Ketoconazole(kee toe koe’ na zole)
Apo-Ketoconazole (CAN), Extina, Ketoderm (CAN), Nizoral A-D, Novo-Ketoconazole (CAN), Xolegel, Xolegel Core Pack, Xolegel Duo Convenience Pack
PREGNANCY CATEGORY C
Drug class
Antifungal (imidazole)
Therapeutic Actions
Impairs the synthesis of ergosterol, the main sterol of fungal cell membranes, allowing increased permeability and leakage of cellular components and causing cell death.
Indications
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)
Topical treatment of seborrheic dermatitis in patients older than 12 yr
Cream, gel: Tinea corporis (ringworm), tinea cruris (jock itch), and tinea pedis (athlete’s foot), cutaneous candidiasis
Shampoo: Reduction of scaling due to dandruff
Orphan drug use: With cyclosporine to diminish cyclosporine-induced nephrotoxicity in organ transplant
Unlabeled uses: Treatment of onychomycosis, pityriasis versicolor, vaginal candidiasis, tinea pedis, tinea corporis, tinea cruris, tinea capitis; CNS fungal infections at high doses (800–1,200 mg/day); advanced prostate cancer at doses of 400 mg every 8 hr; Cushing syndrome (800–1,200 mg/day); refractory depression
Contraindications and Cautions
Contraindicated with allergy to ketoconazole; fungal meningitis; administration with terfenadine, astemizole, ergot derivatives, oral triazolam; pregnancy; lactation.
Use cautiously with hepatic failure (increased risk of hepatocellular necrosis).
Available Forms
Tablets—200 mg; shampoo—1% (OTC), 2%; topical gel—2%; cream—2%; topical foam—2%
Dosages
Adults
200 mg PO daily. Up to 400 mg/day in severe infections. Treatment period must be long enough to prevent recurrence, 1 wk–6 mo, depending on infecting organism and site.
Pediatric patients older than 2 yr
3.3–6.6 mg/kg/day PO as a single dose.
Pediatric patients younger than 2 yr
Safety and efficacy not established.
Shampoo
Moisten hair and scalp thoroughly with water; apply sufficient shampoo to produce a lather; leave on hair for 5 min. Shampoo twice a week for 4 wk with at least 3 days between shampooing. Up to 8 wk may be needed.
Topical
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