Diflucan

[Fluconazole]

In two comparative trials evaluating the efficacy of DIFLUCAN for the suppression of relapse of cryptococcal meningitis, a statistically significant increase was observed in median AST (SGOT) levels from a baseline value of 30 IU/ L to 41 IU/ L in one trial and 34 IU/ L to 66 IU/ L in the other. The overall rate of serum transaminase elevations of more than 8 times the upper limit of normal was approximately 1% in fluconazole-treated patients in clinical trials. These elevations occurred in patients with severe underlying disease, predominantly AIDS or malignancies, most of whom were receiving multiple concomitant medications, including many known to be hepatotoxic.

The incidence of abnormally elevated serum transaminases was greater in patients taking DIFLUCAN concomitantly with one or more of the following medications: rifampin, phenytoin, isoniazid, valproic acid, or oral sulfonylurea hypoglycemic agents.

Immunologic

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In rare cases, anaphylaxis has been reported. The following adverse events have occurred under conditions where a causal association is uncertain:

Cardiovascular

QT prolongation, torsade de pointes. (See PRECAUTIONS.)

Central Nervous System

Seizures.

Dermatologic

Exfoliative skin disorders including Stevens-Johnson syndrome and toxic epidermal necrolysis (see WARNINGS), alopecia.

Hematopoietic and Lymphatic

Leukopenia, including neutropenia and agranulocytosis, thrombocytopenia.

Metabolic

Hypercholesterolemia, hypertriglyceridemia, hypokalemia.

Adverse Reactions in Children

In Phase II/ III clinical trials conducted in the United States and in Europe, 577 pediatric patients, ages 1 day to 17 years were treated with DIFLUCAN at doses up to 15 mg/ kg/ day for up to 1,616 days. Thirteen percent of children experienced treatment related adverse events. The most commonly reported events were

vomiting (5%),
abdominal pain (3%),
nausea (2%),
diarrhea (2%).

Treatment was discontinued in 2.3% of patients due to adverse clinical events and in 1.4% of patients due to laboratory test abnormalities. The majority of treatment-related laboratory abnormalities were elevations of transaminases or alkaline phosphatase.

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