May 30, 2016
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Sporanox Oral Solution

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Sporanox Oral Solution


  • Only SPORANOX® Oral Solution has been demonstrated effective for oral and/or esophageal candidiasis.
  • SPORANOX® Oral Solution contains the excipient hydroxypropyl-β-cyclodextrin which produced adenocarcinomas in the large intestine and exocrine pancreatic adenocarcinomas in a rat carcinogenicity study. These findings were not observed in a similar mouse carcinogenicity study. The clinical relevance of these adenocarcinomas is unknown. (See Carcinogenesis, Mutagenesis, and Impairment of Fertility.)
  • Taking SPORANOX® Oral Solution under fasted conditions improves the systemic availability of itraconazole. Instruct patients to take SPORANOX® Oral Solution without food, if possible.
  • SPORANOX® Oral Solution should not be used interchangeably with SPORANOX® Capsules.
  • Instruct patients about the signs and symptoms of congestive heart failure, and if these signs or symptoms occur during SPORANOX® administration, they should discontinue SPORANOX® and contact their healthcare provider immediately.
  • Instruct patients to stop SPORANOX® treatment immediately and contact their healthcare provider if any signs and symptoms suggestive of liver dysfunction develop. Such signs and symptoms may include unusual fatigue, anorexia, nausea and/or vomiting, jaundice, dark urine, or pale stools.
  • Instruct patients to contact their physician before taking any concomitant medications with itraconazole to ensure there are no potential drug interactions.
  • Instruct patients that hearing loss can occur with the use of itraconazole. The hearing loss usually resolves when treatment is stopped, but can persist in some patients. Advise patients to discontinue therapy and inform their physicians if any hearing loss symptoms occur.
  • Instruct patients that dizziness or blurred/double vision can sometimes occur with itraconazole. Advise patients that if they experience these events, they should not drive or use machines.

Last reviewed on RxList: 6/19/2014
This monograph has been modified to include the generic and brand name in many instances.

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