United States - English - NLM (National Library of Medicine)

tagi pharma, inc. - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 300 mg - - ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. safety of use of ursodiol beyond 24 months is not established. - ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss. - ursodiol will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. hence, patients with such stones are not candidates for ursodiol therapy. - patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula are not candidates for ursodiol therapy. - allergy to bile acids.

United States - English - NLM (National Library of Medicine)

actavis pharma, inc. - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 300 mg - - ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. safety of use of ursodiol beyond 24 months is not established. - ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss. - ursodiol will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. hence, patients with such stones are not candidates for ursodiol therapy. - patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula are not candidates for ursodiol therapy. - allergy to bile acids.

United States - English - NLM (National Library of Medicine)

avpak - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 300 mg - - ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. safety of use of ursodiol beyond 24 months is not established. - ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss. - ursodiol will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. hence, patients with such stones are not candidates for ursodiol therapy. - patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula are not candidates for ursodiol therapy. - allergy to bile acids.

United States - English - NLM (National Library of Medicine)

american health packaging - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 250 mg - ursodiol tablets are indicated for the treatment of patients with primary biliary cirrhosis (pbc). patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. pregnancy category b. reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times the recommended maximum human dose (based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ursodiol. there are no adequate or well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. it is not known whether ursodiol is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when ursodiol are administered to a nursing mother. th

United States - English - NLM (National Library of Medicine)

impax generics - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 250 mg - ursodiol tablets are indicated for the treatment of patients with primary biliary cirrhosis (pbc). patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. pregnancy category b. reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times the recommended maximum human dose (based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ursodiol. there are no adequate or well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. it is not known whether ursodiol is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when ursodiol are administered to a nursing mother. th

United States - English - NLM (National Library of Medicine)

bluepoint laboratories - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 250 mg - ursodiol tablets are indicated for the treatment of patients with primary biliary cirrhosis (pbc). patients with complete biliary obstruction and known known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. pregnancy category b. reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times the recommended maximum human dose (based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ursodiol. there are no adequate or well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. it is not known whether ursodiol is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when ursodiol are administered to a nursing moth

United States - English - NLM (National Library of Medicine)

impax generics - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 250 mg - ursodiol tablets are indicated for the treatment of patients with primary biliary cirrhosis (pbc). patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. pregnancy category b. reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times the recommended maximum human dose (based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ursodiol. there are no adequate or well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. it is not known whether ursodiol is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when ursodiol are administered to a nursing mother. th

United States - English - NLM (National Library of Medicine)

actavis pharma, inc. - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 250 mg -       ursodiol tablets, usp 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cirrhosis (pbc).       patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation.       reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times the recommended maximum human dose (based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ursodiol. there are no adequate or well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.       it is not known whether ursodiol is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when ursodiol tablets, us

United States - English - NLM (National Library of Medicine)

par pharmaceutical, inc. - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 250 mg - ursodiol tablets, usp are indicated for the treatment of patients with primary biliary cirrhosis (pbc). patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. pregnancy category b. reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times the recommended maximum human dose (based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ursodiol. there are no adequate or well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. it is not known whether ursodiol is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when ursodiol are administered to a nursing mothe

United States - English - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 250 mg - ursodiol tablets, 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cholangitis (pbc). patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. risk summary available published data on the use of ursodiol in pregnant women derived from randomized controlled trials, observational studies, and case series collected over several decades have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. most of the reported exposures to ursodiol occurred in the second and third trimester of pregnancy. in animal reproduction studies, ursodiol had no adverse effects on embryo-fetal development when administered at doses greater than human therapeutic doses (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or ot