Neonatal Drug Therapy Manual

Ursodiol

Disclaimer: Official controlled document is the CHEO and Ottawa Hospital online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Updated June 2, 2022 - 3:00pm

Alternate Name(s): 
Ursodeoxycholic Acid, Urso, UDCA
Classification: 
Gallstone Dissolution Agent; hydrophobic bile acid reducer
Original Date: 
May 2022
Indications: 
  • Treatment of Cholestasis
Administration: 
  • PO
  • Ideally taken with food
Dosage: 
  • Cholestasis treatment: 10-30 mg/kg/day divided BID-TID. 
  • Cholestasis prevention (from long term TPN): limited data,  20-25 mg/kg/day divided BID-QID has been used.
Side Effects: 
  • GI: diarrhea/constipation, vomiting, nausea
  • Rare: increased LFTs, leukopenia, thrombocytopenia, skin reactions
Parameters to Monitor: 
  • bilirubin, LFTs, CBC
References: 
  • Lexi-Comp Online Database, accessed May 2022
  • Liu SY, Chang LW, Wang J, Xie M, Chen LL, Liu W. Ursodeoxycholic acid prevention on cholestasis associated with total parenteral nutrition in preterm infants: a randomized trial. World J Pediatr. 2022 Feb;18(2):100-108.
  • Gokmen T, Oguz SS, Bozdag S, Erdeve O, Uras N, Dilmen U. A controlled trial of erythromycin and UDCA in premature infants during parenteral nutrition in minimizing feeding intolerance and liver function abnormalities. J Perinatol. 2012;32(2):123-128.
  • Arslanoglu S, Moro GE, Tauschel HD, Boehm G. Ursodeoxycholic acid treatment in preterm infants: a pilot study for the prevention of cholestasis associated with total parenteral nutrition. J Pediatr Gastroenterol Nutr. 2008;46(2):228-231.
  • British National Formulary for Children- 2018/19 edition. 

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