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Itraconazole Dosage

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Usual Adult Dose for Blastomycosis

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

Comments:
-Capsule formulation
-A loading dose should be used in life-threatening situations.
-If no obvious improvement or if evidence of progressive fungal disease at 200 mg/day, the dose should be increased in 100 mg increments to a maximum of 400 mg/day.

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
Duration of therapy: 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
Total duration of therapy:
-Pulmonary infection: 6 to 12 months
-Disseminated extrapulmonary infection: At least 12 months
-Immunocompromised patients: At least 12 months

CNS infection (after initial regimen of IV amphotericin B): 200 mg orally 2 or 3 times a day
Duration of therapy: 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.

Usual Adult Dose for Histoplasmosis

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

Comments:
-Capsule formulation
-A loading dose should be used in life-threatening situations.
-If no obvious improvement or if evidence of progressive fungal disease at 200 mg/day, the dose should be increased in 100 mg increments to a maximum of 400 mg/day.

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
Duration of therapy: 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
Total duration of therapy: 12 weeks

Chronic cavitary pulmonary infection: 200 mg orally 3 times a day for 3 days, then 200 mg orally once or twice a day
Duration of therapy: At least 1 year (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
Duration of therapy: At least 1 year

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
Total duration of therapy: At least 12 months

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
Duration of therapy: 6 to 12 weeks

CNS infection (after initial regimen of IV amphotericin B): 200 mg orally 2 or 3 times a day
Duration of therapy: At least 1 year and until CSF abnormalities resolve and histoplasmal antigen is undetectable

Primary prophylaxis in immunosuppressed patients: 200 mg orally once a day

Prevention of recurrence (secondary prophylaxis): 200 mg orally once a day

Comments:
-The oral solution formulation is preferred, but the capsule formulation may be used.
-Lifelong suppressive therapy with this drug may be needed if immunosuppression cannot be reversed.

CDC, National Institutes of Health (NIH), and 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
Duration of therapy: 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
Total duration of therapy: At least 12 months

Confirmed meningitis (after initial regimen of IV amphotericin B): 200 mg orally 2 or 3 times a day
Duration of therapy: At least 12 months and until CSF abnormalities resolve

Primary prophylaxis: 200 mg orally once a day

Long-term suppressive therapy (secondary prophylaxis): 200 mg orally once a day

Comments:
-Recommended as preferred therapy
-The oral solution formulation is preferred.

Usual Adult Dose for Aspergillosis - Aspergilloma

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

Comments:
-Capsule formulation
-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 intolerant of, or refractory to, amphotericin B

IDSA Recommendations:
Invasive aspergillosis: 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day
Empirical and preemptive antifungal therapy: 200 mg orally twice a day
Prophylaxis against invasive aspergillosis: 200 mg orally twice a day

Comments:
-Recommended as alternative (salvage) therapy for invasive aspergillosis and prophylaxis against invasive aspergillosis in patients intolerant of, or refractory to, primary antifungal therapy
-Recommended as primary therapy for empirical and preemptive antifungal therapy

Usual Adult Dose for Aspergillosis - Invasive

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

Comments:
-Capsule formulation
-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 intolerant of, or refractory to, amphotericin B

IDSA Recommendations:
Invasive aspergillosis: 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day
Empirical and preemptive antifungal therapy: 200 mg orally twice a day
Prophylaxis against invasive aspergillosis: 200 mg orally twice a day

Comments:
-Recommended as alternative (salvage) therapy for invasive aspergillosis and prophylaxis against invasive aspergillosis in patients intolerant of, or refractory to, primary antifungal therapy
-Recommended as primary therapy for empirical and preemptive antifungal therapy

Usual Adult Dose for Oral Thrush

Oropharyngeal candidiasis: 200 mg orally once a day
Duration of therapy: 1 to 2 weeks

Oropharyngeal candidiasis unresponsive/refractory to treatment with fluconazole tablets: 100 mg orally twice a day

Comments:
-Oral solution formulation
-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.
-Only the oral solution has demonstrated efficacy for oral and/or esophageal candidiasis.
-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.

IDSA Recommendations:
Oropharyngeal candidiasis: 200 mg orally per day
Duration of therapy for uncomplicated infection: 7 to 14 days

Comments:
-Oral solution formulation
-Recommended as alternative therapy for refractory infection

CDC, NIH, and IDSA Recommendations for HIV-infected Patients:
Oropharyngeal candidiasis (initial episodes): 200 mg orally per day
Duration of therapy: 7 to 14 days

Secondary prophylaxis (suppressive therapy): 200 mg orally per day

Comments:
-Oral solution formulation
-Recommended as alternative oral therapy
-Secondary prophylaxis not routinely recommended.

Usual Adult Dose for Esophageal Candidiasis

100 mg orally once a day
Duration of therapy: At least 3 weeks and for 2 weeks after symptoms resolve

Comments:
-Oral solution formulation
-Doses up to 200 mg/day may be used based on clinical judgment of patient response.
-The oral solution should be vigorously swished in the mouth (10 mL at a time) for several seconds and swallowed.
-Only the oral solution has demonstrated efficacy for oral and/or esophageal candidiasis.

IDSA Recommendations: 200 mg orally per day
Duration of therapy: 14 to 21 days

Comments:
-Oral solution formulation
-Recommended as alternative therapy for refractory infection

CDC, NIH, and IDSA Recommendations for HIV-infected Patients: 200 mg orally per day
Duration of therapy: 14 to 21 days

Comments:
-Oral solution formulation
-Recommended as preferred therapy

Usual Adult Dose for Onychomycosis - Toenail

200 mg orally once a day
Duration of therapy: 12 consecutive weeks

Comments:
-Capsule or tablet formulation
-Capsules: 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.

Uses:
-Capsules: For the treatment of onychomycosis of the toenail (with or without fingernail involvement) due to dermatophytes (tinea unguium) in non-immunocompromised patients
-Tablets: For the treatment of onychomycosis of the toenail due to Trichophyton rubrum or T mentagrophytes in non-immunocompromised patients

Usual Adult Dose for Onychomycosis - Fingernail

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

Comments:
-Capsule formulation
-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 2 or 3 times a day
Duration of therapy:
-Uncomplicated coccidioidal pneumonia: 3 to 6 months
-Diffuse pneumonia and chronic progressive fibrocavitary pneumonia: At least 1 year

CDC, NIH, and IDSA Recommendations for HIV-infected Patients:
Mild infection (e.g., focal pneumonia): 200 mg orally twice a day
Severe nonmeningeal infection (diffuse pulmonary or severely ill patients with extrathoracic disseminated disease) - acute phase: 400 mg orally per day
Meningeal infection: 200 mg orally twice a day
Chronic suppressive therapy (secondary prophylaxis): 200 mg orally twice a day

Comments:
-Recommended as preferred therapy for mild infections and chronic suppressive therapy
-Preferred therapy for severe nonmeningeal infections includes treatment with IV amphotericin B until clinical improvement followed by a triazole; as alternative therapy, some experts add a triazole (this drug preferred for bone disease) to amphotericin B therapy and continue the triazole after amphotericin B is stopped.
-Recommended as alternative therapy for meningeal infections; a specialist should be consulted.

Usual Adult Dose for Sporotrichosis

IDSA Recommendations:
Cutaneous or lymphocutaneous infection:
-Recommended dose: 200 mg orally once a day
-If patients do not respond: 200 mg orally twice a day
Duration of therapy: 2 to 4 weeks after all lesions resolve (usually 3 to 6 months total)

Osteoarticular infection: 200 mg orally twice a day
Total duration of therapy: At least 12 months

Less severe pulmonary infection: 200 mg orally twice a day
Duration of therapy: At least 12 months

Meningeal infection, disseminated infection, or severe or life-threatening pulmonary infection (after initial regimen of IV amphotericin B): 200 mg orally twice a day
Total duration of therapy: At least 12 months

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.

Usual Adult Dose for Cryptococcosis

IDSA Recommendations:
Mild to moderate pulmonary infection (nonmeningeal) in immunocompetent patients: 200 orally twice a day
Duration of therapy: 6 to 12 months

Maintenance (suppressive) and prophylactic therapy in HIV-infected patients: 200 mg orally twice a day
Duration of therapy: At least 1 year

Comments:
-Recommended as alternative therapy; fluconazole is preferred.
-The oral solution formulation is preferred.
-Primary prophylaxis not routinely recommended.

Usual Adult Dose for Cryptococcal Meningitis - Immunosuppressed Host

CDC, NIH, and IDSA Recommendations for HIV-infected Patients:
Consolidation therapy: 200 mg orally twice a day
Duration of therapy: 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.

Usual Adult Dose for Vaginal Candidiasis

Vulvovaginal candidiasis: 200 mg orally twice a day for 1 day

Comments:
-Capsule formulation

CDC, NIH, and IDSA Recommendations for HIV-infected Patients:
Uncomplicated vulvovaginal candidiasis: 200 mg orally per day for 3 to 7 days

Comments:
-Oral solution formulation
-Recommended as alternative therapy

Usual Adult Dose for Microsporidiosis

CDC, NIH, and IDSA Recommendations for HIV-infected Patients:
Disseminated infection due to Trachipleistophora or Anncaliia: 400 mg orally per day

Comments:
-This drug may be useful when used in conjunction with albendazole.

Usual Adult Dose for Systemic Fungal Infection

IDSA Recommendations:
Empirical therapy: 200 mg orally twice a day

Comments:
-Recommended as alternative therapy for suspected invasive candidiasis in neutropenic patients

Usual Adult Dose for Fungal Infection Prophylaxis

IDSA Recommendations:
Antifungal prophylaxis for patients with chemotherapy-induced neutropenia: 200 mg orally twice a day

Comments:
-Recommended as alternative therapy

Usual Adult Dose for Tinea Versicolor

Study (n=36)
200 mg orally once a day for 7 days

Usual Adult Dose for Paracoccidioidomycosis

200 mg orally once a day for 6 months

Usual Pediatric Dose for Blastomycosis

IDSA Recommendations for Children:
Mild to moderate infection: 10 mg/kg orally per day
Maximum dose: 400 mg/day
Duration of therapy: 6 to 12 months

Moderately severe to severe infection (after initial regimen of IV amphotericin B): 10 mg/kg orally per day
Maximum dose: 400 mg/day
Total duration of therapy: 12 months

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
Maximum dose: 400 mg/day
Total duration of therapy: 3 months; longer therapy may be needed for patients with severe disease, immunosuppression, or primary immunodeficiency syndromes

Prevention of recurrence (secondary prophylaxis): 5 mg/kg orally per day
Maximum dose: 200 mg/day

Comments:
-The oral solution formulation is generally used.
-Lifelong suppressive therapy with this drug may be needed if immunosuppression cannot be reversed.

CDC, NIH, 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
Maximum dose: 200 mg/dose
Duration of therapy: 12 months; 12 weeks may be sufficient for patients with functional cellular immunity

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
Maximum dose: 200 mg/dose
Duration of therapy: 12 months

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
Maximum dose: 200 mg/dose
Duration of therapy: 12 months

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
Maximum dose: 200 mg/dose
Duration of therapy: At least 12 months and until CSF abnormalities resolve and histoplasmal antigen is undetectable

Secondary prophylaxis (suppressive therapy): 5 to 10 mg/kg orally per day
Maximum dose: 200 mg/dose

Comments:
-Recommended as preferred therapy
-The oral solution formulation is preferred.
-Consolidation therapy should be followed by chronic suppressive therapy.

CDC, NIH, and 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
Duration of therapy: 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
Total duration of therapy: At least 12 months

Confirmed meningitis (after initial regimen of IV amphotericin B): 200 mg orally 2 or 3 times a day
Duration of therapy: At least 12 months and until CSF abnormalities resolve

Primary prophylaxis: 200 mg orally once a day

Long-term suppressive therapy (secondary prophylaxis): 200 mg orally once a day

Comments:
-Recommended as preferred therapy
-The oral solution formulation is preferred.

Usual Pediatric Dose for Oral Thrush

IDSA Recommendations:
Oropharyngeal candidiasis in patients 5 years or older: 2.5 mg/kg orally twice a day

Comments:
-Oral solution formulation

CDC, NIH, IDSA, PIDS, and AAP Recommendations for HIV-exposed and HIV-infected Children:
Fluconazole-refractory oropharyngeal candidiasis: 2.5 mg/kg orally twice a day
Maximum dose: 400 mg/day
Duration of therapy: 7 to 14 days

Secondary prophylaxis: 2.5 mg/kg orally twice a day

Comments:
-Oral solution formulation
-Recommended as alternative therapy for fluconazole-refractory infection
-Secondary prophylaxis not routinely recommended.

CDC, NIH, and IDSA Recommendations for HIV-infected Adolescents:
Oropharyngeal candidiasis (initial episodes): 200 mg orally per day
Duration of therapy: 7 to 14 days

Secondary prophylaxis (suppressive therapy): 200 mg orally per day

Comments:
-Oral solution formulation
-Recommended as alternative oral therapy
-Secondary prophylaxis not routinely recommended.

Usual Pediatric Dose for Esophageal Candidiasis

IDSA Recommendations:
5 years or older: 2.5 mg/kg orally twice a day

Comments:
-Oral solution formulation

CDC, NIH, IDSA, PIDS, and AAP Recommendations for HIV-exposed and HIV-infected Children: 2.5 mg/kg orally twice a day
Duration of therapy: At least 3 weeks and for at least 2 weeks after symptoms resolve

Comments:
-Oral solution formulation
-Recommended as preferred therapy

CDC, NIH, and IDSA Recommendations for HIV-infected Adolescents: 200 mg orally per day
Duration of therapy: 14 to 21 days

Comments:
-Oral solution formulation
-Recommended as preferred therapy

Usual Pediatric Dose for Coccidioidomycosis

CDC, NIH, 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

Comments:
-Recommended as alternative therapy for secondary prophylaxis and mild to moderate nonmeningeal infections
-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 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.

CDC, NIH, and IDSA Recommendations for HIV-infected Adolescents:
Mild infection (e.g., focal pneumonia): 200 mg orally twice a day
Severe nonmeningeal infection (diffuse pulmonary or severely ill patients with extrathoracic disseminated infection) - acute phase: 400 mg orally per day
Meningeal infection: 200 mg orally twice a day
Chronic suppressive therapy (secondary prophylaxis): 200 mg orally twice a day

Comments:
-Recommended as preferred therapy for mild infections and chronic suppressive therapy
-Preferred therapy for severe nonmeningeal infections includes treatment with IV amphotericin B until clinical improvement followed by a triazole; as alternative therapy, some experts add a triazole (this drug preferred for bone disease) to amphotericin B therapy and continue the triazole after amphotericin B is stopped.
-Recommended as alternative therapy for meningeal infections; a specialist should be consulted.

Usual Pediatric Dose for Cryptococcosis

CDC, NIH, IDSA, PIDS, and AAP Recommendations for HIV-exposed and HIV-infected Children:
Suppressive therapy (secondary prophylaxis): 5 mg/kg orally once a day
Maximum dose: 200 mg/dose
Duration of therapy: At least 1 year

Comments:
-Recommended as alternative therapy; fluconazole is preferred.
-Oral solution formulation

Usual Pediatric Dose for Cryptococcal Meningitis - Immunosuppressed Host

CDC, NIH, 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
Maximum dose:
-Loading dose: 200 mg/dose
-Maintenance dose: 400 mg/day
Duration of therapy: At least 8 weeks

Comments:
-Recommended as alternative therapy; fluconazole is preferred.
-The oral solution formulation is preferred.
-Consolidation therapy should begin after at least 2 weeks of successful induction therapy and should be followed by secondary prophylaxis.

CDC, NIH, and IDSA Recommendations for HIV-infected Adolescents:
Consolidation therapy: 200 mg orally twice a day
Duration of therapy: 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.

Usual Pediatric Dose for Vaginal Candidiasis

CDC, NIH, and IDSA Recommendations for HIV-infected Adolescents:
Uncomplicated vulvovaginal candidiasis: 200 mg orally per day for 3 to 7 days

Comments:
-Oral solution formulation
-Recommended as alternative therapy

Usual Pediatric Dose for Microsporidiosis

CDC, NIH, and IDSA Recommendations for HIV-infected Adolescents:
Disseminated infection due to Trachipleistophora or Anncaliia: 400 mg orally per day

Comments:
-This drug may be useful when used in conjunction with albendazole.

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.

Usual Pediatric Dose for Tinea Capitis

Continuous regimen:
Trichophyton tonsurans and T violaceum (endothrix) species: 5 mg/kg/day orally for 2 to 4 weeks
Microsporum canis (ectothrix) species: 5 mg/kg/day orally for 4 to 6 weeks

Pulse regimen:
T tonsurans, T violaceum (endothrix), and M canis (ectothrix) species: 5 mg/kg/day orally for 1 week followed by a 3-week period off of treatment

Comments:
-Capsule formulation recommended for pulse regimen.
-Patient is evaluated on week 4 from the start of therapy for clinical response; if evidence of tinea capitis remains, additional pulse therapies may be required up to a maximum of 3 pulses.

Renal Dose Adjustments

Caution is recommended.

Liver Dose Adjustments

Caution is recommended.

Dose Adjustments

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

Precautions

US BOXED WARNINGS:
-CHF: This drug should not be used for onychomycosis in patients with evidence of ventricular dysfunction such as CHF or history of CHF. Negative inotropic effects observed with IV use. If signs/symptoms of CHF appear during use of the capsule or tablet formulation, the drug should be discontinued. If signs/symptoms of CHF appear during use of the oral solution formulation, continued use of this drug should be reassessed.
-DRUG INTERACTIONS: Coadministration of the following drugs with itraconazole is contraindicated: pimozide, quinidine, cisapride, dofetilide, oral midazolam, felodipine, nisoldipine, triazolam, levacetylmethadol/levomethadyl, lovastatin, simvastatin, ergot alkaloids (e.g., dihydroergotamine, ergometrine/ergonovine, ergotamine, methylergometrine/methylergonovine), methadone, disopyramide, dronedarone, irinotecan, lurasidone, ranolazine, eplerenone, and, in patients with renal or liver dysfunction, colchicine. Coadministration with itraconazole may lead to increased plasma levels of these drugs and may increase or prolong pharmacologic effects and/or side effects of these drugs. For example, increased plasma levels of some of these drugs may result in QT prolongation and ventricular tachyarrhythmias, including torsades de pointes (a potentially fatal arrhythmia). The manufacturer product information should be consulted for specific examples.

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 dialyzable.

Other Comments

Administration advice:
-Administer doses greater than 200 mg/day in 2 divided doses.
-Administer capsules with a full meal to ensure maximal absorption; swallow capsules whole.
-Administer the oral solution without food to maximize absorption.
-Do not use the oral solution and capsules interchangeably.
-Administer tablets with a full meal, same time each day.
-Administer capsules or tablets with an acidic beverage (e.g., non-diet cola) in patients with reduced gastric acidity due to disease (e.g., achlorhydria) or concomitant drugs (e.g., antacids, gastric acid secretion suppressors).
-Administer acid neutralizing agents (e.g., aluminum hydroxide) at least 1 hour before or 2 hours after administration of capsules or tablets.

Storage requirements:
-Capsules: Store at 15C to 25C (59F to 77F); protect from light and moisture.
-Oral solution: Store at or below 25C (77F); do not freeze.
-Tablets: Store at 15C to 25C (59F to 77F); excursions permitted to 15C to 30C (59F to 86F); protect from light and moisture.

General:
-Current guidelines should be consulted for additional information.
-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.
-The safety of oral solution use beyond 6 months has not been established.

Monitoring:
-Cardiovascular: Signs/symptoms of CHF in patients with risk factors (during therapy)
-General: Antifungal activity in patients with reduced gastric acidity; drug serum levels (after at least 2 weeks of therapy)
-Hepatic: Liver function tests

Patient advice:
-Do not drive or operate machinery if dizziness or blurred/double vision occurs.

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