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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NEWS HIGHLIGHTS

Published Studies Related to Diflucan (Fluconazole)

A phase II randomized trial of amphotericin B alone or combined with fluconazole in the treatment of HIV-associated cryptococcal meningitis. [2009.06.15]
BACKGROUND: Cryptococcosis is a life-threatening infection among patients with human immunodeficientcy virus (HIV) infection. Therapeutic options for the treatment of central nervous system cryptococcosis are limited, especially in resource-limited settings... CONCLUSIONS: AmB plus fluconazole administered at a dosage of 800 mg for 14 days, followed by fluconazole administered at a dosage of 800 mg daily for 56 days, is well-tolerated and efficacious among HIV-positive patients with central nervous system cryptococcosis. These results have significant treatment implications and should be validated in a randomized phase III trial.

The epidemiology of Candida colonization and invasive candidiasis in a surgical intensive care unit where fluconazole prophylaxis is utilized: follow-up to a randomized clinical trial. [2009.04]
OBJECTIVE: To determine whether Candida glabrata colonization and invasive candidiasis (IC) increased among critically ill surgical patients 3 years after the introduction of fluconazole prophylaxis to a surgical intensive care unit (SICU). SUMMARY BACKGROUND DATA: Fluconazole prophylaxis has been shown in randomized clinical trials to reduce the occurrence of candidiasis in some patient populations, including high-risk SICU patients. One such trial was performed in The Johns Hopkins Hospital SICU in 1998. Whether the epidemiology of Candida colonization and IC has changed in SICUs where fluconazole prophylaxis is routinely utilized has not been adequately studied... CONCLUSIONS: There was no increase in C. glabrata colonization or in the proportion of IC due to C. glabrata after a 3-year period of routine fluconazole prophylaxis for selected SICU patients.

Improved treatment of vulvovaginal candidiasis with fluconazole plus probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14. [2009.03]
CONCLUSION: This study has shown that probiotic lactobacilli can increase the effectiveness of an anti-fungal pharmaceutical agent in curing disease. 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.

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.

Microemulsion based vaginal gel of fluconazole: formulation, in vitro and in vivo evaluation. [2009.01.05]
The objective of the present investigation was to develop and evaluate microemulsion based gel for the vaginal delivery of fluconazole (FLZ). The solubility of FLZ in oils and surfactants was evaluated to identify components of the microemulsion... The small-scale clinical studies indicated that the FLZ-MBG shows faster onset of action than Candid V gel although no difference was observed in the clinical efficacy.

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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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PATIENT REVIEWS / RATINGS / COMMENTS

Diflucan review by 40 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		vaginal yeast infection
Dosage & duration:		1 tablet taken once for the period of once
Other conditions:		none
Other drugs taken:		Difflucan cream
		Reported Results
Benefits:		the infection vanished after 2 days, I had already tried canesten cream and that did not help cure the infection fully.
Side effects:		none I could see, the infection vanished after 2 days and did not come back. i don't know if there are any side effects by taking the tablet you may wish to look in to it further.
Comments:		One tablet and then cream twice a day for a week. The tablet was taken once only. I used the cream a few more times during the day in the beginning of the treatment when I needed it.

Diflucan review by 30 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Yeast Infection
Dosage & duration:		1 single dose pill taken repeated dose 2x, one week apart for the period of 1 week
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Eliminate yeast infection
Side effects:		The yeast infection occurred after taking oral antibiotics. After I took the first dose of Diflucan, I developed an itchy, raised, red, rough rash on both sides of my face and the yeast infection only moderately improved. I took a second dose a week later and the same problem occurred. After that incident I discontinued use. The Diflucan never did resolve the yeast problem and for months after I continued to suffer from skin rashes that may or may not have been related. Eventually the yeast problem went away by taking probiotics and an herbal Usnea tincture.
Comments:		One single dose oral pill. Repeated dose one week later.

Diflucan review by 30 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Yeast Infection
Dosage & duration:		1 single dose pill taken repeated dose 2x, one week apart for the period of 1 week
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Eliminate yeast infection
Side effects:		The yeast infection occurred after taking oral antibiotics. After I took the first dose of Diflucan, I developed an itchy, raised, red, rough rash on both sides of my face and the yeast infection only moderately improved. I took a second dose a week later and the same problem occurred. After that incident I discontinued use. The Diflucan never did resolve the yeast problem and for months after I continued to suffer from skin rashes that may or may not have been related. Eventually the yeast problem went away by taking probiotics and an herbal Usnea tincture.
Comments:		One single dose oral pill. Repeated dose one week later.