A fixed-dose combination (FDC) of a leukotriene receptor antagonist (LTRA) and a second-generation, non-sedating H1-antihistamine. It provides dual-action therapy for allergic conditions by blocking both cysteinyl leukotriene (CysLT1) receptors and histamine (H1) receptors. This combination is widely used in India for managing moderate to severe allergic rhinitis and chronic urticaria, offering synergistic relief from nasal congestion, sneezing, itching, and wheal formation.
Adult: One tablet (Montelukast 10mg + Fexofenadine 120mg) once daily in the evening.
Note: Take orally with a glass of water. Can be taken with or without food, but for consistent absorption of fexofenadine, take consistently with respect to meals. Avoid taking with fruit juices (apple, orange, grapefruit) or antacids containing aluminum and magnesium hydroxide.
The combination exerts a complementary anti-allergic effect. Montelukast selectively antagonizes cysteinyl leukotriene type 1 (CysLT1) receptors on airway smooth muscle and inflammatory cells, blocking the pro-inflammatory effects of leukotrienes (LTC4, LTD4, LTE4). Fexofenadine is a selective, competitive peripheral H1-receptor antagonist, inhibiting histamine-mediated symptoms. Together, they suppress both the early (histamine-driven) and late-phase (leukotriene and cytokine-driven) components of the allergic response.
Pregnancy: Category B (Montelukast) and Category C (Fexofenadine) as per US FDA. Use only if clearly needed and potential benefit justifies potential risk to the fetus. Limited human data. Consult physician.
Driving: Usually safe, as fexofenadine is non-sedating. However, patients should be cautioned that individual responses vary; if drowsiness or dizziness occurs, they should not drive or operate machinery.
| Rifampicin | Decreases plasma concentration of montelukast. May reduce efficacy. | Moderate |
| Phenobarbital, Phenytoin | Decreases plasma concentration of montelukast via CYP enzyme induction. | Moderate |
| Erythromycin, Ketoconazole | May increase plasma concentration of montelukast (CYP3A4 inhibition). Clinical significance unclear. | Mild |
| Aluminum/Magnesium containing antacids (e.g., Magaldrate) | Significantly reduce fexofenadine absorption if taken simultaneously. Administer at least 2 hours apart. | Moderate |
| Fruit Juices (Apple, Orange, Grapefruit) | Inhibit OATP transporters, reducing fexofenadine absorption and efficacy. | Moderate |
| Other CNS Depressants (Alcohol, Benzodiazepines, Opioids) | Additive sedative effect, though fexofenadine has low sedation potential. | Mild to Moderate |
Same composition (Montelukast (10mg) + Fexofenadine (120mg)), different brands: