Cholic Acid (1 brand name, 1 dosage form, 1 route)
Available dosage forms: CAPSULE.
Routes of administration: ORAL.
Brand Names
- CHOLBAM
Related Health Topics
Related Conditions
Contraindications
None.
Adverse Reactions
The following clinically significant adverse reaction is described elsewhere in the labeling: •Exacerbation of Liver Impairment [see Warnings and Precautions (5.1)]
Mechanism of Action
Cholic acid is a primary bile acid synthesized from cholesterol in the liver. In bile acid synthesis disorders due to SEDs in the biosynthetic pathway, and in PDs including Zellweger spectrum disorders, deficiency of primary bile acids leads to unregulated accumulation of intermediate bile acids and cholestasis. Bile acids facilitate fat digestion and absorption by forming mixed micelles and facilitate absorption of fat-soluble vitamins in the intestine. 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.
Overdosage
Concurrent elevations of serum GGT and ALT may indicate CHOLBAM overdose. If an overdose is suspected, discontinue CHOLBAM and treat symptoms. Continue to monitor laboratory parameters of liver function and consider restarting at a lower dose when the parameters return to baseline [see Dosage and Administration (2.2) and Warnings and Precautions (5.1)].