FLUCONAZOLE SUMMARY
FLUCONAZOLE TABLETS
Rx only
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 Viaflex® Plus plastic containers.
Fluconazole is indicated for the treatment of:
- Vaginal candidiasis (vaginal yeast infections due to Candida).
- Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.
- Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis
Fluconazole 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.
|
NEWS HIGHLIGHTS
Published Studies Related to 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.
Clinical Trials Related to 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
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
Amphotericin Alone or in Combination With Fluconazole for AIDS-Associated Meningitis [Completed]
This study will examine the effectiveness and safety of a combination treatment for
cryptococcal meningitis, a fungal infection common in persons with acquired immune deficiency
syndrome (AIDS) in the developing world. The standard initial treatment includes two
medications: amphotericin B for 2 weeks followed by 8 weeks of fluconazole. This study will
look at whether study participants recover more quickly and have fewer side effects if they
are given both drugs at the same time for 2 weeks followed by 8 weeks of fluconazole as
compared to the standard treatment. Participants will be followed for approximately 6 months
from the time they are enrolled into the study.
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.
|
PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 3 ratings/reviews, Fluconazole has an overall score of 6. The effectiveness score is 6 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Fluconazole review by 45 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | yeast infection |
| Dosage & duration: | | one pill taken once only for the period of once only |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | After about five days the yeast infection symptoms (itchiness, pain) disappeared. |
| Side effects: | | None. |
| Comments: | | I took the single pill dose of the fluconazole and after about 24 hours the symptoms of the yeast infection started to subside, completely disappearing after about five days. |
|
| | Fluconazole review by 23 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | yeast infection |
| Dosage & duration: | | one pill taken once a day for the period of 3-7 days |
| Other conditions: | | None |
| Other drugs taken: | | Clotrimazole | | |
Reported Results |
| Benefits: | | pill added nothing to the treatment process |
| Side effects: | | no known side effects from the pill |
| Comments: | | I was prescribed fluconazole (pill taken orally) and clotrimazole (cream applied topically) for the treatment of candida. I was first told to take the pill, and then use the cream in 3 days if the pill did not work to reduce the yeast infection. I took the pill for 3 days alone, without the cream, and saw no improvement. I took the pill plus the cream for 4 more days, and it slowly started to clear up. I was told that one pill, taken once, and not repeatedly each day, should have cleared it up. |
|
| | Fluconazole review by 23 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | yeast infection |
| Dosage & duration: | | one pill taken once a day for the period of 3-7 days |
| Other conditions: | | None |
| Other drugs taken: | | Clotrimazole | | |
Reported Results |
| Benefits: | | pill added nothing to the treatment process |
| Side effects: | | no known side effects from the pill |
| Comments: | | I was prescribed fluconazole (pill taken orally) and clotrimazole (cream applied topically) for the treatment of candida. I was first told to take the pill, and then use the cream in 3 days if the pill did not work to reduce the yeast infection. I took the pill for 3 days alone, without the cream, and saw no improvement. I took the pill plus the cream for 4 more days, and it slowly started to clear up. I was told that one pill, taken once, and not repeatedly each day, should have cleared it up. |
|
|
|
Page last updated: 2009-10-20
|
