A fixed-dose combination (FDC) hepatoprotective agent that provides synergistic action through complementary mechanisms. Silymarin, a flavonolignan complex from *Silybum marianum* (milk thistle), acts as an antioxidant, anti-inflammatory, and membrane stabilizer. Ursodeoxycholic Acid (UDCA), a hydrophilic bile acid, promotes choleresis, displaces toxic hydrophobic bile acids, and exerts anti-apoptotic and immunomodulatory effects. This combination is widely used in India for the management of various hepatobiliary disorders, particularly toxic and metabolic liver diseases.
Adult: One tablet (Silymarin 70mg + UDCA 150mg) two to three times daily, preferably with meals. For PBC: The dose is UDCA-based (13-15 mg/kg/day), so this FDC may not provide adequate UDCA and is not first-line monotherapy for PBC.
Note: Swallow the tablet whole with a glass of water. Can be taken with food to improve tolerability and possibly Silymarin absorption, though it reduces UDCA bioavailability. For optimal UDCA absorption, it is sometimes recommended to take at least 1 hour before or 2 hours after a meal, but for this FDC, taking with meals is standard to improve GI tolerance and patient compliance.
The combination works via dual, complementary pathways. Silymarin provides cytoprotection by scavenging free radicals, inhibiting lipid peroxidation, and stimulating protein synthesis to promote hepatocyte regeneration. UDCA modifies the bile acid pool, increasing the proportion of hydrophilic, non-toxic bile acids, which protects cholangiocytes and hepatocytes from bile acid-induced apoptosis. Together, they reduce hepatocellular injury, inflammation, and fibrosis.
Pregnancy: Category B (US FDA). UDCA is used for intrahepatic cholestasis of pregnancy. Silymarin data is limited. Use only if potential benefit justifies potential risk to the fetus. Not recommended as a routine combination in pregnancy.
Driving: Unlikely to affect ability. However, patients should be cautioned about potential dizziness.
| Aluminum-based Antacids, Bile Acid Sequestrants (Cholestyramine, Colestipol) | Reduced absorption of UDCA. Separate administration by at least 2-4 hours. | Major |
| Cyclosporine | UDCA may increase absorption of cyclosporine, potentially increasing its blood levels and toxicity. Monitor cyclosporine levels closely. | Major |
| Ciprofloxacin, Dapsone, Nitrofurantoin | Silymarin may inhibit CYP3A4/CYP2C9, potentially increasing levels of these drugs. | Moderate |
| Oral Contraceptives, Estrogens | May counteract UDCA's effect on cholesterol saturation of bile. Silymarin has weak estrogenic activity. | Moderate |
| Rosuvastatin, other Statins | Increased risk of myopathy? Theoretical, but monitor for muscle pain. UDCA may affect cholesterol metabolism. | Moderate |
| Warfarin | Silymarin may potentiate anticoagulant effect by inhibiting metabolism. Monitor INR closely. | Major |
Same composition (Silymarin (70mg) + Ursodeoxycholic Acid (150mg)), different brands: