Cetirizine + Ambroxol

Cetirizine, a second-generation H1-receptor antagonist, selectively blocks peripheral H1-receptors, thereby reducing the effects of histamine such as itching, sneezing, and rhinorrhea. Ambroxol is a mucolytic agent that stimulates serous cells in the mucous glands, leading to increased production of thinner, less viscous mucus. It also enhances mucociliary clearance and stimulates surfactant production. The combination targets both the allergic inflammatory component and the excessive, viscous mucus production often associated with allergic respiratory conditions and productive cough. Combination rationale: This Fixed Dose Combination is rational as it simultaneously addresses both the allergic symptoms and the mucolytic needs in respiratory conditions. Cetirizine effectively reduces allergic reactions like sneezing and rhinorrhea, while Ambroxol thins and clears respiratory secretions, facilitating productive cough relief. This synergistic action provides comprehensive symptom management for patients suffering from allergic productive cough or conditions with excessive, viscous mucus associated with an allergic component.

Adult

Tablet: Cetirizine 10mg + Ambroxol 60mg, 1 tablet once or twice daily orally. Syrup: Cetirizine 5mg + Ambroxol 30mg per 5mL, 5-10 mL twice daily orally.

Pediatric

Syrup: Generally for children above 6 years. Cetirizine 5mg + Ambroxol 30mg per 5mL. 5 mL twice daily. Dosing should be individualized based on age and weight, and for younger children, specific pediatric formulations may be available.

Renal adjustment

Cetirizine: Reduce dose to half in moderate renal impairment (CrCl 31-50 mL/min); once daily in severe impairment (CrCl 11-30 mL/min). Ambroxol: Caution and dose reduction required in severe renal impairment. Consider half dose or extended intervals for the combination in moderate to severe renal impairment (CrCl <50 mL/min).…

• Hypersensitivity to cetirizine, ambroxol, or any excipients
• Severe renal impairment (CrCl <10 mL/min)
• Severe hepatic impairment
• Peptic ulcer disease (Ambroxol should be used with caution)