A fixed-dose combination (FDC) antifungal and antiprotozoal/antibacterial agent. Fluconazole is a triazole antifungal that inhibits fungal cytochrome P450-dependent enzyme lanosterol 14-α-demethylase, disrupting ergosterol synthesis in fungal cell membranes. Tinidazole is a 5-nitroimidazole derivative with activity against anaerobic bacteria and protozoa, disrupting DNA structure and inhibiting nucleic acid synthesis. This combination is primarily used in gynecological infections where mixed fungal (Candida) and anaerobic/trichomonal infections are suspected or confirmed.
Adult: One single-dose tablet (Fluconazole 75mg + Tinidazole 1000mg) taken orally. For recurrent or persistent infection, a second dose may be repeated after 72 hours or as directed by physician. Typically not used as a chronic therapy.
Note: Take orally with or without food. Taking with food may reduce gastric upset from Tinidazole. Swallow whole with a full glass of water. For vaginal infections, sexual partner(s) may require concurrent treatment (e.g., Tinidazole alone) to prevent reinfection.
Fluconazole: Inhibits the fungal cytochrome P450 enzyme 14α-demethylase. This inhibition prevents the conversion of lanosterol to ergosterol, an essential component of the fungal cell membrane. Depletion of ergosterol and accumulation of methylated sterols leads to increased membrane permeability, inhibition of growth, and cell death. Tinidazole: Its nitro group is reduced by intracellular electron transport proteins in anaerobic microorganisms. The reduced nitro group generates cytotoxic compounds that damage microbial DNA, causing strand breaks and loss of helical structure, inhibiting nucleic acid synthesis and leading to cell death.
Pregnancy: CONTRANDICATED in first trimester. Tinidazole is mutagenic in bacteria and carcinogenic in rodents. Fluconazole in high doses is teratogenic. Use in second/third trimester only if potential benefit justifies potential fetal risk (Pregnancy Category D for high-dose fluconazole; Category C for this low dose and for Tinidazole).
Driving: May cause dizziness, vertigo, ataxia, or visual disturbances. Patients should not drive or operate machinery until their individual response is known.
| Warfarin | Fluconazole inhibits metabolism, increasing INR and bleeding risk. | Major |
| Sulfonylureas (e.g., Glimepiride) | Fluconazole increases sulfonylurea levels, causing hypoglycemia. | Major |
| Phenytoin | Fluconazole increases phenytoin levels; phenytoin may decrease fluconazole levels. | Major |
| Rifampicin | Decreases Fluconazole levels significantly. | Moderate |
| Alcohol | Disulfiram-like reaction with Tinidazole (flushing, tachycardia, nausea). | Major |
| Lithium | Tinidazole may increase lithium levels and risk of toxicity. | Moderate |
| Cyclosporine, Tacrolimus | Fluconazole increases calcineurin inhibitor levels, causing nephrotoxicity. | Major |
| Statins (especially Simvastatin, Atorvastatin) | Fluconazole increases statin levels, raising risk of myopathy/rhabdomyolysis. | Major |
| Oral Contraceptives | Potential for decreased efficacy; advise alternative barrier method. | Moderate |
| Cisapride, Terfenadine, Astemizole | Fluconazole inhibits metabolism, leading to QTc prolongation and torsades de pointes (CONTRAINDICATED). | Major |
Same composition (Fluconazole (75mg) + Tinidazole (1000mg)), different brands: