Ketoconazole

Indications:

• systemic mycosis
• serious chronic resistant mucocutaneous candidiasis
• serious resistant gastrointestinal mycosis
• chronic resistant vaginal candidiasis
• resistant dermatophyte infections of skin or fingernails
• prophylaxis against mycosis in immunosuppressed patients
• pituitary Cushing's disease

Cautions:

• avoid in porphyria
• pregnancy
• beware interactions - See current issue of BNF

Contra-indications:

• hepatic impairment

Side-effects:

• nausea
• pruritus
• rashes
• fatal liver damage - See current issue of BNF
• up to 25% of patients have abnormal liver function tests

Routes of administration:

• oral:
  • tablets
  • suspension
• topical preparations are also available e.g. shampoo

MRHA guidance states:

• Oral ketoconazole should no longer be prescribed or used for fungal infections
• Doctors should review patients who are taking this medicine for a fungal infection, with a view to stopping treatment or choosing an appropriate alternative
• Pharmacists should refer patients with a prescription of oral ketoconazole for treatment of a fungal infection to their treating doctor for a non-urgent appointment to discuss suitable alternative treatments
• Topical ketoconazole formulations (such as creams, ointments, and shampoos) have very low systemic absorption and may continue to be used as currently approved
• Ketoconazole is sometimes used off-label for patients with Cushing's syndrome. Arrangements are being put in place to ensure this group of patients continue to have access to oral ketoconazole

The summary of products characteristics must be consulted before prescribing this drug.

Reference:

• MRHA (August 1st 2013). Oral ketoconazole: do not prescribe or use for fungal infections - risk of liver injury outweighs benefits