A fixed-dose combination (FDC) antimicrobial agent containing a 5-nitroimidazole derivative (Satranidazole) and a second-generation fluoroquinolone (Ofloxacin). It is primarily indicated for the treatment of mixed anaerobic and aerobic bacterial infections, particularly in amoebiasis, giardiasis, and certain bacterial infections. The combination provides synergistic or additive effects against a broad spectrum of pathogens, covering both protozoa and bacteria. Satranidazole is a newer nitroimidazole with a longer half-life and potentially better tolerability profile compared to older agents like metronidazole.
Adult: One tablet (Satranidazole 300mg + Ofloxacin 200mg) twice daily for 5-7 days. For amoebiasis/giardiasis: Often 3-5 days. For severe or complicated infections: May be extended to 7-10 days as per physician's discretion.
Note: Take tablet with a full glass of water, with or without food (taking with food may reduce GI upset). Maintain adequate hydration. Do not crush or chew unless advised. Complete the full prescribed course even if symptoms improve.
The combination exerts a dual bactericidal and protozoacidal action. Satranidazole, after intracellular reduction of its nitro group, generates toxic radicals that damage DNA and other critical macromolecules in anaerobic microorganisms. 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, and quinolones cause arthropathy in juvenile animals. USE IS CONTRAINDICATED during pregnancy, especially in first trimester. Use only if potential benefit justifies potential fetal risk in life-threatening situations.
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, Ca), Sucralfate, Iron, Zinc salts | Markedly reduced absorption of ofloxacin due to chelation. Maintain at least 2-4 hour gap. | Major |
| Warfarin and other oral anticoagulants | Ofloxacin may potentiate anticoagulant effect, increasing INR and bleeding risk. Monitor INR closely. | Major |
| Theophylline | Ofloxacin may decrease clearance of theophylline, leading to toxicity (nausea, seizures). Monitor theophylline levels. | Major |
| NSAIDs (e.g., Ibuprofen, Diclofenac) | May increase the risk of CNS stimulation and seizures when combined with fluoroquinolones. | Moderate |
| Corticosteroids (systemic) | Increased risk of tendon rupture, especially in elderly, when combined with ofloxacin. | Major |
| Other QT-prolonging drugs (e.g., Amiodarone, Sotalol, Macrolides, TCAs) | Additive effect on QT prolongation, increasing risk of torsades de pointes. | Major |
| Alcohol | Disulfiram-like reaction with satranidazole (flushing, tachycardia, nausea). STRICTLY AVOID. | Major |
Same composition (Satranidazole (300mg) + Ofloxacin (200mg)), different brands: