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itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non immunocompromised patients 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 are also indicated for the treatment of the following fungal infections in non immunocompromised patients 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 adverse reactions post marketing experience 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 2 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 2 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 19 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 2 to 4 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 11 given itraconazole capsules in which patients with onychomycosis of the toenails received 2 mg of itraconazole capsules once daily for 12 consecutive weeks results of these studies demonstrated mycologic cure defined as simultaneous occurrence of negative koh plus negative culture in 54 of patients thirty five percent 35 of patients were considered an overall success mycologic cure plus clear or minimal nail involvement with significantly decreased signs and 14 of patients demonstrated mycologic cure plus clinical cure clearance of all signs with or without residual nail deformity the mean time to overall success was approximately 1 months twenty one percent 21 of the overall success group had a relapse worsening of the global score or conversion of koh or culture from negative to positive onychomycosis of the fingernail analyses were conducted on data from a double blind placebo controlled study n 73 total 37 given itraconazole capsules in which patients with onychomycosis of the fingernails received a 1 week course of 2 mg of itraconazole capsules b i d followed by a 3 week period without itraconazole which was followed by a second 1 week course of 2 mg of itraconazole capsules b i d results demonstrated mycologic cure in 61 of patients fifty six percent 56 of patients were considered an overall success and 47 of patients demonstrated mycologic cure plus clinical cure the mean time to overall success was approximately 5 months none of the patients who achieved overall success relapsed
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