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itraconazole

Pronunciation

Generic Name: itraconazole (IT ra KON a zole)
Brand Name: Onmel, Sporanox, Sporanox PulsePak

What is itraconazole?

Itraconazole is an antifungal medication that fights infections caused by fungus.

Itraconazole is used to treat infections caused by fungus, which can invade any part of the body including the lungs, mouth or throat, toenails, or fingernails.

Itraconazole may also be used for purposes not listed in this medication guide.

What is the most important information I should know about itraconazole?

You should not take this medicine if you have ever had congestive heart failure.

You should not take itraconazole to treat a toenail or fingernail infection if you are pregnant or may become pregnant during treatment.

Some medicines can cause unwanted or dangerous effects when used with itraconazole. Your doctor may need to change your treatment plan if you use any of the following drugs: cisapride, colchicine (if you have liver or kidney disease), dihydroergotamine, disopyramide, dofetilide, dronedarone, eplerenone, ergonovine, ergotamine, felodipine, irinotecan, lurasidone, lovastatin, methylergonovine, methadone, oral midazolam, nisoldipine, pimozide, quinidine, ranolazine, simvastatin, or triazolam.

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Many drugs can interact with itraconazole. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with itraconazole.

What should I discuss with my healthcare provider before taking itraconazole?

You should not take this medicine if you are allergic to itraconazole or similar medicines such as fluconazole or ketoconazole, or if you have ever had congestive heart failure.

You should not take itraconazole to treat a toenail or fingernail infection if you are pregnant or may become pregnant during treatment.

Some medicines can cause unwanted or dangerous effects when used with itraconazole. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • cisapride;

  • colchicine (if you have liver or kidney disease);

  • eplerenone;

  • irinotecan;

  • methadone;

  • ranolazine;

  • disopyramide, dofetilide, dronedarone, quinidine;

  • felodipine or nisoldipine;

  • lovastatin or simvastatin;

  • oral midazolam, triazolam;

  • lurasidone, pimozide; or

  • ergot medicines such as dihydroergotamine, ergonovine, ergotamine, or methylergonovine.

To make sure itraconazole is safe for you, tell your doctor if you have:

  • heart disease, a heart rhythm disorder, circulation problems, or a history of stroke;

  • chronic obstructive pulmonary disease (COPD) or other breathing disorder;

  • kidney disease;

  • cirrhosis or other liver disease;

  • cystic fibrosis; or

  • a personal or family history of Long QT syndrome.

FDA pregnancy category C. It is not known whether itraconazole will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Itraconazole passes into breast milk and can harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take itraconazole?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

The itraconazole capsule should be taken after a full meal.

Take itraconazole oral solution (liquid) on an empty stomach, at least 1 hour before or 2 hours after a meal. Swish the liquid in your mouth for several seconds before swallowing it.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

The Sporanox PulsePak has a special dosing schedule that includes not taking the medicine for several days in a row. Follow all dosing instructions carefully.

Do not crush, chew, break, or open an itraconazole capsule. Swallow it whole.

Itraconazole capsules should not be used in place of itraconazole oral solution (liquid) if that is what your doctor has prescribed. Make sure you have received the correct type of this medicine at the pharmacy and ask the pharmacist if you have any questions.

If you also take a stomach acid reducer (Tagamet, Pepcid, Axid, Zantac, and others), take itraconazole with an acidic drink such as non-diet cola.

Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Itraconazole will not treat a viral infection such as the common cold or flu.

While using itraconazole, you may need frequent blood tests.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking itraconazole?

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid taking antacids within 1 hour before or 2 hours after you take itraconazole. Some antacids can make it harder for your body to absorb itraconazole.

Itraconazole side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives, severe skin rash, tingling in your arms or legs; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking itraconazole and call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • confusion, ringing in your ears, problems with hearing;

  • fast heartbeats;

  • numbness or tingly feeling, blurred vision, double vision, loss of bladder control;

  • severe pain in your upper stomach spreading to your back, nausea and vomiting;

  • little or no urinating, pain or burning when you urinate;

  • signs of congestive heart failure--shortness of breath (even with mild exertion), cough with mucus, fast heartbeats, swelling, rapid weight gain, sleep problems; or

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • headache, dizziness;

  • nausea, vomiting, upset stomach, constipation;

  • hair loss;

  • fever, muscle aches, joint pain;

  • changes in your menstrual periods;

  • impotence, erection problems; or

  • unusual or unpleasant taste in the mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Itraconazole dosing information

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.

What other drugs will affect itraconazole?

Many drugs can interact with itraconazole, and some drugs should not be used together. Tell your doctor about all your medicines and any you start or stop using during treatment with itraconazole, especially:

  • antipsychotic medicine or a sedative (such Valium or Xanax);

  • HIV/AIDS medicine;

  • medicine to treat high cholesterol;

  • an antibiotic--ciprofloxacin, clarithromycin, erythromycin;

  • a blood thinner--rivaroxaban, warfarin, Coumadin, Jantoven;

  • cancer medicine--dasatinib, nilotinib, and others;

  • drugs to treat urinary problems--Detrol, Flomax, Vesicare;

  • heart or blood pressure medication--aliskiren, digoxin, diltiazem, verapamil, and others;

  • immunosuppressants--dexamethasone, everolimus, and others;

  • medicine to prevent organ transplant rejection--cyclosporine, sirolimus, and others;

  • migraine headache medicine--eletriptan and others;

  • narcotic pain medicine-- fentanyl, oxycodone, and others; or

  • seizure medicine--carbamazepine and others.

This list is not complete and many other drugs can interact with itraconazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about itraconazole.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 11.01. Revision Date: 2014-11-04, 5:03:21 PM.

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