| Initial U.S. Approval: 2015
Mechanism of Action
Endogenous bile acids including cholic acid enhance bile flow and provide the physiologic feedback inhibition of bile acid synthesis. The mechanism of action of cholic acid has not been fully established; however, it is known that cholic acid and its conjugates are endogenous ligands of the nuclear receptor, farnesoid X receptor (FXR). FXR regulates enzymes and transporters that are involved in bile acid synthesis and in the enterohepatic circulation to maintain bile acid homeostasis under normal physiologic conditions.
INDICATIONS AND USAGE:
Limitation of use:
| HOW SUPPLIED/STORAGE AND HANDLING
50 mg Capsules
CHOLBAM capsules are available as two-piece gelatin capsules with a Swedish orange cap imprinted with "50mg" and Swedish orange body with imprinted with "ASK001". The capsules contain a white or off-white powder and are supplied in bottles of:
90 capsules (NDC 45043-001-02)
CHOLBAM capsules are available as two-piece gelatin capsules with a white cap imprinted with "250mg" and white body with imprinted with "ASK002". The capsules contain a white or off-white powder and are supplied in bottles of:
90 capsules (NDC 45043-002-02)
Store at 20–25°C (69-77°F), excursions permitted between 15-30°C (59-86°F). [see USP Controlled Room Temperature].
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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