A fixed-dose combination (FDC) tablet used primarily for the treatment of intestinal amoebiasis and giardiasis, with adjunctive relief from associated gas and bloating. Diloxanide is a luminal amoebicide, Ornidazole is a nitroimidazole antimicrobial effective against anaerobic bacteria and protozoa, and Simethicone is an anti-flatulent.
Adult: One tablet (Diloxanide 375mg + Ornidazole 250mg + Simethicone 25mg) three times daily for 5-10 days, usually 5 days for giardiasis and 10 days for amoebiasis. Take after meals.
Note: Swallow the tablet whole with a full glass of water, after meals to minimize gastrointestinal upset. Do not crush or chew.
Diloxanide acts directly as a luminal amoebicide, likely by disrupting protein synthesis in the trophozoites of Entamoeba histolytica. Ornidazole is a prodrug; its nitro group is reduced by microbial nitroreductases, generating cytotoxic intermediates that damage microbial DNA, leading to cell death. Simethicone is a physiologically inert anti-foaming agent that reduces surface tension of gas bubbles, causing them to coalesce and be expelled more easily.
Pregnancy: Category C (US FDA). Ornidazole is contraindicated in the first trimester. Avoid in second and third trimesters unless potential benefit justifies potential fetal risk. Diloxanide data is limited.
Driving: May cause dizziness, drowsiness, or visual disturbances. Patients should not drive or operate machinery if affected.
| Warfarin/Acenocoumarol | Ornidazole may potentiate anticoagulant effect, increasing INR and bleeding risk. | Major |
| Lithium | Ornidazole may increase lithium levels, risk of toxicity. | Major |
| Phenobarbital, Phenytoin | May increase metabolism of Ornidazole, reducing its efficacy. | Moderate |
| Cyclosporine, Tacrolimus | Ornidazole may increase levels of these immunosuppressants. | Moderate |
| Alcohol | Disulfiram-like reaction (flushing, tachycardia, nausea) with Ornidazole. | Major |
| Other neurotoxic drugs (e.g., Isoniazid) | Increased risk of peripheral neuropathy. | Moderate |