A fixed-dose combination (FDC) of a second-generation selective H1-antihistamine (Cetirizine) and a mucolytic/expectorant agent (Ambroxol). It is primarily indicated for the symptomatic relief of allergic respiratory conditions like allergic rhinitis and cough associated with thick, viscous mucus. Cetirizine blocks histamine-mediated allergic symptoms, while Ambroxol thins and loosens bronchial secretions, facilitating expectoration.
Adult: One tablet (Cetirizine 5mg + Ambroxol 60mg) twice daily. May be reduced to once daily based on symptom severity and response.
Note: Administer orally after food to minimize gastric irritation from ambroxol. Swallow whole with a full glass of water. Maintain adequate hydration to enhance mucolytic effect. Do not crush or chew.
Cetirizine competitively antagonizes histamine at the H1-receptor, inhibiting the vasodilatory, pruritic, and secretory responses of allergic reactions. Ambroxol is a metabolite of bromhexine. It stimulates the synthesis and secretion of surfactant in type II pneumocytes, depolymerizes acid mucopolysaccharide fibers in bronchial mucus, and activates the ciliary transport system, thereby reducing mucus viscosity and improving mucociliary clearance.
Pregnancy: Category B (US FDA). Cetirizine: Animal studies show no risk, human data limited. Ambroxol: Animal studies show no teratogenicity, but insufficient human data. Use only if potential benefit justifies potential risk to the fetus, preferably after first trimester.
Driving: May impair ability to drive or operate machinery. Patients should not engage in these activities until their individual response is known, especially during initial treatment.
| CNS Depressants (Alcohol, Benzodiazepines, Opioids) | Additive sedative effect, increased risk of drowsiness and impaired psychomotor performance. | Major |
| Theophylline | Ambroxol may increase theophylline concentration, increasing risk of toxicity. | Moderate |
| Anticholinergics (Atropine, Tricyclic Antidepressants) | Cetirizine has mild anticholinergic properties; additive effects may increase risk of dry mouth, urinary retention, constipation. | Moderate |
| Drugs metabolized by CYP2D6 (e.g., Metoprolol, Codeine) | Ambroxol is a CYP2D6 inhibitor; may increase plasma levels of these drugs. | Moderate |
Same composition (Cetirizine (5mg) + Ambroxol (60mg)), different brands: