Following a systematic review of available data, therapeutic use is now restricted to patients resistant to, or intolerant of, other effective antifungal therapies.
The following indications have been removed from the Summary of Product Characteristics (SPC):
- chronic, recurrent vaginal candidosis
- systemic fungal infections
- prophylaxis of mycotic infections in patients with reduced immune responses
- systemic candidosis
- culturally determined dermatophyte infections of fingernails
- oesophageal candidosis
- treatment of paracoccidioidomycosis, histoplasmosis, coccidioidmycosis and blastomycosis.
The updated SPC also includes new warnings about the duration of treatment (thought to be the main risk factor for serious hepatotoxicity), monitoring requirements for hepatic function (before and during treatment), the addition of drugs that are contraindicated for use with ketoconazole and new post-marketing adverse effects
Further information: MHRA