Ursolin

Ursolin

ursodeoxycholic acid

Manufacturer:

Berlin Pharm

Distributor:

Berlin Pharm
Concise Prescribing Info
Contents
Ursodeoxycholic acid
Indications/Uses
Dissolution of radiolucent, non-calcified gallstones in patients who are not candidates for cholecystectomy. Primary biliary cirrhosis. Prevention of gallstone in obese patients undergoing rapid wt loss.
Dosage/Direction for Use
Adult Gallstone dissolution 8-10 mg/kg daily given in 2 or 3 divided doses. Gallstone prevention 600 mg daily (300 mg bid). Primary biliary cirrhosis 10-15 mg/kg daily in 2-4 divided doses.
Administration
Should be taken with food.
Contraindications
Hypersensitivity or intolerance. Allergy to bile acids. Calcified cholesterol, radiopaque or radiolucent bile pigment stones. Patients w/ reasons for cholecystectomy eg, unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis or biliary GI fistula.
Special Precautions
Patients w/ congenital or acquired deficiency in sulfation predisposing to lithocholate-induced liver damage. Patients w/ variceal bleeding, hepatic encephalopathy, ascites, or in need of urgent liver transplant. Measure AST & ALT at initiation of therapy & thereafter. Not recommended during pregnancy. Lactation. Childn. Elderly.
Adverse Reactions
Fatigue, headache, insomnia; abdominal pain, cholescystitis, constipation, diarrhea, dyspepsia, flatulence, GI disorder, nausea, vomiting; UTI, dysmenorrhea; arthralgia, arthritis, back pain, myalgia, musculoskeletal pain; bronchitis, coughing, pharyngitis, rhinitis, sinusitis, URTI; allergy, chest pain, viral infection, influenza-like symptoms; alopecia.
Drug Interactions
Reduced absorption w/ Al-based antacids, cholestyramine & colestipol. Counteracted effectiveness w/ clofibrate, estrogen & OC.
MIMS Class
Cholagogues, Cholelitholytics & Hepatic Protectors
ATC Classification
A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.
Presentation/Packing
Form
Ursolin cap 250 mg
Packing/Price
10 × 10's
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