A fixed-dose combination (FDC) antiprotozoal and anti-flatulent agent primarily used for the treatment of intestinal amoebiasis and giardiasis. Diloxanide is a luminal amoebicide, Tinidazole is a systemic nitroimidazole with activity against trophozoites, and Simethicone provides symptomatic relief from gas-related discomfort. This combination is widely prescribed in India for parasitic diarrheas and dysentery.
Adult: 1 tablet three times a day for 5-10 days, typically 5 days for giardiasis and 10 days for amoebiasis. To be taken after meals.
Note: Take after food to minimize GI upset and improve Diloxanide's luminal action. Swallow whole with a glass of water. Do not crush or chew.
Diloxanide acts as a direct luminal amoebicide, primarily in the cyst and trophozoite forms in the intestinal lumen. Tinidazole is a prodrug activated by reduction of its nitro group within the anaerobic microorganism, generating cytotoxic radicals that damage DNA and inhibit nucleic acid synthesis. Simethicone is a physiologically inert surfactant that reduces surface tension of gas bubbles in the GI tract, causing them to coalesce and be expelled more easily.
Pregnancy: Category C (Tinidazole). Contraindicated in first trimester. Avoid in second and third trimesters unless potential benefit outweighs risk. Tinidazole crosses placenta. Diloxanide data insufficient.
Driving: May cause dizziness, vertigo, or confusion. Patients should be cautioned about operating machinery or driving until their response is known.
| Alcohol | Disulfiram-like reaction (flushing, headache, nausea, vomiting, tachycardia) | Major |
| Warfarin and other coumarin anticoagulants | Tinidazole may inhibit metabolism, increasing INR and risk of bleeding | Major |
| Phenytoin, Phenobarbital | May increase Tinidazole metabolism, reducing efficacy. Tinidazole may increase Phenytoin levels. | Moderate |
| Lithium | Tinidazole may increase lithium levels, risk of toxicity | Moderate |
| Cyclosporine | Tinidazole may increase cyclosporine levels | Moderate |
| Fluorouracil (5-FU) | Tinidazole may reduce clearance, increasing toxicity | Moderate |
Same composition (Diloxanide (62.5mg) + Tinidazole (75mg) + Simethicone (12.5mg)), different brands: