A fixed-dose combination of a potent non-steroidal anti-inflammatory drug (NSAID) and a proteolytic enzyme. Diclofenac provides analgesic, anti-inflammatory, and antipyretic effects by inhibiting cyclooxygenase (COX) enzymes, thereby reducing prostaglandin synthesis. Serratiopeptidase, derived from Serratia marcescens, is an enzyme with fibrinolytic, anti-inflammatory, and anti-edemic properties, believed to enhance the penetration of diclofenac into inflamed tissues and aid in the breakdown of inflammatory exudates. This combination is widely used in India for conditions requiring rapid relief from pain and inflammation, particularly in musculoskeletal disorders.
Adult: One tablet (Diclofenac 50mg + Serratiopeptidase 10mg) twice daily after meals. For sustained-release formulations: One tablet once daily. The maximum duration for self-medication of acute pain should not exceed 10 days without physician consultation.
Note: Take with or immediately after food with a full glass of water to minimize gastric irritation. Do not crush, chew, or break enteric-coated/sustained-release tablets. Swallow whole. Maintain adequate fluid intake.
Diclofenac non-selectively inhibits both cyclooxygenase-1 (COX-1) and COX-2 isoforms, though with some relative selectivity for COX-2. This inhibition blocks the conversion of arachidonic acid to prostaglandin G2 and subsequently to prostaglandin H2, the precursors for various prostanoids (prostaglandins, prostacyclin, thromboxane). The reduction in prostaglandin E2 (PGE2) and prostacyclin (PGI2) at sites of inflammation mediates its anti-inflammatory, analgesic, and antipyretic effects. Serratiopeptidase is a proteolytic enzyme that hydrolyzes (breaks down) non-living proteinaceous matter such as fibrin, fibrinogen, and other inflammatory mediators (bradykinin, histamine, serotonin). It reduces the viscosity of exudates, facilitates drainage, and enhances tissue permeability, potentially allowing better diffusion of diclofenac and reducing edema.
Pregnancy: Category C (First and Second Trimester): Use only if potential benefit justifies potential fetal risk. Avoid in third trimester (Category D) due to risk of premature closure of ductus arteriosus, oligohydramnios, and inhibition of labor. Not recommended for use.
Driving: May cause dizziness, drowsiness, or blurred vision. Patients should not drive or operate machinery if they experience these effects.
| Anticoagulants (Warfarin, Acenocoumarol) | Increased risk of bleeding due to antiplatelet effect of diclofenac and impaired hemostasis | Major |
| Anti-platelets (Aspirin, Clopidogrel) | Additive GI bleeding risk; may diminish cardioprotective effect of low-dose aspirin | Major |
| Other NSAIDs (including COX-2 inhibitors) | Increased risk of GI and renal toxicity without added benefit | Major |
| ACE Inhibitors (Enalapril, Ramipril), ARBs (Losartan) | Reduced antihypertensive effect; increased risk of renal impairment | Moderate |
| Diuretics (Furosemide, Hydrochlorothiazide) | Reduced diuretic and antihypertensive efficacy; risk of renal failure | Moderate |
| Lithium | Increased serum lithium levels and toxicity due to reduced renal clearance | Major |
| Methotrexate | Increased methotrexate levels and toxicity (especially with high-dose MTX) | Major |
| Corticosteroids (Prednisolone) | Markedly increased risk of GI ulceration and bleeding | Major |
| SSRIs (Fluoxetine, Sertraline) | Increased risk of upper GI bleeding | Moderate |
| Cyclosporine, Tacrolimus | Increased nephrotoxicity | Major |
| Antibiotics (Quinolones) | Potential increased risk of CNS stimulation/seizures | Moderate |
Same composition (Diclofenac (50mg) + Serratiopeptidase (10mg)), different brands: