A fixed-dose combination (FDC) of Nitazoxanide, a broad-spectrum antiparasitic and antiviral agent, and Ofloxacin, a second-generation fluoroquinolone antibiotic. This combination is primarily used in the Indian market for the empirical treatment of acute infectious diarrhea and gastroenteritis, targeting both bacterial and parasitic pathogens, including Cryptosporidium and Giardia. It is a widely prescribed FDC for traveler's diarrhea and community-acquired diarrheal illnesses.
Adult: One tablet (Nitazoxanide 125mg + Ofloxacin 50mg) twice daily for 3 days. For persistent diarrhea, may be extended to 5-7 days as per physician's advice.
Note: Take with food (to enhance Nitazoxanide absorption and reduce GI upset). Swallow whole with a full glass of water. Do not take with dairy products, calcium-fortified juices, or antacids containing calcium, magnesium, aluminum, or iron (separate by at least 2 hours) as they impair Ofloxacin absorption. Maintain adequate hydration.
The combination provides a dual mechanism targeting different pathogens. Nitazoxanide interferes with the pyruvate:ferredoxin oxidoreductase (PFOR) enzyme pathway essential for anaerobic energy metabolism in protozoa and some bacteria. Ofloxacin inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes critical for DNA replication, transcription, and repair.
Pregnancy: Category C (US FDA). Avoid use, especially in first trimester. Nitazoxanide and Ofloxacin cross the placenta. Ofloxacin is associated with arthropathy in immature animals. Use only if potential benefit justifies potential fetal risk.
Driving: May cause dizziness, lightheadedness, or visual disturbances. Patients should be cautioned about operating machinery or driving until they are sure they are not affected.
| Antacids (Al, Mg, Ca), Sucralfate, Iron, Zinc | Markedly reduced absorption of Ofloxacin | Major |
| Warfarin | Increased anticoagulant effect; increased INR | Major |
| NSAIDs (e.g., Ibuprofen) | Increased risk of CNS stimulation and seizures | Moderate |
| Corticosteroids (e.g., Prednisolone) | Increased risk of tendon rupture with Ofloxacin | Major |
| Oral Hypoglycemics (e.g., Glimepiride) | Ofloxacin may enhance or diminish hypoglycemic effect | Moderate |
| Theophylline | Increased Theophylline levels, risk of toxicity | Major |
| Probenecid | Increased Ofloxacin serum levels | Moderate |
| Other QT-prolonging drugs (e.g., Amiodarone, Sotalol) | Additive QT prolongation, risk of arrhythmias | Major |
Same composition (Nitazoxanide (125mg) + Ofloxacin (50mg)), different brands: