Formulary
Itraconazole: Indications, Dosing, Side Effects and Interactions
Itraconazole clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 8 min read
Itraconazole: Indications, Dosing, Side Effects and Interactions
Itraconazole clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Vulvovaginal candidiasis**
- **Adult** (By Mouth): 200 mg twice daily for 1 day.
**Vulvovaginal candidiasis (recurrent)**
- **Adult** (By Mouth): 50-100 mg daily for 6 months.
**Oral or oesophageal candidiasis that has not responded to fluconazole**
- **Adult** (By Mouth Using Oral Solution): 100-200 mg twice daily for 2 weeks, continue for another 2 weeks if no response; the higher dose should not be used for longer than 2 weeks if no signs of improvement.
**Oral or oesophageal candidiasis in HIV-positive or other immunocompromised patients**
- **Adult** (By Mouth Using Oral Solution): 200 mg daily in 1-2 divided doses for 1 week (continue for another week if no response).
**Systemic candidiasis where other antifungal drugs inappropriate or ineffective**
- **Adult** (By Mouth): 100-200 mg once daily.
- **Adult** (By Intravenous Infusion): 200 mg every 12 hours for 2 days, then 200 mg once daily for max. 12 days.
**Systemic candidiasis (invasive or disseminated) where other antifungal drugs inappropriate or ineffective**
- **Adult** (By Mouth): 200 mg twice daily.
**Pityriasis versicolor**
- **Adult** (By Mouth): 200 mg once daily for 7 days.
**Tinea pedis,Tinea manuum**
- **Adult** (By Mouth): 100 mg once daily for 30 days, alternatively 200 mg twice daily for 7 days.
**Tinea corporis,Tinea cruris**
- **Adult** (By Mouth): 100 mg once daily for 15 days, alternatively 200 mg once daily for 7 days.
**Onychomycosis**
- **Adult** (By Mouth): 200 mg once daily for 3 months, alternatively 200 mg twice daily for 7 days, subsequent courses repeated after 21-day intervals; fingernails 2 courses, toenails 3 courses.
**Aspergillosis**
- **Adult** (By Mouth): 200 mg twice daily.
**Systemic aspergillosis where other antifungal drugs inappropriate or ineffective**
- **Adult** (By Intravenous Infusion): 200 mg every 12 hours for 2 days, then 200 mg once daily for max. 12 days.
**Histoplasmosis**
- **Adult** (By Mouth): 200 mg 3 times a day for 3 days, then 200 mg 1-2 times a day.
- **Adult** (By Intravenous Infusion): 200 mg every 12 hours for 2 days, then 200 mg once daily for max. 12 days.
**Systemic cryptococcosis including cryptococcal meningitis where other antifungal drugs inappropriate or ineffective**
- **Adult** (By Mouth): 200 mg once daily, increased to 200 mg twice daily, increased dose used in invasive or disseminated disease and in cryptococcal meningitis.
- **Adult** (By Intravenous Infusion): 200 mg every 12 hours for 2 days, then 200 mg once daily for max. 12 days.
**Maintenance in HIV-infected patients to prevent relapse of underlying fungal infection and prophylaxis in neutropenia when standard therapy inappropriate**
- **Adult** (By Mouth): 200 mg once daily, increased to 200 mg twice daily, increased dose used only if low plasma-itraconazole concentration.
**Prophylaxis of deep fungal infections (when standard therapy inappropriate) in patients with haematological malignancy or undergoing bone-marrow transplantation who are expected to become neutropenic**
- **Adult** (By Mouth Using Oral Solution): 5 mg/kg daily in 2 divided doses, to be started before transplantation or before chemotherapy (taking care to avoid interaction with cytotoxic drugs) and continued until neutrophil count recovers, safety and efficacy not established in elderly patients.
**Oropharyngeal candidiasis for itraconazole**
- **Child 1 month-11 years** (By mouth): 3-5 mg/kg once daily (max. per dose 100 mg) for 15 days.
- **Child 12-17 years** (By mouth): 100 mg once daily for 15 days.
**Oropharyngeal candidiasis in patients with AIDS or neutropenia for itraconazole**
- **Child 1 month-11 years** (By mouth): 3-5 mg/kg once daily (max. per dose 200 mg) for 15 days.
- **Child 12-17 years** (By mouth): 200 mg once daily for 15 days.
**Systemic candidiasis where other antifungal drugs inappropriate or ineffective for itraconazole**
- **Child** (By mouth): 5 mg/kg once daily (max. per dose 200 mg), increased to 5 mg/kg twice daily (max. per dose 200 mg), increased dose used in invasive or disseminated disease.
- **Child** (By intravenous infusion): 2.5 mg/kg every 12 hours (max. per dose 200 mg) for 2 days, then 2.5 mg/kg once daily (max. per dose 200 mg) for max. 12 days.
**Pityriasis versicolor for itraconazole**
- **Child 1 month-11 years** (By mouth): 3-5 mg/kg once daily (max. per dose 200 mg) for 7 days.
- **Child 12-17 years** (By mouth): 200 mg once daily for 7 days.
**Tinea pedis, Tinea manuum for itraconazole**
- **Child 1 month-11 years** (By mouth): 3-5 mg/kg once daily (max. per dose 100 mg) for 30 days.
- **Child 12-17 years** (By mouth): 100 mg once daily for 30 days, alternatively 200 mg twice daily for 7 days.
**Tinea corporis, Tinea cruris for itraconazole**
- **Child 1 month-11 years** (By mouth): 3-5 mg/kg once daily (max. per dose 100 mg) for 15 days.
- **Child 12-17 years** (By mouth): 100 mg once daily for 15 days, alternatively 200 mg once daily for 7 days.
**Tinea capitis for itraconazole**
- **Child 1-17 years** (By mouth): 3-5 mg/kg once daily (max. per dose 200 mg) for 2-6 weeks.
**Onychomycosis for itraconazole**
- **Child 1-11 years** (By mouth): 5 mg/kg daily (max. per dose 200 mg) for 7 days, subsequent courses repeated after 21-day intervals; fingernails 2 courses, toenails 3 courses.
- **Child 12-17 years** (By mouth): 200 mg once daily for 3 months, alternatively 200 mg twice daily for 7 days, subsequent courses repeated after 21-day intervals; fingernails 2 courses, toenails 3 courses.
**Systemic aspergillosis where other antifungal drugs inappropriate or ineffective for itraconazole**
- **Child** (By intravenous infusion): 2.5 mg/kg every 12 hours (max. per dose 200 mg) for 2 days, then 2.5 mg/kg once daily (max. per dose 200 mg) for max. 12 days.
- **Child** (By mouth): 5 mg/kg once daily (max. per dose 200 mg), increased to 5 mg/kg twice daily (max. per dose 200 mg), increased dose used in invasive or disseminated disease.
**Histoplasmosis for itraconazole**
- **Child** (By mouth): 5 mg/kg 1-2 times a day (max. per dose 200 mg).
**Systemic cryptococcosis including cryptococcal meningitis where other antifungal drugs inappropriate or ineffective for itraconazole**
- **Child** (By mouth): 5 mg/kg once daily (max. per dose 200 mg), increased to 5 mg/kg twice daily (max. per dose 200 mg), increased dose used in invasive or disseminated disease and in cryptococcal meningitis.
- **Child** (By intravenous infusion): 2.5 mg/kg every 12 hours (max. per dose 200 mg) for 2 days, then 2.5 mg/kg once daily (max. per dose 200 mg) for max. 12 days.
**Maintenance in HIV-infected patients to prevent relapse of underlying fungal infection and prophylaxis in neutropenia when standard therapy inappropriate for itraconazole**
- **Child** (By mouth): 5 mg/kg once daily (max. per dose 200 mg), increased to 5 mg/kg twice daily (max. per dose 200 mg), increased dose used only if low plasma-itraconazole concentration.
