A comprehensive, single-dose, fixed-dose combination therapy designed for the empirical treatment of mixed vaginal infections, primarily bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC), with a secondary antibacterial and probiotic component. Secnidazole provides long-acting anti-anaerobic and anti-protozoal coverage, Fluconazole treats fungal overgrowth, Azithromycin offers broad-spectrum antibacterial action against atypical and aerobic pathogens, and Lactobacillus spores help restore the normal vaginal flora post-treatment.
Adult: A single oral dose of one kit/sachet containing Secnidazole 1000mg + Fluconazole 150mg + Azithromycin 1000mg + Lactobacillus 60 million spores. Usually taken as a one-time dose. Not for chronic daily use.
Note: Take orally, as a single dose. Can be taken with or without food, but taking Azithromycin on an empty stomach (1 hour before or 2 hours after food) improves absorption. The Lactobacillus spore component is acid-resistant. Swallow whole with a full glass of water. Do not crush or chew.
This combination employs a multi-target approach: Secnidazole's nitro group is reduced by anaerobic bacteria/protozoa, forming cytotoxic compounds that damage DNA. Fluconazole inhibits fungal cytochrome P450 14α-demethylase, depleting ergosterol in the fungal cell membrane. Azithromycin binds to the 50S ribosomal subunit of susceptible bacteria, inhibiting protein synthesis. Lactobacillus spores germinate in the gut/vagina, producing lactic acid and bacteriocins to lower pH and inhibit pathogen growth.
Pregnancy: CONTRANDICATED in the first trimester. Secnidazole is pregnancy category C (risk cannot be ruled out). Fluconazole is category D for high-dose/long-term use (teratogenic); single 150mg dose is category C. Azithromycin is category B (generally considered safe). Overall, this FDC should be avoided during pregnancy, especially the first trimester. Use only if potential benefit justifies potential fetal risk.
Driving: May cause dizziness, vertigo, or confusion. Patients should not drive or operate machinery until they know how the medication affects them.
| Warfarin/Acenoocumarol | Fluconazole and Azithromycin may potentiate anticoagulant effect, increasing INR and bleeding risk. | Major |
| Cyclosporine, Tacrolimus | Fluconazole inhibits CYP3A4, increasing levels of these calcineurin inhibitors, risk of nephrotoxicity. | Major |
| Phenytoin | Fluconazole increases phenytoin levels; phenytoin may decrease Fluconazole levels. Monitor levels. | Major |
| Oral Hypoglycemics (Sulfonylureas) | Fluconazole may increase their levels, causing hypoglycemia. | Moderate |
| Theophylline | Azithromycin may increase theophylline levels (less likely than other macrolides). | Moderate |
| Digoxin | Azithromycin may increase digoxin absorption in some patients, leading to toxicity. | Moderate |
| Antacids (Al, Mg) | Reduce Azithromycin absorption. Administer Azithromycin at least 1 hour before antacids. | Moderate |
| Alcohol | Disulfiram-like reaction with Secnidazole (flushing, tachycardia, nausea). Avoid for at least 72 hours after dose. | Major |
| QT-prolonging drugs (e.g., Amiodarone, Sotalol, Fluoroquinolones) | Additive risk of QT prolongation and arrhythmias with Azithromycin. | Major |
| Rifampin | Decreases Fluconazole levels significantly. | Major |
Same composition (Secnidazole (1000mg) + Fluconazole (150mg) + Azithromycin (1000mg) + Lactobacillus (60millionspores)), different brands: