{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "secnidazole",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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",
        "cached_file": "labels/secnidazole.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/secnidazole.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/secnidazole.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/secnidazole.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/secnidazole.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/secnidazole.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/secnidazole.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/secnidazole.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Lactation: Breastfeeding is not recommended.",
        "source": "US FDA label for secnidazole (Solosec), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/secnidazole.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/secnidazole.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/secnidazole.json",
        "verbatim": true
      }
    ]
  }
}