A fixed-dose combination oral suspension containing a nitroimidazole (Satranidazole) and a fluoroquinolone (Ofloxacin) antibiotic. It is primarily used for the treatment of mixed anaerobic and aerobic bacterial infections, particularly in amoebiasis, giardiasis, and bacterial diarrhea/dysentery prevalent in the Indian context. Satranidazole is a second-generation 5-nitroimidazole with a broader spectrum and better tolerability than metronidazole, while Ofloxacin provides coverage against common Gram-negative enteric pathogens.
Adult: 10 ml (containing Satranidazole 150mg + Ofloxacin 100mg) twice daily for 5-7 days. For amoebiasis/giardiasis: May extend to 7-10 days.
Note: Shake the bottle well before use. Use the measuring cup provided. Take on an empty stomach (1 hour before or 2 hours after food) for optimal absorption of Ofloxacin. Can be taken with food if GI upset occurs, but may slightly delay absorption. Maintain adequate hydration. Do not take with dairy products, calcium-fortified juices, antacids, or iron/zinc supplements (separate by at least 2-4 hours).
The combination provides synergistic or additive bactericidal and antiprotozoal activity. Satranidazole enters microbial cells and undergoes nitro-reduction to form toxic metabolites that damage DNA and inhibit nucleic acid synthesis, particularly in anaerobic bacteria and protozoa. Ofloxacin inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for DNA replication, transcription, and repair, leading to rapid bacterial cell death.
Pregnancy: Category C (US FDA). Both drugs cross the placenta. Satranidazole is mutagenic in bacteria; Ofloxacin causes arthropathy in immature animals. Use only if potential benefit justifies potential fetal risk. Avoid in first trimester. Not recommended for routine use.
Driving: May cause dizziness, lightheadedness, or visual disturbances. Patients should not drive or operate machinery until their response to the drug is known.
| Antacids (Aluminum, Magnesium), Sucralfate, Iron, Zinc Supplements | Markedly reduced absorption of Ofloxacin due to chelation | Major |
| Warfarin and other Oral Anticoagulants | Increased anticoagulant effect, risk of bleeding (Satranidazole may inhibit metabolism) | Major |
| Theophylline | Ofloxacin may increase Theophylline serum levels, risk of toxicity | Major |
| NSAIDs (e.g., Ibuprofen, Diclofenac) | Increased risk of CNS stimulation and seizures | Moderate |
| Corticosteroids (Systemic) | Increased risk of tendon rupture with Ofloxacin | Major |
| Oral Hypoglycemics (e.g., Glibenclamide) | Satranidazole may potentiate hypoglycemic effect | Moderate |
| Alcohol | Disulfiram-like reaction with Satranidazole (flushing, palpitations, nausea) | Major |
| Other QT-prolonging drugs (e.g., Erythromycin, Amiodarone, TCAs) | Additive risk of cardiac arrhythmias | Major |
| Probenecid | Decreases renal clearance of Ofloxacin, increasing its level | Moderate |
Same composition (Satranidazole (75mg/5ml) + Ofloxacin (50mg/5ml)), different brands: