A fixed-dose combination (FDC) of a third-generation cephalosporin (Cefixime) and a second-generation fluoroquinolone (Ofloxacin). Cefixime acts by inhibiting bacterial cell wall synthesis, while Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV. This combination provides broad-spectrum, synergistic bactericidal activity against a wide range of Gram-positive and Gram-negative organisms, including many resistant strains. It is primarily used for the treatment of mixed infections, particularly in the respiratory, gastrointestinal, and genitourinary tracts, where a single antibiotic may be insufficient. The FDC is widely used in India, though its use is subject to regulatory scrutiny regarding rational use.
Adult: One tablet (Cefixime 200mg + Ofloxacin 200mg) every 12 hours. For less severe infections, once daily dosing may be considered based on clinician's judgment.
Note: Administer orally. Can be taken with or without food. However, for optimal absorption of Ofloxacin, administer at least 2 hours before or 4 hours after antacids, sucralfate, iron, zinc, or calcium supplements. Maintain adequate hydration.
This combination exerts a dual bactericidal mechanism. Cefixime binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, inhibiting the final transpeptidation step of peptidoglycan synthesis. This leads to the formation of a defective cell wall and osmotic lysis of the bacterium. Ofloxacin inhibits bacterial DNA synthesis by blocking the enzymes DNA gyrase (topoisomerase II) and topoisomerase IV. DNA gyrase is responsible for negative supercoiling of DNA, essential for replication and transcription. Inhibition leads to rapid bacterial death.
Pregnancy: CONTRANDICATED (Pregnancy Category D for Ofloxacin, Category B for Cefixime). Ofloxacin causes arthropathy in immature animals. Risk of fetal harm outweighs any benefit.
Driving: May cause dizziness, lightheadedness, or visual disturbances. Patients should be cautioned about operating machinery or driving until they know how the medication affects them.
| Antacids (Al, Mg), Sucralfate, Iron, Zinc, Calcium | Markedly reduced absorption of Ofloxacin due to chelation. | Major |
| Warfarin | Increased anticoagulant effect; increased risk of bleeding. | Major |
| NSAIDs (e.g., Ibuprofen) | Increased risk of CNS stimulation and seizures. | Moderate |
| Theophylline | Increased theophylline levels; risk of toxicity (nausea, seizures). | Major |
| Probenecid | Increased and prolonged blood levels of Cefixime. | Moderate |
| Corticosteroids (systemic) | Increased risk of tendon rupture with Ofloxacin. | Major |
| Anti-diabetic drugs (Insulin, Sulfonylureas) | May potentiate hypoglycemic effect; monitor blood glucose. | Moderate |
| Drugs prolonging QT interval (e.g., Erythromycin, Antiarrhythmics) | Additive effect on QT prolongation; risk of arrhythmias (Torsades de Pointes). | Major |