Choludexan (Ursodeoxycholic acid)
COMPOSITION
Each capsule contains ursodeoxycholic acid 300
mg.
THERAPEUTIC INDICATIONS
- Uncomplicated cholelithiasis, when cholesterol
gallstones in gallbladder by impossibility of their surgical or endoscopic
removal;
- Nonalcoholic steatohepatitis;
- Acute and chronic viral hepatitis;
- Toxic liver injuries;
- Chronic active hepatitis;
- Alcohol-induced liver injuries;
- Primary biliary cirrhosis;
- Primary sclerosing cholangitis;
- Cystic fibrosis;
- Congenital intrahepatic atresia of biliary tracts;
- Cholestasis by parenteral nutrition;
- Biliary reflux-gastritis and reflux-esophagitis;
- Biliary dyspeptic syndrome;
- Biliary dyskinesia;
- For prophylaxy ofliver injuries by use of hormonal contraceptives or treatment
with cytostatic agents, formations of bilious concrements when patients with
adiposity fast losing body weight.
CONTRAINDICATIONS
Choludexan is indicated in case of raised
sensitivity to the medicine, and also: for acute inflammatory diseases of
gallbladder and bilious channels; for nonfunctioning gallbladder; for
cholelithiasis (with high Ca2+); for bilious-gastroenteric fistula; for chronic
hepatites; fot acute cholecystitis; for acute cholangitis; for inflammatory
processes in large and small intestine; for liver cirrhosis in a stage of
decompensation; for hepatic and/or renal insufficiency; for pancreatitis; for
gallbladder empyema.
ADVERSE EFFECTS
Diarrhea (may be dose dependant), spinal pain.
Rare – calcination of cholelithes, increase of hepatic transaminase activity,
alopecia, constipation, dizzinesses, nausea, vomiting, allergic reactions.
DOSAGE AND
ADMINISTRATION
Choludexan is prescribed once daily before
bedtime or twice a day. Ingest a whole capsule not
chewing with the sufficient quantity of liquid.
Dosage scheme:
- for treatment of acute and chronic liver diseases for dissolution of
gallstones Choludexan is prescribed in a doze of 10-15 mg/kg of body weight a
day continuously.
- for treatment of chronic liver diseases Choludexan is prescribed in a doze of
10-15 mg/kg of body weight a day, duration of treatment is from several months
till 2 years.
- for dissolution of gallstones Choludexan is prescribed in a doze of 10-15
mg/kg of body weight a day, duration of treatment is from 6 months till 2 years.
If within 12 months from the beginning of treatment reduction of gallstones is
not observed, reception of preparation is considered to be inexpedient.
- for prevention of repeated cholelithiasis is recommended reception of the
preparation in a doze of 300 mg 2 times a day for several months (on average for
3 months).
- for treatment of biliary reflux-gastritis and a reflux-esophagitis it is
prescribed 300 mg (1 capsule) of Choludexan before bedtime. Duration of
treatment usually makes 10-14 days.
DRUG INTERACTIONS
The antacids containing aluminium ions and
ion-exchange resins (cholesteramine), reduce absorption of the medicine.
Hypolipidaemic drugs (especially clofibrate), estrogen, neomicin or progestins
increase saturation of bile with cholesterol and can reduce ability of the
medicine to dissolve cholesteric bilious concrements.
PREGNANCY AND LACTATION
Administration during pregnancy is
contraindicated.
If there is a necessity to use Choludexan during lactation the question of
breast feeding termination should be taken in consideration as there is no data
on excretion of ursodeoxycholic acid with breast milk.
MANUFACTURED FORM
Hard gelatin capsules for oral use. 10 capsules
are in a blister. 2 blisters are in carton box together with the leaflet.
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