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DIFLUCAN® TABLET, SUSPENSION (Fluconazole TABLET, SUSPENSION)

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DIFLUCAN® TABLET, SUSPENSION Quick Finder

INDICATIONS AND USAGE

DIFLUCAN (fluconazole) is indicated for the treatment of:

1.
Vaginal candidiasis (vaginal yeast infections due to Candida).
2.
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DOSAGE AND ADMINISTRATION

Dosage and Administration in Adults

Single Dose

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CONTRAINDICATIONS

DIFLUCAN (fluconazole) is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. There is no information regarding cross-hypersensitivity between fluconazole...

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WARNINGS

(1) Hepatic injury: DIFLUCAN should be administered with caution to patients with liver dysfunction. DIFLUCAN has been associated with rare cases of serious hepatic toxicity, including fatalities...

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ADVERSE REACTIONS

DIFLUCAN is generally well tolerated.

In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and hematological function test results and...

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OVERDOSAGE

There have been reports of overdose with fluconazole accompanied by hallucination and paranoid behavior.

In the event of overdose, symptomatic treatment (with supportive measures and gastric lavage if...

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DESCRIPTION

DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration, as a powder for oral suspension.

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CLINICAL PHARMACOLOGY

Pharmacokinetics and Metabolism

The pharmacokinetic properties of fluconazole are similar following administration by the intravenous or oral...

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CLINICAL STUDIES

Cryptococcal meningitis

In a multicenter study comparing DIFLUCAN (200 mg/day) to amphotericin B (0.3 mg/kg/day) for treatment of cryptococcal...

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HOW SUPPLIED

DIFLUCAN Tablets: Pink trapezoidal tablets containing 50, 100, or 200 mg of fluconazole are packaged in bottles or unit dose blisters. The 150 mg fluconazole tablets are pink and oval shaped, packaged in a...

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This Patient Information has been approved by the U.S. Food...

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LAB-0099-31.0
Revised: 01/2023

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