Drug Information for SPORANOX (ITRACONAZOLE) ORAL SOLUTION (Ortho Biotech Products, L.P.): INDICATIONS AND USAGE

SPORANOX^® (itraconazole) Injection/Oral Solution is indicated for empiric therapy of febrile neutropenic patients with suspected fungal infections. (NOTE: In a comparative trial, the overall response rate for itraconazole-treated subjects was higher than for amphotericin B-treated subjects. However, compared to amphotericin B-treated subjects, a larger number of itraconazole-treated subjects discontinued treatment due to persistent fever and a change in antifungal medication due to fever. Whereas, a larger number of amphotericin B-treated subjects discontinued due to drug intolerance. (See CLINICAL STUDIES section.)

SPORANOX^® (itraconazole) Oral Solution is also indicated for the treatment of oropharyngeal and esophageal candidiasis.

(See CLINICAL PHARMACOLOGY: Special Populations, WARNINGS, and ADVERSE REACTIONS: Post-marketing Experience for more information.)