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Uses

Blastomycosis

Treatment of North American blastomycosis caused by Blastomyces dermatitidis.

Drugs of choice are IV amphotericin B (especially for severe infections and those involving the CNS) or oral itraconazole; fluconazole and ketoconazole are considered alternatives.

Oral ketoconazole usually has been effective when used in immunocompetent individuals with mild to moderate pulmonary or extrapulmonary blastomycosis. Consider that treatment failures have been reported when ketoconazole was used for treatment of cutaneous or pulmonary blastomycosis in individuals who had asymptomatic or subclinical CNS involvement at the time of the initial diagnosis. (See Meningitis and Other CNS Infections under Cautions.)

Candida Infections

Treatment of candidiasis, candiduria, chronic mucocutaneous candidiasis, or oropharyngeal and esophageal candidiasis.

Has been used for treatment of uncomplicated vulvovaginal candidiasis†. Not a drug of choice for initial treatment; single-dose fluconazole is the only oral regimen included in current CDC recommendations for treatment of uncomplicated vulvovaginal candidiasis. Recommended by CDC and others as one of several alternatives for maintenance treatment of recurrent vulvovaginal candidiasis† in women with a history of recurrent infections.

Chromomycosis

Treatment of chromomycosis (chromoblastomycosis) caused by Phialophora. A response may not be attained in those with more extensive disease.

Optimum regimens for chromomycosis have not been identified. Flucytosine may be a drug of choice used alone or in conjunction with another antifungal (e.g., IV amphotericin B, oral itraconazole, oral ketoconazole).

Coccidioidomycosis

Treatment of mild to moderate coccidioidomycosis caused by Coccidioides immitis.

Drugs of choice are IV amphotericin B (especially for severe infections and those in immunocompromised patients including HIV-infected individuals) or oral fluconazole; itraconazole and ketoconazole are considered alternatives.

Dermatophytoses

Treatment of certain dermatophytoses of the skin, scalp, and nails, including tinea capitis (scalp ringworm), tinea corporis (ringworm of the body), tinea cruris (jock itch; groin ringworm), tinea pedis (athlete’s foot, foot ringworm), tinea manuum (hand ringworm), and tinea unguium (onychomycosis; nail ringworm) caused by Epidermophyton, Microsporum, or Trichophyton.

Used for severe recalcitrant cutaneous dermatophyte infections in patients who have not responded to topical therapy or have not responded to or are unable to take other oral antifungals (e.g., griseofulvin).

Tinea corporis and tinea cruris generally can be effectively treated using a topical antifungal; an oral antifungal may be necessary if the disease is extensive, dermatophyte folliculitis is present, the infection does not respond to topical therapy, or the patient is immunocompromised or has a coexisting disease. Tinea capitis and tinea barbae generally are treated using an oral antifungal.

While topical antifungals usually are effective for treatment of uncomplicated tinea manuum and tinea pedis, an oral antifungal usually is necessary for treatment of severe, chronic, or recalcitrant tinea pedis, for treatment of chronic moccasin-type (dry-type) tinea pedis, and for treatment of tinea unguium (onychomycosis).

Histoplasmosis

Treatment of histoplasmosis caused by Histoplasma capsulatum.

Drugs of choice are IV amphotericin B (especially for life-threatening infections including those in HIV-infected individuals) or oral itraconazole; ketoconazole and fluconazole are considered alternatives.

Paracoccidioidomycosis

Treatment of paracoccidioidomycosis (South American blastomycosis) caused by Paracoccidioides brasiliensis.

Drug of choice for initial treatment of severe infections is IV amphotericin B; oral azole antifungals (e.g., ketoconazole, itraconazole) can be used in patients with less severe infections.

Pityriasis (Tinea) Versicolor

Has been effective for treatment of pityriasis (tinea) versicolor†, a superficial infection caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).

Pityriasis (tinea) versicolor generally can be treated topically with an imidazole-derivative azole antifungal (e.g., clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole), an allylamine antifungal (e.g., terbinafine), ciclopirox olamine, or certain other topical therapies (e.g., selenium sulfide 2.5%). An oral antifungal (e.g., itraconazole, ketoconazole) may be indicated, with or without a topical agent, in patients who have extensive or severe infections or who fail to respond to or have frequent relapses with topical therapy.

Acanthamoeba Infections

Has been used in conjunction with a topical anti-infective (e.g., miconazole, neomycin, metronidazole, propamidine isethionate) in the treatment of Acanthamoeba keratitis†. Optimum therapy for Acanthamoeba keratitis remains to be clearly established, but prolonged local and systemic therapy with multiple anti-infectives and often surgical treatment (e.g., penetrating keratoplasty) usually required.

A regimen of oral ketoconazole, rifampin, and co-trimoxazole has been used for treatment of chronic Acanthamoeba meningitis† in several immunocompetent children. (See Meningitis and Other CNS Infections under Cautions.)

Leishmaniasis

Has been used for treatment of cutaneous or mucocutaneous leishmaniasis† caused by various Leishmania spp. (e.g., Leishmania major†, L. mexicana†, L. panamensis†, L. braziliensis†, L. tropica†). Usual drugs of choice are pentavalent antimony compounds (e.g., sodium stibogluconate or meglumine antimonate [drugs not commercially available in the US]). Preferred alternatives or additional drugs of choice are IV amphotericin B (conventional or liposomal formulations) and parenteral pentamidine; other alternatives include oral azole antifungals (e.g., itraconazole, ketoconazole) or topical paromomycin (for cutaneous leishmaniasis when there is a low potential for mucosal spread).

Has been used in a limited number of patients for treatment of antimony-resistant visceral leishmaniasis (kala-azar) caused by L. donovani†, but may be less effective in these infections than in the treatment of cutaneous leishmaniasis. Usual drugs of choice for initial treatment of visceral leishmaniasis are pentavalent antimony compounds, but resistance and treatment failures are becoming increasingly common; IV amphotericin B and pentamidine are considered alternatives.

Prostate Cancer

Because of ketoconazole’s ability to inhibit testicular and adrenal steroid synthesis, the drug has been used in the treatment of advanced prostatic carcinoma†.

Cushing’s Syndrome

Has been used effectively for palliative treatment of Cushing’s syndrome† (hypercortisolism), including adrenocortical hyperfunction associated with adrenal or pituitary adenoma or ectopic corticotropin-secreting tumors.

Has been used in a limited number of geriatric patients ≥75 years of age for treatment of corticotropin-dependent Cushing’s syndrome; may provide an effective alternative in patients who cannot tolerate surgical treatment.

Hirsutism and Precocious Puberty

Has been used with some success in a limited number of patients for treatment of dysfunctional hirsutism†.

Has been used in a limited number of boys for treatment of precocious puberty†.

Hypercalcemia

Has been used with some success for treatment of hypercalcemia in adults with sarcoidosis†. Has reduced serum calcium concentrations in some, but not all, patients with sarcoidosis-associated hypercalcemia; hypercalcemia and increased serum 1,25-dihydroxyvitamin D concentrations may recur when ketoconazole dosage is decreased or the drug discontinued.

Has been effective in a few adolescents for treatment of tuberculosis-associated hypercalcemia†.