Manufactured by: Manufactured for:Ben Venue Laboratories, Inc.Bedford Laboratories™Bedford, OH 44146 Bedford, OH 44146November 2008 FZC-P02
Fluconazole is indicated for the treatment of:Oropharyngeal and esophageal candidiasis.
In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.
Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section.
Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.
Fluconazole 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.
Fluconazole is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients.
There is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents.
Caution should be used in prescribing fluconazole to patients with hypersensitivity to other azoles.
Coadministration of terfenadine is contraindicated in patients receiving fluconazole at multiple doses of 400 mg or higher based upon results of a multiple dose interaction study.
Coadministration of cisapride is contraindicated in patients receiving fluconazole.(See CLINICAL PHARMACOLOGY : Drug Interaction Studies and PRECAUTIONS.)
Hepatic injury: Fluconazole has been associated with rare cases of serious hepatic toxicity, including fatalities primarily in patients with serious underlying medical conditions.
In cases of fluconazole associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex or age of the patient has been observed.
Fluconazole hepatotoxicity has usually, but not always, been reversible on discontinuation of therapy.
Patients who develop abnormal liver function tests during fluconazole therapy should be monitored for the development of more severe hepatic injury.
Fluconazole should be discontinued if clinical signs and symptoms consistent with liver disease develop that may be attributable to fluconazole.Anaphylaxis: In rare cases, anaphylaxis has been reported.Dermatologic: Patients have rarely developed exfoliative skin disorders during treatment with fluconazole.
In patients with serious underlying diseases (predominantly AIDS and malignancy), these have rarely resulted in a fatal outcome.Patients who develop rashes during treatment with fluconazole should be monitored closely and the drug discontinued if lesions progress.