Pregnancy Category C
Impairs the synthesis of ergosterol, the main sterol of fungal cell membranes, allowing increased permeability and leakage of cellular components and causing cell death.
- Treatment of systemic fungal infections: candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis
- Treatment of dermatophytosis (recalcitrant infections not responding to topical or griseofulvin therapy)
- Unlabeled uses: treatment of onychomycosis, pityriasis versicolor, vaginal candidiasis; CNS fungal infections at high doses (800-1,200 mg/d); treatment of advanced prostate cancer at doses of 400 mg q8h
- Topical treatment of tinea corporis and tinea cruris caused by
- Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum and the treatment of tinea versicolor caused by Malassezia furfur (topical administration)
- Reduction of scaling due to dandruff (shampoo)
- Orphan drug use: with cyclosporine to diminish cyclosporine-induced nephrotoxicity in organ transplant
- Contraindicated in the presence of allergy to ketoconazole; fungal meningitis; pregnancy; lactation.
- Use caution in the presence of hepatocellular failure (increased risk of hepatocellular necrosis).
- CNS: Headache, dizziness, somnolence, photophobia
- GI: Hepatotoxicity, nausea, vomiting, abdominal pain
- GU: Impotence, oligospermia (with very high doses)
- Hematologic: Thrombocytopenia, leudopenia, hemolytic anemia
- Hypersensitivity: Urticaria to anaphylaxis
- General: Pruritus, fever, chills, gynecomastia
- Local: Severe irritation, pruritus, stinging with topical application
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