A fixed-dose combination (FDC) drug used for the treatment of acute infectious diarrhea. Racecadotril is an enkephalinase inhibitor with antisecretory action, reducing fluid and electrolyte loss. Ofloxacin is a broad-spectrum fluoroquinolone antibiotic effective against common bacterial enteropathogens. This combination addresses both the symptom (watery diarrhea) and the cause (bacterial infection) in indicated cases.
Adult: One tablet (Racecadotril 100mg + Ofloxacin 200mg) twice daily. Typically prescribed for 3-5 days, not to exceed 7 days.
Note: Take tablet with or without food. Swallow whole with a full glass of water. Maintain adequate hydration with Oral Rehydration Solution (ORS) to prevent dehydration. Do not take with dairy products, calcium-fortified juices, or antacids containing calcium, magnesium, or aluminum (take Ofloxacin at least 2 hours before or 4 hours after these).
Racecadotril acts as a prodrug, converted to thiorphan, which inhibits membrane-bound enkephalinase in the intestinal epithelium. This inhibition prevents the breakdown of endogenous enkephalins, which in turn activate delta-opioid receptors. Receptor activation inhibits adenylate cyclase, reducing cyclic AMP levels and subsequent hypersecretion of water and electrolytes into the gut lumen. It does not affect intestinal motility. Ofloxacin inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes critical for DNA replication, transcription, repair, and recombination. This leads to rapid bactericidal activity.
Pregnancy: CONTRANDICATED. Ofloxacin is Pregnancy Category C (US FDA). Animal studies show cartilage damage in immature animals. Risk of arthropathy in the fetus. Racecadotril data in pregnancy is insufficient. Safer alternatives exist.
Driving: May impair alertness and cause dizziness or visual disturbances. Patients should not drive or operate machinery until their response is known.
| Antacids (Al, Mg, Ca), Sucralfate, Iron/Zinc supplements | Markedly reduced absorption of Ofloxacin 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, especially in elderly | Major |
| Oral Anticoagulants (Warfarin) | Ofloxacin may enhance anticoagulant effect; increased INR risk | Moderate |
| Theophylline | Ofloxacin inhibits its metabolism; increased theophylline toxicity risk | Major |
| Probenecid | Reduces renal secretion of Ofloxacin, increasing its blood levels | Moderate |
| Antiarrhythmics (Amiodarone, Sotalol), Antipsychotics | Additive QT prolongation risk, leading to Torsades de Pointes | Major |
| Oral Hypoglycemics (Sulfonylureas) | Ofloxacin may enhance hypoglycemic effect | Moderate |
Same composition (Racecadotril (100mg) + Ofloxacin (200mg)), different brands: