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Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Hepatic injury: DIFLUCAN should be administered with caution to patients with liver dysfunction. Dermatologic: Exfoliative skin disorders during treatment with DIFLUCAN have been reported. Use in Pregnancy: There are no adequate and well-controlled studies of DIFLUCAN in pregnant women. The convenience and efficacy of the single dose oral tablet of fluconazole regimen for the treatment of vaginal yeast infections should be weighed against the acceptability of a higher incidence of drug related adverse events with DIFLUCAN (26%) versus intravaginal agents (16%) in U.S. Fluconazole, with or without metabolic activation, was negative in tests for mutagenicity in 4 strains of S. An open-label, randomized, controlled trial has shown DIFLUCAN to be effective in the treatment of oropharyngeal candidiasis in children 6 months to 13 years of age. The use of DIFLUCAN in children with cryptococcal meningitis, Candidaesophagitis, or systemic Candida infections is supported by the efficacy shown for these indications in adults and by the results from several small noncomparative pediatric clinical studies. In a noncomparative study of children with serious systemic fungal infections, most of which were candidemia, the effectiveness of DIFLUCAN was similar to that reported for the treatment of candidemia in adults.
The efficacy of DIFLUCAN for the suppression of cryptococcal meningitis was successful in 4 of 5 children treated in a compassionate-use study of fluconazole for the treatment of life-threatening or serious mycosis.


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DIFLUCAN has been associated with rare cases of serious hepatic toxicity, including fatalities primarily in patients with serious underlying medical conditions. There is no information regarding the efficacy of fluconazole for primary treatment of cryptococcal meningitis in children.
In open noncomparative studies of relatively small numbers of patients, fluconazole tablets USP were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. Before prescribing fluconazole tablets USP for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section under package insert.


In cases of DIFLUCAN-associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex, or age of the patient has been observed.
Patients with deep seated fungal infections who develop rashes during treatment with DIFLUCAN should be monitored closely and the drug discontinued if lesions progress. Studies comparing fluconazole tablets USP to amphotericin B in non-HIV infected patients have not been conducted. DIFLUCAN hepatotoxicity has usually, but not always, been reversible on discontinuation of therapy. Fluconazole should be discontinued in patients treated for superficialfungal infection who develop a rash that may be attributed to fluconazole.
Patients who develop abnormal liver function tests during DIFLUCAN therapy should be monitored for the development of more severe hepatic injury. DIFLUCAN should be discontinued if clinical signs and symptoms consistent with liver disease develop that may be attributable to DIFLUCAN.



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