Fluconazole

DRUG INFORMATION

  ADULT
    - 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
    - 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
    - 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

  CHILD
    - 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
    - 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
    - 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

  RENAL IMPAIRMENT
    - 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
    - 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

  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 fluconazole (Fluconazole),
      retrieved 2026-08-29

  PREGNANCY
    - 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
    - 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
    - These reported anomalies are similar to those seen in animal studies.
      Source: US FDA label for fluconazole (Fluconazole), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - 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
    - 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
    - (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