A fixed-dose combination analgesic and antipyretic agent. Nimesulide is a preferential COX-2 inhibitor NSAID with anti-inflammatory, analgesic, and antipyretic properties. Paracetamol (Acetaminophen) is a centrally acting analgesic and antipyretic with weak peripheral anti-inflammatory activity. The combination provides synergistic analgesia for moderate to severe pain, particularly in musculoskeletal conditions, with a favorable GI tolerability profile compared to traditional NSAIDs. It is widely used in India for short-term management of acute painful conditions.
Adult: One tablet (Nimesulide 100mg + Paracetamol 325mg) twice daily, after meals. The interval between doses should not be less than 6 hours.
Note: Take with or after a meal to minimize gastric irritation. Swallow the tablet whole with a full glass of water. Do not crush or chew. Do not take on an empty stomach. Do not co-administer with other Paracetamol-containing products to avoid overdose.
The combination works via complementary and synergistic mechanisms. Nimesulide inhibits prostaglandin synthesis primarily by selective inhibition of cyclooxygenase-2 (COX-2) enzyme, with minimal effect on COX-1, leading to reduced inflammation and pain at the peripheral site. Paracetamol's exact mechanism is complex; it acts centrally by inhibiting prostaglandin synthesis in the CNS (likely via COX-2 and COX-3 inhibition), potentiating descending serotonergic pathways, and interacting with the endocannabinoid and TRPV1 systems, providing analgesia and reducing fever.
Pregnancy: Pregnancy Category C (US FDA). Avoid, especially in the third trimester, due to risk of premature closure of ductus arteriosus, oligohydramnios, and potential for prolonged labor. Use during first and second trimesters only if potential benefit justifies potential fetal risk. Paracetamol alone is preferred for pain/fever in pregnancy.
Driving: May cause dizziness, vertigo, drowsiness, or blurred vision. Patients should be cautioned about operating machinery or driving until they know how the medication affects them.
| Warfarin, Acenocoumarol | Increased risk of bleeding due to protein binding displacement and antiplatelet effect of Nimesulide. | Major |
| Other NSAIDs (e.g., Aspirin, Ibuprofen, Diclofenac) | Increased risk of GI toxicity (ulcers, bleeding) and renal impairment with no added therapeutic benefit. | Major |
| Methotrexate | Nimesulide may decrease renal clearance of Methotrexate, increasing its toxicity (myelosuppression). | Major |
| Lithium | Nimesulide may decrease renal clearance of Lithium, leading to increased Lithium levels and toxicity. | Major |
| Diuretics (Furosemide, Thiazides) | Reduced diuretic and antihypertensive efficacy; increased risk of renal impairment. | Moderate |
| ACE Inhibitors (Ramipril, Enalapril) / ARBs (Losartan) | Reduced antihypertensive effect; increased risk of renal impairment, especially in volume-depleted patients. | Moderate |
| Cyclosporine, Tacrolimus | Increased risk of nephrotoxicity. | Moderate |
| Anticonvulsants (Phenytoin, Carbamazepine, Barbiturates) | Increased metabolism of Paracetamol to its toxic metabolite (NAPQI), increasing hepatotoxicity risk. | Moderate |
| Isoniazid | Increased risk of Paracetamol-induced hepatotoxicity. | Moderate |
| Alcohol (Chronic use) | Significantly increases the risk of hepatotoxicity from both Nimesulide and Paracetamol. | Major |
| Chloramphenicol | Increased half-life of Chloramphenicol (Paracetamol effect). | Moderate |
| Metoclopramide, Domperidone | Increased absorption rate of Paracetamol. | Minor |
Same composition (Nimesulide (100mg) + Paracetamol (325mg)), different brands: