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secnidazole (Solosec)
Indications:
- treatment of bacterial vaginosis (FDA-approved Sept 2017)
Contraindications:
- breast feeding (wait at least 96 hours)
Dosage:
- 2 g oral packet, single dose
- sprinkle the granules on applesauce, yogurt, or pudding
- eat the mixture within 30 minutes without chewing or crunching the granules
Adverse effects:
- headache, dysgeusia, nausea, vomiting, diarrhea
- vulvovaginal candidiasis (may require antifungal treatment)
- potential risk for carcinogenicity
Mechanism of action:
- enters the bacterial cell as an inactive prodrug, where the nitro group is reduced by bacterial enzymes to radical anions that interfere with bacterial DNA synthesis
General
nitroimidazole
antibacterial agent
Database Correlations
PUBCHEM correlations
References
- Lowes R
FDA Approves Secnidazole (Solosec) for Bacterial Vaginosis
Medscape - Sep 18, 2017.
http://www.medscape.com/viewarticle/885860
- Windle ML.
FDA New Drug and Biologic Approvals -- 2017 Year-in-Review
Medscape - Jan 11, 2018.
https://reference.medscape.com/viewarticle/890871
- U.S. Food and Drug Administration.
Novel Drug Approvals for 2017.
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
- Schwebke JR, Morgan FG Jr, Koltun W, Nyirjesy P.
A phase-3, double-blind, placebo-controlled study of the
effectiveness and safety of single oral doses of secnidazole
2 g for the treatment of women with bacterial vaginosis.
Am J Obstet Gynecol. 2017 Dec;217(6):678.e1-678.e9. Epub 2017 Sep 1.
PMID: 28867602
- Bohbot JM, Vicaut E, Fagnen D, Brauman M.
Treatment of bacterial vaginosis: a multicenter, double-blind,
double-dummy, randomised phase III study comparing secnidazole
and metronidazole.
Infect Dis Obstet Gynecol. 2010;2010. pii: 705692. Epub 2010 Sep 15.
PMID: 20885970 Free PMC Article
- Highlights of Prescribing Information. Solsec.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209363s000lbl.pdf