Ketoconazole Indications and Dosage
- Actinomadura madurae †
- Actinomadura sp. †
- Blastomyces dermatitidis
- blastomycosis
- Candida albicans
- Candida glabrata
- Candida guilliermondii
- Candida kefyr
- Candida krusei
- Candida parapsilosis
- Candida pseudotropicalis
- Candida sp.
- Candida stellatoidea
- Candida tropicalis
- candidiasis
- candidiasis prophylaxis †
- candiduria
- chromomycosis
- Coccidioides immitis
- coccidioidomycosis
- dandruff
- Epidermophyton floccosum
- fungal keratitis †
- fungal prophylaxis
- Histoplasma capsulatum
- histoplasmosis
- Leishmania braziliensis †
- Leishmania major †
- Leishmania mexicana †
- Leishmania panamensis †
- Leishmania tropica †
- leishmaniasis †
- Malassezia furfur
- Microsporum audouinii
- Microsporum canis
- Microsporum gypseum
- onychomycosis †
- oropharyngeal candidiasis (thrush)
- Paracoccidioides brasiliensis †
- paracoccidioidomycosis
- Petriellidium boydii
- Phialophora sp.
- prostate cancer †
- seborrheic dermatitis
- Sporothrix schenckii †
- tinea capitis †
- tinea corporis
- tinea cruris
- tinea manuum †
- tinea pedis †
- tinea versicolor
- Trichophyton mentagrophytes
- Trichophyton rubrum
- Trichophyton tonsurans
- vulvovaginal candidiasis †
- vulvovaginal candidiasis prophylaxis †
† non-FDA-approved indication
Ketoconazole Indications and Dosage
The following organisms are generally considered susceptible to ketoconazole in vitro: Actinomadura madurae † ; Actinomadura sp. † ; Blastomyces dermatitidis; Candida sp. (including Candida albicans; Candida glabrata; Candida guilliermondii; Candida kefyr; Candida krusei; Candida parapsilosis; Candida pseudotropicalis; Candida stellatoidea; Candida tropicalis); Coccidioides immitis; Epidermophyton floccosum; Histoplasma capsulatum; Leishmania braziliensis † ; Leishmania major † ; Leishmania tropica † ; Leishmania mexicana † ; Leishmania panamensis † ; Malassezia furfur; Microsporum audouinii; Microsporum canis; Microsporum gypseum; Paracoccidioides brasiliensis † ; Petriellidium boydii; Phialophora sp.; Sporothrix schenckii † ; Trichophyton mentagrophytes; Trichophyton rubrum; Trichophyton tonsurans.
For the treatment of candidiasis, candiduria, or chromomycosis:
Oral dosage:
Adults: 200 mg PO once daily. Serious infection may require 400 mg PO once daily.
Children >= 2 years of age: 3.3 - 6.6 mg/kg PO once daily.
Children < 2 years of age: Safety and efficacy have not been established.
For the treatment of blastomycosis, chronic mucocutaneous candidiasis, coccidioidomycosis, histoplasmosis, paracoccidioidomycosis:
Oral dosage:
Adults: 200 - 400 mg PO once daily. For blastomycosis, doses of 400 mg PO once daily were successful in 79% of patients and doses of 800 mg PO once daily were successful in 100% of patients, although adverse reactions were more prevalent with the higher dosage. In a review of coccidioidomycosis, a dose of 400 mg PO once daily was recommended.
For the treatment of mucocutaneous candidiasis:
- for oropharyngeal candidiasis (thrush):
Oral dosage:
Adults: 200 mg PO once daily. Serious infection may require 400 mg PO once daily. Treatment should be continued until tests indicate that active fungal infection has subsided.
- for oropharyngeal candidiasis (thrush) in HIV-infected children:
Oral dosage:
Children: In one study, 22 subjects received
ketoconazole 7 mg/kg/day PO and 24 subjects received
fluconazole 3 mg/kg/day, with treatment continuing for 5 - 49 days. Patients treated with
fluconazole had a higher clinical and mycological cure rate (88% and 71%, respectively) than those treated with
ketoconazole (81% and 57%, respectively).
- for vulvovaginal candidiasis † :
Oral dosage:
Nonpregnant adult females: 200 - 600 mg PO once daily for 3 - 6 days.
Pregnant adult females: Not recommended.
- for cutaneous candidiasis caused by Candida sp.:
Topical dosage:
Adults and children: Apply a sufficient amount of 2%
ketoconazole cream to the affected and surrounding areas once daily for 2 weeks.
For the treatment of tinea corporis, tinea cruris, tinea versicolor caused by Trichophyton rubrum, Trichophyton mentagrophytes and Epidermophyton floccosum; tinea versicolor caused by Malassezia furfur:
Topical dosage (cream):
Adults and children: Apply a sufficient amount of 2% ketoconazole cream to the affected and surrounding areas once daily for 2 weeks. Tinea pedis infection may require 6 weeks of treatment.
Topical dosage (shampoo):
Adults: Apply to damp skin of the affected area and to surrounding area, as a single application. Lather and leave in place for 5 minutes, then rinse off with water.
- for the treatment of tinea capitis † , tinea corporis † , tinea cruris † , tinea pedis † , tinea manuum † , tinea unguium (onychomycosis † ) caused by Trichophyton sp., Microsporum sp. or Epidermophyton sp., and tinea versicolor † :
Oral dosage:
Adults: 200 mg PO once daily. Serious infection may require 400 mg PO once daily.
Children >= 2 years of age: 3.3 - 6.6 mg/kg PO once daily.
Children < 2 years of age: Safety and efficacy have not been established.
- for the treatment of recalcitrant cutaneous dermatophyte infections unresponsive to topical ketoconazole therapy or oral griseofulvin, or for patients unable to take griseofulvin:
Oral dosage:
Adults: An initial dose 200 mg PO once daily is recommended. Serious infection may require 400 mg PO once daily. Treatment should be continued until tests indicate that systemic active fungal infection has subsided.
Children >= 2 years of age: 3.3 - 6.6 mg/kg/day PO once daily.
Children < 2 years of age: Safety and efficacy have not been established.
For the treatment of dandruff, to control flaking, scaling, or itching:
Topical dosage (1% shampoo, e.g., Nizoral® A-D, OTC product):
Adults and children > 12 years: Apply to hair every 3 - 4 days for up to 8 weeks, if needed, or as directed by a doctor.
Topical dosage (2% shampoo, prescription product):
Adults: Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area. Lather and leave in place for 5 minutes, and then rinse off with water. One application should be sufficient. In a clinical trial, 246 patients with moderate to severe dandruff were randomized to either ketoconazole 2% shampoo or selenium sulfide 2.5% shampoo. Ketoconazole was statistically superior to selenium sulfide at day 8 only. Both products were superior to placebo. Ketoconazole was better tolerated than selenium sulfide.
Children: Safe and effective use has not been established.
For fungal prophylaxis:
- in neutropenic or cancer patients:
Oral dosage:
Adults:
Ketoconazole, in doses ranging from 200 - 400 mg PO once daily has been found equivalent to or slightly better than nystatin in preventing localized fungal infection in cancer patients.
- for secondary oral, vaginal, or esophageal candidiasis prophylaxis † in HIV-infected patients with frequent or severe recurrences of candidiasis:
Oral dosage:
Adults and adolescents:
Ketoconazole 200 mg PO once daily as an alternative to
fluconazole has been recommended. The routine preventive therapy of candidiasis is not recommended due to the potential of developing drug-resistant candida.
Pregnant females: Topical antifungal therapy such as nystatin may be preferable.
Children and infants: Ketoconazole 5 - 10 mg/kg PO every 12 - 24 hours as an alternative to fluconazole has been recommended. The routine preventive therapy of candidiasis is not recommended due to the potential of developing drug-resistant candida.
- for secondary vulvovaginal candidiasis prophylaxis † in women with recurrent vulvovaginal candidiasis (i.e., four or more symptomatic episodes annually):
Oral dosage:
Adult and adolescent females: Following an initial treatment regimen of
ketoconazole 400 mg PO once daily for 10 - 14 days, maintenance therapy with
ketoconazole 100 mg PO once daily for <= 6 months was successful in reducing the frequency of recurrent vulvovaginal candidiasis.
Pregnant females: Topical antifungal therapy such as nystatin may be preferable.
For the treatment of cutaneous or mucocutaneous leishmaniasis † :
Oral dosage:
Adults: 400 - 600 mg PO in a single daily dose for a duration of 28 days. In some cases a second course of therapy may be needed.
For the treatment of seborrheic dermatitis:
Topical dosage (2% shampoo, prescription product):
Adults: Wash hair and scalp with enough shampoo to wet hair. Gently massage shampoo over the entire scalp area, and allow it to remain on wet hair for 1 minute. Rinse hair, and repeat the application of shampoo. Allow shampoo to remain on wet hair for 3 minutes this time. Rinse hair thoroughly. Use twice weekly (allow at least 3 days between applications) for 4 weeks. Use intermittently thereafter as needed to maintain control.
For the treatment of fungal keratitis † :
Ophthalmic dosage † :
Adults: An extemporaneously prepared ophthalmic suspension of 2% ketoconazole has been used in a small number of patients with fungal keratitis with some success. NOTE: Ketoconazole cream for topical application must not be applied to the eye.
For the treatment of advanced prostate cancer † :
Oral dosage:
Adults: 400 mg PO every 8 hours has been used in a limited number of patients over a 6 month period with measurable success.
Patients with hepatic impairment:
No dosage adjustment guidelines are available; however, patients with hepatic disease are at increased risk of hepatotoxicity.
Patients with renal impairment:
No dosage adjustment needed.
† non-FDA-approved indication
[ Last revised: 12/2/2004 11:39:00 AM ]
References
. Trachtenberg J, Pont A. Ketoconazole therapy for advanced prostate cancer. Lancet 1984:433 - 5.
. Turhan A, Connors JM, Klimo P. Ketoconazole versus nystatin as prophylaxis against fungal infection for lymphoma patients receiving chemotherapy. Am J Clin Oncol 1987;10:355 - 9.
. Jones PG, Kauffman CA, McAuliffe LS et al. Efficacy of ketoconazole v nystatin in prevention of fungal infections in neutropenic patients. Arch Intern Med 1984;144:549 - 51.
. Stevens DA. Coccidioidomycosis. N Engl J Med 1995;332:1077 - 82.
. Centers for Disease Control and Prevention (CDC). The Living Document: USPHS/IDSA Guidelines for the prevention of opportunistic infections in persons infected with human immunodeficiency virus. Retrieved November 28, 2001. Available on the World Wide Web at http://www.hivatis.org.
. Danby FW, Maddin WS, Margesson LJ et al. A randomized, double-blind, placebo-controlled trial of ketoconazole 2% shampoo versus selenium sulfide 2.5% shampoo in the treatment of moderate to severe dandruff. J Am Acad Dermatol 1993;29:1008 - 12.
. Hernandez-Sampelayo T. Fluconazole versus ketoconazole in the treatment of oropharyngeal candidiasis in HIV-infected children. Eur J Clin Microbiol Infect Dis 1994;13:340 - 44.
. Sobel JD. Recurrent vulvovaginal candidiasis. A prospective study of the efficacy of maintenance ketoconazole therapy. N Engl J Med 1986;315:1455 - 8.
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