A fixed-dose combination (FDC) therapy designed for the empirical treatment of mixed vaginal infections, primarily targeting bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and trichomoniasis. It combines a triazole antifungal (Fluconazole), a macrolide antibiotic (Azithromycin), and a nitroimidazole antiprotozoal/antibacterial (Secnidazole) to provide broad-spectrum coverage against common vaginal pathogens. This FDC is intended as a single-dose or short-course therapy to improve patient compliance. Its use is controversial and subject to regulatory scrutiny in India due to concerns about antibiotic overuse and the promotion of antimicrobial resistance (AMR).
Adult: A single oral dose of one sachet/kit containing Fluconazole 150mg + Azithromycin 1g + Secnidazole 1g, taken as directed. Some brands may recommend a two-dose regimen (e.g., one dose on Day 1 and Day 3). MUST be taken under medical supervision.
Note: Take orally with a full glass of water. Azithromycin absorption is reduced by food; take on an empty stomach (at least 1 hour before or 2 hours after a meal) for optimal absorption. The entire sachet/kit contents should be taken at once. Do not crush or chew the tablets/capsules.
This combination exerts a synergistic or additive effect against a polymicrobial vaginal infection. Fluconazole inhibits fungal ergosterol synthesis, damaging the cell membrane of Candida species. Azithromycin binds to the 50S ribosomal subunit of susceptible bacteria (e.g., Gardnerella vaginalis, Chlamydia trachomatis), inhibiting protein synthesis. Secnidazole undergoes intracellular reduction of its nitro group, generating cytotoxic radicals that damage DNA and disrupt cellular processes of anaerobic bacteria (e.g., BV-associated anaerobes) and protozoa (Trichomonas vaginalis).
Pregnancy: Pregnancy Category C (US FDA) for Fluconazole (high-dose is Category D). Azithromycin is Category B. Secnidazole is Category C (contraindicated in first trimester). This combination is GENERALLY NOT RECOMMENDED during pregnancy, especially the first trimester. Use only if potential benefit justifies potential fetal risk, and for a clear, confirmed indication. Single-dose Fluconazole 150mg is considered low risk for topical effect, but systemic combination therapy requires extreme caution.
Driving: May cause dizziness, vertigo, or seizures. Patients should be cautioned about operating machinery or driving until they are sure they are not affected.
| Warfarin/Acenoocumarol | 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 |
| Cyclosporine, Tacrolimus | Fluconazole increases calcineurin inhibitor levels, risk of nephrotoxicity. | Major |
| Rifampicin | Reduces Fluconazole levels significantly. | Major |
| Drugs prolonging QT interval (e.g., Amiodarone, Sotalol, Fluoroquinolones, Antipsychotics) | Additive risk of QT prolongation and arrhythmias with Azithromycin. | Major |
| Digoxin | Azithromycin may increase digoxin levels (by affecting gut flora). | Moderate |
| Ergot alkaloids (Ergotamine) | Risk of ergotism with Azithromycin (CYP3A4 inhibition). | Major |
| Disulfiram | Concurrent use with Secnidazole can cause psychotic reactions (disulfiram-like reaction). | Major |
| Alcohol | Secnidazole can cause disulfiram-like reaction (flushing, nausea, vomiting, tachycardia). | Major |
| Lithium | Azithromycin may increase lithium levels. | Moderate |
| Colchicine | Azithromycin may increase colchicine levels, risk of toxicity (especially in renal impairment). | Major |
Same composition (Fluconazole (150mg) + Azithromycin (1gm) + Secnidazole (1gm)), different brands: