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

avkare, 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)

major pharmaceuticals - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 300 mg - ursodiol is a bile acid available as 300-mg capsules suitable for oral administration. ursodiol is ursodiol usp (ursodeoxycholic acid), a naturally occurring bile acid found in small quantities in normal human bile and in larger quantities in the biles of certain species of bears. 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 usp has a molecular weight of 392.58. its structure is shown below: inactive ingredients. pregelatinized starch, colloidal silicon dioxide, magnesium stearate. the capsule shell consists of fd&c blue #1, fd&c red #40, fd&c yellow #6, titanium dioxide, and gelatin. the capsule imprinting ink consists of shellac glaze in ethanol, black iron oxide, n-butyl alcohol, propylene glycol, fd&c blue #2 aluminum lake, fd&c red #40 aluminum lake, fd&c blue #1 aluminum l

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)

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)

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)

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)

puracap laboratories, llc - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 300 mg - ursodiol is a bile acid available as 300 mg capsules suitable for oral administration. ursodiol, usp (ursodeoxycholic 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, usp has a molecular weight of 392.57. its structure is shown below: inactive ingredients : corn starch, magnesium stearate, silicon dioxide and the capsule shell contain the following ingredients, gelatin, titanium dioxide, d&c red # 28, fd&c blue # 1 and fd&c red # 40. the imprinting ink contains the following: black iron oxide, d&c yellow # 10 aluminum lake, fd&c blue # 1 aluminum lake, fd&c blue # 2 aluminum lake, fd&c red # 40 aluminum lake, propylene glycol and shellac glaze.

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.