Itraconazole

Oral itraconazole: Dose is indication specific. See Summary of Product Characteristics or BNF for dosing information.

Intravenous itraconazole: 

Renal impairment

• Oral: No dose adjustment required but carry out therapeutic drug monitoring.
  • The oral bioavailability of itraconazole may be reduced in patients with renal insufficiency
• IV:
  • Creatinine clearance of 30ml/min or more: No adjustment required. Monitor U&Es regularly.
  • Creatinine clearance less than 30ml/min: AVOID. Use is contra-indicated by manufacturer.
    • This is because Hydroxypropyl-β-cyclodextrin, an excipient of the itraconazole intravenous formulation, is eliminated through glomerular filtration.
    • Consider changing to oral itraconazole or alternative antifungal. Discuss with Micro/ID.

Hepatic impairment

• Use with caution. Closely monitor liver function and monitor for side effects.
• Carry out therapeutic drug monitoring.

Therapeutic Drug Monitoring is required. See Therapeutic Drug Monitoring (TDM) for Antifungal Agents

Before itraconazole is started see the Summary of Product Characteristics (SPC) for itraconazole for information about interactions, cautions and contraindications.

• Itraconazole is a substrate of CYP3A4, and an inhibitor of CYP3A4 and P-glycoprotein. 
• The co-administration of itraconazole with several medications is contraindicated. See SPC for more information.
• Caution is recommended for the use of itraconazole with several medications. See SPC for more information.

Contraception: Women of childbearing potential MUST use effective contraception during treatment with itraconazole and continue contraception until the menstrual period following the end of itraconazole therapy. 

Pregnancy: Use only in life-threatening situations where the potential benefit to the mother outweighs the potential harm to the foetus.

•  Use of oral and IV itraconazole contraindicated in non-life threatening situations.

Breastfeeding: Discuss with pharmacy.

• Monitor LFTs before itraconazole is started and regularly during use of itraconazole. Rare reports of hepatotoxicity, including in patients without pre-existing liver disease. Advise patient to report signs and symptoms suggestive of hepatitis. Discontinue if signs of hepatitis develop.

• Avoid use in patients with congestive heart failure or with a history of congestive heart failure unless the benefit clearly outweighs the risk.

• Use with caution in patients with known risk factors for congestive heart failure. Clinicians should review the risks and benefits of itraconazole therapy for these patients.

• Transient or permanent hearing loss has been reported in patients receiving treatment with itraconazole. The hearing loss usually resolves when treatment is stopped, but can persist in some patients. 

• The OUH Antifungal Patient Information Leaflet can be found HERE

• Neon Healthcare Ltd. Summary of Product Characteristics. Itraconazole 10mg/ml concentrate and solvent for solution for infusion. [online]. Last revision of the text: 2/2/22. Accessed via: www.emc.medicines.org.uk Accessed 12/5/25

• Janssen-Cilag Ltd. Summary of Product Characteristics. Sporanox 100mg capsules. [online] Last revision of the text: 8/11/23. Accessed via Medicines and Healthcare Products Regulatory Authority Products webpage https://products.mhra.gov.uk/search/?search=itraconazole&page Accessed 12/5/25

• Janssen-Cilag Ltd. Summary of Product Characteristics. Sporanox 10mg/ml oral solution. [online] Last revision of the text:11/12/24. Accessed via Medicines and Healthcare Products Regulatory Authority Products webpage https://products.mhra.gov.uk/search/?search=itraconazole&page Accessed 12/5/25

• The Renal Drug Database. Itraconazole. [online]. Last updated: 11/8/24. Accessed via: https://renaldrugdatabase.com Accessed 12/5/25

• Sanford Guide. Itraconazole [Internet] Last revision of the text: 24/3/25. Accessed 12/5/25

• Sanford Guide. Obesity dosing adjustment [Internet] Last revision of the text: 25/4/25. Accessed 12/5/25