A fixed-dose combination (FDC) medication containing a second-generation antihistamine (Cetirizine), an analgesic-antipyretic (Paracetamol), and a decongestant (Phenylephrine). It is primarily indicated for the symptomatic relief of allergic rhinitis and the common cold, addressing sneezing, rhinorrhea, nasal congestion, headache, body ache, and fever. The combination provides comprehensive relief from upper respiratory symptoms. The FDC was approved by the Indian regulatory authorities (CDSCO) for specific symptomatic relief, though its rationality is sometimes debated in clinical circles.
Adult: One tablet every 8 to 12 hours. Maximum: 3 tablets in 24 hours.
Note: Take with or without food. Swallow whole with a glass of water. Do not crush or chew. Can be taken after meals to minimize potential gastric discomfort from Paracetamol. Maintain adequate hydration.
The combination works synergistically: Cetirizine competitively antagonizes histamine at peripheral H1 receptors, inhibiting allergic response. Paracetamol inhibits central cyclooxygenase (COX), particularly COX-2 in the brain, reducing prostaglandin synthesis involved in pain and fever. Phenylephrine acts as a selective alpha-1 adrenergic receptor agonist, causing vasoconstriction in the nasal mucosa, reducing edema and congestion.
Pregnancy: Category B (Cetirizine, Phenylephrine) / Category A (Paracetamol in 1st/2nd trimester, Category C in 3rd). Use only if clearly needed. Avoid in first trimester unless benefit outweighs risk. Paracetamol is preferred analgesic/antipyretic. Phenylephrine should be avoided, especially in the 1st and 3rd trimesters due to theoretical risk of reduced uterine blood flow and teratogenicity.
Driving: May impair ability to drive or operate machinery. Cetirizine can cause drowsiness and dizziness, especially during initial therapy or with alcohol. Patients should not drive until their individual response is known.
| Monoamine Oxidase Inhibitors (e.g., Phenelzine, Selegiline) | Risk of severe hypertensive crisis due to Phenylephrine. | Contraindicated |
| Other sympathomimetics (e.g., Pseudoephedrine, Decongestant nasal sprays) | Additive pressor effects, increasing risk of hypertension and tachycardia. | Major |
| CNS Depressants (e.g., Alcohol, Benzodiazepines, Opioids) | Increased sedative effect of Cetirizine. | Moderate |
| Antihypertensives (Beta-blockers, Alpha-blockers, Diuretics) | Phenylephrine may antagonize hypotensive effect. | Moderate |
| Drugs inducing liver enzymes (e.g., Rifampicin, Carbamazepine, Phenytoin) | Increased risk of Paracetamol hepatotoxicity due to enhanced toxic metabolite (NAPQI) formation. | Moderate |
| Warfarin | Chronic high-dose Paracetamol may potentiate anticoagulant effect; monitor INR. | Moderate |
| Anticholinergics (e.g., Atropine, Tricyclic Antidepressants) | Additive anticholinergic effects (dry mouth, urinary retention, blurred vision). | Moderate |
Same composition (Cetirizine (5mg) + Paracetamol (325mg) + Phenylephrine (10mg)), different brands: