Description
Release form
Capsules.
packaging 50 pcs
Indications
uncomplicated gallstone disease (biliary sludge, dissolution of cholesterol gallstones in the gallbladder with a functioning gallbladder, prevention of recurrence of stone formation after cholecystectomy)
chronic active hepatitis
toxic (including medicinal) liver damage
non-alcoholic steatohepatitis
primary biliary cirrhosis
primary sclerosis pulmonary fibrosis biliary reflux gastritis and reflux esophagitis.
Contraindications
hypersensitivity
x-ray-positive (high calcium) gallstones
nonfunctional gallbladder
gall-gastric fistula
acute cholecystitis
acute cholangitis
cirrhosis cirrhosis cirrhosis and / or renal failure
obstruction of the biliary tract
empyema gallbladder
children under 3 years of age.
Caution: children aged 3-4 years, as difficulty swallowing capsules.
Use during pregnancy and lactation
Women of childbearing age are advised to use non-hormonal contraceptives during the period of use of the drug.
The use of UDCA during pregnancy is only possible if the expected benefit to the mother outweighs the potential risk to the fetus. There are currently no data on the allocation of UDCA with breast milk.
If necessary, the use of UDCA during lactation should decide on the termination of breastfeeding.
Composition
1 capsule contains:
active substance:
ursodeoxycholic acid 250 mg
excipients:
silicon dioxide colloidal (Aerosil A-200 or A-300),
calcium hydrogen phosphate dihydrate, srdlkd, sodium sulfide dihydrate, srdlkd -90 or collidone 90 F),
lactose monohydrate (milk sugar)
hard gelatin capsule composition: body – titanium dioxide,
gelatin cap – titanium dioxide, gelatin, indigo carmine.
Dosage and administration
Inside, without chewing, with plenty of water.
Diffuse liver disease, gallstone disease (cholesterol gallstones and biliary sludge): Exhol ® is prescribed continuously for a long time (from several months to several years) in a daily dose of 10 mg / kg to 12-15 mg / kg (2-5 caps.). Duration of administration for dissolving stones – until complete dissolution, plus another 3 months for the prevention of relapse of stone formation. In case of diffuse liver diseases, the daily dose of the Exhol ® preparation is divided into 2-3 doses, the capsules are taken with food. In gallstone disease, the entire daily dose is taken once at night.
Biliary reflux gastritis and reflux esophagitis: the drug is prescribed at 250 mg / day (1 caps.), before bedtime. The course of treatment is from 10-14 days to 6 months, if necessary – up to 2 years.
After cholecystectomy, for the prevention of repeated cholelithiasis: the recommended dose is 250 mg 2 times a day for several months.
Toxic, drug damage to the liver, alcoholic liver disease and atresia of the biliary tract: the daily dose is set at the rate of 10-15 mg / kg in 2-3 doses. The duration of therapy is 6-12 months or more.
Primary biliary cirrhosis: the drug is prescribed at a rate of 10-15 mg / kg / day (if necessary, up to 20 mg / kg) in 2-3 doses. The duration of therapy is from 6 months to several years.
Primary sclerosing cholangitis: 12 15 mg / kg / day (up to 20 mg / kg) in 2 3 doses. The duration of therapy is from 6 months to several years.
Non-alcoholic steatohepatitis: 13 15 mg / kg / day in 2 3 doses. The duration of therapy is from 6 months to several years.
Cystic fibrosis: the dose is set at the rate of 20 30 mg / kg / day (up to 20 mg / kg) in 2 3 doses. The duration of therapy is from 6 months to several years. For children over 3 years of age, the dose of the drug is prescribed individually, at the rate of 10-20 mg / kg / day.
Side effects
Back pain, nausea, vomiting, diarrhea (may be dose-dependent), constipation, transient (transient) increased activity of hepatic transaminases, allergic reactions rarely – calcification of gallstones, exacerbation of previously existing psoriasis, alopecia.
Drug Interaction
Antacids, containing aluminum and ion exchange resins (colestyramine), reduce the absorption of the drug.
Hypolipidemic drugs (especially clofibrate), estrogens, neomycin, or progestins increase the level of bile cholesterol and may reduce the ability to dissolve cholesterol bile nodules.
Overdose
No overdose has been detected.
In case of overdose, symptomatic treatment is performed.
Storage conditions
Store in a dry, dark place at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
The Expiration of
is 3 years.
Active ingredient
Ursodeoxycholic acid
Pharmacy leave terms
Prescription
Dosage form
Dosage form
Capsules
Canonfarma, Russia
