Fluconazole (Diflucan) Indications and Dosage
- Blastomyces dermatitidis †
- Candida albicans
- Candida glabrata
- Candida guilliermondii
- Candida kefyr
- Candida krusei
- Candida parapsilosis
- Candida pseudotropicalis
- Candida sp.
- Candida stellatoidea
- Candida tropicalis
- candidemia
- candidiasis
- candidiasis prophylaxis †
- candiduria
- Coccidioides immitis †
- coccidioidomycosis †
- coccidioidomycosis prophylaxis †
- cryptococcosis prophylaxis †
- Cryptococcus neoformans
- esophageal candidiasis
- fungal prophylaxis
- Histoplasma capsulatum †
- meningitis
- oropharyngeal candidiasis (thrush)
- Paracoccidioides brasiliensis †
- peritonitis
- pneumonia
- Sporothrix schenckii †
- urinary tract infection (UTI)
- vulvovaginal candidiasis
† non-FDA-approved indication
Fluconazole (Diflucan) Indications and Dosage
The following organisms are generally considered susceptible to fluconazole in vitro: 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 † ; Cryptococcus neoformans; Histoplasma capsulatum † ; Paracoccidioides brasiliensis † ; Sporothrix schenckii † .
For the treatment of systemic or invasive candidemia:
Oral or Intravenous dosage:
Adults: In general, 400 mg PO or IV on the first day, then 200-400 mg PO or IV once daily for at least 4 weeks (and at least 2 weeks following symptom resolution). Many medical experts believe further studies are warranted before fluconazole can be routinely recommended for treatment of systemic fungal infections. In studies comparing fluconazole to amphotericin B in patients with invasive candidal infection, fluconazole 400 mg PO once daily was equivalent to amphotericin B in efficacy. Toxicity was lower in the fluconazole group.
Children, infants, and neonates > 14 days: 6-12 mg/kg/day PO or IV for at least 4 weeks.
Neonates 0-14 days: 6-12 mg/kg every 72 hours PO or IV for at least 4 weeks. After the first 2 weeks of life, administer the dose once daily.
- for the treatment of urinary tract infection (UTI) caused by Candida sp. (e.g. candiduria):
Oral or Intravenous dosage:
Adults: The optimum dosage has not been established, however doses of 50-200 mg PO or IV once daily have been used.
- for the treatment of peritonitis caused by Candida sp.:
Oral or Intravenous dosage:
Adults: The optimum dosage has not been established, however doses of 50-200 mg PO or IV once daily have been used.
- for the treatment of pneumonia caused by Candida sp.:
Oral or Intravenous dosage:
Adults: The optimum dosage has not been established, however doses of up to 400 mg PO or IV once daily have been used.
For the treatment of coccidioidomycosis † :
Oral dosage:
Adults: 400-600 mg PO once daily has been recommended.
For the treatment of fungal meningitis:
- for meningitis due to Cryptococcus neoformans:
Oral or Intravenous dosage:
Adults: 400 mg PO or IV on the first day or once daily until clinical response occurs, followed by 200-400 mg PO or IV once daily. Fluconazole 200 mg PO once daily should be administered for a period of 10-12 weeks after the cerebrospinal fluid cultures are negative.
Children, infants, and neonates > 14 days: 12 mg/kg PO or IV on the first day, followed by 6-12 mg/kg IV or PO once daily. Dosages above 600 mg/day are not recommended. The recommended duration of therapy is 10-12 weeks after the cerebrospinal fluid cultures are negative.
Neonates 0-14 days: 2 mg/kg PO or IV on the first day, followed by 6-12 mg/kg IV or PO every 72 hours. The recommended duration of therapy is 10-12 weeks after the cerebrospinal fluid cultures are negative. After the first 2 weeks of life, administer the dose once daily.
- for empiric treatment of chronic meningitis † due to Candida albicans, Coccidioides immitis † , or Histoplasma capsulatum † :
Oral or Intravenous dosage:
Adults: Doses of 400-800 mg PO or IV once daily, for 12-18 months, depending on response, have been suggested. Fluconazole is potentially useful for empiric therapy of chronic meningitis due to Candida albicans, Coccidioides immitis, or Histoplasma capsulatum.
For the treatment of mucocutaneous candidiasis:
- for oropharyngeal candidiasis (thrush):
Oral or Intravenous dosage:
Adults: 200 mg PO or IV on the first day, then 100 mg PO or IV once daily. Treatment should continue for two weeks after resolution of symptoms.
Pregnant females: Topical antifungal therapy such as nystatin may be preferable.
Children, infants and neonates > 14 days: 6 mg/kg PO or IV on the first day, followed by 3 mg/kg PO or IV once daily. Administer treatment for at least 2 weeks to decrease the chance of relapse.
Neonates 0-14 days: 6 mg/kg PO or IV on the first day, followed by 3 mg/kg PO or IV every 72 hours. After the first 2 weeks of life, administer the dose once daily.
- for esophageal candidiasis:
Oral or Intravenous dosage:
Adults: 200 mg IV or PO on the first day, then 100 mg PO or IV daily. Depending on the severity, up to 400 mg/day PO or IV can be given. Patients should be treated for a minimum of 3 weeks and for at least 2 weeks following the resolution of symptoms. Fluconazole 100-200 mg PO once daily was superior to ketoconazole in an 8 week study of AIDS patients with candidal esophagitis.
Pregnant females: Topical antifungal therapy such as nystatin may be preferable.
Children, infants, and neonates > 14 days: 6 mg/kg PO or IV on the first day, followed by 3 mg/kg PO or IV once daily. Doses up to 12 mg/kg/day PO or IV can be used if clinically necessary. Dosages above 600 mg/day are not recommended. Treatment should continue for a minimum of 3 weeks and for at least 2 weeks following the resolution of symptoms.
Neonates 0-14 days: 6 mg/kg PO or IV on the first day, followed by 3 mg/kg PO or IV every 72 hours. After the first 2 weeks of life, administer the dose once daily. Doses up to 12 mg/kg PO or IV can be used if clinically necessary. Treatment should continue for a minimum of 3 weeks and for at least 2 weeks following the resolution of symptoms.
- for vulvovaginal candidiasis:
Oral or Intravenous dosage:
Adult and adolescent females: 150 mg PO or IV as a single dose. A single oral 150 mg dose of fluconazole was compared with seven days of intravaginal clotrimazole in 358 women with moderate to severe candida vaginitis. The response to oral fluconazole and to intravaginal clotrimazole was similar. Long-term (6 months) weekly suppressive treatment with fluconazole 150 mg PO once weekly was shown to reduce the rate of occurrence of symptomatic vulvovaginal candidiasis but did not present a long-term cure.
Pregnant females: Topical antifungal therapy such as nystatin may be preferable.
For fungal prophylaxis:
- for primary prophylaxis of superficial and/or systemic fungal infection in bone marrow transplant (BMT) patients:
Oral dosage:
Adults: 400 mg PO once daily. In patients who are anticipated to experience < 500/mm3, therapy should begin several days prior to the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises back above 1000/mm3. Both superficial and systemic fungal infections occurred less frequently in bone marrow transplant patients who received fluconazole prophylaxis until the neutrophil count reached 1000 than in patients who received placebo; however, there was a tendency for patients receiving fluconazole to develop Candida krusei infections. A lower dose of 100 mg PO once daily beginning 7 days before transplantation and continuing for 180 days post-transplant or for the duration of immunosuppression has also been recommended.
- for primary prophylaxis of superficial and/or systemic fungal infection in patients with acute leukemia:
Oral or Intravenous dosage:
Adults: In one study, fluconazole 400 mg PO once daily or 200 mg IV every 12 hours was begun at the initiation of chemotherapy and was continued until 7 days after the neutrophil count reached 1000/mm3. The median duration of oral therapy was 16 days. Both superficial and invasive fungal infections were less frequent in the fluconazole recipients than in patients receiving placebo. Another open-label study compared fluconazole oral solution or capsules (400 mg PO once daily, n=246) with itraconazole oral solution (2.5 mg/kg PO twice daily, n=248 for primary fungal prophylaxis in patients with hematologic malignancy and significant neutropenia (i.e., neutrophil count <500 cells/mm3 for at least 10 days). There was no difference between treatment groups in regards to the number of patients who recovered from neutropenia or in the duration of neutropenia. Both treatments were similar in efficacy and safety in preventing fungal infections in these patients.
- for primary prophylaxis † of systemic fungal infection in HIV-infected patients with < 200 CD4+ cells/mm3:
Oral dosage:
Adults: Several different oral dosages have been studied. A retrospective study of the prevention of fungal infection in HIV-positive patients with < 200 CD4+ cells demonstrated a dosage of 100 mg/day PO every third week reduced the incidence of systemic mycoses significantly compared to patients who received no antifungal prophylaxis. In patients with < 50 CD4+ cells/mm3, fluconazole 200 mg PO once daily was superior to clotrimazole lozenges in preventing the development of invasive fungal infection during a median follow-up period of 35 months.
