Gastro-Intestinal

ABC FARMACEUTICI S.P.A., Italia

VN-22135-19

24/07/2019

TV TPI CO. LTD.

Ursodeoxycholic acid

250mg

• Dissolution of non-opaque gallstones with normal gallbladder function.
• For the treatment of primary biliary cirrhosis (PBC)
• Hepatobiliar disorder associated with cystic fibrosis in children aged 6 years to less than 18 years

There is no age limit for the use of ursodeoxycholic acid hard capsules in the treatment of PBC and dissolution of non-opaque gallstones. For patients weighing less than 47 kg or patients unable to swallow hard ursodeoxycholic acid capsules, suspension may be used.
The recommended daily dosage for various indications is as follows:
• Dissolve gallstones:
Adults: The usual dose is 8 - 12 mg/kg/day, taken in the evening, for example 750 mg every night.
Treatment time lasts about 6 - 24 months, depending on the size and composition of the stones.
X-ray or ultrasound every 6 months until the gallstones disappear.
Treatment should be continued until two consecutive x-ray or ultrasound examinations 4 to 12 weeks apart reveal no gallstones. Because these techniques do not allow reliable images of stones smaller than 2 mm in diameter. The possibility of gallstone recurrence after bile acid treatment is estimated to be up to 50% by year 5. The effectiveness of ursodeoxycholic acid in treating radiopaque or partially radiopaque gallstones has not been tested but is often is less soluble than non-opaque stones. Non-cholesterol stones account for 10-15% of non-opaque stones and may not be dissolved by bile acids.
Elderly: There is no evidence to suggest that dose adjustment is necessary in adults but appropriate prophylactic measures should be considered.
Children: Cholesterol gallstones and PBC are rare in children but when they occur, dosage should be based on weight. There are no complete data on safety and efficacy in this population.
Symptomatic treatment of the of primary biliary cirrhosis (PBC)
For the first 3 months of treatment, ursodeoxycholic acid should be taken divided 2-3 times/day.
• Treatment of hepatobiliary disorders associated with cystic fibrosis:
Children:
Children 6-18 years old with cystic fibrosis: 20 mg/kg daily divided into 2-3 times, can increase to 30 mg/kg/day if necessary.

24

Hard capsule

50 Capsules/Box