Ursodeoxycholic Acid (UDCA) is a hydrophilic, tertiary bile acid used primarily as a hepatoprotective and choleretic agent. It is the drug of choice for the dissolution of radiolucent, cholesterol-rich gallstones in a functioning gallbladder and for the treatment of primary biliary cholangitis (PBC). In the Indian context, it is widely prescribed for various cholestatic liver disorders, including drug-induced liver injury, alcoholic liver disease, and non-alcoholic fatty liver disease (NAFLD). The oral suspension form (125mg/5ml) enhances palatability and dosing accuracy, particularly in pediatric, geriatric, and dysphagic patients.
Adult: Gallstone dissolution: 8-12 mg/kg/day in 2-3 divided doses, taken with meals. PBC: 13-15 mg/kg/day in 2-4 divided doses. For a 60kg adult, the 125mg/5ml suspension dose would be approximately 20ml (500mg) to 30ml (750mg) per day, divided.
Note: Shake the bottle well before use. Use the measuring cup or oral syringe provided. Administer with meals to enhance absorption and tolerance. For gallstone dissolution, bedtime dose is particularly important. Do not take concurrently with aluminum-based antacids or bile acid sequestrants (e.g., cholestyramine); maintain a 2-hour gap.
UDCA exerts multiple hepatoprotective and choleretic effects. 1) It replaces endogenous, hydrophobic, cytotoxic bile acids (like chenodeoxycholic and deoxycholic acid) in the bile acid pool, reducing their detergent-like injury to hepatocyte and biliary epithelial cell membranes. 2) It stimulates hepatobiliary secretion, inducing a bicarbonate-rich choleresis, which improves bile flow and protects cholangiocytes against the damaging effects of retained hydrophobic bile acids. 3) It promotes the dissolution of cholesterol-rich gallstones by reducing cholesterol secretion into bile and facilitating the micellar solubilization of cholesterol.
Pregnancy: Pregnancy Category B (US FDA). Animal studies show no risk, but adequate human studies are lacking. Use during pregnancy only if clearly needed, typically for cholestasis of pregnancy. It is the preferred treatment for intrahepatic cholestasis of pregnancy to reduce maternal itching and fetal risks.
Driving: UDCA has no known influence on the ability to drive and use machines. Dizziness is a rare side effect.
| Cholestyramine, Colestipol, Colesevelam | Markedly reduce absorption of UDCA by binding it in the intestine, decreasing efficacy. | Major |
| Aluminum-based Antacids | May reduce UDCA absorption. Separate administration by at least 2 hours. | Moderate |
| Ciclosporin (Cyclosporine) | UDCA may increase the absorption of ciclosporin, potentially raising its blood levels and risk of toxicity. Monitor ciclosporin levels closely. | Moderate |
| Oral Contraceptives, Estrogens | May counteract the cholesterol-desaturating effect of UDCA, reducing efficacy in gallstone dissolution. | Moderate |
| Clofibrate, Fibrates | May increase biliary cholesterol secretion, antagonizing UDCA's effect on gallstone dissolution. | Moderate |
| Dapsone | UDCA may increase absorption of dapsone. | Minor |
Same composition (Ursodeoxycholic Acid (125mg/5ml)), different brands: