Ursofalk

Ursofalk

ursodeoxycholic acid

Manufacturer:

Dr Falk

Distributor:

DCH Auriga
Concise Prescribing Info
Contents
Ursodeoxycholic acid
Indications/Uses
Dissolution of cholesterol gallstones in the gallbladder. Symptomatic treatment of primary biliary cirrhosis in patients w/o decompensated hepatic cirrhosis. Cap Bile reflux gastritis.
Dosage/Direction for Use
Cap Dissolution of cholesterol gallstones Approx 10 mg/kg body wt equiv to: >100 kg 5 cap, 81-100 kg 4 cap, 61-80 kg 3 cap, up to 60 kg 2 cap. To be taken in the evening at bedtime daily for 6-24 mth. Bile reflux gastritis 1 cap once daily in the evening before bedtime for 10-14 days. Symptomatic treatment of primary biliary cirrhosis Daily dose depends on body wt & ranges from 3-7 cap (14+2 mg/kg body wt). Take in divided doses throughout the day for the 1st 3 mth of treatment. When liver function parameters improve, may take once daily in the evening. FC tab Dissolution of cholesterol gallstones Approx 10 mg/kg body wt equiv 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. To be taken in the evening at bedtime daily for 6-24 mth. Symptomatic treatment of primary biliary cirrhosis Daily dose depends on body wt & ranges from 1½-3½ FC tab (14±2 mg/kg body wt). Take in divided doses over the day for the 1st 3 mth of treatment. When liver function parameters improve, may take once daily in the evening.
Administration
Should be taken with food.
Contraindications
Hypersensitivity to bile acids or any excipient of the formulation. Acute inflammation of the gallbladder or biliary tract; occlusion of the biliary tract; frequent episodes of biliary colic; radio-opaque calcified gallstones; impaired contractility of the gallbladder.
Special Precautions
Monitor liver function parameters during the 1st 3 mth of treatment (every 4 wk, thereafter every 3 mth). Visualize gallbladder w/ overview & occlusion views in standing & supine positions 6-10 mth after beginning of treatment (for dissolution of cholesterol gallstones). Do not use if the gallbladder cannot be visualized in X-ray images. Decompensation of hepatic cirrhosis in very rare cases; discontinue use if persistent diarrhoea occurs (for treatment of advanced stages of primary biliary cirrhosis). Women of childbearing potential should be treated only if they use reliable contraception. Female patients should use an effective non-hormonal method of contraception (for dissolution of gallstones). In patients w/ primary biliary cirrhosis: in rare cases, clinical symptoms may worsen at the beginning of treatment eg, itching may increase (reduce dose to 1 cap daily or half an FC tab daily & then gradually increase again). Pregnancy.
Adverse Reactions
Pasty or soft stools, or diarrhoea.
Drug Interactions
Inhibition of absorption & efficacy when administered concomitantly w/ colestyramine, colestipol or antacids containing Al hydroxide &/or smectite (Al oxide). May affect (ciclosporin) or reduce (ciprofloxacin) absorption. Slight elevation of rosuvastatin plasma levels. Reduced Cmax & AUC of nitrendipine. Reduced therapeutic effects of dapsone. Oestrogenic hormones & blood cholesterol lowering agents eg, clofibrate increase biliary lithiasis, which is a counter-effect to UDCA used for dissolution of gallstones.
ATC Classification
A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.
Presentation/Packing
Form
Ursofalk cap 250 mg
Packing/Price
25 × 4's
Form
Ursofalk FC tab 500 mg
Packing/Price
50's
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