A synergistic hepatoprotective and choleretic combination therapy. Silymarin, a standardized extract from *Silybum marianum* (milk thistle), provides antioxidant, anti-fibrotic, and membrane-stabilizing effects. Ursodeoxycholic Acid (UDCA) is a hydrophilic bile acid that replaces toxic hydrophobic bile acids, stimulates bile flow, and exerts anti-apoptotic, immunomodulatory, and cytoprotective effects on cholangiocytes and hepatocytes. This combination is widely used in India for managing a spectrum of acute and chronic liver disorders, particularly those involving cholestasis and toxic/metabolic injury.
Adult: 10 ml (one measuring cup) twice daily, usually after meals. For PBC: Dose is often titrated based on body weight (13-15 mg/kg/day of UDCA), which may require additional UDCA monotherapy supplementation.
Note: Shake the bottle well before use. Use the provided measuring cup. Administer orally after meals to improve UDCA absorption and reduce potential gastrointestinal upset. Maintain adequate fluid intake. For gallstone dissolution, it should be taken at bedtime. Therapy for chronic conditions requires months to years of continuous use.
The combination works via complementary pathways. Silymarin acts as a free radical scavenger, stabilizes hepatocyte membranes by inhibiting toxin binding, stimulates ribosomal RNA polymerase, promoting protein synthesis and hepatocyte regeneration, and has anti-fibrotic effects by inhibiting hepatic stellate cell activation. UDCA enriches the bile acid pool, displacing toxic hydrophobic bile acids (like chenodeoxycholic acid and deoxycholic acid), reducing their detergent injury to membranes. It stimulates bicarbonate-rich choleresis, protects cholangiocytes against apoptosis, and modulates immune responses by decreasing expression of HLA class I molecules on hepatocytes.
Pregnancy: Category B2 (Australia) / Not formally classified by US FDA. UDCA is used off-label for intrahepatic cholestasis of pregnancy. Use only if the potential benefit justifies the potential risk to the fetus. Silymarin data in pregnancy is limited. Avoid unless clearly needed.
Driving: No specific effects reported. However, if patients experience dizziness or fatigue (from liver disease or rarely the drug), they should avoid driving or operating machinery.
| Aluminum-based Antacids, Bile Acid Sequestrants (Cholestyramine, Colestipol) | Markedly reduce absorption of UDCA by binding it in the intestine. | Major. Administer UDCA at least 2-3 hours apart. |
| Cyclosporine | UDCA may increase the absorption of Cyclosporine, potentially raising its blood levels and risk of toxicity. | Moderate. Monitor Cyclosporine levels closely. |
| Oral Contraceptives, Estrogens | May counteract UDCA's efficacy in gallstone dissolution by increasing biliary cholesterol saturation. | Moderate. |
| Ciprofloxacin, Dapsone | Silymarin may inhibit CYP3A4 and other enzymes, potentially increasing levels of these drugs. | Moderate. Monitor for adverse effects. |
| Rosuvastatin, other Statins | Silymarin may inhibit OATP1B1 transporter, potentially increasing statin levels and risk of myopathy. | Moderate. Monitor for muscle pain. |
| Hypoglycemic Agents (e.g., Metformin, Glibenclamide) | Silymarin may have additive hypoglycemic effects. | Moderate. Monitor blood glucose levels. |
Same composition (Silymarin (35mg/5ml) + Ursodeoxycholic Acid (50mg/5ml)), different brands: