A fixed-dose combination (FDC) therapy for the management of moderate to severe allergic respiratory conditions, particularly bronchial asthma and allergic rhinitis. It provides a synergistic triple-action approach: Montelukast is a leukotriene receptor antagonist (LTRA) that blocks inflammatory mediators; Levocetirizine is a potent second-generation H1-antihistamine that alleviates allergic symptoms; Acebrophylline is a mucolytic and bronchodilator that improves airway clearance and reduces bronchospasm. This combination is widely prescribed in India for its comprehensive control of both upper and lower airway inflammation and symptoms.
Adult: One tablet (Montelukast 5mg + Levocetirizine 10mg + Acebrophylline 200mg) once daily, preferably in the evening. For allergic rhinitis, can be taken in the morning if sedation is not an issue.
Note: Administer orally with or without food. Swallow whole with a glass of water. Do not crush or chew. For asthma, therapy should be taken regularly even during symptom-free periods. Not for acute relief of asthma attacks.
The combination exerts a multi-targeted effect on the allergic-inflammatory cascade. Montelukast selectively antagonizes cysteinyl leukotriene type 1 (CysLT1) receptors, blocking the action of leukotrienes (LTD4) which cause bronchoconstriction, vascular permeability, and eosinophil recruitment. Levocetirizine is a potent and selective peripheral H1-receptor inverse agonist, inhibiting histamine-mediated symptoms like itching, sneezing, and rhinorrhea. Acebrophylline provides dual action: (1) It acts as a mucolytic by depolymerizing mucopolysaccharide fibers in bronchial secretions, reducing viscosity, and (2) Its metabolite, theophylline, acts as a bronchodilator via non-selective phosphodiesterase (PDE) inhibition and adenosine receptor antagonism.
Pregnancy: Category B for Montelukast and Levocetirizine (animal studies show no risk, human data limited). Acebrophylline/Theophylline is Category C. Use only if potential benefit justifies potential fetal risk. Preferably avoid in first trimester. Consult physician.
Driving: May impair ability to drive or operate machinery, especially during initial therapy or when dose is increased, due to potential sedation from Levocetirizine. Patients should not engage in such activities until their individual response is known.
| Rifampicin, Phenobarbital, Phenytoin, Carbamazepine | Induce CYP450 enzymes, significantly decreasing Montelukast and Theophylline (from Acebrophylline) plasma levels, reducing efficacy. | Major |
| Erythromycin, Clarithromycin, Ciprofloxacin, Fluconazole, Ketoconazole | Inhibit CYP450 enzymes (CYP1A2, CYP3A4), increasing Theophylline and potentially Montelukast levels, leading to toxicity risk (seizures, arrhythmias). | Major |
| Other CNS Depressants (Alcohol, Benzodiazepines, Opioids) | Additive sedative effect with Levocetirizine, impairing alertness and coordination. | Moderate |
| Theophylline (as separate drug) | Additive Theophylline exposure from Acebrophylline, increasing risk of toxicity (nausea, tachycardia, seizures). | Major |
| Beta-2 Agonists (Salbutamol, Terbutaline) | Additive bronchodilation with Acebrophylline; synergistic therapeutic effect but may increase risk of hypokalemia and tachycardia. | Moderate |
| Diuretics (especially Loop Diuretics like Furosemide) | Theophylline component may antagonize diuretic effect. Concurrent use may increase risk of hypokalemia. | Moderate |
Same composition (Montelukast (5mg) + Levocetirizine (10mg) + Acebrophylline (200mg)), different brands: