Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Immunology | Family Medicine | Urology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Janssen Pharmaceuticals
Approval Status: Approved March 1997
Treatment Area: oral thrush
SPORANOX (itraconazole) Oral solution has been approved for the
treatment of painful and debilitating fungal infections of the
esophagus or the mouth, commonly called thrush.
In clinical studies, SPORANOX Oral Solution was as effective as
current front-line therapy in healing the white plaques and raw,
ulcerated lesions associated with candidiasis.
Data presented at the 11th International Conference on AIDS in
Vancouver in July, comparing SPORANOX Oral Solution to fluconazole
tablets, a leading treatment for thrush, showed that an average of
84% of patients with oral thrush were cured or had no visible
lesions after treatment with either 7 to 14 days of SPORANOX Oral
Solution (200 mg/day) or fluconazole tablets (200 mg day one,
followed by 100 mg for 13 days). There were 190 patients in that
Similar results were found in a double-blind randomized study of
119 patients with esophageal candidiasis. An average of 86% of
patients were cured or improved with 100 mg/day of either SPORANOX
Oral Solution or fluconazole tablets, administered for 21 days.
Only 11% of patients on SPORANOX Oral Solution and 21% of patients
on fluconazole tablets required higher doses (200 mg/day).
SPORANOX Oral Solution may also be effective in treating oral
candidiasis patients who were clinical fluconazole failures. Of
patients who did not show clinical improvement with fluconazole
tablets (minimum 200 mg/day for at least 14 days), 55% had complete
resolution of oral lesions, after 200 mg/day of SPORANOX after
200mg/day of SPORANOX Oral Solution for periods of 14 to 28 days in
an open-label study of 74 patients.
SPORANOX Oral Solution is generally well-tolerated.
Gastrointestinal upset and diarrhea are the most frequently
observed adverse events at 10.3%. Other side effects include fever
(6.3%). Co-administration of SPORANOX Oral Solution with
terfenadine, astemizole, cisapride, oral triazolam, oral midazolam,
lovastatin or simvastatin is contraindicated. SPORANOX Oral
Solution and SPORANOX Capsules should not be used interchangeably.
SPORANOX Capsules are not indicated for treatment of oral and
Thrush affects nearly half of all HIV-positive individuals and
up to 95% of patients with AIDS. Oral and esophageal candidiasis
cause painful sores in the mouth or esophagus, often causing great
difficulty eating or taking medication, and leading to nutritional
deficits and weight loss.