After improving the functional parameters of the liver, the daily dose can be applied 1 time in the evening. The duration of treatment is not limited. In rare cases, clinical symptoms may worsen at the beginning of treatment (itching becomes more frequent). In this case, the daily dose should be reduced (to 250 mg), and then gradually increase it (increasing the daily dose weekly) until the recommended dosage regimen is reached.
Chronic hepatitis of various origins, non-alcoholic steatohepatitis and alcoholic liver disease
The average daily dose is from 10 to 15 mg of ursodeoxycholic acid per 1 kg of body weight in 2-3 doses. The duration of therapy is 6-12 months or more.
Primary sclerosing cholangitis, cystic fibrosis (cystic fibrosis)
With primary sclerosing cholangitis: 12-15 mg / kg / day (up to 20 mg / kg / day) in 2-3 doses. Duration of use – from 6 months to several years.
With cystic fibrosis (cystic fibrosis): 20-30 mg / kg / day in 2-3 doses. Duration of use – from 6 months to several years.
Biliary dyskinesia
The average daily dose is 10 mg of ursodeoxycholic acid per 1 kg of body weight in 2 divided doses for 2 weeks to 2 months. If necessary, the treatment should be repeated. The dosage regimen is set by the doctor.
Calculation of the daily number of capsules depending on the patient s body weight and recommended dose per 1 kg of body weight
Body weight, kg10 mg / kg / day12 mg / kg / day15 mg / kg / day20 mg / kg / day30 mg / kg / day
34-351 caps. 250 mg2 caps. 250 mg or 1 capsule. 500 mg2 caps. 250 mg or 1 capsule. 500 mg3 caps. 250 mg 4 caps. 250 mg or 2 caps. 500 mg
36-402 caps. 250 mg or 1 capsule. 500 mg2 caps. 250 mg or 1 capsule. 500 mg2 caps. 250 mg or 1 capsule. 500 mg3 caps. 250 mg 5 caps. 250 mg
41-452 caps. 250 mg or 1 capsule. 500 mg2 caps. 250 mg or 1 capsule. 500 mg3 caps. 250 mg 4 caps. 250 mg or
2 caps. 500 mg 5 caps. 250 mg
45-502 caps. 250 mg or 1 capsule. 500 mg2 caps. 250 mg or 1 capsule. 500 mg3 caps. 250 mg 4 caps. 250 mg or
2 caps. 500 mg6 caps. 250 mg or 3 caps. 500 mg
51-552 caps. 250 mg or 1 capsule. 500 mg3 caps. 250 mg3 caps. 250 mg 4 caps. 250 mg or
2 caps. 500 mg7 caps. 250 mg
56-602 caps. 250 mg or 1 capsule. 500 mg3 caps. 250 mg 4 caps. 250 mg or 2 caps. 500 mg 5 caps. 250 mg7 caps. 250 mg
61-653 caps. 250 mg3 caps. 250 mg 4 caps. 250 mg or 2 caps. 500 mg 5 caps. 250 mg each 8 caps. 250 mg or 4 caps. 500 mg
66-703 caps. 250 mg3 caps. 250 mg 4 caps. 250 mg or 2 caps. 500 mg6 caps. 250 mg or 3 caps. 500 mg8 caps. 250 mg or 4 caps. 500 mg
71-753 caps. 250 mg 4 caps. 250 mg or 2 caps. 500 mg 5 caps. 250 mg6 caps. 250 mg or 3 caps. 500 mg9 caps. 250 mg
76-803 caps. 250 mg 4 caps. 250 mg or 2 caps. 500 mg 5 caps. 250 mg6 caps. 250 mg or 3 caps. 500 mg each 10 caps. 250 mg or 5 caps. 500 mg
81-853 caps. 250 mg 4 caps. 250 mg or 2 caps. 500 mg 5 caps. 250 mg7 caps. 250 mg each 10 caps. 250 mg or 5 caps. 500 mg
86-904 caps. 250 mg or 2 caps. 500 mg 4 caps. 250 mg or 2 caps. 500 mg 5 caps. 250 mg7 caps. 250 mg11 caps. 250 mg
91-954 caps. 250 mg or 2 caps. 500 mg 5 caps. 250 mg6 caps. 250 mg or 3 caps. 500 mg8 caps. 250 mg or 4 caps. 500 mg11 caps. 250 mg
96-1004 caps. 250 mg or 2 caps. 500 mg 5 caps. 250 mg6 caps. 250 mg or 3 caps. 500 mg8 caps. 250 mg or 4 caps. 500 mg12 caps. 250 mg or 5 caps. 500 mg
101-1054 caps. 250 mg or 2 caps. 500 mg 5 caps. 250 mg6 caps. 250 mg or 3 caps. 500 mg8 capm. 250 mg or 4 caps. 500 mg13 caps. 250 mg
105-1104 caps. 250 mg or 2 caps. 500 mg 5 caps. 250 mg7 caps. 250 mg9 caps. 250 mg13 caps. 250 mg
for children from 3 years old – individually (based on 10-20 mg / kg / day).
Side effects 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 cirrhosis of the liver may occur, which disappears after discontinuation of the drug.
Other: allergic reactions.
Drug Interactions
Colestyramine, 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 effectiveness. If the use of drugs containing at least one of these substances is necessary, they must be taken at least 2 hours before taking the drug Ursodez ®.
Ursodeoxycholic acid may enhance absorption of cyclosporine from the intestines. Therefore, in patients taking cyclosporine, the concentration of cyclosporin in the blood should be checked and the dose of cyclosporin should be adjusted if necessary.
In some cases, Ursodez ® may decrease the absorption of ciprofloxacin.
Hypolipidemic drugs (especially clofibrate), estrogens, neomycin, or gestagens increase bile saturation with cholesterol and may reduce the ability to dissolve cholesterol bile calculi.
Overdose
No overdose has been detected. In case of overdose, symptomatic treatment is performed.
Storage Conditions
Keep this medicine out of the reach of children, dry, protected from light at a temperature not exceeding 25 ° C.
Shelf life
Shelf life of capsules 250 mg – 5 years, capsules 500 mg – 3 years.
Active ingredient
Ursodeoxycholic Chisloth
Pharmacy terms
prescription
dosage form
capsules
Possible product names
Ursodez capsules 500 mg, 30 pcs.
Northern Star, Russia
