Medicine Overview
Adult Dose
| Clinical Information | Administration 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 Information | Administration 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
- Pruritus (56-70%)
- Fatigue (19-25%)
- Severe pruritus (19-23%)
- Reduced HDL-C (9-20%)
- Abdominal pain and discomfort (10-19%)
- Rash (7-10%)
- Oropharyngeal pain (7-8%)
- Dizziness (7%)
- Constipation (7%)
- Peripheral edema (3-7%)
- Palpitations (3-7%)
- Pyrexia (7%)
- Thyroid function abnormality (4-6%)
- Eczema (3-6%)
Drug Interaction
Drug Interaction
| Drug Name | Risk 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 Interaction
| Disease Name | Risk Factors |
|---|---|
|
Complete biliary obstruction
|
Can worsen bile duct problems
|
Pregnancy
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.