A fixed-dose combination (FDC) antifungal and antiprotozoal/antibacterial agent. Fluconazole is a triazole antifungal that inhibits ergosterol synthesis. Ornidazole is a 5-nitroimidazole derivative active against anaerobic bacteria and protozoa. This combination is primarily used in the Indian context for the treatment of mixed vaginal infections, specifically vulvovaginal candidiasis (VVC) complicated by bacterial vaginosis (BV) or trichomoniasis, providing broad-spectrum coverage in a single dose.
Adult: One single dose of Fluconazole 150mg + Ornidazole 750mg, taken orally with or without food. For mixed vaginal infections, often administered as a single dose. In some cases of severe or recurrent infection, a second dose of ornidazole 750mg may be advised after 12 hours (fluconazole is not repeated).
Note: Swallow the tablet whole with a full glass of water. Can be taken with food to minimize potential gastrointestinal upset. Avoid alcohol during treatment and for at least 72 hours after the last dose due to risk of disulfiram-like reaction (flushing, nausea, vomiting, palpitations) from ornidazole.
The combination exerts a dual mechanism. Fluconazole inhibits fungal cytochrome P450-dependent 14α-demethylase, blocking the conversion of lanosterol to ergosterol, an essential component of the fungal cell membrane. This leads to increased membrane permeability and inhibition of fungal growth. Ornidazole, after intracellular reduction of its nitro group, generates cytotoxic intermediates that cause DNA strand breaks and inhibit nucleic acid synthesis in susceptible anaerobic bacteria and protozoa.
Pregnancy: CONTRANDICATED, especially in first trimester. Fluconazole is Pregnancy Category C (risk in human pregnancy not ruled out; high doses are teratogenic). Ornidazole is Category B (animal studies show no risk, but adequate human studies lacking). The combination is not recommended. For mixed infections in pregnancy, use topical azoles and metronidazole as per safety profile and trimester.
Driving: May cause dizziness, vertigo, or visual disturbances. Patients should not drive or operate machinery until they know how the medicine affects them.
| Warfarin | Fluconazole inhibits metabolism, increasing INR and bleeding risk. | Major |
| Sulfonylureas (e.g., Glimepiride) | Fluconazole inhibits metabolism, causing hypoglycemia. | Major |
| Phenytoin | Fluconazole increases phenytoin levels; phenytoin may decrease fluconazole levels. | Major |
| Rifampicin | Decreases fluconazole levels by inducing metabolism. | Moderate |
| Hydrochlorothiazide | Increases fluconazole levels by reducing renal clearance. | Moderate |
| Alcohol | Disulfiram-like reaction with Ornidazole (flushing, vomiting, tachycardia). | Major |
| Lithium | Ornidazole may increase lithium levels and risk of toxicity. | Moderate |
| Cyclosporine, Tacrolimus | Fluconazole increases levels, risk of nephrotoxicity. | Major |
Same composition (Fluconazole (150mg) + Ornidazole (750mg)), different brands: