Itraconazole

DRUG INFORMATION

  ADULT
    - Table 1: Dosage and Administration of TOLSURA Indications Daily Dosing Treatment
      of Blastomycosis and Histoplasmosis Recommended dose 130 mg (2 × 65 mg capsules)
      once daily If no obvious improvement, or there is evidence of progressive fungal
      disease, the dose should be increased in 65 mg increments to a maximum of 260
      mg/day (130 mg (2 × 65 mg capsules) twice daily).
      Source: This line points to a numbered table that this card does not show - read
      that table in the label before you dose. US FDA label for itraconazole (Tolsura),
      section 'dosage and administration', retrieved 2026-08-29
    - Doses above 130 mg/day should be given in two divided doses.
      Source: US FDA label for itraconazole (Tolsura), section 'dosage and
      administration', retrieved 2026-08-29
    - Treatment of Aspergillosis Recommended dose 130 mg (2 × 65 mg capsules) once daily
      260 mg/day (130 mg (2 × 65 mg capsules) twice daily) Treatment in Life-Threatening
      Situations Although clinical studies did not provide for a loading dose, it is
      recommended, based on pharmacokinetic data, that a loading dose should be used.
      Source: US FDA label for itraconazole (Tolsura), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness in pediatric patients have not been established. The
      long-term effects of itraconazole on bone growth in children are unknown. Bone
      lesions were observed in the young adult rats dosed with oral itraconazole for 3
      to 12 months [see Nonclinical Toxicology (13.2) ] .
      Source: US FDA label for itraconazole (Tolsura), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Several of these reports included concurrent administration of quinidine which is
      contraindicated [see Boxed Warning , Contraindications (4.1) and Drug Interactions
      (7.1) ] . 8.6 Renal Impairment Limited data are available on the use of oral
      itraconazole in patients with renal impairment.
      Source: US FDA label for itraconazole (Tolsura), section 'use in specific
      populations', retrieved 2026-08-29
    - It is recommended that patients with renal impairment be carefully monitored when
      taking TOLSURA [see Clinical Pharmacology (12) and Warnings and Precautions (5.1)
      ] . 8.7 Hepatic Impairment Limited data are available on the use of oral
      itraconazole in patients with hepatic impairment.
      Source: US FDA label for itraconazole (Tolsura), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - It is recommended that patients with renal impairment be carefully monitored when
      taking TOLSURA [see Clinical Pharmacology (12) and Warnings and Precautions (5.1)
      ] . 8.7 Hepatic Impairment Limited data are available on the use of oral
      itraconazole in patients with hepatic impairment.
      Source: US FDA label for itraconazole (Tolsura), section 'use in specific
      populations', retrieved 2026-08-29
    - In patients with elevated or abnormal liver enzymes or active liver disease, or
      who have experienced liver toxicity with other drugs, treatment with TOLSURA is
      strongly discouraged unless there is a serious or life-threatening situation where
      the expected benefit exceeds the risk.
      Source: US FDA label for itraconazole (Tolsura), section 'use in specific
      populations', retrieved 2026-08-29
    - Hepatotoxicity : Serious hepatotoxicity, including liver failure and death were
      reported with the use of itraconazole.
      Source: US FDA label for itraconazole (Tolsura), section 'warnings and cautions',
      retrieved 2026-08-29

  PREGNANCY
    - Risk Summary There are no data on exposure to itraconazole during pregnancy for
      the approved indications.
      Source: US FDA label for itraconazole (Tolsura), section 'pregnancy', retrieved
      2026-08-29
    - Published epidemiologic studies of women exposed to short courses of treatment
      with itraconazole in the first trimester of pregnancy have reported no risk of
      major birth defects overall and inconclusive findings on the risk of miscarriage
      (see Data ) .
      Source: US FDA label for itraconazole (Tolsura), section 'pregnancy', retrieved
      2026-08-29
    - In animal reproduction studies, itraconazole was found to cause a dose-related
      increase in maternal toxicity, embryotoxicity, and teratogenicity in rats at
      dosage levels of approximately (6-25 times the maximum recommended human dose
      [MRHD] of 390 mg/day based on mg/kg comparisons), and in mice at dosage levels of
      approximately 80 mg/kg/day (12 times the MRHD).
      Source: US FDA label for itraconazole (Tolsura), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - In rats, the teratogenicity consisted of major skeletal defects; in mice, it
      consisted of encephaloceles and/or macroglossia. 8.2 Lactation Risk Summary
      Itraconazole is excreted in human milk; however, there are no data on the amount
      of itraconazole in human milk, the effects on the breastfed child, or the effects
      on milk production.
      Source: US FDA label for itraconazole (Tolsura), section 'use in specific
      populations', retrieved 2026-08-29
    - The developmental and health benefits of breastfeeding should be considered along
      with the mother's clinical need for TOLSURA and any potential adverse effects on
      the breastfed child from TOLSURA or from the underlying maternal condition. 8.4
      Pediatric Use Safety and effectiveness in pediatric patients have not been
      established.
      Source: US FDA label for itraconazole (Tolsura), section 'use in specific
      populations', retrieved 2026-08-29