# Itraconazole ```text 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 ``` --- Dawaa Reference is a reference for prescribers, not a medical device, and does not replace clinical judgement. [Privacy policy](/privacy)