Medicine Overview

Indication

Know Medicine, Follow Guideline

Adult Dose

Clinical InformationAdministration Information
Indication: Primary Biliary Cholangitis
Age: Adults
Condition: Noncirrhotic or compensated Child-Pugh class A
Dose: Tablet – 5 mg
Frequency: by mouth once daily
Note: Starting dose. Before initiating, determine patient’s Child-Pugh classification (A, B, or C) using nomogram. Indicated in combination with ursodeoxycholic acid in adults with an inadequate response for at least 1 year or as monotherapy in adults unable to tolerate ursodeoxycholic acid.
Indication: Primary Biliary Cholangitis
Age: Adults
Condition: Noncirrhotic or compensated Child-Pugh class A (titration)
Dose: Tablet – 10 mg
Frequency: once daily
Note: If an adequate response has not been achieved after 3 months at 5 mg/day, and obeticholic acid is being tolerated, increase dose. Not to exceed 10 mg/day.

Child Dose

Clinical InformationAdministration Information
Age: Pediatric
Dose: No approved pediatric dosage available
Note: No approved pediatric dosage available
Administration
  • Can be taken with or without food
  • Take at regular intervals
Side Effect

Drug Interaction

Drug NameRisk Factors
Bile-acid binding resins
May reduce absorption, systemic exposure, and efficacy of obeticholic acid
Warfarin
May decrease INR; monitor INR and adjust warfarin dose accordingly

Disease Interaction

Disease NameRisk Factors
Complete biliary obstruction
Can worsen bile duct problems

Pregnancy

Lactation
Special Use
Precaution
Overdose
Pharmacology
Storage
Store at 15°C to 30°C in a dry place protected from light. Keep out of reach of children

Data Sources

Clinical & regulatory information on this page is compiled from the following government sources:

DISCLAIMER: This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment.