A fixed-dose combination (FDC) of hepatoprotective agents. Silymarin, a standardized extract from *Silybum marianum* (milk thistle), acts as an antioxidant and membrane stabilizer. Ursodeoxycholic Acid (UDCA), a hydrophilic bile acid, promotes choleresis, displaces toxic bile acids, and exerts anti-apoptotic and immunomodulatory effects. This combination is widely used in India for managing various hepatobiliary disorders, leveraging complementary mechanisms to protect liver cells and improve bile flow.
Adult: Typically, one tablet/capsule twice daily after meals. Common Indian strengths: Silymarin 140 mg + UDCA 150 mg or Silymarin 70 mg + UDCA 300 mg. The dose must be individualized based on condition and patient weight. For UDCA-specific conditions like PBC, monotherapy at 13-15 mg/kg/day is standard; the FDC may not provide adequate UDCA dose.
Note: Administer tablets/capsules with a full glass of water, AFTER MEALS (lunch and dinner). Taking with food enhances Silymarin absorption and reduces gastrointestinal side effects of UDCA (like diarrhea). Do not crush or chew sustained-release formulations. For gallstone dissolution, therapy is long-term (months to years) and requires periodic ultrasound monitoring.
The combination works via synergistic and complementary pathways. UDCA promotes the secretion of a bicarbonate-rich bile flow (hydrocholeresis), displaces toxic hydrophobic bile acids (like chenodeoxycholic acid and lithocholic acid) from the bile acid pool, and stabilizes hepatocyte membranes against bile acid-induced damage. Silymarin acts as a potent antioxidant by scavenging free radicals, increasing intracellular glutathione levels, and inhibiting lipid peroxidation. It also stimulates ribosomal RNA polymerase, promoting hepatocyte protein synthesis and regeneration.
Pregnancy: Category B2 (Australia) / Not formally classified by US FDA. UDCA is used in the third trimester for intrahepatic cholestasis of pregnancy (ICP) under specialist care. Silymarin data is limited. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus, typically for treating specific conditions like ICP.
Driving: No known effects on driving ability. However, if dizziness or malaise is experienced as a side effect, patients 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. Efficacy is reduced. | Major |
| Cyclosporine | UDCA may increase the absorption of cyclosporine, potentially increasing its blood levels and risk of toxicity. Monitor cyclosporine levels closely. | Moderate |
| Oral Contraceptives, Estrogens | May counteract the gallstone-dissolving effect of UDCA by increasing biliary cholesterol secretion. | Moderate |
| Ciprofloxacin, Dapsone | Silymarin may inhibit hepatic metabolism (CYP3A4, UGT), potentially increasing levels of these drugs. | Moderate |
| Rosuvastatin, other Statins | Silymarin may inhibit OATP1B1 transporter, potentially increasing statin levels and risk of myopathy. Monitor for muscle pain. | Moderate |
| Hypoglycemic Agents (e.g., Metformin, Glibenclamide) | Silymarin may have additive hypoglycemic effects. Monitor blood glucose. | Moderate |
| Warfarin | Theoretical interaction; Silymarin may affect coagulation. Monitor INR periodically. | Minor |
Same composition (Silymarin (NA) + Ursodeoxycholic Acid (NA)), different brands: