II. Indication: Cholelithiasis

  1. Comorbid condition that precludes safe Cholecystectomy and symptomatic Gallstones
  2. Symptomatic patient unwilling to undergo surgery
    1. Small Gallstones (<5mm) with functioning gallbladder and no cystic duct obstruction

III. Contraindications

  1. Excludes the 85% of patients who cannot meet the following criteria
    1. Gallstones >0.5mm (as opposed to the normal small, floating, CholesterolGallstones)
    2. Non-functional Gallbladder

IV. Dosing: Ursodiol (Actigal)

  1. Dose: 8-10 mg/kg/day PO divided bid to tid
  2. Course: 6-12 months

V. Dosing: Chenodeoxycholic Acid

  1. Do NOT use in pregnancy (Pregnancy Category X)
  2. Start: 250 mg twice daily for 2 weeks
  3. Titrate
    1. Increase by 250 mg/day each week
    2. Maximum: 13-16 mg/kg/day divided bid (or until sub-maximal dose that is tolerated)

VI. Efficacy

  1. Stones dissolving over 6-12 months: 60-90%
  2. Stones reoccuring within 5 years: 25-50%
  3. Better prognosis associated factors
    1. Single Gallstone AND
    2. Non-obese AND
    3. Young patient

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Cost: Medications

ursodiol (on 5/17/2017 at Medicaid.Gov Survey of pharmacy drug pricing)
URSODIOL 250 MG TABLET Generic $1.21 each
URSODIOL 300 MG CAPSULE Generic $3.34 each
URSODIOL 500 MG TABLET Generic $2.25 each

Ontology: Chenodeoxycholic Acid (C0008024)

Definition (MSH) A bile acid, usually conjugated with either glycine or taurine. It acts as a detergent to solubilize fats for intestinal absorption and is reabsorbed by the small intestine. It is used as cholagogue, a choleretic laxative, and to prevent or dissolve gallstones.
Concepts Pharmacologic Substance (T121) , Steroid (T110) , Biologically Active Substance (T123)
MSH D002635
SnomedCT 82490009, 387510002, 89132005
English Acid, Chenic, Acid, Chenique, Acid, Chenodeoxycholic, Acid, Gallodesoxycholic, Chenic Acid, Chenique Acid, Chenodiol, Gallodesoxycholic Acid, Henohol, Cholan-24-oic acid, 3,7-dihydroxy-, (3alpha,5beta,7alpha)-, Chenic acid, CHENODEOXYCHOLIC ACID, Chenodeoxycholic acid (substance), Chenodiol (substance), gall stone dissolution chenodiol (discontinued), chenodiol (discontinued) (medication), chenodiol (discontinued), chenodeoxycholic acid, CHENODIOL, Chenodeoxycholic Acid [Chemical/Ingredient], acid chenodeoxycholic, cdca, chenodiol, Chenodeoxycholic acid, 3 alpha,7 alpha, Dihydroxycholanic acid, CDCA, CDCA - Chenodeoxycholic acid, Chenic acid preparation, Chenodeoxycholic acid preparation, Chenodeoxycholic acid product, Chenodiol (product), Chenodeoxycholic Acid
Swedish Kenodeoxicholsyra
Czech kyselina chenodeoxycholová
Finnish Kenodeoksikoolihappo
Russian KHENODEZOKSIKHOLEVAIA KISLOTA, KHENODIOL, KHENOVAIA KISLOTA, GALLODEZOKSIKHOLEVAIA KISLOTA, KHENODEZOKSIKHOLAT, ГАЛЛОДЕЗОКСИХОЛЕВАЯ КИСЛОТА, ХЕНОВАЯ КИСЛОТА, ХЕНОДЕЗОКСИХОЛАТ, ХЕНОДЕЗОКСИХОЛЕВАЯ КИСЛОТА, ХЕНОДИОЛ
Japanese ケニン酸, ケノデオキシコール酸塩, 3α,7α-ジヒドロキシ-5β-コラン-24-酸, ケノデオキシコール酸, ケノデオキシコレート, ケノジオール, アントロポデオキシコール酸, ケノデオキシコール酸ナトリウム, ガロデスオキシコール酸
Polish Kwas chenodeoksycholowy
Spanish quenodiol (sustancia), 3 alfa, 7 alfa, ácido dihidroxicolánico, preparado de ácido quenodesoxicólico, preparado de ácido quénico, quenodiol (producto), quenodiol, ácido quenodesoxicólico (sustancia), ácido quenodesoxicólico, Quenodiol, Ácido Quénico, Ácido Galodesoxicólico, Ácido Quenodesoxicólico
French Acide chénodéoxycholique, Chénodiol
German Chenodiol, Chenodesoxycholsäure, Chenosäure, Gallodesoxycholsäure
Italian Acido chenodesossicolico
Portuguese Ácido Galodesoxicólico, Ácido Quênico, Ácido Quenodesoxicólico, Quenodiol

Ontology: Ursodiol (C0042105)

Definition (NCI) A synthetically-derived form of ursodiol, a bile acid produced by the liver and secreted and stored in the gallbladder. Also produced by the Chinese black bear liver, ursodiol has been used in the treatment of liver disease for centuries. This agent dissolves or prevents cholesterol gallstones by blocking hepatic cholesterol production and decreasing bile cholesterol. Ursodiol also reduces the absorption of cholesterol from the intestinal tract.
Definition (NCI_NCI-GLOSS) A drug that is used to dissolve gallstones in people who can't have surgery to remove them. It is also being studied in the prevention of colorectal cancer. Ursodiol belongs to the family of drugs called anticholelithics.
Definition (MSH) An epimer of chenodeoxycholic acid. It is a mammalian bile acid found first in the bear and is apparently either a precursor or a product of chenodeoxycholate. Its administration changes the composition of bile and may dissolve gallstones. It is used as a cholagogue and choleretic.
Definition (PDQ) A synthetically-derived form of ursodiol, a bile acid produced by the liver and secreted and stored in the gallbladder. Also produced by the Chinese black bear liver, ursodiol has been used in the treatment of liver disease for centuries. This agent dissolves or prevents cholesterol gallstones by blocking hepatic cholesterol production and decreasing bile cholesterol. Ursodiol also reduces the absorption of cholesterol from the intestinal tract. Check for "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=306453&idtype=1" active clinical trials or "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=306453&idtype=1&closed=1" closed clinical trials using this agent. ("http://nciterms.nci.nih.gov:80/NCIBrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C1818" NCI Thesaurus)
Concepts Pharmacologic Substance (T121) , Biologically Active Substance (T123) , Steroid (T110)
MSH D014580
SnomedCT 41143004, 108669000, 317791009, 386889007
English Acid, Deoxyursocholic, Acid, Ursacholic, Acid, Ursodeoxycholic, Deoxyursocholic Acid, Ursacholic Acid, Ursodeoxycholic Acid, 3 alpha,7 beta-Dihydroxy-5 beta-cholan-24-oic Acid, Cholan-24-oic acid, 3,7-dihydroxy-, (3alpha,5beta,7beta)-, (3alpha,5beta,7beta)-3,7-Dihydroxycholan-24-oic acid, Ursodiol, URSODIOL, ursodiol, Ursodiol (substance), ursodiol (medication), gall stone dissolution ursodiol, Ursodeoxycholic Acid [Chemical/Ingredient], 3 alpha,7 beta Dihydroxy 5 beta cholan 24 oic Acid, ursodeoxycholic acid, Ursodeoxycholic acid (substance), Ursodeoxycholic acid product, UDCA, Ursodeoxycholic acid, 3 alpha, 7 beta Dihydroxy-5 beta cholanic acid, UDCA - Ursodeoxycholic acid, Ursodesoxycholic acid, Ursodiol (product), Ursodeoxycholic acid [dup] (substance)
Swedish Ursodeoxycholsyra
Spanish ácido urodesoxicólico, ursodiol (sustancia), ácido ursodesoxicólico, ácido ursodesoxicólico (sustancia), ursodiol (producto), ursodiol, ácido colánico 3 alfa, 7 beta dihidroxi - 5 beta, ácido urodesoxicólico (sustancia), ácido 3 alfa, 7 beta dihidroxi - 5 beta-colánico, Ácido Desoxiursocólico, Ácido Ursodesoxicólico
Czech kyselina ursodeoxycholová, UDCA
Finnish Ursodeoksikoolihappo
Russian DEZOKSIURSOKHOLEVAIA KISLOTA, URSODEZOKSIKHOLEVAIA KISLOTA, URSOFAL'K, ДЕЗОКСИУРСОХОЛЕВАЯ КИСЛОТА, УРСОДЕЗОКСИХОЛЕВАЯ КИСЛОТА, УРСОФАЛЬК
Japanese ウルソデスオキシコール酸, 3α,7β-ジヒドロキシ-5β-コラン-24-酸, デオキシウルソコール酸, ウルソデオキシコール酸
Polish Kwas ursodeoksycholowy
French Acide ursodésoxycholique, Ursodésoxycholique, acide
German Desoxyursocholsäure, Ursodesoxycholsäure
Italian Acido ursodesossicolico
Portuguese Ácido Desoxiursocólico, Ácido Ursodesoxicólico

Ontology: gallstone-dissolving agents (C2010378)

Concepts Pharmacologic Substance (T121)
English gall stone dissolution, gallstone-dissolving agents, gallstone-dissolving agents (medication)