THE INFORMATION IN THE OBPHARMACOPOEIATM
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.
Ursodiol, ursodeoxycholic acid, (Actigall®)
Molecular weight of 392.57
Naturally occurring bile acid
Ursodiol suppresses hepatic synthesis and secretion of cholesterol, and also
inhibits intestinal absorption of cholesterol. It appears to have little
inhibitory effect on synthesis and secretion into bile of endogenous bile acids,
and does not appear to affect secretion of phospholipids into bile [1].
- Treatment of 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 [1].
8-10 mg/kg/day given in 2 or 3 divided doses
- For the prevention of gallstone formation in obese patients experiencing rapid
weight loss [1]
600 mg/day (300 mg b.i.d.
- For the treatment of pruritus associated with intrahepatic
cholestasis of pregnancy (ICP) [2-4]. Prospective controlled studies are required to confirm the benefit of
ursodeoxycholic acid treatment on fetal outcome [5-8].
15mg / kg per day given in three or four divided doses
(300 mg capsules)
1.
Actigall® prescribing information. Watson Pharmaceuticals, Inc.,
March 2009
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=19396
2.
Zapata R, Ursodeoxycholic acid in the treatment of intrahepatic cholestasis of
pregnancy. A 12-year experience.
Liver Int. 2005 Jun;25(3):548-54. PMID: 15910492
3. Glantz A,et al. Intrahepatic cholestasis of pregnancy: a randomized
controlled trial comparing dexamethasone and ursodeoxycholic acid. Hepatology. 2005 Dec;42(6):1399-405.
PMID: 16317669
4. Pusl T, Beuers U Intrahepatic cholestasis of pregnancy. Orphanet J
Rare Dis. 2007 May 29;2:26. PMID:17535422
5. Burrows RF,I nterventions for treating cholestasis in pregnancy.
Cochrane Database Syst Rev. 2001;(4):CD000493.
PMID: 11687082
6.
Sentilhes L, Bacq Y.[ Intrahepatic cholestasis of pregnancy]
J Gynecol Obstet Biol Reprod (Paris). 2008 Apr;37(2):118-26. Epub 2007 Nov 19.
PMID: 18006244
7.
Sentilhes L,et al. Fetal death in a patient with intrahepatic cholestasis of
pregnancy.
Obstet Gynecol. 2006 Feb;107(2 Pt 2):458-60. PMID: 16449148
8.
Lee RH, et al. Sudden fetal death in intrahepatic
cholestasis of pregnancy. Obstet Gynecol. 2009 Feb;113(2 Pt 2):528-31. PMID: 19155945
