A fixed-dose combination (FDC) of proteolytic enzymes (Trypsin and Bromelain), a bioflavonoid (Rutoside), and a non-steroidal anti-inflammatory drug (NSAID - Diclofenac). This combination is primarily used in India for the management of acute inflammatory conditions, post-operative/traumatic edema, and pain. The enzymes and rutoside are believed to enhance the anti-inflammatory and anti-edema effects of diclofenac, potentially allowing for lower NSAID doses and improved tissue permeability.
Adult: One tablet three times daily (TDS) after meals. The total daily dose of diclofenac is 150mg. Duration should not exceed 7-10 days without re-evaluation.
Note: Take with or immediately after food with a full glass of water to minimize gastrointestinal irritation. Do not crush, chew, or break the enteric-coated tablet. Swallow whole.
Diclofenac provides primary analgesic and anti-inflammatory action via non-selective inhibition of cyclooxygenase (COX-1 and COX-2), reducing prostaglandin synthesis. Trypsin and Bromelain are proteolytic enzymes that may reduce edema by breaking down inflammatory mediators (bradykinin, fibrin), improving microcirculation, and facilitating tissue drainage. Rutoside (a flavonoid) is thought to reduce capillary fragility and permeability through antioxidant activity and inhibition of hyaluronidase, potentially stabilizing capillary walls and reducing swelling. The combination aims for a multi-targeted approach to inflammation, pain, and edema.
Pregnancy: Category C (First and Second Trimester): Use only if potential benefit justifies potential risk to fetus. Avoid in third trimester (Category D) due to risk of premature closure of ductus arteriosus, delayed labor, and increased bleeding risk.
Driving: May cause dizziness, vertigo, or visual disturbances. Patients should not drive or operate machinery if affected.
| Anticoagulants (Warfarin, Acenocoumarol) | Increased risk of bleeding due to antiplatelet effect of diclofenac and possible enzyme effects. | Major |
| Anti-platelets (Aspirin, Clopidogrel) | Increased GI bleeding risk. | Major |
| Other NSAIDs (including COX-2 inhibitors) | Increased risk of GI and renal toxicity; no therapeutic advantage. | Major |
| ACE Inhibitors (Ramipril, Enalapril) / ARBs (Losartan) | Reduced antihypertensive effect; increased risk of renal impairment. | Moderate |
| Diuretics (Furosemide, Hydrochlorothiazide) | Reduced diuretic efficacy; risk of renal failure. | Moderate |
| Lithium | Increased serum lithium levels and toxicity. | Major |
| Methotrexate | Increased methotrexate toxicity (especially with high dose). | Major |
| Corticosteroids (Prednisolone) | Markedly increased risk of GI ulceration. | Major |
| Antibiotics (Quinolones e.g., Ciprofloxacin) | Increased risk of CNS stimulation/seizures. | Moderate |
| Cyclosporine, Tacrolimus | Increased nephrotoxicity. | Major |
Same composition (Trypsin (48mg) + Bromelain (90mg) + Rutoside (100mg) + Diclofenac (50mg)), different brands: