A fixed-dose combination (FDC) analgesic, antipyretic, anti-inflammatory, and antihistaminic formulation designed for symptomatic relief of moderate to severe pain, fever, and allergic symptoms associated with conditions like the common cold, flu, sinusitis, and allergic rhinitis. It combines a non-narcotic analgesic (Paracetamol), a selective COX-2 inhibitor NSAID (Nimesulide), a second-generation antihistamine (Cetirizine), a nasal decongestant (Phenylephrine), and a central nervous system stimulant (Caffeine). The combination aims to provide synergistic relief from multiple symptoms. Note: The safety of Nimesulide is under scrutiny in many countries, and its use is restricted in India to a maximum of 15 days for acute conditions.
Adult: One tablet twice daily, after meals. The maximum recommended dose is two tablets in 24 hours. Nimesulide component should not exceed 200mg/day.
Note: To be taken orally with a full glass of water, preferably after meals to minimize gastric irritation. Do not crush or chew. Maintain adequate hydration. Do not co-administer with other products containing Paracetamol, NSAIDs, or antihistamines.
This combination exerts a multi-targeted effect. Paracetamol acts centrally on COX-3 and the serotonergic and cannabinoid pathways to reduce pain and fever. Nimesulide is a preferential COX-2 inhibitor, reducing prostaglandin synthesis at sites of inflammation, providing analgesic and anti-inflammatory effects. Cetirizine is a potent, selective peripheral H1-receptor antagonist, inhibiting histamine-mediated allergic symptoms. Phenylephrine is a selective alpha-1 adrenergic agonist causing vasoconstriction in nasal mucosa, reducing edema and congestion. Caffeine acts as an adjuvant analgesic, constricting cerebral blood vessels and potentially enhancing the absorption and efficacy of other analgesics.
Pregnancy: Category C (US FDA). Not recommended, especially in the third trimester. Paracetamol is preferred as a single agent for pain/fever if needed. Nimesulide is contraindicated due to risk of premature closure of ductus arteriosus. Cetirizine is Category B but combination use is not advised.
Driving: May impair ability to drive or operate machinery. Cetirizine can cause drowsiness/sedation. Caffeine may cause nervousness. Patients should not drive until their individual response is known.
| Warfarin/Anticoagulants | Increased risk of bleeding (Nimesulide inhibits platelet function, may displace warfarin) | Major |
| Other NSAIDs (e.g., Ibuprofen, Aspirin) | Increased risk of GI toxicity and renal impairment; additive with Paracetamol for hepatotoxicity risk | Major |
| MAO Inhibitors (e.g., Phenelzine, Selegiline) | Potentiates pressor effects of Phenylephrine, can cause hypertensive crisis | Contraindicated |
| Alcohol | Increased risk of hepatotoxicity (Paracetamol/Nimesulide) and CNS depression (Cetirizine) | Major |
| SSRIs/SNRIs (e.g., Fluoxetine, Venlafaxine) | Increased risk of serotonin syndrome (Paracetamol) and bleeding (Nimesulide) | Moderate |
| Antihypertensives (Beta-blockers, Diuretics) | Phenylephrine may antagonize hypotensive effect; NSAIDs reduce efficacy of diuretics/ACE inhibitors | Moderate |
| CNS Depressants (Benzodiazepines, Opioids) | Additive sedation with Cetirizine | Moderate |
| CYP1A2 Inhibitors (e.g., Ciprofloxacin, Fluvoxamine) | Increased Caffeine levels, risk of caffeine toxicity | Moderate |
| Anticholinergics (e.g., Atropine, TCAs) | Additive anticholinergic effects with Cetirizine/Phenylephrine | Moderate |
Same composition (Caffeine (25mg) + Cetirizine (5mg) + Nimesulide (100mg) + Paracetamol (325mg) + Phenylephrine (5mg)), different brands: