DIFLUCAN SUMMARY
DIFLUCAN®
(Fluconazole Tablets)
(Fluconazole Injection - for intravenous infusion only)
(Fluconazole for Oral Suspension)
DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration, as a powder for oral suspension and as a sterile solution for intravenous use in glass and in Viaflex® Plus plastic containers.
DIFLUCAN (fluconazole) is indicated for the treatment of:
-
Vaginal candidiasis (vaginal yeast infections due to
Candida).
-
Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, DIFLUCAN was also effective for the treatment of
Candida
urinary tract infections, peritonitis, and systemic
Candida
infections including candidemia, disseminated candidiasis, and pneumonia.
-
Cryptococcal meningitis. Before prescribing DIFLUCAN (fluconazole) for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing DIFLUCAN to amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis. DIFLUCAN is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to 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, anti-infective therapy should be adjusted accordingly.
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