Sporanox Oral Solution (Itraconazole Oral Solution) Drug Information: Medication Guide and Patient Information

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May 27, 2012

Sporanox Oral Solution

Thrush »

What causes thrush?

Small amounts of the candida fungus are present in the mouth, digestive tract, and skin of most healthy people and are normally kept in check by other bacteria and microorganisms in the body. However, certain illnesses, stress, or medications can disturb the delicate balance, causing the fungus candida to grow out of control, causing thrush.

Medications that upset the balance of microorganisms in the mouth and may cause thrush include corticosteroids, antibiotics, and birth control pills. Illnesses or medical situations that make candida infection more likely to develop include uncontrolled diabetes, HIV infection, cancer, dry mouth, or pregnancy (caused by the hormonal changes that occur with pregnancy). People who smoke or wear dentures that don't fit properly also are at increased risk for thrush. In addition, babies can pass the infection to their mothers during breast-feeding.

What are the symptoms of t...

Read the Thrush article »

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Sporanox Oral Solution

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PATIENT INFORMATION

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 pancreatic adenocarcinomas in a rat carcinogenicity study. These findings were not observed in a similar mouse carcinogenicity study. The clinical relevance of these findings 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.