A fixed-dose combination analgesic and antipyretic agent, widely used in India for the management of moderate to severe pain and fever. Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory, and antipyretic properties. Paracetamol (Acetaminophen) is a centrally-acting analgesic and antipyretic with weak peripheral anti-inflammatory activity. The combination provides synergistic analgesia by targeting both peripheral (ibuprofen) and central (paracetamol) pain pathways, allowing for lower effective doses of each component and potentially reducing the risk of dose-dependent side effects.
Adult: One tablet (Ibuprofen 400mg + Paracetamol 325mg) every 6-8 hours as needed for pain or fever. The minimum effective dose should be used for the shortest duration necessary.
Note: Take with or after food or a glass of milk to minimize gastric irritation. Swallow whole with a full glass of water. Do not crush or chew. Do not lie down for at least 10 minutes after taking the tablet. Should not be used for more than 3 days for fever or 5 days for pain without consulting a doctor.
The combination exerts a synergistic analgesic and antipyretic effect through complementary mechanisms. Ibuprofen acts peripherally by non-selectively inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing the synthesis of prostaglandins (PGs), which are key mediators of pain, inflammation, and fever at the site of injury. Paracetamol's mechanism is complex and not fully understood but is believed to act centrally by inhibiting a variant of the COX enzyme (sometimes called COX-3) in the brain and spinal cord, reducing the production of PGs involved in pain and fever perception. It also modulates the descending serotonergic pathways and may involve the endocannabinoid system.
Pregnancy: Pregnancy Category: Not formally assigned to combination. Ibuprofen: Category C (first and second trimester), Category D (third trimester - contraindicated due to risk of premature ductus arteriosus closure and oligohydramnios). Paracetamol: Category B (considered safest analgesic during pregnancy). Use: Avoid ibuprofen, especially in third trimester. Paracetamol alone is preferred for pain/fever during pregnancy. Use combination only if clearly needed and under strict medical supervision, avoiding third trimester entirely.
Driving: May cause dizziness, drowsiness, or blurred vision in some individuals. Patients should not drive or operate machinery if they experience these effects.
| Warfarin/Acenocoumarol | Increased risk of bleeding due to antiplatelet effect of ibuprofen and potential displacement from protein binding. | Major |
| Aspirin (low-dose) | Ibuprofen may antagonize the antiplatelet effect of aspirin. Also increases GI toxicity. | Major |
| Other NSAIDs (e.g., Diclofenac, Naproxen) | Increased risk of GI and renal adverse effects without therapeutic benefit. | Major |
| ACE Inhibitors (e.g., Ramipril, Enalapril) / ARBs (e.g., Telmisartan) | Reduced antihypertensive effect; increased risk of renal impairment. | Moderate |
| Diuretics (e.g., Furosemide, Hydrochlorothiazide) | Reduced diuretic and antihypertensive efficacy; risk of renal failure. | Moderate |
| Lithium | Ibuprofen can decrease renal clearance of lithium, leading to toxicity. | Major |
| Methotrexate | Ibuprofen may reduce renal clearance of methotrexate, increasing toxicity risk. | Major |
| SSRIs (e.g., Sertraline, Escitalopram) | Increased risk of upper GI bleeding. | Moderate |
| Corticosteroids (e.g., Prednisolone) | Markedly increased risk of GI ulceration and bleeding. | Major |
| Antacids | May reduce the absorption rate of ibuprofen. | Minor |
| Alcohol (Chronic use) | Increased risk of paracetamol-induced hepatotoxicity and ibuprofen-induced GI bleeding. | Major |
| Anticonvulsants (e.g., Phenytoin, Carbamazepine) | Increased metabolism of paracetamol to its toxic metabolite (NAPQI). | Moderate |
| Isoniazid | Increased risk of paracetamol hepatotoxicity. | Moderate |
Same composition (Ibuprofen (400mg) + Paracetamol (325mg)), different brands: