Indication: This product is mainly used for patients with more severe conditions in the following indications: 1. Candidiasis: used to treat oropharyngeal and esophageal Candida infections; disseminated Candidiasis, including peritonitis, pneumonia, urinary tract infections, etc.; Candida vulvovaginitis. It can also be used to prevent Candida infections in bone marrow transplant patients receiving cytotoxic drugs or radiotherapy. 2. Cryptococcosis: used to treat new cryptococcosis other than meninges; when treating cryptococcal meningitis, this product can be used as a maintenance treatment drug after initial treatment with amphotericin B combined with flucytosine. 3. Coccidioidomycosis. 4. This product can also replace itraconazole for the treatment of blastomycosis and histoplasmosis.

Indication: This product is mainly used for patients with more severe conditions in the following indications: 1. Candidiasis: used to treat oropharyngeal and esophageal Candida infections; disseminated candidiasis, including peritonitis, pneumonia, urinary tract infections, etc.; Candida vulvovaginitis; it can also be used to prevent the occurrence of Candida infections in bone marrow transplant patients receiving cytotoxic drugs or radiotherapy; 2. Cryptococcosis: used to treat new cryptococcosis other than meninges; when treating cryptococcal meningitis, this product can be used as a maintenance therapy after initial treatment with amphotericin B combined with flucytosine; 3. Coccidioidomycosis; 4. This product can also replace itraconazole for the treatment of blastomycosis and histoplasmosis.

Indication: This product is mainly used for patients with more severe conditions in the following indications: 1. Candidiasis: used to treat oropharyngeal and esophageal Candida infections; disseminated Candidiasis, including Candida vulvovaginitis such as peritonitis, pneumonia, and urinary tract infections. It can also be used to prevent the occurrence of Candida infections in bone marrow transplant patients receiving cytotoxic drugs or radiotherapy. 2. Cryptococcal disease: used to treat new cryptococci other than meninges; when treating cryptococcal meningitis, this product can be used as a maintenance treatment after initial treatment with amphotericin B combined with flucytosine. 3. Coccidioidomycosis. 4. This product can also replace itraconazole for the treatment of blastomycosis and histoplasmosis.

Indication: This product is mainly used for patients with more severe conditions in the following indications: 1. Candidiasis: used to treat oropharyngeal and esophageal Candida infections; disseminated Candidiasis, including Candida vulvovaginitis such as peritonitis, pneumonia, and urinary tract infections. It can also be used to prevent the occurrence of Candida infections in bone marrow transplant patients receiving cytotoxic drugs or radiotherapy. 2. Cryptococcal disease: used to treat new cryptococci other than meninges; when treating cryptococcal meningitis, this product can be used as a maintenance treatment after initial treatment with amphotericin B combined with flucytosine. 3. Coccidioidomycosis. 4. This product can also replace itraconazole for the treatment of blastomycosis and histoplasmosis.

Indication: 1 Systemic fungal infections, such as systemic candidiasis, paracoccidioidomycosis, and histoplasmosis. 2 Infections of the skin, hair, and toes caused by dermatophytes and/or yeasts (dermatophytes, onychomycosis, perionychia, tinea versicolor, chronic skin and mucosal candidiasis, etc.), when local treatment is ineffective or it is difficult to apply the medicine due to factors such as the site, area, and depth of infection, this drug can be used for treatment.

Indication: 1 Systemic fungal infections, such as systemic candidiasis, paracoccidioidomycosis, and histoplasmosis. 2 Infections of the skin, hair, and toes caused by dermatophytes and/or yeasts (dermatophytes, onychomycosis, perionychia, tinea versicolor, chronic skin and mucosal candidiasis, etc.), when local treatment is ineffective or it is difficult to apply the medicine due to factors such as the site, area, and depth of infection, this drug can be used for treatment.

Indication: Itraconazole capsules immunocompromised and non-immunocompromised 1. Blastomycosis, pulmonary and extrapulmonary 2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non- meningeal histoplasmosis, and 3. Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. Itraconazole capsules non-immunocompromised 1. Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and 2. Onychomycosis of the fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. (See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS: Postmarketing Experience for more information.) Description of Clinical Studies: Blastomycosis: Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=73 combined) in patients with normal or abnormal immune status. The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 6 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases. Histoplasmosis: Analyses were conducted on data from two open-label, non-concurrently controlled studies (N=34 combined) in patients with normal or abnormal immune status (not including HIV-infected patients). The median dose was 200 mg/day. A response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 12 months. Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis, compared with the natural history of untreated cases. Histoplasmosis in HIV-infected patients: Data from a small number of HIV-infected patients suggested that the response rate of histoplasmosis in HIV-infected patients is similar to that of non-HIV-infected patients. The clinical course of histoplasmosis in HIV-infected patients is more severe and usually requires maintenance therapy to prevent relapse. Aspergillosis: Analyses were conducted on data from an open-label, “single-patient-use” protocol designed to make itraconazole available in the U.S. for patients who either failed or were intolerant of amphotericin B therapy (N=190). The findings were corroborated by two smaller open-label studies (N=31 combined) in the same patient population. Most adult patients were treated with a daily dose of 200 to 400 mg, with a median duration of 3 months. Results of these studies demonstrated substantial evidence of effectiveness of itraconazole as a second-line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin B therapy. Onychomycosis of the toenail: Analyses were conducted on data from three double-blind, placebo-controlled studies (N=214 total; 110 given itraconazole capsules Onychomycosis of the fingernail: Analyses were conducted on data from a double-blind, placebo-controlled study (N=73 total; 37 given itraconazole capsules