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Diflucan - Warnings & Precautions

[Fluconazole]



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. There is no information regarding the efficacy of fluconazole for primary treatment of cryptococcal meningitis in children.

The safety profile of DIFLUCAN in children has been studied in 577 children ages 1 day to 17 years who received doses ranging from 1 to 15 mg/ kg/ day for 1 to 1,616 days. (See ADVERSE REACTIONS.)

Efficacy of DIFLUCAN has not been established in infants less than 6 months of age. (See CLINICAL PHARMACOLOGY.) A small number of patients (29) ranging in age from 1 day to 6 months have been treated safely with DIFLUCAN.
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