{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "fluconazole",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Oropharyngeal candidiasis: The recommended dosage of fluconazole for oropharyngeal candidiasis is 200 mg on the first day, followed by 100 mg once daily.",
        "source": "US FDA label for fluconazole (Fluconazole), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fluconazole.json",
        "verbatim": true
      },
      {
        "text": "Esophageal candidiasis: The recommended dosage of fluconazole for esophageal candidiasis is 200 mg on the first day, followed by 100 mg once daily.",
        "source": "US FDA label for fluconazole (Fluconazole), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fluconazole.json",
        "verbatim": true
      },
      {
        "text": "Doses up to 400 mg/day may be used, based on medical judgment of the patient's response to therapy.",
        "source": "US FDA label for fluconazole (Fluconazole), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fluconazole.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Use in Pediatric Patients for the Treatment of Oropharyngeal Candidiasis An open-label, randomized, controlled trial has shown fluconazole to be effective in the treatment of oropharyngeal candidiasis in pediatric patients 6 months to 13 years of age.",
        "source": "US FDA label for fluconazole (Fluconazole), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/fluconazole.json",
        "verbatim": true
      },
      {
        "text": "Dosage and Administration in Adults Multiple Dose SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL AND INTRAVENOUS ADMINISTRATION. In general, a loading dose of twice the daily dose is recommended on the first day of therapy to result in plasma concentrations close to steady-state by the second day of therapy.",
        "source": "US FDA label for fluconazole (Fluconazole), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fluconazole.json",
        "verbatim": true
      },
      {
        "text": "The safety profile of fluconazole in children has been studied in 577 pediatric patients from 1 day to 17 years of age who received doses ranging from 1 to 15 mg/kg/day for 1 to 1,616 days.",
        "source": "US FDA label for fluconazole (Fluconazole), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/fluconazole.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "After the loading dose, the daily dose (according to indication) should be based on the following summary: Creatinine Clearance (mL/min) Recommended Dose (%) >50 100 ≤50 (no dialysis) 50 Hemodialysis 100% after each hemodialysis Patients on hemodialysis should receive 100% of the recommended dose after each hemodialysis; on non-dialysis days, patients should receive a reduced dose according to their creatinine clearance.",
        "source": "US FDA label for fluconazole (Fluconazole), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fluconazole.json",
        "verbatim": true
      },
      {
        "text": "The following formula may be used to estimate creatinine clearance in pediatric patients: K × linear length or height (cm) serum creatinine (mg/100 mL) (Where K=0.55 for pediatric patients older than 1 year and 0.45 for infants.) Administration Fluconazole in Sodium Chloride Injection, USP may be administered by intravenous infusion.",
        "source": "US FDA label for fluconazole (Fluconazole), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fluconazole.json",
        "verbatim": true
      }
    ],
    "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 fluconazole (Fluconazole), retrieved 2026-08-29",
        "cached_file": "labels/fluconazole.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Potential for Fetal Harm: Use in pregnancy should be avoided except in patients with severe or potentially life-threatening fungal infections in whom fluconazole may be used if the anticipated benefit outweighs the possible risk to the fetus.",
        "source": "US FDA label for fluconazole (Fluconazole), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/fluconazole.json",
        "verbatim": true
      },
      {
        "text": "A few published case reports describe a pattern of distinct congenital anomalies in infants exposed in utero to high dose maternal fluconazole (400 to 800 mg/day) during most or all of the first trimester.",
        "source": "US FDA label for fluconazole (Fluconazole), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/fluconazole.json",
        "verbatim": true
      },
      {
        "text": "These reported anomalies are similar to those seen in animal studies.",
        "source": "US FDA label for fluconazole (Fluconazole), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/fluconazole.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Fluconazole was present in low levels in breast milk following administration of a single 150 mg dose, based on data from a study in 10 breastfeeding women who temporarily or permanently discontinued breastfeeding 5 days to 19 months postpartum.",
        "source": "US FDA label for fluconazole (Fluconazole), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/fluconazole.json",
        "verbatim": true
      },
      {
        "text": "The estimated daily infant dose of fluconazole from breast milk (assuming mean milk consumption of 150 mL/kg/day) based on the mean peak milk concentration (2.61 mcg/mL [range: 1.57 to 3.65 mcg/mL] at 5.2 hours post-dose) was 0.39 mg/kg/day, which is approximately 13% of the recommended pediatric dose for oropharyngeal candidiasis.",
        "source": "US FDA label for fluconazole (Fluconazole), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/fluconazole.json",
        "verbatim": true
      },
      {
        "text": "(Labeled pediatric dose is 6 mg/kg/day on the first day followed by 3 mg/kg/day; estimated infant dose is 13% of 3 mg/kg/day maintenance dose).",
        "source": "US FDA label for fluconazole (Fluconazole), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/fluconazole.json",
        "verbatim": true
      }
    ]
  }
}