SOLOSEC
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SOLOSEC (SOLOSEC).
Secnidazole is a nitroimidazole antibiotic that exerts its bactericidal activity by entering the bacterial cell and inhibiting DNA synthesis. The nitro group of secnidazole is reduced intracellularly to form free radicals and other reactive intermediates that damage bacterial DNA.
| Metabolism | Secnidazole is predominantly metabolized in the liver via oxidation, primarily by CYP3A4 enzymes, with minor contributions from CYP2C9 and CYP2C19. |
| Excretion | Renal: approximately 75% as unchanged drug; fecal/biliary: minor (estimated <10%) |
| Half-life | Terminal elimination half-life approximately 8-12 hours in patients with normal renal function; may be prolonged in renal impairment |
| Protein binding | Approximately 15-30% bound to plasma proteins (primarily albumin) |
| Volume of Distribution | Approximately 1.0-1.5 L/kg, indicating extensive tissue distribution |
| Bioavailability | Oral: nearly complete (approximately 80-100%) |
| Onset of Action | Oral: clinical effect (e.g., relief of trichomoniasis symptoms) typically within 24-48 hours |
| Duration of Action | Sufficient for single-dose therapy; clinical cure achieved with a single 2 g oral dose for trichomoniasis |
2 g orally as a single dose for trichomoniasis.
| Dosage form | GRANULE |
| Renal impairment | No dosage adjustment required for GFR ≥30 mL/min. For GFR <30 mL/min, administer 1 g as a single dose; not recommended for patients on hemodialysis. |
| Liver impairment | No dosage adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). For severe hepatic impairment (Child-Pugh C), use is not recommended due to lack of data. |
| Pediatric use | Safety and efficacy in pediatric patients have not been established; use is not recommended. |
| Geriatric use | No specific dosage adjustment required; use with caution due to potential age-related renal impairment and comorbidities. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SOLOSEC (SOLOSEC).
| Breastfeeding | Excreted in human milk; unknown M/P ratio. Caution advised due to potential adverse reactions in breastfed infants. Decision to discontinue nursing or drug based on importance to mother. |
| Teratogenic Risk | Pregnancy Category B. No evidence of teratogenicity in animal studies. Insufficient human data in first trimester; use only if clearly needed. Risk cannot be ruled out in second and third trimesters. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA black box warnings.
| Serious Effects |
["Hypersensitivity to secnidazole or any other nitroimidazole derivative.","Severe hepatic impairment (Child-Pugh Class C)"]
| Precautions | ["Carcinogenicity: Nitroimidazoles have been associated with carcinogenicity in animal studies; use only when indicated.","Fungal overgrowth: May cause overgrowth of non-susceptible organisms, particularly Candida.","Neurologic effects: Caution in patients with history of peripheral neuropathy or CNS disorders; discontinue if neurologic symptoms develop.","Hepatic impairment: Use with caution in patients with hepatic impairment; no dose adjustment recommended for mild/moderate impairment, but avoid in severe impairment.","Alcohol interaction: Avoid alcohol during therapy and for at least 2 days after completion due to disulfiram-like reaction."] |
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| No specific monitoring required. Standard prenatal care. Monitor for maternal adverse effects such as nausea, headache, and dizziness. |
| Fertility Effects | No known adverse effects on fertility in animal studies. Human data not available. |