**Prophylaxis of deep fungal infections (when standard therapy inappropriate) in patients with haematological malignancy or undergoing bone-marrow transplantation who are expected to become neutropenic for itraconazole**
- **Child** (By mouth using oral solution): 2.5 mg/kg twice daily, to be started before transplantation or before chemotherapy (taking care to avoid interaction with cytotoxic drugs) and continued until neutrophil count recovers, safety and efficacy not established.
Cautions
Active liver disease; elderly; history of hepatotoxicity with other drugs; susceptibility to congestive heart failure Cautions, further information Susceptibility to congestive heart failure There have been reports of heart failure associated with itraconazole. Those at risk may include patients receiving higher daily doses and longer courses, patients with cardiac disease, patients with chronic lung disease, and patients receiving treatment with calcium channel blockers. Manufacturer advises avoid in patients with ventricular dysfunction, such as history of congestive heart failure, unless the infection is serious.
Contraindications
Acute porphyrias
Side effects
General side-effects: Common or very common Alopecia; constipation; diarrhoea; dyspnoea; gastrointestinal discomfort; headache; heart failure; hepatic disorders; hyperbilirubinaemia; nausea; oedema; pulmonary oedema; skin reactions; vision disorders; vomiting Uncommon Hearing loss; taste altered Rare or very rare Angioedema; hypersensitivity vasculitis; hypertriglyceridaemia; pancreatitis; photosensitivity reaction; severe cutaneous adverse reactions (SCARs) Frequency not known Peripheral neuropathy (discontinue) Specific side-effects: Common or very common With intravenous use Chest pain; confusion; cough; dizziness; drowsiness; electrolyte imbalance; fatigue; gastrointestinal disorder; granulocytopenia; hyperglycaemia; hyperhidrosis; hypersensitivity; hypertension; hypotension; myalgia; pain; renal impairment; tachycardia; tremor; urinary incontinence Uncommon With intravenous use Dysphonia; numbness; thrombocytopenia With oral use Flatulence; increased risk of infection; menstrual disorder Rare or very rare With oral use Erectile dysfunction; leucopenia; sensation abnormal; serum sickness; tinnitus; urinary frequency increased Side-effects, further information Potentially life-threatening hepatotoxicity reported very rarely - discontinue if signs of hepatitis develop.
Interactions
**Other interactions (23):**
- Itraconazole is mainly metabolized through CYP3A4.
- Other substances that either share this metabolic pathway or modify CYP3A4 activity may influence the pharmacokinetics of itraconazole.
- Similarly, itraconazole may modify the pharmacokinetics of other substances that share this metabolic pathway.
- Itraconazole is a strong CYP3A4 inhibitor and a P-glycoprotein inhibitor.
- Drugs that may decrease itraconazole plasma concentrations Co-administration of itraconazole with strong enzyme inducers of CYP3A4 may decrease the exposure of itraconazole and hydroxy-itraconazole...
- Examples include: - Antibacterials: isoniazid, rifabutin (see also under 'Drugs that may have their plasma concentrations increased by itraconazole'), rifampicin.
Pregnancy
Manufacturer advises use only in life-threatening situations (toxicity at high doses in animal studies).
Breast feeding
Small amounts present in milk-may accumulate; manufacturer advises avoid.
Hepatic impairment
Manufacturer advises use only in serious or life-saving situations where potential benefit outweighs risk of hepatotoxicity.
Renal impairment
With oral use: Manufacturer advises caution (risk of congestive heart failure). With intravenous use: Manufacturer advises caution in mild to moderate impairment (risk of congestive heart failure); avoid if creatinine clearance less than 30 mL/minute. See Prescribing in renal impairment . Dose adjustments With oral use: Manufacturer advises dose adjustment may be considered (bioavailability possibly reduced).
Medicinal forms
Solution,Capsule,Suspension,Solution,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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