Acebrophylline (200mg) + Montelukast (10mg) is a fixed-dose combination (FDC) medication used for the management of chronic obstructive pulmonary disease (COPD) and bronchial asthma. It combines a mucolytic/bronchodilator (Acebrophylline) with a leukotriene receptor antagonist (Montelukast) to provide synergistic action in reducing airway inflammation, improving bronchial airflow, and facilitating mucus clearance. This combination is particularly relevant in the Indian context for managing moderate to severe obstructive airway diseases.
Adult: One tablet (Acebrophylline 200mg + Montelukast 10mg) orally twice daily. Usually administered after meals to reduce gastric irritation.
Note: Take tablet whole with a glass of water, preferably after food. Do not crush or chew. For asthma, Montelukast is most effective when taken in the evening. Maintain a consistent dosing schedule.
The combination exerts a dual mechanism: Acebrophylline acts as a bronchodilator, mucolytic, and anti-inflammatory agent, while Montelukast selectively blocks the cysteinyl leukotriene type 1 (CysLT1) receptor, inhibiting the pro-inflammatory effects of leukotrienes (LTD4). This results in reduced bronchoconstriction, decreased vascular permeability, and inhibition of inflammatory cell recruitment.
Pregnancy: Category C (US FDA). Acebrophylline and Montelukast cross the placenta. Use only if potential benefit justifies potential risk to the fetus. Montelukast alone is Category B. Avoid in first trimester unless absolutely necessary.
Driving: May cause dizziness, drowsiness, or blurred vision. Patients should not drive or operate machinery until they know how the medication affects them.
| Ciprofloxacin, Erythromycin, Fluconazole | Inhibit metabolism of Acebrophylline (via CYP1A2/CYP3A4), leading to increased serum levels and risk of toxicity. | Major |
| Phenobarbital, Phenytoin, Rifampicin | Induce metabolism of both drugs, reducing their plasma concentrations and therapeutic efficacy. | Major |
| Warfarin | Acebrophylline may potentiate anticoagulant effect; increased INR monitoring required. | Moderate |
| Beta-blockers (e.g., Propranolol) | May antagonize bronchodilator effects of Acebrophylline. | Moderate |
| Aspirin, other NSAIDs | Increased risk of bronchospasm in aspirin-sensitive asthmatics; Montelukast may offer some protection. | Moderate |
| Gemfibrozil | May significantly increase Montelukast plasma concentration. | Moderate |
Same composition (Acebrophylline (200mg) + Montelukast (10mg)), different brands: