This is a fixed-dose combination (FDC) tablet primarily indicated for the treatment of mixed vaginal infections, specifically those involving fungal (Candida albicans), bacterial (Gardnerella vaginalis, other anaerobes), and protozoal (Trichomonas vaginalis) pathogens. The combination provides broad-spectrum coverage against common causative agents of vaginitis and cervicitis. The rationale is to treat polymicrobial infections simultaneously, improving patient compliance and reducing the risk of treatment failure. The 'NA' for Azithromycin in the composition name is a common but misleading notation in some Indian FDCs; it typically implies a standard dose of 500mg or 1g, but the exact quantity must be verified from the specific brand's packaging.
Adult: Typically administered as a single-dose therapy or a short course. Common regimen: ONE tablet (containing Fluconazole 100mg, Azithromycin 500mg or 1g, Secnidazole 200mg) as a single dose. Some brands may recommend a 2-3 day course. The exact dosage MUST be followed as per the specific brand's prescribing information.
Note: Take orally, with or without food. However, taking Azithromycin on an empty stomach (1 hour before or 2 hours after food) improves absorption. To minimize GI upset, it can be taken with food. Swallow whole with a full glass of water. Do not crush or chew.
This combination exerts a synergistic antimicrobial effect on the polymicrobial ecosystem often responsible for vaginal infections. Fluconazole inhibits fungal ergosterol synthesis, Azithromycin inhibits bacterial protein synthesis, and Secnidazole causes cytotoxic damage to anaerobic bacteria and protozoa's DNA.
Pregnancy: Pregnancy Category C (US FDA). Fluconazole: High doses are teratogenic; single low dose (150mg) risk is uncertain. Azithromycin: Category B, considered relatively safe. Secnidazole: Category C, contraindicated in first trimester, use with caution later. This FDC is GENERALLY NOT RECOMMENDED during pregnancy, especially the first trimester. Use only if potential benefit justifies potential fetal risk, and after confirming a mixed infection.
Driving: May cause dizziness, vertigo, or seizures. Patients should be cautioned about driving or operating machinery if they experience these effects.
| Warfarin, Acenocoumarol | Fluconazole inhibits metabolism, increasing anticoagulant effect and risk of bleeding. Monitor INR closely. | Major |
| Sulfonylureas (Glibenclamide, Glimepiride) | Fluconazole increases sulfonylurea levels, causing hypoglycemia. | Major |
| Phenytoin | Fluconazole increases Phenytoin levels. Phenytoin may decrease Fluconazole levels. Monitor Phenytoin levels. | Major |
| Cyclosporine, Tacrolimus, Sirolimus | Fluconazole increases calcineurin inhibitor levels, increasing risk of nephrotoxicity and neurotoxicity. | Major |
| Theophylline | Azithromycin may increase Theophylline levels (less risk than with Erythromycin). Monitor Theophylline levels. | Moderate |
| Digoxin | Azithromycin may increase Digoxin absorption in some patients, leading to toxicity. Monitor Digoxin levels. | Moderate |
| Antacids (Aluminium, Magnesium) | Reduce Azithromycin absorption. Administer Azithromycin at least 1 hour before or 2 hours after antacids. | Moderate |
| Alcohol | Disulfiram-like reaction with Secnidazole (flushing, tachycardia, nausea, vomiting). Avoid alcohol during and for at least 72 hours after treatment. | Major |
| Other QT-prolonging agents (Amiodarone, Sotalol, Fluoroquinolones, Tricyclic Antidepressants) | Additive risk of life-threatening cardiac arrhythmias. Avoid combination. | Major |
Same composition (Fluconazole (100mg) + Azithromycin (NA) + Secnidazole (200mg)), different brands: