SOLOSEC is generally well-tolerated1
  • The adverse event (AE) profile for trichomoniasis was consistent with that seen with the treatment of bacterial vaginosis (BV).1,2
  • There were no serious treatment-emergent AEs.2


Pooled SOLOSEC Safety Results from Clinical Studies
Safety During Pregnancy
SOLOSEC has no pregnancy restrictions.1
  • Available data on pregnancy are limited to animal studies.1
Metronidazole and tinidazole are contraindicated in the first trimester of pregnancy.5,6
References:
1. SOLOSEC [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc; 2021. 2. Muzny CA, Schwebke JR, Nyirjesy P, et al. Efficacy and Safety of Single Oral Dosing of Secnidazole for Trichomoniasis in Women: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Delayed-Treatment Study. Clin Infect Dis 2021. 3. Hillier SL, Nyirjesy P, Waldbaum AS, et al. Secnidazole treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol 2017;130(2):379-386. 4. 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 [published correction appears in Am J Obstet Gynecol 2018;219(1):110]. Am J Obstet Gynecol 2017;217(6):678.e1-678.e9. 5. Flagyl [prescribing information]. New York, NY: Pfizer; 2021. 6. Tinidazole Tablets [prescribing information]. Buffalo Grove, IL: G.D. PACK Pharmaceuticals, LLC; 2018.