Protect from freezing.This leaflet contains important information about fluconazole. Mycologically, 76% of fluconazole treated patients had the infecting organism eradicated compared to 11% for nystatin treated patients.The proportion of patients with clinical relapse 2 weeks after the end of treatment was 14% for subjects receiving fluconazole and 16% for subjects receiving nystatin.

Treatment was discontinued in 2.3% of patients due to adverse clinical events and in 1.4% of patients due to laboratory test abnormalities. However, there was no consistent difference between the older and younger patients with respect to individual side effects. After the loading dose, the daily dose (according to indication) should be based on the following table:Patients on hemodialysis should receive 100% of the recommended dose after each hemodialysis; on non-dialysis days, patients should receive a reduced dose according to their creatinine clearance.These are suggested dose adjustments based on pharmacokinetics following administration of multiple doses. Male rats treated with 5 mg/kg/day and 10 mg/kg/day had an increased incidence of hepatocellular adenomas.Fluconazole, with or without metabolic activation, was negative in tests for mutagenicity in four strains of Fluconazole did not affect the fertility of male or female rats treated orally with daily doses of 5 mg/kg, 10 mg/kg or 20 mg/kg or with parenteral doses of 5 mg/kg, 25 mg/kg or 75 mg/kg, although the onset of parturition was slightly delayed at 20 mg/kg PO. Ten of these patients were concomitantly receiving diuretics. The incidence of abnormally elevated serum transaminases was greater in patients taking fluconazole concomitantly with one or more of the following medications: rifampin, phenytoin, isoniazid, valproic acid, or oral sulfonylurea hypoglycemic agents.In addition, the following adverse events have occurred during post-marketing experience.The pattern and incidence of adverse events and laboratory abnormalities recorded during pediatric clinical trials are comparable to those seen in adults.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 fluconazole at doses up to 15 mg/kg/day for up to 1,616 days. Patients who develop abnormal liver function tests during fluconazole therapy should be monitored for the development of more severe hepatic injury. Check with your doctor before starting any new medicines within seven days of taking fluconazole.Like all medicines, fluconazole may cause some side effects that are usually mild to moderate.Allergic reactions to fluconazole are rare, but they can be very serious if not treated right away by a doctor. In post-marketing experience, spontaneous reports of anemia and acute renal failure were more frequent among patients 65 years of age or older than in those between 12 and 65 years of age. Call your doctor if your skin or eyes become yellow, your urine turns a darker color, your stools (bowel movements) are light-colored, or if you vomit or feel like vomiting or if you have severe skin itching.In patients with serious conditions such as AIDS or cancer, rare cases of severe rashes with skin peeling have been reported. The individual AUC values of norethindrone decreased very slightly (<5%) in 3 of the 21 subjects after fluconazole treatment.A second randomized, double-dummy, placebo-controlled, cross over study in three phases was performed to determine the effect of route of administration of fluconazole on the interaction between fluconazole and midazolam.

02 Caution should be exercised when fluconazole is administered to a nursing woman.An open-label, randomized, controlled trial has shown fluconazole to be effective in the treatment of oropharyngeal candidiasis in children 6 months to 13 years of age (See The use of fluconazole in children with cryptococcal meningitis, In a noncomparative study of children with serious systemic fungal infections, most of which were candidemia, the effectiveness of fluconazole was similar to that reported for the treatment of candidemia in adults. Systemic infections: doses of up to 400mg/day have been used. Fluconazole helps stop too much yeast from growing in the vagina so the yeast infection goes away.

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