Drug updated on 9/4/2024
Dosage Form | granules (oral; 2 g/packet) |
Drug Class | Nitroimidazole antimicrobials |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older.
- Indicated for the treatment of trichomoniasis in patients 12 years of age and older.
Latest News
Summary
- Solosec (secnidazole) is indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older and for the treatment of trichomoniasis in patients 12 years of age and older.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Secnidazole (2g) vs. Placebo: Secnidazole demonstrated a significantly higher clinical cure rate compared to placebo, with an odds ratio (OR) of 7.54 (95% CI, 3.89-14.60; p < 0.00001) for patients with three or fewer BV episodes and OR of 4.74 (95% CI: 1.51-14.84; p = 0.008) for those with four or more episodes.
- Secnidazole (2g) vs. 1g and vs. Metronidazole: Secnidazole (2g) had a significantly higher clinical cure rate compared to 1g. No significant difference was observed between 2g secnidazole and metronidazole (500 mg bid for 5 days).
- Secnidazole vs. Ornidazole: Ornidazole was superior to secnidazole in clinical cure at the 4th week post-treatment, with a relative risk (RR) of 0.81 (95% CI [0.73-0.89], p < 0.0001).
- The reviewed studies mention adverse events as secondary outcomes but do not provide specific details on the nature or frequency of these events.
- There is no specific comparative safety data provided between secnidazole and other drugs like metronidazole or ornidazole.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Solosec (secnidazole) Prescribing Information. | 2022 | Lupin Pharmaceuticals Inc., Baltimore, MD |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Secnidazole for treatment of bacterial vaginosis: a systematic review. | 2019 | BMC Womens Health |
Efficacy and safety of single dose of oral secnidazole 2 g in treatment of bacterial vaginosis: a systematic review and meta-analysis. | 2019 | European Journal of Obstetrics & Gynecology and Reproductive Biology |