- for oral, vaginal, or esophageal candidiasis prophylaxis † in HIV-infected patients:
Oral dosage:
Adults: The routine primary candidiasis prophylaxis in patients with AIDS or immunodeficiency syndrome-related complex is not recommended due to the potential of developing drug-resistant candida. For patients with frequent or severe recurrences of oral, vaginal, or esophageal candidiasis, the CDC recommends a dose of 100-200 mg PO once daily. Fluconazole 200 mg PO once per week was more effective than placebo in preventing either oropharyngeal, vaginal, or esophageal candidiasis in women with 300 CD4+ cells/mm3 or less during a median follow-up period of 29 months. In a study of HIV-positive patients with previous thrush episodes, thrush occurred in 8 of 13 patients receiving placebo and in none of 12 patients receiving fluconazole 100 mg PO once daily for 12 weeks. A dose of 150 mg PO once weekly has also been successful in preventing relapse. Doses of 50 mg PO every other day or 150 mg as a single PO dose were adequate protection for the 3 months’ duration in patients with less advanced HIV disease and who had just experienced their first episode of candidiasis while 50 mg PO every day was best for patients with full-blown AIDS.
Pregnant females: Topical antifungal therapy such as nystatin may be preferable.
Children and infants: The CDC recommends 3-6 mg/kg PO once daily. The routine preventive therapy of candidiasis in HIV patients is not recommended due to the potential of developing drug-resistant candida.
- for cryptococcosis prophylaxis † in HIV-infected patients:
Oral dosage:
Adults and adolescents: For primary prophylaxis in HIV-infected patients with a CD4+ count < 50, fluconazole 100-200 mg PO once daily may be given; however, use is not routinely indicated. The CDC recommends fluconazole 200 mg PO once daily for secondary prophylaxis. Fluconazole is superior to itraconazole in preventing relapse and is considered the preferred agent. Although patients receiving secondary prophylaxis (chronic maintenance therapy) might be at low risk for recurrence of systemic mycosis when their CD4+ cell count increases to > 100 cells/µL on highly active antiretroviral therapy (HAART), the number of patients who have been evaluated are insufficient to warrant a recommendation to discontinue prophylaxis.
Pregnant females: Fluconazole is not recommended. Amphotericin B is the preferred agent, especially in the first trimester.
Children and infants: The CDC recommends 3-6 mg/kg PO once daily.
- for secondary coccidioidomycosis prophylaxis † in HIV-infected patients:
Oral dosage:
Adults and adolescents: The CDC recommends 400 mg PO once daily. Although patients receiving secondary prophylaxis (chronic maintenance therapy) might be at low risk for recurrence of systemic mycosis when their CD4+ cell count increases to > 100 cells/µL on highly active antiretroviral therapy (HAART), the number of patients who have been evaluated are insufficient to warrant a recommendation to discontinue prophylaxis.
Pregnant females: Fluconazole is not recommended. Amphotericin B is the preferred agent, especially in the first trimester.
Children and infants: The CDC recommends 6 mg/kg PO once daily.
Maximum Dosage Limits:
- Adults: Maximum dosage information is not available. In some cases, loading doses of up to 400 mg PO/IV bid for two days have been used.
- Elderly: Maximum dosage information is not available. In some cases, loading doses of up to 400 mg PO/IV bid for two days have been used.
- Adolescents: Maximum dosage information is not available. In some cases, loading doses of up to 400 mg PO/IV bid for two days have been used.
- Children: 12 mg/kg/day PO/IV, not to exceed 600 mg/day PO/IV.
- Infants: 12 mg/kg/day PO/IV.
- Neonates > 14 days: 12 mg/kg/day PO/IV.
- Neonates <= 14 days: Individualize dosage.
Patients with hepatic impairment:
No dosage adjustment required.
Patients with renal impairment:
CrCl > 50 ml/min: no dosage adjustment needed.
CrCl 21-50 ml/min: following the usual loading dose, reduce recommended maintenance dose by 50%.
CrCl 11-20 ml/min: following the usual loading dose, reduce recommended maintenance dose by 75%.
Intermittent hemodialysis:
The manufacturer recommends 100% of the usual daily dose after each dialysis session. Further adjustments may be needed depending upon the clinical situation.
Continuous hemodialysis (CAVHD, CVVHD):
Definitive dosage recommendations have not been established. Fluconazole is significantly removed by CAVHD or CVVHD. A dose roughly 3.8 times that used for anuric nondialyzed patients has been recommended, assuming a combined dialysis and ultrafiltrate flow rate of 1.5 L/hr.
† non-FDA-approved indication
[ Last revised: 12/22/2005 12:22:00 PM ]
References
. Stevens DA, Greene SI, Lang OS. Thrush can be prevented in patients with acquired immunodeficiency syndrome and the acquired immunodeficiency syndrome-related complex. Arch Intern Med 1991;151:2458-64.
. Rex JH, Bennett JE, Sugar AM et al. A randomized trial comparing fluconazole with amphotericin B for the treatment of candidemia in patients without neutropenia. N Engl J Med 1994;331:1325-30.
. Goodman JL, Winston DJ, Greenfield RA et al. A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation. N Engl J Med 1992;326:845-51.
. Momin F, Chandrasekar PH. Antimicrobial prophylaxis in bone marrow transplantation. Ann Intern Med 1995;123:205-15.
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