A fixed-dose combination (FDC) medication primarily used for the symptomatic relief of common cold, allergic rhinitis, and sinusitis. It combines an analgesic-antipyretic (Paracetamol), a first-generation antihistamine (Chlorpheniramine), a nasal decongestant (Phenylephrine), and a mild CNS stimulant (Caffeine). This combination addresses multiple symptoms simultaneously, including fever, pain, nasal congestion, sneezing, and rhinorrhea. The inclusion of caffeine is intended to counteract the sedative effects of chlorpheniramine and potentially enhance the analgesic effect of paracetamol.
Adult: One tablet every 6-8 hours. Maximum: 4 tablets in 24 hours. Should not be used for more than 5-7 days for self-medication of cold symptoms.
Note: Take with or without food. Taking with food may reduce gastric irritation. Swallow whole with a full glass of water. Do not crush or chew. Avoid taking at bedtime if caffeine causes insomnia.
This combination works synergistically on different pathways: Paracetamol inhibits central cyclooxygenase (COX), particularly the COX-2 variant, and modulates the endogenous cannabinoid system, reducing pain and fever. Chlorpheniramine competitively antagonizes histamine at the H1 receptor, reducing allergic symptoms like sneezing and rhinorrhea. Phenylephrine is a selective alpha-1 adrenergic receptor agonist, causing vasoconstriction in the nasal mucosa, reducing edema and congestion. Caffeine is a non-selective adenosine receptor antagonist, which can reduce drowsiness caused by chlorpheniramine and may have a mild adjuvant analgesic effect.
Pregnancy: Category C (US FDA). Paracetamol is generally considered safe. Chlorpheniramine is Category B but should be avoided in third trimester due to risk of neonatal withdrawal or anticholinergic effects. Phenylephrine is Category C; avoid especially in first trimester. Caffeine crosses placenta; high doses associated with miscarriage/low birth weight. Use only if potential benefit justifies potential risk, at the lowest effective dose for shortest duration.
Driving: May impair ability to drive or operate machinery. Chlorpheniramine causes drowsiness. Caffeine may cause restlessness or later fatigue. Patients should not drive until their individual response is known, especially during initial therapy.
| Monoamine Oxidase Inhibitors (MAOIs) - e.g., Phenelzine, Selegiline | Risk of severe hypertensive crisis due to potentiation of phenylephrine's sympathomimetic effects. | Contraindicated |
| Other CNS Depressants (Alcohol, Benzodiazepines, Opioids, Sedative Antihistamines) | Additive CNS depression with Chlorpheniramine, impairing alertness and psychomotor performance. | Major |
| Other Sympathomimetics (Decongestants, ADHD medications, Appetite suppressants) | Additive cardiovascular effects (hypertension, tachycardia, arrhythmia risk) with Phenylephrine. | Major |
| Beta-blockers (especially non-selective like Propranolol) | Unopposed alpha-adrenergic activity of phenylephrine can lead to severe hypertension and bradycardia. | Major |
| Anticholinergic drugs (Tricyclic Antidepressants, Antipsychotics, Antispasmodics) | Additive anticholinergic side effects (dry mouth, urinary retention, constipation, confusion) with Chlorpheniramine. | Moderate |
| Warfarin | Chronic high-dose Paracetamol (>2g/day for several days) may potentiate anticoagulant effect, increasing INR. | Moderate |
| CYP1A2 Inhibitors (Ciprofloxacin, Fluvoxamine, Oral Contraceptives) | Can increase Caffeine levels, leading to caffeine toxicity symptoms (anxiety, tremor, insomnia). | Moderate |
| Lithium | Caffeine may increase renal lithium excretion, potentially decreasing lithium levels. | Moderate |
| Antihypertensives | Phenylephrine may antagonize the blood pressure-lowering effect. | Moderate |
Same composition (Caffeine (30mg) + Chlorpheniramine Maleate (4mg) + Paracetamol (500mg) + Phenylephrine (10mg)), different brands: