{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "tinidazole",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Trichomoniasis: a single 2 g oral dose taken with food.",
        "source": "US FDA label for tinidazole (Tindamax), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tinidazole.json",
        "verbatim": true
      },
      {
        "text": "Treat sexual partners with the same dose and at the same time ( 2.3 ) Giardiasis: Adults: a single 2 g dose taken with food.",
        "source": "US FDA label for tinidazole (Tindamax), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tinidazole.json",
        "verbatim": true
      },
      {
        "text": "Pediatric patients older than three years of age: a single dose of 50 mg/kg (up to 2 g) with food ( 2.4 ) Amebiasis, Intestinal: Adults: 2 g per day for 3 days with food.",
        "source": "US FDA label for tinidazole (Tindamax), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tinidazole.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Other than for use in the treatment of giardiasis and amebiasis in pediatric patients older than three years of age, safety and effectiveness of tinidazole in pediatric patients have not been established. Pediatric Administration: For those unable to swallow tablets, tinidazole tablets may be crushed in artificial cherry syrup, to be taken with food [see Dosage and Administration ( 2.2 )].",
        "source": "US FDA label for tinidazole (Tindamax), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/tinidazole.json",
        "verbatim": true
      },
      {
        "text": "Trichomoniasis: a single 2 g oral dose taken with food. Treat sexual partners with the same dose and at the same time ( 2.3 ) Giardiasis: Adults: a single 2 g dose taken with food. Pediatric patients older than three years of age: a single dose of 50 mg/kg (up to 2 g) with food ( 2.4 ) Amebiasis, Intestinal: Adults: 2 g per day for 3 days with food.",
        "source": "US FDA label for tinidazole (Tindamax), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tinidazole.json",
        "verbatim": true
      },
      {
        "text": "Pediatric patients older than three years of age: a single dose of 50 mg/kg (up to 2 g) with food ( 2.4 ) Amebiasis, Intestinal: Adults: 2 g per day for 3 days with food.",
        "source": "US FDA label for tinidazole (Tindamax), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tinidazole.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 8.6 Renal Impairment Because the pharmacokinetics of tinidazole in patients with severe renal impairment (CrCL < 22 mL/min) are not significantly different from those in healthy subjects, no dose adjustments are necessary in these patients.",
        "source": "US FDA label for tinidazole (Tindamax), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/tinidazole.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Patients undergoing hemodialysis: If tinidazole is administered on the same day as and prior to hemodialysis, it is recommended that an additional dose of tinidazole equivalent to one-half of the recommended dose be administered after the end of the hemodialysis [see Clinical Pharmacology ( 12.3 )]. 8.7 Hepatic Impairment There are no data on tinidazole pharmacokinetics in patients with impaired hepatic function.",
        "source": "US FDA label for tinidazole (Tindamax), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/tinidazole.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Teratogenic effects: Pregnancy Category C The use of tinidazole in pregnant patients has not been studied.",
        "source": "US FDA label for tinidazole (Tindamax), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/tinidazole.json",
        "verbatim": true
      },
      {
        "text": "Since tinidazole crosses the placental barrier and enters fetal circulation it should not be administered to pregnant patients in the first trimester.",
        "source": "US FDA label for tinidazole (Tindamax), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/tinidazole.json",
        "verbatim": true
      },
      {
        "text": "Embryo-fetal developmental toxicity studies in pregnant mice indicated no embryo-fetal toxicity or malformations at the highest dose level of 2,500 mg/kg (approximately 6.3-fold the highest human therapeutic dose based upon body surface area conversions).",
        "source": "US FDA label for tinidazole (Tindamax), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/tinidazole.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Tinidazole is excreted in breast milk in concentrations similar to those seen in serum.",
        "source": "US FDA label for tinidazole (Tindamax), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/tinidazole.json",
        "verbatim": true
      },
      {
        "text": "Tinidazole can be detected in breast milk for up to 72 hours following administration.",
        "source": "US FDA label for tinidazole (Tindamax), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/tinidazole.json",
        "verbatim": true
      },
      {
        "text": "Interruption of breast-feeding is recommended during tinidazole therapy and for 3 days following the last dose.",
        "source": "US FDA label for tinidazole (Tindamax), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/tinidazole.json",
        "verbatim": true
      }
    ]
  }
}