secnidazole (Solosec)
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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
More general terms
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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/20885970 Free PMC Article
- ↑ Highlights of Prescribing Information. Solsec. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209363s000lbl.pdf