Diflucan

[Fluconazole]

Pediatric Studies

Oropharyngeal candidiasis:

An open-label, comparative study of the efficacy and safety of DIFLUCAN (2-3 mg/ kg/ day) and oral nystatin (400,000 I. U. 4 times daily) in immunocompromised children with oropharyngeal candidiasis was conducted. Clinical and mycological response rates were higher in the children treated with fluconazole.

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Clinical cure at the end of treatment was reported for 86% of fluconazole treated patients compared to 46% of nystatin treated patients. Mycologically, 76% of fluconazole treated patients had the infecting organism eradicated compared to 11% for nystatin treated patients. Fluconazole Nystatin Enrolled 96 90
Clinical Cure 76/ 88 (86%) 36/ 78 (46%) Mycological eradication* 55/ 72 (76%) 6/ 54 (11%)

* Subjects without follow-up cultures for any reason were considered nonevaluable for mycological response.
The proportion of patients with clinical relapse 2 weeks after the end of treatment was 14% for subjects receiving DIFLUCAN and 16% for subjects receiving nystatin. At 4 weeks after the end of treatment the percentages of patients with clinical relapse were 22% for DIFLUCAN and 23% for nystatin.

DOSAGE AND ADMINISTRATION

Dosage and Administration in Adults:

Single Dose

Vaginal candidiasis:

The recommended dosage of DIFLUCAN for vaginal candidiasis is 150 mg as a single oral dose.

Multiple Dose

SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF DIFLUCAN (FLUCONAZOLE) IS THE SAME FOR ORAL (TABLETS AND SUSPENSION) AND INTRAVENOUS ADMINISTRATION. In general, a loading dose of twice the daily dose is recommended on the first day of therapy to result in plasma concentrations close to steady-state by the second day of therapy.

The daily dose of DIFLUCAN for the treatment of infections other than vaginal candidiasis should be based on the infecting organism and the patient's response to therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse.

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