Secnidazole

DRUG INFORMATION

  ADULT
    - Bacterial Vaginosis (female patients 12 years of age and older): Administer a
      single 2-gram packet of granules once orally, without regard to the timing of
      meals. ( 2.1 ) Trichomoniasis (patients 12 years of age and older): Administer a
      single 2-gram packet of granules once orally, without regard to the timing of
      meals. Treat sexual partners with the same dose and at the same time.
      Source: US FDA label for secnidazole (Solosec), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of SOLOSEC for the treatment of bacterial vaginosis
      have been established in pediatric patients aged 12 to 17 years old. Use of
      SOLOSEC in this age group is supported by evidence from a multicenter, open-label
      safety study in 40 pediatric female patients with bacterial vaginosis [see Adverse
      Reactions (6.1) ] and evidence from adequate and well-controlled studies in adult
      women [see Clinical Studies (14.1) ] .
      Source: US FDA label for secnidazole (Solosec), section 'pediatric use', retrieved
      2026-08-29
    - Bacterial Vaginosis (female patients 12 years of age and older): Administer a
      single 2-gram packet of granules once orally, without regard to the timing of
      meals. ( 2.1 ) Trichomoniasis (patients 12 years of age and older): Administer a
      single 2-gram packet of granules once orally, without regard to the timing of
      meals. Treat sexual partners with the same dose and at the same time.
      Source: US FDA label for secnidazole (Solosec), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for secnidazole (Solosec),
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for secnidazole (Solosec),
      retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Limited available data with SOLOSEC use in pregnant women are
      insufficient to inform a drug associated risk of adverse developmental outcomes .
      Source: US FDA label for secnidazole (Solosec), section 'pregnancy', retrieved
      2026-08-29
    - In animal reproduction studies, there were no adverse developmental outcomes when
      secnidazole was administered orally to pregnant rats and rabbits during
      organogenesis at doses up to 4 times the clinical dose (see Data ).
      Source: US FDA label for secnidazole (Solosec), section 'pregnancy', retrieved
      2026-08-29
    - The estimated background risk of major birth defects and miscarriage for the
      indicated population is unknown.
      Source: US FDA label for secnidazole (Solosec), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Lactation: Breastfeeding is not recommended.
      Source: US FDA label for secnidazole (Solosec), section 'use in specific
      populations', retrieved 2026-08-29
    - In a peri- and post-natal development study in rats, secnidazole was administered
      at 30, 100 and 300 mg/kg/day from Day 6 of gestation through Day 20 of lactation.
      Source: US FDA label for secnidazole (Solosec), section 'use in specific
      populations', retrieved 2026-08-29
    - Secnidazole was not associated with any adverse effects on gestation, parturition,
      lactation or on subsequent development of first generation (F1) and second
      generation (F2) offspring at these doses, equivalent to up to 1.4 times the
      clinical dose based on AUC comparisons.
      Source: US FDA label for secnidazole (Solosec), section 'use in specific
      populations', retrieved 2026-08-29