Ursodiol

Drug Levels and Effects:




Summary of Use during Lactation:


Because of the low levels of ursodiol (ursodeoxycholicacid) in breastmilk, amounts ingested by the infant are small and are not expected to cause any adverse effects in breastfed infants. No special precautions are required.


Drug Levels:


Maternal Levels.

A woman received oral ursodiol 750 mg daily throughout pregnancy for primary biliary cirrhosis. She continued ursodiol postpartum and ursodiol was undetectable in her breastmilk by HPLC assay. Details of milk collection and assay limits were not reported.[1]

Seven mothers with intrahepatic cholestasis of pregnancy were given oral ursodiol 14 mg/kg daily beginning an average of 14 days prior to delivery and continuing postpartum. Colostrum samples taken in the first 72 hours postpartum contained an average of 118 mcg/L. The mothers treated with ursodiol had levels of bileacidsin colostrum that were much less elevated than 9 untreated control women with cholestasis of pregnancy.[2]

A woman with primary biliary cirrhosis developed severe pruritus and elevated serum bileacids3 weeks postpartum. Ursodiol was started at a dose of 500 mg (7.5 mg/kg) daily increased to 1500 mg (25 mg/kg) daily over the next 8 weeks. Total bileacidsin breastmilk increased from 0.5 micromol/L to 1 micromol/L after 8 weeks of therapy; after 16 weeks, total bileacidsin milk were 0.6 micromol/L. Urodiol milk levels were undetectable before drug initiation, 63 mcg/L at an ursodiol dose of 500 mg daily after 2 weeks, 118 mcg/L with a dose of 1 gram daily after 4 weeks, 79 mcg/L with a dose of 1.5 grams daily after 11 weeks, and 196 mcg/L with a dose of 1.5 grams daily after 19 weeks.[3]

Infant Levels.

Relevant published information was not found as of the revision date.


Effects in Breastfed Infants:


One breastfed (extent not stated) infant developed normally over the first 6 months of life during maternal ursodiol therapy of 750 to 1000 mg daily.[1]

Seven women who were taking ursodiol 14 mg/kg daily near term and postpartum. They reported no adverse reactions in their breastfed infants during the early postpartum period.[2]

A mother receiving oral ursodiol 250 mg 3 times daily for primary biliary cirrhosis reportedly breastfed her infant normally, although the extent and duration of breastfeeding was not stated.[4]

A woman with primary biliary cirrhosis developed severe pruritus and elevated serum bileacids3 weeks postpartum. Ursodiol was started at a dose of 500 mg (7.5 mg/kg) daily, increasing to 1500 mg (25 mg/kg) daily over the next 8 weeks. Psychomotor development of her breastfed (extent not stated) infant was normal, and no apparent side effects were observed in the infant.[3]


Possible Effects on Lactation:


Relevant published information was not found as of the revision date.


References:


1. Rudi J, Schonig T, Stremmel W. [Therapy with ursodeoxycholicacidin primary biliary cirrhosis in pregnancy]. Zentralbl Gastroenterol. 1996;34:188-91. PMID:8650973
2. Brites D, Rodrigues CMP. Elevated levels of bileacidsin colostrum of patients with cholestasis of pregnancy are decreased following ursodeoxycholicacidtherapy. J Hepatol. 1998;29:743-51. PMID:9833912
3. Vitek L, Zelenkova M, Bruha R. Safe use of ursodeoxycholicacidin a breast-feeding patient with primary biliary cirrhosis. Dig Liver Dis. 2010;42:911-2. PMID:20619755
4. Goh SK, Gull SE, Alexander GJ. Pregnancy in primary biliary cirrhosis complicated by portal hypertension: report of a case and review of the literature. BJOG. 2001;108:760-2. PMID:11467706



Substance Identification:




Substance Name:

Ursodiol

CAS Registry Number:

128-13-2

Drug Class:


  • Bile
  • Acids
  • and Salts

  • Cholagogues and Choleretics

  • Cholic
  • Acids

    Administrative Information:




    LactMed Record Number:


    510


    Last Revision Date:


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