A fixed-dose combination (FDC) therapy for the symptomatic management of respiratory conditions characterized by productive cough, allergic inflammation, and bronchoconstriction. It synergistically addresses mucus hypersecretion, histamine-mediated allergic symptoms, and leukotriene-mediated airway inflammation. This combination is widely used in India for conditions like allergic bronchitis and cough-variant asthma, offering convenience and improved compliance.
Adult: One tablet (Ambroxol 75mg + Levocetirizine 5mg + Montelukast 10mg) once daily, preferably in the evening. Can be taken with or without food.
Note: Swallow the tablet whole with a glass of water. Do not crush or chew (unless specified as a chewable tablet). Can be taken at the same time each day, evening dosing may help control nocturnal symptoms and minimize potential daytime drowsiness from levocetirizine.
This combination exerts a triple action: Ambroxol reduces mucus viscosity and promotes clearance, Levocetirizine blocks peripheral H1 receptors inhibiting early-phase allergic response, and Montelukast competitively antagonizes cysteinyl leukotriene type 1 (CysLT1) receptors, inhibiting late-phase allergic inflammation and bronchoconstriction.
Pregnancy: Category B2 (Montelukast), Category B (Levocetirizine data limited), Ambroxol (limited data). Use only if clearly needed and potential benefit justifies potential risk to the fetus. Avoid in first trimester unless absolutely necessary.
Driving: May impair ability to drive or operate machinery. Patients should not engage in these activities until they know how the medication affects them, especially regarding drowsiness or dizziness.
| CNS Depressants (Alcohol, Benzodiazepines, Opioids) | Additive sedative effect with levocetirizine. | Major |
| Rifampicin, Phenobarbital, Carbamazepine | Induce CYP enzymes, may reduce montelukast plasma concentration. | Moderate |
| Gemfibrozil | Inhibits CYP2C8, may increase monteluzkast concentration. | Moderate |
| Anticholinergic drugs (Atropine, TCAs) | Additive anticholinergic effects (dry mouth, urinary retention) with levocetirizine. | Moderate |
| Theophylline | Ambroxol may increase theophylline concentration; monitor for toxicity. | Moderate |
Same composition (Ambroxol (75mg) + Levocetirizine (5mg) + Montelukast (10mg)), different brands: