Itraconazole Dosage

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Usual Adult Dose for Blastomycosis

Capsules: 200 mg orally once a day; if no obvious improvement or if evidence of progressive fungal disease, the dose should be increased in 100 mg increments to a maximum of 400 mg/day
Treatment should be continued for a minimum of 3 months and until clinical parameters and laboratory tests indicate the active fungal infection has subsided.

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 (following an initial regimen of IV amphotericin B): 200 mg orally 3 times a day for 3 days, then 200 mg orally once or twice a day
Total treatment duration:
Pulmonary blastomycosis: 6 to 12 months
Disseminated extrapulmonary blastomycosis: At least 12 months
Immunocompromised patients: At least 12 months

CNS blastomycosis (following an 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

Usual Adult Dose for Histoplasmosis

Capsules: 200 mg orally once a day; if no obvious improvement or if evidence of progressive fungal disease, the dose should be increased in 100 mg increments to a maximum of 400 mg/day
Treatment should be continued for a minimum of 3 months and until clinical parameters and laboratory tests indicate the active fungal infection has subsided.

Oral solution (preferred):
IDSA recommendations:
Mild to moderate acute pulmonary infection in patients with symptoms longer than 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 (following an initial regimen of IV amphotericin B): 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day for a total treatment duration of 12 weeks

Chronic cavitary pulmonary histoplasmosis: 200 mg orally 3 times a day for 3 days, then 200 mg orally once or twice a day for at least 1 year (18 to 24 months is preferred by some clinicians due to risk of relapse)

Mild to moderate progressive disseminated histoplasmosis: 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day for at least 1 year

Moderately severe to severe progressive disseminated histoplasmosis (following an initial regimen of IV amphotericin B): 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day for a total treatment duration of at least 12 months

Histoplasmosis with symptomatic mediastinal granuloma or with complications (pericarditis, rheumatologic syndromes, symptomatic mediastinal lymphadenitis) that require treatment with corticosteroids: 200 mg orally 3 times a day for 3 days, then 200 mg orally once or twice a day for 6 to 12 weeks

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

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

CNS histoplasmosis (following an initial regimen of IV amphotericin B): 200 mg orally 2 or 3 times a day for at least 1 year and until CSF abnormalities resolve and histoplasmal antigen is undetectable

Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and IDSA recommendations for HIV-infected patients:
Less severe disseminated histoplasmosis: 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 histoplasmosis (following an initial regimen of IV amphotericin B): 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day for a total treatment duration of greater than 12 months

Confirmed meningitis (following an initial regimen of IV amphotericin B): 200 mg orally 2 or 3 times a day for a total treatment duration of at least 1 year and until CSF abnormalities

Primary prophylaxis: 200 mg orally once a day

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

Usual Adult Dose for Aspergillosis - Aspergilloma

Capsules: 200 to 400 mg orally per day in one or two divided doses
Treatment should be continued for a minimum of 3 months and until clinical parameters and laboratory tests indicate the active fungal infection has subsided.

IDSA recommendations:
Invasive aspergillosis: 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day
Empirical and preemptive therapy: 200 mg orally twice a day
Primary prophylaxis in immunocompromised patients (alternative therapy): 200 mg orally twice a day

Usual Adult Dose for Aspergillosis - Invasive

Capsules: 200 to 400 mg orally per day in one or two divided doses
Treatment should be continued for a minimum of 3 months and until clinical parameters and laboratory tests indicate the active fungal infection has subsided.

IDSA recommendations:
Invasive aspergillosis: 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day
Empirical and preemptive therapy: 200 mg orally twice a day
Primary prophylaxis in immunocompromised patients (alternative therapy): 200 mg orally twice a day

Usual Adult Dose for Oral Thrush

Oral solution:
Oropharyngeal candidiasis: 200 mg orally once a day for 1 to 2 weeks

Clinical signs and symptoms of oropharyngeal candidiasis generally resolve within several days. Only the oral solution has been demonstrated effective for oral and/or esophageal candidiasis.

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

Clinical response will be seen in 2 to 4 weeks in patients responding to therapy. Patients may be expected to relapse shortly after discontinuing therapy.

Usual Adult Dose for Esophageal Candidiasis

Oral solution: 100 mg orally once a day for a minimum of 3 weeks
Treatment should continue for 2 weeks following resolution of symptoms. Doses up to 200 mg/day may be used.

Only the oral solution has been demonstrated effective for oral and/or esophageal candidiasis.

Usual Adult Dose for Onychomycosis - Toenail

Capsules (with or without fingernail involvement) or tablets: 200 mg orally once a day for 12 consecutive weeks

Usual Adult Dose for Onychomycosis - Fingernail

Fingernails only:
Capsules: 200 mg orally twice a day for 1 week; the dosing should be repeated after 3 weeks without itraconazole for a total of 2 treatment pulses

Usual Adult Dose for Coccidioidomycosis

(Not approved by FDA)

IDSA recommendations: 200 mg orally 2 or 3 times a day

Duration:
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 (nonmeningeal): 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day
Meningeal infection (as an alternative to fluconazole): 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day
Primary prophylaxis: 200 mg orally twice a day
Prevention of recurrence (secondary prophylaxis): 200 mg orally twice a day

Usual Adult Dose for Sporotrichosis

(Not approved by FDA)

Oral solution (preferred):
IDSA recommendations:
Cutaneous or lymphocutaneous infection: 200 mg orally once a day for 2 to 4 weeks after all lesions have resolved (usually a total of 3 to 6 months); 200 mg orally twice a day is recommended if a response is not obtained

Osteoarticular infection: 200 mg orally twice a day for at least 12 months; if used following an initial regimen of IV amphotericin B (alternative therapy), itraconazole should be continued for a total treatment duration of at least 12 months

Less severe pulmonary infection: 200 mg orally twice a day for at least 12 months

Meningeal infection, disseminated infection, or severe or life-threatening pulmonary infection (following an initial regimen of IV amphotericin B for each infection): 200 mg orally twice a day for a total treatment duration of 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

Usual Adult Dose for Cryptococcosis

(Not approved by FDA)

Oral solution (preferred):
IDSA recommendations:
Mild to moderate pulmonary infection (nonmeningeal) in immunocompetent patients: 200 orally twice a day for 6 to 12 months
Prevention of recurrence (secondary prophylaxis) in HIV-infected patients: 200 mg orally twice a day

Fluconazole is the preferred agent. Itraconazole is recommended as an alternative if fluconazole is unavailable or contraindicated.

Usual Adult Dose for Cryptococcal Meningitis - Immunosuppressed Host

(Not approved by FDA)

Oral solution (preferred):
CDC, NIH, and IDSA recommendations for HIV-infected patients:
Consolidation therapy (after at least 2 weeks of successful induction therapy): 200 mg orally twice a day for 8 weeks or as determined by target CD4+ counts
Maintenance therapy: 200 mg orally once a day

Fluconazole is the preferred agent. Itraconazole is recommended as an alternative if fluconazole is unavailable or contraindicated.

Usual Adult Dose for Vaginal Candidiasis

(Not approved by FDA)

Capsules: 200 mg orally twice a day for 1 day

CDC, NIH, and IDSA recommendations for HIV-infected patients:
Oral solution: 200 mg orally once a day for 3 to 7 days

Usual Adult Dose for Microsporidiosis

(Not approved by FDA)

CDC, NIH, and IDSA recommendations for HIV-infected patients:
Disseminated infection due to Trachipleistophora or Anncaliia: 400 mg orally once a day in conjunction with albendazole

This regimen is recommended as alternative therapy.

Usual Adult Dose for Tinea Versicolor

(Not approved by FDA)

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

Usual Adult Dose for Paracoccidioidomycosis

(Not approved by FDA)

200 mg orally once a day for 6 months

Usual Pediatric Dose for Blastomycosis

(Not approved by FDA)

IDSA recommendations for children:
Mild to moderate infection: 10 mg/kg orally per day (up to 400 mg/day) for 6 to 12 months

Moderately severe to severe infection (following an initial regimen of IV amphotericin B): 10 mg/kg orally per day (up to 400 mg/day) for a total treatment duration of 12 months

Usual Pediatric Dose for Histoplasmosis

(Not approved by FDA)

Oral solution:
IDSA recommendations for children:
Acute pulmonary infection: 5 to 10 mg/kg/day orally in 2 divided doses (up to 400 mg/day)

Progressive disseminated histoplasmosis (following an initial regimen of IV amphotericin B): 5 to 10 mg/kg/day orally in 2 divided doses (up to 400 mg/day) for a total treatment duration of 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 (up to 200 mg/day)

CDC, NIH, and IDSA recommendations:
HIV-exposed and HIV-infected infants and children:
Mild disseminated histoplasmosis: 2 to 5 mg/kg (up to 200 mg/dose) orally 3 times a day for 3 days, then 2 to 5 mg/kg (up to 200 mg/dose) orally twice a day for 12 months

Consolidation therapy for moderately severe to severe disseminated histoplasmosis (following an initial regimen of IV amphotericin B): 2 to 5 mg/kg (up to 200 mg) orally 3 times a day for 3 days, then 2 to 5 mg/kg (up to 200 mg) twice a day for 12 months

Consolidation therapy for CNS infection (following an initial regimen of IV amphotericin B): 2 to 5 mg/kg (up to 200 mg) orally 3 times a day for 3 days, then 2 to 5 mg/kg (up to 200 mg) orally twice a day for at least 12 months and until CSF abnormalities resolve and histoplasmal antigen is undetectable

Prophylaxis to prevent recurrence: 5 mg/kg (up to 200 mg/dose) orally twice a day

HIV-infected adolescents:
Less severe disseminated histoplasmosis: 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 histoplasmosis (following an initial regimen of IV amphotericin B): 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day for a total treatment duration of greater than 12 months

Confirmed meningitis (following an initial regimen of IV amphotericin B): 200 mg orally 2 or 3 times a day for a total treatment duration of at least 1 year and until CSF abnormalities

Primary prophylaxis: 200 mg orally once a day

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

Usual Pediatric Dose for Oral Thrush

(Not approved by FDA)

Oral solution:
IDSA recommendations for patients 5 years or older:
Oropharyngeal candidiasis: 2.5 mg/kg orally twice a day

CDC, NIH, and IDSA recommendations:
HIV-exposed and HIV-infected infants and children:
Oropharyngeal candidiasis: 2.5 mg/kg orally twice a day (up to 200 mg/day) for 7 to 14 days
Fluconazole-refractory oropharyngeal candidiasis: 2.5 mg/kg orally twice a day (up to 400 mg/day) for 7 to 14 days

HIV-infected adolescents:
Oropharyngeal candidiasis, including fluconazole-refractory infections: 200 mg orally once a day for 7 to 14 days

Usual Pediatric Dose for Esophageal Candidiasis

(Not approved by FDA)

Oral solution:
IDSA recommendations for patients 5 years or older: 2.5 mg/kg orally twice a day

CDC, NIH, and IDSA recommendations:
HIV-exposed and HIV-infected infants and children: 5 mg/kg/day orally in one or two divided doses for 14 to 21 days
HIV-infected adolescents: 200 mg orally once a day for 14 to 21 days

Usual Pediatric Dose for Coccidioidomycosis

(Not approved by FDA)

CDC, NIH, and IDSA recommendations:
HIV-exposed and HIV-infected infants and children:
Mild infection (nonmeningeal): 5 to 10 mg/kg orally twice a day for 3 days, then 2 to 5 mg/kg orally twice a day for 3 to 6 months
Diffuse pulmonary or disseminated infection (nonmeningeal) in stable patients: 5 to 10 mg/kg orally twice a day for 3 days, then 2 to 5 mg/kg orally twice a day (up to 400 mg/day) for at least 1 year
Prophylaxis to prevent recurrence: 2 to 5 mg/kg (up to 200 mg/dose) orally twice a day

HIV-infected adolescents:
Mild infection (nonmeningeal): 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day
Meningeal infection (as an alternative to fluconazole): 200 mg orally 3 times a day for 3 days, then 200 mg orally twice a day
Primary prophylaxis: 200 mg orally twice a day
Prevention of recurrence (secondary prophylaxis): 200 mg orally twice a day

Usual Pediatric Dose for Cryptococcosis

(Not approved by FDA)

Oral solution:
CDC, NIH, and IDSA recommendations for HIV-exposed and HIV-infected infants and children:
Prophylaxis to prevent recurrence: 5 mg/kg (up to 200 mg/dose) orally once a day

Fluconazole is the preferred agent. Itraconazole is recommended as an alternative if fluconazole is unavailable or contraindicated.

Usual Pediatric Dose for Cryptococcal Meningitis - Immunosuppressed Host

(Not approved by FDA)

Oral solution (preferred):
CDC, NIH, and IDSA recommendations:
HIV-exposed and HIV-infected infants and children:
Consolidation therapy for CNS infection: 2.5 to 5 mg/kg (up to 200 mg/dose) orally 3 times a day for 3 days, then 5 to 10 mg/kg/day orally in one or two divided doses (up to 200 mg/dose) for at least 8 weeks

HIV-infected adolescents:
Consolidation therapy (after at least 2 weeks of successful induction therapy): 200 mg orally twice a day for 8 weeks or as determined by target CD4+ counts
Maintenance therapy: 200 mg orally once a day

Fluconazole is the preferred agent. Itraconazole is recommended as an alternative if fluconazole is unavailable or contraindicated.

Usual Pediatric Dose for Vaginal Candidiasis

(Not approved by FDA)

CDC, NIH, and IDSA recommendations for HIV-infected adolescents:
Oral solution: 200 mg orally once a day for 3 to 7 days

Usual Pediatric Dose for Sporotrichosis

(Not approved by FDA)

Oral solution (preferred):
IDSA recommendations for children:
Cutaneous or lymphocutaneous infection: 6 to 10 mg/kg orally per day (up to 400 mg/day)
Disseminated infection (following an initial regimen of IV amphotericin B): 6 to 10 mg/kg orally per day (up to 400 mg/day)

Usual Pediatric Dose for Tinea Capitis

(Not approved by FDA)

Continuous regimen:
Trichophyton tonsurans and Trichophyton 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:
Capsules:
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

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

The manufacturer recommends caution when administering oral itraconazole to patients with renal dysfunction.

Liver Dose Adjustments

The manufacturer recommends caution when administering oral itraconazole to patients with liver dysfunction.

Dose Adjustments

Adults:
Use of a loading dose is recommended in life-threatening situations.
Capsules: 200 mg orally 3 times a day for the first 3 days of therapy followed by usual oral dosage of 200 to 400 mg/day

Precautions

Itraconazole use is contraindicated in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF except for the treatment of life-threatening or other serious infections. Itraconazole has been shown to produce negative inotropic effects. For patients with risk factors for CHF, prescribers should carefully review the risks and benefits of itraconazole therapy. These risk factors include cardiac disease such as ischemic and valvular disease; significant pulmonary disease such as chronic obstructive pulmonary disease; and renal failure and other edematous disorders. Such patients should be made aware of the signs and symptoms of CHF, should be treated with caution, and should be monitored for signs and symptoms of CHF during therapy. If signs or symptoms of CHF appear during therapy with itraconazole capsules or tablets, the drug should be discontinued. If signs or symptoms of CHF appear during therapy with itraconazole oral solution, continued itraconazole use should be reassessed.

Itraconazole has been associated with reports of CHF. Heart failure was reported during postmarketing experience more often in patients receiving 400 mg per day; however, there were cases reported in patients receiving lower doses.

Itraconazole can inhibit the metabolism of calcium channel blockers. Since calcium channel blockers can have negative inotropic effects which may add to those of itraconazole and increase the risk of CHF, caution is recommended with concurrent use. Coadministration of itraconazole with nisoldipine or felodipine is contraindicated.

Itraconazole may potentially interact with many drugs. These interactions may be serious and/or life-threatening. Patients should be advised to report all concurrent medications they are taking. Coadministration of pimozide, quinidine, cisapride, dofetilide, oral midazolam, felodipine, nisoldipine, triazolam, or levacetylmethadol (levomethadyl), lovastatin, simvastatin, ergot alkaloids [such as dihydroergotamine, ergometrine (ergonovine), ergotamine, and methylergometrine (methylergonovine)], or methadone with itraconazole is contraindicated. Itraconazole, a potent CYP450 3A4 inhibitor, may increase plasma concentrations of drugs metabolized by this pathway. Serious cardiovascular events, including QT prolongation, torsades de pointes, ventricular tachycardia, cardiac arrest, and/or sudden death have been reported in patients using cisapride, pimozide, levacetylmethadol (levomethadyl), methadone, or quinidine concomitantly with itraconazole and/or other CYP450 3A4 inhibitors.

Itraconazole should not be given for the treatment of onychomycosis to pregnant patients or to women contemplating pregnancy.

Itraconazole has been associated with cases of serious hepatotoxicity, including liver failure and death. Some cases had neither preexisting liver dysfunction nor a serious underlying medical condition, and some cases developed within the first week of treatment. Treatment with itraconazole is strongly discouraged in patients with elevated or abnormal liver enzymes or active liver disease, or who developed liver toxicity with other drugs unless there is a serious or life-threatening situation and benefit is expected to exceed the risk. Liver function tests are recommended in patients with preexisting hepatic function abnormalities or those who have experienced liver toxicity with other drugs and should be considered in all patients receiving itraconazole. If clinical signs or symptoms of liver toxicity occur, treatment should be discontinued at once and liver function testing should be performed.

If neuropathy occurs that may be attributable to itraconazole, the therapy should be discontinued.

Transient or permanent hearing loss has been reported with itraconazole therapy. Several of these reports included concomitant quinidine, which is contraindicated. Hearing loss generally resolves when treatment is stopped, but may persist in some patients. Patients should be advised to discontinue therapy and notify their physicians if any hearing loss symptoms occur.

Itraconazole oral solution as treatment for oropharyngeal and/or esophageal candidiasis was not studied in severely neutropenic patients. Due to the pharmacokinetic properties of the oral solution, it is not recommended for initial use in patients at immediate risk of systemic candidiasis.

Alternative therapy should be considered for cystic fibrosis patients who do not respond to itraconazole oral solution.

Some clinicians consider the dosage of the solution to be approximately one-half that of the capsule, although an exact dosage conversion has not been determined by the manufacturer and the two formulations are approved by the FDA for different indications.

Studies have shown that absorption of itraconazole is impaired when gastric acid production is decreased; therefore, itraconazole should be administered with a cola beverage if the patient has achlorhydria or is taking H2-receptor antagonists or other gastric acid suppressors. Antacids should be administered at least 1 hour before or 2 hours after administration of itraconazole capsules. Although the effect of H2-antagonists with itraconazole oral solution is expected to be much less than with the capsules, caution is recommended when the 2 drugs are coadministered.

Hypochlorhydria has been reported in HIV-infected patients. Itraconazole absorption may be decreased in these patients. Administration with a cola beverage will usually help enhance the absorption.

The safety of itraconazole oral solution use beyond 6 months has not been established.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Itraconazole is not dialyzable.

Other Comments

Doses greater than 200 mg/day should be given in 2 divided doses.

The oral solution and capsules should not be used interchangeably.

Itraconazole capsules should be taken with a full meal or a cola beverage to ensure maximal absorption.

The oral solution should be taken on an empty stomach to maximize absorption. It should be vigorously swished in the mouth (10 mL at a time) for several seconds and swallowed.

Itraconazole tablets should be taken with a full meal.

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