Diflucan (Fluconazole) - Summary

DIFLUCAN SUMMARY

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 and as a sterile solution for intravenous use in glass and in Viaflex^® Plus plastic containers.

DIFLUCAN (fluconazole) is indicated for the treatment of:

1. Vaginal candidiasis (vaginal yeast infections due to Candida).
2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, DIFLUCAN was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.
3. Cryptococcal meningitis. Before prescribing DIFLUCAN (fluconazole) for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing DIFLUCAN to amphotericin B in non-HIV infected patients have not been conducted.

Prophylaxis. DIFLUCAN is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.

Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.

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DIFLUCAN NEWS HIGHLIGHTS

Published Studies Related to Diflucan (Fluconazole)

Improved treatment of vulvovaginal candidiasis with fluconazole plus probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14. [2009.02.02]
Abstract Aims: To determine the ability of probiotic lactobacilli to improve the treatment of vulvovaginal candidiasis (VVC) using a randomized, double-blind and placebo-controlled trial. Methods and Results: Fifty-five women diagnosed with VVC by vaginal discharge positive for Candida spp... Significance and Impact of the Study: This novel finding of probiotic lactobacilli augmenting the cure rate of yeast vaginitis, not only offers an alternative approach to a highly prevalent condition that adversely affects the quality of life of women around the world, but also raises the question of how this combination works.

Single-dose fluconazole versus standard 2-week therapy for oropharyngeal candidiasis in HIV-infected patients: a randomized, double-blind, double-dummy trial. [2008.11.15]
BACKGROUND: Oropharyngeal candidiasis is the most common opportunistic infection affecting patients with human immunodeficiency virus (HIV) infection. Because of convenience, cost, and reluctance to complicate antiretroviral treatment regimens, single-dose fluconazole [generic for Diflucan] may be a favorable regimen for treatment of moderate to severe oropharyngeal candidiasis. We conducted a prospective, randomized, double-blind, placebo-controlled trial to compare the clinical and mycological responses, relapse rates, and safety of a single 750-mg dose and a 14-day course of treatment with fluconazole... CONCLUSION: A single dose of 750 mg of fluconazole was safe, well tolerated, and as effective as the standard 14-day fluconazole therapy in patients with HIV infection and acquired immunodeficiency syndrome who had oropharyngeal candidiasis coinfection.

Empirical fluconazole versus placebo for intensive care unit patients: a randomized trial. [2008.07.15]
BACKGROUND: Invasive infection with Candida species is an important cause of morbidity and mortality in intensive care unit (ICU) patients. Optimal preventive strategies have not been clearly defined. OBJECTIVE: To see whether empirical fluconazole [generic for Diflucan] improves clinical outcomes more than placebo in adult ICU patients at high risk for invasive candidiasis... CONCLUSION: In critically ill adults with risk factors for invasive candidiasis, empirical fluconazole did not clearly improve a composite outcome more than placebo.

Fluconazole prophylaxis: can we eliminate invasive Candida infections in the neonatal ICU? [2008.06]
PURPOSE OF REVIEW: Owing to the high mortality, risk of neurodevelopmental impairment and end-organ involvement with fungal infections in the neonate, prevention of invasive Candida infections in extremely preterm infants should be a priority for each neonatal ICU. RECENT FINDINGS: Even with prompt or empiric treatment, mortality and neurodevelopmental impairment is high (57%) in infants <1000 g...

Effects of fluconazole in the prophylaxis of oropharyngeal candidiasis in patients undergoing radiotherapy for head and neck tumour: results from a double-blind placebo-controlled trial. [2008.05]
Fluconazole [generic for Diflucan] is recommended in the prophylaxis of oropharyngeal candidiasis (OPC) in patients undergoing radiotherapy for head-neck tumours; however, the actual effectiveness of fluconazole in this setting remains unclear. Adult patients with cervico-cephalic carcinoma submitted to radical or adjuvant radiotherapy were randomized to 100 mg fluconazole (n = 138) or matched placebo (n = 132) oral suspension once daily from the sixth session of radiotherapy up to the end of treatment...

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Clinical Trials Related to Diflucan (Fluconazole)

Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia [Completed]
To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia

A Study Of Diflucan In Children With Ringworm Of The Scalp [Completed]

Comparison of Fluconazole Versus Voriconazole to Treat Fungal Infections in Individuals Receiving Blood and Marrow Transplants [Completed]
The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1: 1 ratio.

Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis [Completed]
To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment of patients with Esophageal Candidiasis

A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients With Recurrent Thrush [Completed]
The purpose of this study is to determine whether it is better to treat patients with fluconazole on a continuous basis to prevent thrush (yeast infection in the mouth) from coming back or to wait and treat each episode of thrush.

Fluconazole is one of the most commonly prescribed drugs to treat thrush and other yeast infections. However, the number of patients with fluconazole-resistant thrush is increasing, and it is not known whether continuous or intermittent use of fluconazole leads to greater resistance. Therefore, it is important to determine the most effective treatment strategy.

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DIFLUCAN PATIENT REVIEWS / RATINGS / COMMENTS

Diflucan review by 32 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		yeast infection
Dosage & duration:		150 mg x 2 taken 1 pill 1st week, 1 pill wk later for the period of 2 WKS
Other conditions:		NONE
Other drugs taken:		NUVARING WELLBUTRIN
		Reported Results
Benefits:		O TOOK THIS TO HELP TO RELIEVE AND CURE MY YEAST INFECTION. I HAD TRIED SEVERAL OTHER CREAMS, ONE WAS OVER THE COUNTER THE OTHER WAS PRESCRIBED BY MY DOCTOR. THIS ORAL MEDICATION WAS THE ONLY ONE THAT WORKED.
Side effects:		I DIDN'T REALLY NOTICE ANY MAJOR SIDE EFFECTS. I WOULD SAY THAT MY THROAT BECAME A LITTLE SCRATCHY AND MAYBE THE VAGINAL AREA BECAME A LITTLE MORE SENSITIVE.
Comments:		I WAS INSTRUCTED TO TAKE OF THE PILL DOSAGES WHICH WAS 150 MILLOGRAMS RIGHT AWAY AND TO TAKE WITH FOOD. THEN I WAS INSTRUCTED TO THE SECOND PILL ONE WEEK LATER IT WAS ALSO 150 MILLIGRAMS IN DOSAGE.