Azole antifungals
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Itraconazole Dosage

Drug Detail:Itraconazole (Itraconazole [ it-ra-kon-a-zole ])

Drug Class: Azole antifungals

Contents
Uses Warnings Before Taking Dosage Side effects Interactions FAQ

Usual Adult Dose for Blastomycosis

100-mg Capsules:

  • Loading dose: 200 mg orally 3 times a day for the first 3 days of therapy
  • Maintenance dose: 200 mg orally once a day
  • If no obvious improvement or if evidence of progressive fungal disease: Dose should be increased in 100 mg increments up to 200 mg orally twice a day
  • Maximum dose: 400 mg/day

65-mg Capsules:
  • Loading dose: 130 mg orally 3 times a day for the first 3 days of therapy
  • Maintenance dose: 130 mg orally once a day
  • If no obvious improvement or if evidence of progressive fungal disease: Dose should be increased in 65 mg increments up to 130 mg orally twice a day
  • Maximum dose: 260 mg/day

Duration of Therapy: At least 3 months and until clinical parameters and laboratory tests indicate the active fungal infection has subsided

Comments:
  • A loading dose should be used in life-threatening situations.

Use: For the treatment of blastomycosis (pulmonary and extrapulmonary) in immunocompromised and non-immunocompromised patients

Infectious Diseases Society of America (IDSA) Recommendations:
  • Mild to moderate pulmonary or mild to moderate disseminated infection without CNS involvement: 200 mg orally 3 times a day for 3 days, then 200 mg orally once or twice a day for 6 to 12 months
  • Moderately severe to severe pulmonary or moderately severe to severe disseminated infection without CNS involvement (after initial regimen of IV amphotericin B): 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day for 6 to 12 months (total) with pulmonary infection, at least 12 months (total) with disseminated extrapulmonary infection, or at least 12 months (total) in immunocompromised patients
  • CNS infection (after initial regimen of IV amphotericin B): 200 mg orally 2 or 3 times a day for at least 12 months and until CSF abnormalities resolve
  • Prevention of recurrence (secondary prophylaxis) in immunosuppressed patients: 200 mg orally once a day

Comments:
  • Lifelong suppressive therapy with this drug may be needed if immunosuppression cannot be reversed.
  • Current guidelines should be consulted for additional information.

Usual Adult Dose for Histoplasmosis

100-mg Capsules:

  • Loading dose: 200 mg orally 3 times a day for the first 3 days of therapy
  • Maintenance dose: 200 mg orally once a day
  • If no obvious improvement or if evidence of progressive fungal disease: Dose should be increased in 100 mg increments up to 200 mg orally twice a day
  • Maximum dose: 400 mg/day

65-mg Capsules:
  • Loading dose: 130 mg orally 3 times a day for the first 3 days of therapy
  • Maintenance dose: 130 mg orally once a day
  • If no obvious improvement or if evidence of progressive fungal disease: Dose should be increased in 65 mg increments up to 130 mg orally twice a day
  • Maximum dose: 260 mg/day

Duration of Therapy: At least 3 months and until clinical parameters and laboratory tests indicate the active fungal infection has subsided

Comments:
  • A loading dose should be used in life-threatening situations.

Use: For the treatment of histoplasmosis (including chronic cavitary pulmonary disease and disseminated, nonmeningeal histoplasmosis) in immunocompromised and non-immunocompromised patients

IDSA Recommendations:
  • Mild to moderate acute pulmonary infection in patients with symptoms beyond 1 month: 200 mg orally 3 times a day for 3 days, then 200 mg orally once or twice a day for 6 to 12 weeks
  • Moderately severe to severe acute pulmonary infection (after initial regimen of IV amphotericin B): 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day for 12 weeks (total)
  • Chronic cavitary pulmonary infection: 200 mg orally 3 times a day for 3 days, then 200 mg orally once or twice a day for at least 12 months (18 to 24 months preferred by some clinicians due to risk of relapse)
  • Mild to moderate progressive disseminated infection: 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day for at least 12 months
  • Moderately severe to severe progressive disseminated infection (after initial regimen of IV amphotericin B): 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day for at least 12 months (total)
  • Infection with symptomatic mediastinal granuloma or with complications (pericarditis, rheumatologic syndromes, symptomatic mediastinal lymphadenitis) that require corticosteroid therapy: 200 mg orally 3 times a day for 3 days, then 200 mg orally once or twice a day for 6 to 12 weeks
  • CNS infection (after initial regimen of IV amphotericin B): 200 mg orally 2 or 3 times a day for at least 12 months and until CSF abnormalities resolve, including Histoplasma antigen levels
  • Primary prophylaxis in immunosuppressed patients: 200 mg orally once a day
  • Prevention of recurrence (secondary prophylaxis): 200 mg orally once a day

US CDC, National Institutes of Health (NIH), and HIV Medicine Association of the IDSA (HIVMA/IDSA) Recommendations for HIV-Infected Patients:
  • Less severe disseminated infection: 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day for at least 12 months
  • Moderately severe to severe disseminated infection (after initial regimen of IV amphotericin B): 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day for at least 12 months (total)
  • Confirmed meningitis (after initial regimen of IV amphotericin B): 200 mg orally 2 or 3 times a day for at least 12 months and until CSF abnormalities resolve
  • Preventing first episode of Histoplasma capsulatum infection (primary prophylaxis): 200 mg orally once a day
  • Long-term suppressive therapy (secondary prophylaxis): 200 mg orally once a day

Comments:
  • IDSA guidelines: The oral solution formulation is preferred, but the capsule formulation may be used.
  • IDSA guidelines: Lifelong suppressive therapy with this drug may be needed if immunosuppression cannot be reversed.
  • HIV guidelines: Recommended as preferred therapy
  • HIV guidelines: The oral solution formulation is preferred.
  • Current guidelines should be consulted for additional information.

Usual Adult Dose for Aspergillosis - Aspergilloma

100-mg Capsules:

  • Loading dose: 200 mg orally 3 times a day for the first 3 days of therapy
  • Maintenance dose: 200 mg orally once or twice a day

65-mg Capsules:
  • Loading dose: 130 mg orally 3 times a day for the first 3 days of therapy
  • Maintenance dose: 130 mg orally once or twice a day

Duration of Therapy: At least 3 months and until clinical parameters and laboratory tests indicate the active fungal infection has subsided

Comments:
  • A loading dose should be used in life-threatening situations.

Use: For the treatment of aspergillosis (pulmonary and extrapulmonary) in immunocompromised and non-immunocompromised patients who are intolerant of, or refractory to, amphotericin B therapy

IDSA Recommendations: 200 mg orally every 12 hours

Comments:
  • Recommended as alternative (salvage) therapy for some invasive syndromes of Aspergillus (e.g., invasive pulmonary aspergillosis, prophylaxis against invasive aspergillosis) and some saprophytic/colonizing syndromes of Aspergillus (e.g., aspergilloma)
  • Recommended as primary therapy for allergic bronchopulmonary aspergillosis
  • Current guidelines should be consulted for additional information.

Usual Adult Dose for Aspergillosis - Invasive

100-mg Capsules:

  • Loading dose: 200 mg orally 3 times a day for the first 3 days of therapy
  • Maintenance dose: 200 mg orally once or twice a day

65-mg Capsules:
  • Loading dose: 130 mg orally 3 times a day for the first 3 days of therapy
  • Maintenance dose: 130 mg orally once or twice a day

Duration of Therapy: At least 3 months and until clinical parameters and laboratory tests indicate the active fungal infection has subsided

Comments:
  • A loading dose should be used in life-threatening situations.

Use: For the treatment of aspergillosis (pulmonary and extrapulmonary) in immunocompromised and non-immunocompromised patients who are intolerant of, or refractory to, amphotericin B therapy

IDSA Recommendations: 200 mg orally every 12 hours

Comments:
  • Recommended as alternative (salvage) therapy for some invasive syndromes of Aspergillus (e.g., invasive pulmonary aspergillosis, prophylaxis against invasive aspergillosis) and some saprophytic/colonizing syndromes of Aspergillus (e.g., aspergilloma)
  • Recommended as primary therapy for allergic bronchopulmonary aspergillosis
  • Current guidelines should be consulted for additional information.

Usual Adult Dose for Oral Thrush

Oral Solution:

  • Oropharyngeal candidiasis: 200 mg orally once a day for 1 to 2 weeks
  • Oropharyngeal candidiasis unresponsive/refractory to treatment with fluconazole tablets: 100 mg orally twice a day

Comments:
  • The oral solution should be vigorously swished in the mouth (10 mL at a time) for several seconds and swallowed.
  • Clinical signs/symptoms of oropharyngeal candidiasis generally resolve within several days.
  • Clinical response for oropharyngeal candidiasis unresponsive/refractory to fluconazole will be seen in 2 to 4 weeks in patients responding to therapy; patients may be expected to relapse shortly after discontinuing therapy.
  • Only the oral solution formulation has been shown effective for oral and/or esophageal candidiasis.

Use: For the treatment of oropharyngeal candidiasis

IDSA Recommendations:
  • Oral solution: 200 mg orally once a day for up to 28 days

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Patients:
  • Oral solution: 200 mg orally per day for 7 to 14 days

Comments:
  • IDSA guidelines: Recommended for fluconazole-refractory oropharyngeal candidiasis
  • HIV guidelines: Recommended as alternative oral therapy for oropharyngeal candidiasis (initial episodes)
  • Current guidelines should be consulted for additional information.

Usual Adult Dose for Esophageal Candidiasis

Oral Solution: 100 mg orally once a day for at least 3 weeks and for 2 weeks after symptoms resolve

Comments:

  • Doses up to 200 mg/day may be used based on clinical judgment of patient's response to therapy.
  • The oral solution should be vigorously swished in the mouth (10 mL at a time) for several seconds and swallowed.
  • Only the oral solution formulation has been shown effective for oral and/or esophageal candidiasis.

Use: For the treatment of esophageal candidiasis

IDSA Recommendations:
  • Oral solution: 200 mg orally per day for 14 to 21 days

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Patients:
  • Oral solution: 200 mg orally per day for 14 to 21 days

Comments:
  • IDSA guidelines: Recommended for fluconazole-refractory infection
  • HIV guidelines: Recommended as preferred therapy for esophageal candidiasis
  • Current guidelines should be consulted for additional information.

Usual Adult Dose for Onychomycosis - Toenail

100-mg Capsules: 200 mg orally once a day for 12 consecutive weeks

Comments:

  • With or without fingernail involvement
  • Diagnosis should be confirmed before starting therapy; appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, nail biopsy) should be obtained.

Use: For the treatment of onychomycosis of the toenail (with or without fingernail involvement) due to dermatophytes (tinea unguium) in non-immunocompromised patients

Usual Adult Dose for Onychomycosis - Fingernail

100-mg Capsules:

  • Treatment pulse: 200 mg orally twice a day for 1 week

Comments:
  • Fingernails only
  • Diagnosis should be confirmed before starting therapy; appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, nail biopsy) should be obtained.
  • The recommended dosing regimen is 2 treatment pulses, which are separated by 3 weeks without treatment; the manufacturer product information should be consulted for further guidance.

Use: For the treatment of onychomycosis of the fingernail due to dermatophytes (tinea unguium) in non-immunocompromised patients

Usual Adult Dose for Coccidioidomycosis

IDSA Recommendations: 200 mg orally twice a day

  • Coccidioidal meningitis: 200 mg orally 2 to 4 times a day

Duration of Therapy:
  • Extrapulmonary soft tissue infection (not associated with bone infection): At least 6 to 12 months
  • Symptomatic chronic cavitary coccidioidal pneumonia: At least 1 year (or longer in some cases)
  • Bone and/or joint infection: 3 years to lifetime (depending on severity of the infection and immunocompetence of the patient)
  • Coccidioidal meningitis: Lifetime

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Patients:
  • Mild to moderate pulmonary infections: 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day
  • Meningeal infections: 200 mg orally 2 to 3 times a day

Comments:
  • IDSA guidelines: Recommended as first-line therapy for extrapulmonary soft tissue infection (not associated with bone infection)
  • IDSA guidelines: Recommended for bone and/or joint infection (unless extensive or limb-threatening skeletal/vertebral infection causing imminent cord compromise); for severe osseous disease, recommended after IV amphotericin B therapy
  • IDSA guidelines: Some experts prefer this drug (instead of fluconazole) for coccidioidal meningitis, but this requires closer monitoring to assure adequate absorption.
  • HIV guidelines: Recommended as preferred therapy for mild to moderate pulmonary infections
  • HIV guidelines: Preferred therapy for severe pulmonary or extrapulmonary infection (except meningitis) includes treatment with IV amphotericin B until clinical improvement followed by a triazole.
  • HIV guidelines: Recommended as alternative therapy for meningeal infections; a specialist should be consulted.
  • Current guidelines should be consulted for additional information.

Usual Adult Dose for Sporotrichosis

IDSA Recommendations:

  • Cutaneous or lymphocutaneous infection: 200 mg orally once a day for 2 to 4 weeks after all lesions resolve (usually 3 to 6 months [total])
  • If patients do not respond: 200 mg orally twice a day
  • Osteoarticular infection: 200 mg orally twice a day for at least 12 months (total)
  • Less severe pulmonary infection: 200 mg orally twice a day for at least 12 months
  • Meningeal infection, disseminated infection, and severe/life-threatening pulmonary infection (after initial regimen of IV amphotericin B): 200 mg orally twice a day for at least 12 months (total)
  • Prevention of recurrence of meningeal infection or disseminated infection (secondary prophylaxis) in patients with AIDS and other immunosuppressed patients: 200 mg orally once a day

Comments:
  • Recommended as preferred therapy
  • The oral solution formulation is preferred.
  • Therapy should be started with a loading dose (200 mg orally 3 times a day for 3 days).
  • Current guidelines should be consulted for additional information.

Usual Adult Dose for Cryptococcosis

IDSA Recommendations:

  • Mild to moderate pulmonary infection (nonmeningeal) in immunocompetent patients: 200 orally twice a day for 6 to 12 months
  • Maintenance (suppressive) and prophylactic therapy in HIV-infected patients: 200 mg orally twice a day for at least 1 year

Comments:
  • Recommended as alternative therapy; fluconazole is preferred.
  • The oral solution formulation is preferred.
  • Primary prophylaxis not routinely recommended.
  • Current guidelines should be consulted for additional information.

Usual Adult Dose for Cryptococcal Meningitis - Immunosuppressed Host

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Patients:

  • Consolidation therapy: 200 mg orally twice a day for at least 8 weeks

Comments:
  • Recommended as alternative consolidation therapy; this drug is less effective than fluconazole.
  • Consolidation therapy should begin after at least 2 weeks of successful induction therapy and should be followed by maintenance therapy.
  • Current guidelines should be consulted for additional information.

Usual Adult Dose for Vaginal Candidiasis

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Patients:

  • Oral solution: 200 mg orally per day for 3 to 7 days

Comments:
  • Recommended as alternative therapy for uncomplicated vulvovaginal candidiasis
  • Current guidelines should be consulted for additional information.

Usual Adult Dose for Microsporidiosis

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Patients: 400 mg orally per day

Comments:

  • In conjunction with albendazole, recommended for disseminated infection due to Trachipleistophora or Anncaliia
  • Current guidelines should be consulted for additional information.

Usual Adult Dose for Paracoccidioidomycosis

Some Experts Recommend: 200 mg orally once a day for 9 to 18 months

Comments:

  • Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Blastomycosis

IDSA Recommendations for Children:

  • Mild to moderate infection: 10 mg/kg orally per day for 6 to 12 months
  • Maximum dose: 400 mg/day
  • Moderately severe to severe infection (after initial regimen of IV amphotericin B): 10 mg/kg orally per day for 12 months (total)
  • Maximum dose: 400 mg/day

Comments:
  • Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Histoplasmosis

IDSA Recommendations for Children:

  • Acute pulmonary infection: 5 to 10 mg/kg/day orally in 2 divided doses
  • Maximum dose: 400 mg/day
  • Progressive disseminated infection (after initial regimen of IV amphotericin B): 5 to 10 mg/kg/day orally in 2 divided doses to complete 3 months of therapy; longer therapy may be needed for patients with severe disease, immunosuppression, or primary immunodeficiency syndromes
  • Maximum dose: 400 mg/day
  • Prevention of recurrence (secondary prophylaxis): 5 mg/kg orally per day
  • Maximum dose: 200 mg/day

US CDC, NIH, HIVMA/IDSA, Pediatric Infectious Diseases Society (PIDS), and American Academy of Pediatrics (AAP) Recommendations for HIV-Exposed and HIV-Infected Children:
  • Acute primary pulmonary infection: 2 to 5 mg/kg orally 3 times a day for 3 days, then 2 to 5 mg/kg orally twice a day for 12 months (12 weeks may be sufficient for patients with functional cellular immunity)
  • Maximum dose: 200 mg/dose
  • Mild disseminated infection: 2 to 5 mg/kg orally 3 times a day for 3 days, then 2 to 5 mg/kg orally twice a day for 12 months
  • Maximum dose: 200 mg/dose
  • Consolidation therapy for moderately severe to severe disseminated infection (after initial regimen of IV amphotericin B): 2 to 5 mg/kg orally 3 times a day for 3 days, then 2 to 5 mg/kg orally twice a day for 12 months
  • Maximum dose: 200 mg/dose
  • Consolidation therapy for CNS infection (after initial regimen of IV amphotericin B): 2 to 5 mg/kg orally 3 times a day for 3 days, then 2 to 5 mg/kg orally twice a day for at least 12 months and until histoplasma antigen is no longer detected in CSF
  • Maximum dose: 200 mg/dose
  • Secondary prophylaxis (suppressive therapy): 5 to 10 mg/kg orally per day
  • Maximum dose: 200 mg/dose

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Adolescents:
  • Less severe disseminated infection: 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day for at least 12 months
  • Moderately severe to severe disseminated infection (after initial regimen of IV amphotericin B): 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day for at least 12 months (total)
  • Confirmed meningitis (after initial regimen of IV amphotericin B): 200 mg orally 2 or 3 times a day for at least 12 months and until CSF abnormalities resolve
  • Preventing first episode of H capsulatum infection (primary prophylaxis): 200 mg orally once a day
  • Long-term suppressive therapy (secondary prophylaxis): 200 mg orally once a day

Comments:
  • The oral solution formulation is generally used and is preferred.
  • IDSA guidelines: Lifelong suppressive therapy with this drug may be needed if immunosuppression cannot be reversed.
  • HIV guidelines for children: Consolidation therapy should be followed by chronic suppressive therapy.
  • HIV guidelines for children and adolescents: Recommended as preferred therapy
  • Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Oral Thrush

US CDC, NIH, HIVMA/IDSA, PIDS, and AAP Recommendations for HIV-Exposed and HIV-Infected Children:
Oral solution:

  • Fluconazole-refractory oropharyngeal candidiasis: 2.5 mg/kg orally twice a day for 7 to 14 days
  • Maximum dose: 400 mg/day
  • Secondary prophylaxis: 2.5 mg/kg orally twice a day

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Adolescents:
Oral solution: 200 mg orally per day for 7 to 14 days

Comments:
  • Children: Recommended as alternative therapy for fluconazole-refractory oropharyngeal candidiasis
  • Children: Secondary prophylaxis is not routinely recommended.
  • Adolescents: Recommended as alternative oral therapy for oropharyngeal candidiasis (initial episodes)
  • Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Esophageal Candidiasis

US CDC, NIH, HIVMA/IDSA, PIDS, and AAP Recommendations for HIV-Exposed and HIV-Infected Children:

  • Oral solution: 2.5 mg/kg orally twice a day for at least 3 weeks and for at least 2 weeks after symptoms resolve

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Adolescents:
  • Oral solution: 200 mg orally per day for 14 to 21 days

Comments:
  • Recommended as preferred therapy for esophageal candidiasis
  • Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Coccidioidomycosis

US CDC, NIH, HIVMA/IDSA, PIDS, and AAP Recommendations for HIV-Exposed and HIV-Infected Children:

  • Mild to moderate nonmeningeal infection (e.g., focal pneumonia): 2 to 5 mg/kg orally 3 times a day for 3 days, then 2 to 5 mg/kg orally twice a day
  • Maximum dose: 200 mg/dose
  • Duration of therapy: Determined by rate of clinical response
  • Lifelong suppression (secondary prophylaxis): 2 to 5 mg/kg orally twice a day
  • Maximum dose: 200 mg/dose

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Adolescents:
  • Mild to moderate pulmonary infections: 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day
  • Meningeal infections: 200 mg orally 2 to 3 times a day

Comments:
  • Children: Recommended as alternative therapy for secondary prophylaxis and mild to moderate nonmeningeal infections
  • Children: Preferred therapy for severe illness with respiratory compromise due to diffuse pulmonary or disseminated nonmeningeal infection includes treatment with IV amphotericin B; after patient is stabilized, an azole (this drug is preferred for bone infections) can be substituted and continued for a total duration of therapy of 1 year; some experts start an azole during amphotericin B therapy.
  • Adolescents: Recommended as preferred therapy for mild to moderate pulmonary infections
  • Adolescents: Preferred therapy for severe pulmonary or extrapulmonary infections (except meningitis) includes treatment with IV amphotericin B until clinical improvement followed by a triazole.
  • Adolescents: Recommended as alternative therapy for meningeal infections; a specialist should be consulted.
  • Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Cryptococcosis

US CDC, NIH, HIVMA/IDSA, PIDS, and AAP Recommendations for HIV-Exposed and HIV-Infected Children:

  • Oral solution: 5 mg/kg orally once a day for at least 1 year
  • Maximum dose: 200 mg/dose

Comments:
  • Recommended as alternative therapy for suppressive therapy (secondary prophylaxis); fluconazole is preferred.
  • Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Cryptococcal Meningitis - Immunosuppressed Host

US CDC, NIH, HIVMA/IDSA, PIDS, and AAP Recommendations for HIV-Exposed and HIV-Infected Children:

  • Consolidation therapy for CNS infection: 2.5 to 5 mg/kg orally 3 times a day for 3 days, then 5 to 10 mg/kg/day orally in 1 or 2 divided doses for at least 8 weeks
  • Maximum dose:
  • Loading dose: 200 mg/dose; 600 mg/day
  • Maintenance dose: 200 mg/dose; 400 mg/day

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Adolescents:
  • Consolidation therapy: 200 mg orally twice a day for at least 8 weeks

Comments:
  • Recommended as alternative therapy; fluconazole is preferred.
  • Consolidation therapy should begin after at least 2 weeks of successful induction therapy and should be followed by maintenance therapy.
  • Children: The oral solution formulation is preferred.
  • Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Vaginal Candidiasis

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Adolescents:

  • Oral solution: 200 mg orally per day for 3 to 7 days

Comments:
  • Recommended as alternative therapy for uncomplicated vulvovaginal candidiasis
  • Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Microsporidiosis

US CDC, NIH, and HIVMA/IDSA Recommendations for HIV-Infected Adolescents: 400 mg orally per day

Comments:

  • In conjunction with albendazole, recommended for disseminated infection due to Trachipleistophora or Anncaliia
  • Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Sporotrichosis

IDSA Recommendations for Children:

  • Cutaneous or lymphocutaneous infection: 6 to 10 mg/kg orally per day
  • Maximum dose: 400 mg/day
  • Disseminated infection (after initial regimen of IV amphotericin B): 6 to 10 mg/kg orally per day
  • Maximum dose: 400 mg/day

Comments:
  • Recommended as preferred therapy
  • The oral solution formulation is preferred.
  • Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Renal dysfunction: Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution recommended.

Comments:

  • Patients with renal dysfunction should be carefully monitored when using the 65-mg capsule formulation.

Liver Dose Adjustments

Liver dysfunction: Caution recommended.

Comments:

  • Patients with liver dysfunction should be carefully monitored when using this drug.
  • Use of this drug is strongly discouraged in patients with elevated/abnormal liver enzymes, with active liver disease, or who had liver toxicity with other agents unless the situation is serious or life-threatening and the expected benefit exceeds the risk.
  • Liver function monitoring is recommended for patients with preexisting liver function abnormalities or those who had liver toxicity with other agents.

Dose Adjustments

Some experts recommend adjusting dose based on drug serum levels and/or drug interactions.

Precautions

US BOXED WARNINGS:

  • CONGESTIVE HEART FAILURE (CHF): Negative inotropic effects were observed with IV use in dogs and healthy human subjects.
  • The 100-mg capsule formulation: This drug should not be used to treat onychomycosis in patients with evidence of ventricular dysfunction such as CHF or history of CHF; if signs/symptoms of CHF occur during use, the drug should be discontinued.
  • The 65-mg capsule formulation: This drug can cause/exacerbate CHF; if signs/symptoms of CHF occur/worsen during use, the benefit and risk of continuing therapy should be reassessed.
  • The oral solution formulation: If signs/symptoms of CHF occur during use, continued use of this drug should be reassessed.
  • DRUG INTERACTIONS: Coadministration of this drug with certain agents metabolized by CYP450 3A4 is contraindicated, including methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (e.g., dihydroergotamine, ergometrine [ergonovine], ergotamine, methylergometrine [methylergonovine]), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor. In patients with varying degrees of renal or liver dysfunction, coadministration with colchicine, fesoterodine, and solifenacin is contraindicated; coadministration with eliglustat is contraindicated in patients who are poor/intermediate metabolizers of CYP450 2D6 and in patients taking strong/moderate CYP450 2D6 inhibitors. Coadministration with this drug may lead to increased plasma levels of these agents and may increase or prolong pharmacologic effects and/or side effects of these agents; for example, increased plasma levels of some of these agents may result in QT prolongation and/or ventricular tachyarrhythmias, including torsades de pointes (a potentially fatal arrhythmia). The manufacturer product information should be consulted for specific examples.

CONTRAINDICATIONS:
  • Treatment of onychomycosis in patients with evidence of ventricular dysfunction such as CHF or history of CHF
  • Use of the oral solution formulation in patients with evidence of ventricular dysfunction such as CHF or history of CHF, except for the treatment of life-threatening or other serious infections
  • Coadministration of certain agents metabolized by CYP450 3A4 as increased plasma levels of such agents may increase or prolong pharmacologic effects and/or side effects to these agents
  • Coadministration with levacetylmethadol (levomethadyl), methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (e.g., dihydroergotamine, ergometrine [ergonovine], ergotamine, methylergometrine [methylergonovine]), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor
  • Coadministration with colchicine, fesoterodine, or solifenacin in patients with varying degrees of hepatic or renal dysfunction
  • Coadministration with eliglustat in patients who are poor/intermediate metabolizers of CYP450 2D6 and in patients taking strong/moderate CYP450 2D6 inhibitors
  • Treatment of onychomycosis in pregnant patients or women considering pregnancy
  • Known hypersensitivity to the active component

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:

  • This drug is not removed by dialysis.

Other Comments

Administration advice:

  • Do not use the oral solution and capsule formulations interchangeably.
  • Continue therapy for at least 3 months and until clinical parameters and laboratory tests indicate the active fungal infection has subsided; an inadequate duration of therapy may cause active infection to recur.
100-mg Capsules:
  • Administer doses greater than 200 mg/day in 2 divided doses.
  • Administer with a full meal to ensure maximal absorption; swallow whole.
  • Administer acid neutralizing agents (e.g., aluminum hydroxide) at least 2 hours before or 2 hours after administration of this product.
65-mg Capsules:
  • Administer with food.
  • Swallow whole; do not chew, crush, or break this product.
  • Not interchangeable or substitutable with other formulations (due to dosing differences); follow the specific dosage recommendations for this product.
  • Do not use this product to treat onychomycosis.
Oral Solution:
  • Administer without food to maximize absorption.

Storage requirements:
  • Capsules: Store the 100-mg capsules at 15C to 25C (59F to 77F); protect from light and moisture. Store the 65-mg capsules at 25C (77F), with excursions permitted to 15C to 30C (59F to 86F); dispense in a tight, light resistant container.
  • Oral solution: Store at or below 25C (77F); do not freeze.

General:
  • Current guidelines should be consulted for additional information.
  • Use of this drug in elderly patients is recommended only if the benefit outweighs the risk.
  • This drug is not approved by US FDA for use in pediatric patients or for use in infections in adults other than oropharyngeal and esophageal candidiasis, blastomycosis, histoplasmosis, aspergillosis, and onychomycosis.
  • Specimens for fungal culture and other relevant laboratory studies (e.g., wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms; therapy may be started before results are known, but once available, antifungal therapy should be adjusted accordingly.
  • Therapeutic drug monitoring has been suggested for systemic infections; drug serum levels should be obtained after at least 2 weeks of use to ensure adequate drug exposure.
  • Alternative therapy should be considered if cystic fibrosis patients show no response to the 100-mg capsules or the oral solution.
  • Limited data are available on the safety of long-term use (exceeding 6 months) of the oral solution.

Monitoring:
  • Cardiovascular: Signs/symptoms of CHF in patients with risk factors (during therapy)
  • Hepatic: Liver function in all patients (during therapy)
  • Nervous System: For neurologic symptoms (during long-term therapy)

Patient advice:
  • Read the US FDA-approved patient labeling (Patient Information).
  • Discontinue this drug and contact health care provider at once if signs/symptoms of CHF occur during therapy.
  • Discontinue therapy at once and contact health care provider if any signs/symptoms suggestive of liver dysfunction (e.g., unusual fatigue, anorexia, nausea and/or vomiting, jaundice, dark urine, pale stools) develop.
  • Discontinue therapy and notify physician if any hearing loss symptoms occur.
  • Do not drive or operate machinery if dizziness or blurred/double vision occurs.
  • Inform physician if you become pregnant or intend to become pregnant during therapy.

Frequently asked questions

  • What home remedies work well for toenail fungus?
  • How do I get rid of nail fungus?
  • What is the difference between Tolsura and Sporanox?
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