Dissolution of cholesterol gallstones Approx 10 mg/kg corresponding to: >100 kg 2½ FC tab, 81-100 kg 2 FC tab, 61-80 kg 1½ FC tab, up to 60 kg 1 FC tab. Symptomatic treatment of PBC Depends on body wt & ranges from 1½-3½ FC tab (14±2 mg/kg). 1st 3 mth of treatment: Should be divided over the day. May be taken once daily in the evening if liver values improve. Childn w/ cystic fibrosis 6 yr-<18 yr 20 mg/kg/day in 2-3 divided doses, w/ further increase to 30 mg/kg/day if necessary.
May be taken with or without food: Swallow whole w/ some liqd. Do not chew.
Contraindications
Hypersensitivity to bile acids. Acute inflammation of the gallbladder & biliary tract; occlusion of biliary duct (occlusion of the common bile duct or a cystic duct); frequent episodes of biliary colic; radiopaque calcified gallstones; impaired contractility of the gallbladder. Unsuccessful portoenterostomy or w/o recovery of good bile flow in childn w/ biliary atresia.
Monitor liver function parameters every 4 wk during the 1st 3 mth, thereafter every 3 mth. Visualize gallbladder w/ overview (oral cholecystography) & occlusion views in standing & supine positions (ultrasound control) 6-10 mth after the beginning of treatment. Should not be used if gallbladder cannot be visualised on x-ray images or in cases of calcified gallstones, impaired contractility of the gallbladder or frequent episodes of biliary colic. Decompensation of the hepatic cirrhosis (very rare); discontinue if persistent diarrhea occurs. Long-term high dose therapy in patients w/ primary sclerosing cholangitis. Female patients should use an effective non-hormonal method of contraception. Pregnancy.
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