TabletsClinical Overview
Obeticholic Acid Tablets (5mg, 10mg) is a synthetic modified bile acid and highly selective, potent farnesoid X receptor (FXR) agonist on the PMBI formulary. FXR is a nuclear receptor expressed in the liver and intestine that regulates bile acid synthesis, inflammation, and fibrosis. Activation of FXR suppresses bile acid synthesis by downregulating CYP7A1, promotes biliary secretion, and reduces hepatic exposure to toxic bile acids. Indicated for the treatment of Primary Biliary Cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients intolerant to UDCA.
Active Pharmaceutical Ingredients
Verified Clinical References
Usage Guidelines
Start with 5 mg orally once daily with or without food. If tolerated and ALP/bilirubin reduction is inadequate after 3 months, titrate to 10 mg once daily. For patients with decompensated cirrhosis or Child-Pugh Class B or C: Strictly contraindicated due to hepatic decompensation and death risk.
General Administration Advice: Adhere strictly to the prescribed dosage, frequency, and treatment course. For oral medications, swallow with sufficient water. Never stop antibiotics, psychiatric medications, or antihypertensives abruptly without clinical direction.
Possible Side Effects
Common: Severe pruritus (dose-dependent, up to 70% of patients), fatigue, abdominal discomfort, dizziness, constipation, arthralgia. Rare/Severe: Hepatic failure, liver-related death in patients with decompensated cirrhosis, and severe dyslipidemia (decreased HDL, increased LDL).
*Note: Individual physiological responses vary. While many patients experience few or no side effects, notify your treating physician if adverse reactions persist or if hypersensitivity (angioedema, skin rash, dyspnea) occurs.
Precautions & Warnings
Black Box Warning: Contraindicated in patients with decompensated cirrhosis (ascites, jaundice, variceal bleeding), hepatic encephalopathy, or complete biliary obstruction; fatal hepatotoxicity reported with improper dosing in advanced liver disease. Manage pruritus with bile acid sequestrants (spaced 4 hours apart) or dose reduction.
Schedule H (Prescription Required)
This medication is scheduled under statutory drug regulatory frameworks (CDSCO / Drugs & Cosmetics Rules). Dispensing requires a valid medical prescription from a registered medical practitioner. Self-medication or unsupervised dosage adjustment carries significant clinical risks.
Medical Disclaimer: Statutory Clinical Disclaimer: The information provided is for educational and price-transparency purposes only and does not constitute medical advice, clinical diagnosis, or gastrointestinal treatment recommendations. Always consult a registered gastroenterologist or qualified medical practitioner before initiating, altering, or discontinuing any gastrointestinal medication or digestive therapy.