Obeticholic
Active pharmaceutical substance formulated in Jan Aushadhi generic products for Gastrointestinal & Digestion treatment.
🧴 Clinical Application
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.
⚠️ 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).
🛡️ Safety 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.
Jan Aushadhi Products containing Obeticholic
Found 2 generic formulation(s) containing this active ingredient.
Obeticholic Acid 10mg Tablets
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.
Obeticholic Acid 5mg Tablets
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.
Brand Equivalents & Price Comparison
Compare Jan Aushadhi generic prices against popular commercial brands for Obeticholic.
| Generic Formulation | Pack Size | Jan Aushadhi Price | Commercial Brand Equivalents | Avg. Commercial Price | Savings |
|---|---|---|---|---|---|
| Obeticholic Acid 10mg Tablets | 10's | ₹93.75 | Cholibet, Obent, Obetogen | ₹349.00 | 73% Save |
| Obeticholic Acid 5mg Tablets | 10's | ₹56.25 | Obilnex, Obent | ₹262.00 | 79% Save |
Frequently Asked Questions (FAQ)
Get answers to common queries about Obeticholic generics.