A fixed-dose combination (FDC) drug used for the management of acute infectious diarrhea. Racecadotril is an enkephalinase inhibitor with antisecretory action, reducing fluid and electrolyte loss. Ofloxacin is a second-generation fluoroquinolone antibiotic with broad-spectrum activity against common enteric pathogens. This combination addresses both the symptom (watery diarrhea) and the underlying bacterial cause, providing a comprehensive approach to acute diarrheal illness in the Indian context, where bacterial gastroenteritis is prevalent.
Adult: One tablet (Racecadotril 15mg + Ofloxacin 50mg) twice daily. Typically prescribed for 3-5 days, not to exceed 7 days.
Note: Administer with or without food. Take with a full glass of water. Maintain adequate fluid intake with ORS to prevent dehydration. Do not crush or chew. Complete the full prescribed course even if symptoms improve earlier.
Racecadotril acts as a prodrug, converted to thiorphan, which inhibits membrane-bound enkephalinase in the intestinal epithelium. This inhibition increases local concentrations of endogenous enkephalins, which stimulate delta-opioid receptors. This activation reduces intracellular cyclic AMP and inhibits the hypersecretion of water and electrolytes into the gut lumen, without affecting 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.
Driving: May impair alertness. Caution advised when driving or operating machinery, especially during initial therapy, due to potential dizziness, lightheadedness, or visual disturbances.
| 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 with Ofloxacin | Major |
| Oral Anticoagulants (Warfarin) | Ofloxacin may enhance anticoagulant effect; increased INR | Moderate |
| Theophylline | Ofloxacin may increase Theophylline levels, risk of toxicity | Moderate |
| Probenecid | Inhibits renal secretion of Ofloxacin, increasing its levels | Moderate |
| Antiarrhythmics (Class IA, III e.g., Amiodarone) | Additive QT prolongation, risk of arrhythmias | Major |
Same composition (Racecadotril (15mg) + Ofloxacin (50mg)), different brands: