A fixed-dose combination (FDC) of a methylxanthine bronchodilator (Doxofylline) and a mucolytic agent (Ambroxol) used for the management of chronic obstructive pulmonary disease (COPD) and bronchial asthma with associated productive cough. Doxofylline is a selective phosphodiesterase-4 (PDE4) inhibitor with a better safety profile than theophylline, while Ambroxol facilitates expectoration by increasing mucus clearance.
Adult: One tablet (Doxofylline 400mg + Ambroxol 30mg) twice daily, preferably after meals.
Note: Swallow the tablet whole with a glass of water, after food to minimize gastric irritation. Do not crush or chew. Maintain adequate hydration to aid mucolytic action.
Doxofylline acts as a bronchodilator and anti-inflammatory agent by selectively inhibiting phosphodiesterase-4 (PDE4), leading to increased intracellular cAMP. This relaxes bronchial smooth muscle and inhibits the release of pro-inflammatory mediators. Ambroxol is a mucolytic and expectorant that stimulates surfactant production, depolymerizes acid mucopolysaccharide fibers in sputum, and enhances ciliary beat frequency, facilitating mucus clearance.
Pregnancy: Category C (US FDA). Animal studies show risk. Use only if potential benefit justifies potential fetal risk. Adequate human data not available. Avoid in first trimester.
Driving: May cause dizziness, nervousness, or blurred vision. Patients should not drive or operate machinery until their response is known.
| Ciprofloxacin/Enoxacin | Markedly increases Doxofylline levels (CYP1A2 inhibition), risk of toxicity. | Major |
| Phenobarbital, Phenytoin, Rifampicin | Decreases Doxofylline levels (CYP450 induction), may reduce efficacy. | Moderate |
| Beta-2 Agonists (Salbutamol, Terbutaline) | Additive bronchodilation; may potentiate hypokalemia and tachycardia. | Moderate |
| Diuretics (especially Loop Diuretics) | Increased risk of hypokalemia with Doxofylline. | Moderate |
| Warfarin | Ambroxol may slightly increase bleeding risk; monitor INR. | Minor |
| Antitussives (e.g., Codeine) | Counteracts the expectorant action of Ambroxol; avoid concurrent use. | Moderate |
Same composition (Doxofylline (400mg) + Ambroxol (30mg)), different brands: