U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

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mixture
Status:
US Previously Marketed
First approved in 1985

Class:
MIXTURE

Conditions:

Glyceryl 1-caprylate (Monooctanoin, Capmul 8210), a semisynthetic esterified glycerol, a cholesterol solvent, that has been used for the dissolution of retained cholesterol gallstones following cholecystectomy. Bile duct infusion of monooctanoin is associated with little toxicity, although potentially serious problems can result from absorption of the drug or tissue infiltration. Gastrointestinal side effects such as anorexia, nausea, vomiting, diarrhea, and abdominal pain have been reported most commonly. Complete gallstone dissolution has occurred in approximately 50-75 percent of patients receiving monooctanoin. Although mechanical stone removal is still considered to be the treatment of choice for retained gallstones, monooctanoin use appeared promising for stone dissolution in patients in whom mechanical removal has been unsuccessful or is impossible. Monoctanoin was approved by the U.S. Food and Drug Administration (FDA) on Oct 29, 1985. It was developed and marketed as Moctanin® by ETHITEK in US.
Status:
US Previously Marketed
First approved in 1985

Class (Stereo):
CHEMICAL (RACEMIC)

Conditions:

Glyceryl 1-caprylate (Monooctanoin, Capmul 8210), a semisynthetic esterified glycerol, a cholesterol solvent, that has been used for the dissolution of retained cholesterol gallstones following cholecystectomy. Bile duct infusion of monooctanoin is associated with little toxicity, although potentially serious problems can result from absorption of the drug or tissue infiltration. Gastrointestinal side effects such as anorexia, nausea, vomiting, diarrhea, and abdominal pain have been reported most commonly. Complete gallstone dissolution has occurred in approximately 50-75 percent of patients receiving monooctanoin. Although mechanical stone removal is still considered to be the treatment of choice for retained gallstones, monooctanoin use appeared promising for stone dissolution in patients in whom mechanical removal has been unsuccessful or is impossible. Monoctanoin was approved by the U.S. Food and Drug Administration (FDA) on Oct 29, 1985. It was developed and marketed as Moctanin® by ETHITEK in US.