Acebrophylline is a bronchodilator and mucoregulatory agent, chemically a xanthine derivative. It is a complex of theophylline-7-acetic acid with ambroxol in a 2:1 molar ratio. It is widely used in India for the management of chronic obstructive pulmonary disease (COPD) and bronchial asthma, particularly when associated with excessive, viscous mucus. It exhibits dual action: bronchodilation via phosphodiesterase (PDE) inhibition and mucociliary clearance enhancement via ambroxol's secretolytic and antioxidant effects.
Adult: 200 mg twice daily (morning and evening). The total daily dose should not exceed 400 mg.
Note: To be taken after food to minimize gastric irritation. The capsule/tablet should be swallowed whole with a full glass of water. Do not crush or chew sustained-release formulations. Maintain adequate hydration to aid mucus clearance.
Acebrophylline exerts a dual mechanism: 1) Bronchodilation: The theophylline component non-selectively inhibits phosphodiesterase (PDE) enzymes (PDE3, PDE4), leading to increased intracellular cyclic AMP (cAMP). This causes relaxation of bronchial smooth muscle. It may also antagonize adenosine receptors (A1 and A2), contributing to bronchodilation and anti-inflammatory effects. 2) Mucoregulation: The ambroxol component stimulates surfactant production from type II pneumocytes, reduces mucus viscosity by breaking down acid mucopolysaccharide fibers, and enhances mucociliary transport. It also possesses antioxidant properties.
Pregnancy: Category C: Animal studies have shown adverse effects. There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Theophylline crosses the placenta.
Driving: May cause dizziness, nervousness, or blurred vision. Patients should be cautioned about driving or operating machinery until they know how the drug affects them.
| Ciprofloxacin / Levofloxacin | Markedly decreases acebrophylline clearance, increasing risk of toxicity. | Major |
| Erythromycin / Clarithromycin | Decreases clearance via CYP1A2/3A4 inhibition, increases serum levels. | Major |
| Phenytoin / Carbamazepine / Phenobarbital | Increases clearance via enzyme induction, reducing efficacy. | Moderate |
| Cimetidine | Decreases clearance, increases serum levels. | Moderate |
| Warfarin | Acebrophylline may potentiate anticoagulant effect; monitor INR. | Moderate |
| Beta-2 Agonists (Salbutamol) | Additive cardiovascular effects (tachycardia, hypokalemia). | Moderate |
| Allopurinol (high dose) | May decrease clearance. | Moderate |
| Smoking / Tobacco | Increases clearance via CYP1A2 induction, requiring higher doses. | Moderate |
Same composition (Acebrophylline (200mg)), different brands: