A fixed-dose combination (FDC) of a broad-spectrum fluoroquinolone antibiotic (Levofloxacin) and a mucolytic/expectorant agent (Ambroxol). Levofloxacin acts by inhibiting bacterial DNA gyrase and topoisomerase IV, providing bactericidal activity against a wide range of Gram-positive and Gram-negative pathogens. Ambroxol enhances the secretion of respiratory tract fluid, reduces mucus viscosity, and stimulates surfactant production, facilitating expectoration and improving airway clearance. This combination is primarily indicated for the treatment of acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia where tenacious sputum is a complicating factor.
Adult: One tablet (Levofloxacin 500mg + Ambroxol 75mg) once daily. For CAP/ABECB: Duration typically 7-14 days.
Note: Take with a full glass of water, with or without food (to minimize GI upset). Avoid taking with dairy products, calcium-fortified juices, or antacids containing divalent cations (Al, Mg, Ca, Fe, Zn) as they significantly reduce levofloxacin absorption. Maintain at least a 2-hour gap. Stay well-hydrated.
Levofloxacin: Inhibits bacterial DNA gyrase (in Gram-negative bacteria) and topoisomerase IV (in Gram-positive bacteria), enzymes essential for DNA replication, transcription, repair, and recombination. This inhibition leads to double-stranded DNA breaks and rapid bacterial cell death (bactericidal). Ambroxol: Depolymerizes acid mucopolysaccharide fibers in sputum, reducing viscosity. It also stimulates type II pneumocytes to produce surfactant and enhances the activity of the ciliary transport system, improving mucociliary clearance.
Pregnancy: CONTRANDICATED (Category C for Levofloxacin in US FDA; not recommended). Animal studies show cartilage damage in immature animals. Ambroxol safety not established.
Driving: May impair reaction time and ability to drive. Dizziness, lightheadedness, and visual disturbances have been reported. Patients should not drive or operate machinery until they know how the drug affects them.
| Antacids (Al, Mg), Sucralfate, Iron, Zinc, Calcium | Markedly reduced absorption of Levofloxacin due to chelation | Major |
| NSAIDs (e.g., Ibuprofen, Diclofenac) | Increased risk of CNS stimulation and seizures | Moderate |
| Corticosteroids (e.g., Prednisolone) | Increased risk of tendon rupture | Major |
| Oral Anticoagulants (Warfarin) | Enhanced anticoagulant effect; increased INR | Moderate |
| Antiarrhythmics (Amiodarone, Sotalol), Antipsychotics | Additive QT prolongation, high risk of arrhythmias | Major |
| Theophylline | Increased theophylline levels; risk of toxicity | Moderate |
| Probenecid | Reduces renal clearance of Levofloxacin, increasing its levels | Moderate |
| CYP3A4 Inhibitors (e.g., Ketoconazole) | May increase Ambroxol levels | Minor |
Same composition (Levofloxacin (500mg) + Ambroxol (75mg)), different brands: