Itraconazole Dosing for Candida Infections
For oropharyngeal candidiasis, itraconazole oral solution 200 mg daily for 7-14 days is the recommended dose, while esophageal candidiasis requires 100 mg daily for a minimum of 3 weeks (up to 200 mg daily based on response). 1
Oropharyngeal Candidiasis
Standard Dosing
- Itraconazole oral solution 200 mg (20 mL) daily for 1-2 weeks is the FDA-approved regimen, with the solution vigorously swished in the mouth (10 mL at a time) for several seconds before swallowing 1
- Clinical signs and symptoms typically resolve within several days of initiating therapy 1
- In pediatric patients, itraconazole cyclodextrin oral solution 5 mg/kg/day provides potentially therapeutic concentrations, though levels are substantially lower than in adults, particularly in children aged 6 months to 2 years 2
- For HIV-infected children, doses of 2.5-5 mg/kg/day have demonstrated efficacy in treating oropharyngeal candidiasis 2
Fluconazole-Refractory Disease
- For patients unresponsive or refractory to fluconazole, itraconazole oral solution 100 mg (10 mL) twice daily is recommended 1
- Clinical response in fluconazole-refractory patients occurs in 2-4 weeks, with approximately 55% achieving complete resolution of oral lesions 1
- This regimen achieves a 55-75% response rate in resistant disease, though fluconazole-resistant isolates have 30% cross-resistance to itraconazole 3
Clinical Trial Evidence
- In randomized controlled trials (n=344,92% HIV-positive), itraconazole oral solution 200 mg/day for 7 or 14 days achieved an 84% clinical response rate, similar to fluconazole tablets 1
- Another trial showed itraconazole oral solution achieved approximately 71% clinical response, comparable to clotrimazole troches 1
- A 14-day course of itraconazole was associated with lower relapse rates than 7-day therapy 1
Esophageal Candidiasis
Standard Dosing
- Itraconazole oral solution 100 mg (10 mL) daily for a minimum of 3 weeks is the FDA-approved dose, with treatment continuing for 2 weeks following resolution of symptoms 1
- Doses up to 200 mg (20 mL) daily may be used based on clinical response 1
- In a double-blind randomized study (n=119,93% HIV-positive), itraconazole oral solution 100 mg/day (escalated to 200 mg/day for non-responders) achieved approximately 86% clinical response, comparable to fluconazole 1
- Only 11% of itraconazole-treated patients required dose escalation to 200 mg, compared to 21% with fluconazole 1
Critical Administration Details
Formulation Matters
- Itraconazole oral solution and capsules should NOT be used interchangeably 1
- Only the oral solution has been demonstrated effective for oral and esophageal candidiasis 1
- The oral solution should be taken without food if possible for optimal absorption 1
- Itraconazole solution has 30% higher absorption than capsule formulation 3
Intravenous Formulation
- IV itraconazole (in hydroxypropyl-β-cyclodextrin) is dosed at 200 mg every 12 hours for 4 doses (2 days), followed by 200 mg daily 2
- This formulation achieves adequate blood levels more rapidly and with less patient-to-patient variability than oral preparations 2
- However, formal studies of IV itraconazole for invasive candidiasis were incomplete at the time of guideline publication 2
Common Pitfalls to Avoid
- Do not use itraconazole capsules for mucosal candidiasis—they have inadequate absorption and are ineffective 3, 1
- Do not assume itraconazole will work for fluconazole-resistant disease—there is 30% cross-resistance, and susceptibility testing is recommended 3
- Patients may relapse shortly after discontinuing therapy, with all responders in one study relapsing within 1 month (median 14 days) when treatment was stopped 1
- Approximately 23% of patients with esophageal candidiasis relapse within 4 weeks after successful treatment 1
- Exercise caution in patients with renal or hepatic impairment, as limited data exist on itraconazole use in these populations 1
- Monitor liver function tests in patients receiving long-term azole therapy (>21 days) 3
Alternative Considerations
- For invasive candidiasis (candidemia), itraconazole is not a first-line agent—amphotericin B or fluconazole are preferred 2
- For prophylaxis in high-risk neutropenic patients, itraconazole solution 2.5 mg/kg every 12 hours during the period of neutropenia is appropriate 2
- In pediatric candidemia, itraconazole approximately 10 mg/kg orally achieved an 81% cure rate, comparable to fluconazole's 82%, with similar mortality rates (9.5% vs 13.6%) 4