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

lgm pharma solutions, llc - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol is a bile acid available as 200 mg and 400 mg capsules suitable for oral administration. ursodiol (ursodesoxycholic acid), is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. it is a bitter-tasting, white powder freely soluble in ethanol, methanol, and glacial acetic acid; sparingly soluble in chloroform; slightly soluble in ether; and insoluble in water. the chemical name for ursodiol is 3α,7β-dihydroxy-5β-cholan-24-oic acid (c24 h40 o4 ). ursodiol has a molecular weight of 392.57. its structure is shown below: inactive ingredients: silicon dioxide, magnesium stearate, and corn starch. gelatin capsules contain gelatin and titanium dioxide and are printed with edible black ink; additionally, the 400 mg capsule also contains fd&c yellow #6 and d&c yellow #10.

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

fh2 pharma llc - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol is a bile acid available as 200 mg and 400 mg capsules suitable for oral administration. ursodiol (ursodesoxycholic acid), is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. it is a bitter-tasting, white powder freely soluble in ethanol, methanol, and glacial acetic acid; sparingly soluble in chloroform; slightly soluble in ether; and insoluble in water. the chemical name for ursodiol is 3α,7β-dihydroxy-5β-cholan-24-oic acid (c24 h40 o4 ). ursodiol has a molecular weight of 392.57. its structure is shown below: inactive ingredients: silicon dioxide, magnesium stearate, and corn starch. gelatin capsules contain gelatin and titanium dioxide and are printed with edible black ink; additionally, the 400 mg capsule also contains fd&c yellow #6 and d&c yellow #10.

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

bryant ranch prepack - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - 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)

bryant ranch prepack - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - 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)

prasco laboratories - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 250 mg

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

bluepoint laboratories - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - 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 ri

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

eywa pharma inc - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - 1. ursodiol capsules, usp are 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 capsules beyond 24 months is not established. 2. ursodiol capsules are indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss. 1. ursodiol capsules will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. hence, patients with such stones are not candidates for ursodiol therapy. 2. 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. 3. allergy to bile acids.

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

rising pharma holdings, inc. - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - 1. ursodiol capsules, usp are 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 capsules, usp beyond 24 months is not established. 2. ursodiol capsules, usp are indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss. 1. 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. 2. 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. 3. allergy to bile acids.

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

bryant ranch prepack - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - 1. ursodiol capsules, usp are 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 capsules beyond 24 months is not established. 2. ursodiol capsules are indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss. 1. ursodiol capsules will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. hence, patients with such stones are not candidates for ursodiol therapy. 2. 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

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

zydus pharmaceuticals (usa) inc. - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - 1. ursodiol capsules are 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 capsules beyond 24 months is not established. 2. ursodiol capsules are indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss. 1. 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. 2. 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. 3. allergy to bile acids.