Ursofalk Tablets / Film-coated
Ursodeoxycholic Acid
500mg
DR.FALK PHARMA GMBH
| Pack size | 50’s (25's Blister x 2) |
|---|---|
| Dispensing mode | POM |
| Source | GERMANY |
| Agent | PHARMALINK |
| Retail Price | 169.50 AED |
Indications
Ursofalk Tablets / Film-coated is used for:
Dissolution of cholesterol-rich gallstones, Primary biliary cirrhosis, Prevention of gallstone formation in obese patients experiencing rapid weight loss,
Adult Dose
Oral
Dissolution of cholesterol-rich gallstones
Adult: 8-12 mg/kg once daily at bedtime or in 2 divided doses continued for 3-4 mth after radiological disappearance of gallstones. Duration of treatment: Up to 2 yr.
Obese patients: Up to 15 mg/kg daily.
Primary biliary cirrhosis
Adult: 10-16 mg/kg daily in 2-4 divided doses, may be taken once daily in the evening after the 1st 3 mth.
Prophylaxis of gallstones in patients undergoing rapid weight loss
Adult: 300 mg bid.
Non-alcoholic fatty liver disease: 13-15 mg/kg/day;
Child Dose
Renal Dose
Administration
Should be taken with food.
Contra Indications
Acute inflammation of gallbladder or biliary tract, occlusion of biliary tract, frequent episodes of biliary colic, radio-opaque calcified gallstones, impaired contractility of gallbladder, non-functioning gallbladder, inflammatory bowel disease, hepatic and intestinal conditions interfering w/ enterohepatic recirculation of bile acids, extrahepatic and intrahepatic cholestasis, ileal resection and stoma, regional ileitis, active duodenal and gastric ulcer; acute, chronic or severe hepatic disease.
Precautions
Excessive diatery intake of calories and cholesterol should be avoided. Liver function tests and bilirubin levels should be monitored every month for three months after start of therapy. 50% of successfully treated patients will develop further gallstones within 10 yr. Pregnancy and lactation. Monitoring Parameters Monitor LFTs mthly for the 1st 3 mth and every 6 mth thereafter.
Lactation: unknown if excreted in breast milk; use caution
Pregnancy-Lactation
Interactions
Cholestyramine, charcoal and antacids may reduce effectiveness. Aluminum-based antacids may reduce absorption. Oestrogens and clofibrate may counteract effectiveness of ursodeoxycholic acid by increasing cholesterol elimination in bile. Possible increase in ciclosporin serum concentration. Decreased effectiveness of dapsone. Possible decrease in serum ciprofloxacin and nitrendipine.
Adverse Effects
Side effects of Ursodeoxycholic Acid :
>10%
Headache, Dizziness, Diarrhea, Dyspepsia, Nausea/vomiting, Back pain, Upper respiratory tract infection
1-10%
Alopecia, Rash, Hyperglycemia, Flatulence, Peptic ulcer, Urinary tract infection, Leukopenia, Thrombocytopenia, Cholecystitis
>1%
Fatigue, Abdominal pain, Thrombocytopenia, Pruritus, Angioedema, Peripheral edema, Biliary pain
Mechanism of Action
Ursodeoxycholic acid suppresses hepatic synthesis and secretion of cholesterol and also inhibits intestinal absorption of cholesterol.
Note
Ursofalk 500mg Tablets / Film-coated manufactured by DR.FALK PHARMA GMBH . Its generic name is Ursodeoxycholic Acid. Ursofalk is availble in United Arab Emirates.
Farmaco UAE drug index information on Ursofalk Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.