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)

Fluconazole prophylaxis in extremely low birth weight infants and neurodevelopmental outcomes and quality of life at 8 to 10 years of age. [2011.05]
OBJECTIVE: To examine the long-term effects of fluconazole prophylaxis in extremely low birth weight infants... CONCLUSIONS: Fluconazole prophylaxis for the prevention of invasive Candida infections is safe in extremely low birth weight infants and does not appear to be associated with any long-term adverse effects on neurodevelopment and quality of life at 8 to 10 years of life. Copyright (c) 2011 Mosby, Inc. All rights reserved.

Randomised controlled trial of prophylactic fluconazole versus nystatin for the prevention of fungal colonisation and invasive fungal infection in very low birth weight infants. [2011.05]
BACKGROUND: Invasive fungal infections are a major cause of morbidity and mortality in preterm infants. The authors conducted the first prospective, randomised controlled trial of nystatin compared with fluconazole for the prevention of fungal colonisation and invasive fungal infection in very low birth weight (VLBW) neonates... CONCLUSIONS: Prophylactic nystatin and fluconazole reduce the incidence of colonisation and invasive fungal infection in VLBW neonates. The authors believe that nystatin is an alternative to fluconazole, because nystatin is safe, inexpensive, well tolerated and effective.

A pseudo-randomised clinical trial of in situ gels of fluconazole for the treatment of oropharngeal candidiasis. [2011.04.19]
CONCLUSIONS: The in situ gel formulation of fluconazole was well tolerated with no severe adverse reaction and offers a better alternative to tablet formulation in the treatment of oropharyngeal candidasis. TRIAL REGISTRATION: Current Controlled Trails ISRCTN90634047.

Tecarfarin, a novel vitamin K reductase antagonist, is not affected by CYP2C9 and CYP3A4 inhibition following concomitant administration of fluconazole in healthy participants. [2011.04]
Comparative pharmacokinetics of vitamin K epoxide reductase antagonists tecarfarin and warfarin were assessed before and after coadministration for 21 days of the CYP450 inhibitor fluconazole in a randomized, open-label, single-center drug interaction study... In contrast, tecarfarin pharmacokinetics were apparently unchanged by fluconazole.

Anidulafungin compared with fluconazole for treatment of candidemia and other forms of invasive candidiasis caused by Candida albicans: a multivariate analysis of factors associated with improved outcome. [2011]
contributed to the treatment differences... CONCLUSIONS: In patients with C. albicans infection, anidulafungin was more

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Clinical Trials Related to Diflucan (Fluconazole)

Safety Study of Fluconazole in Combination With Flucytosine for the Treatment of Early Cryptococcal Infection [Not yet recruiting]
The purpose of this study is to determine if treatment with two medicines in combination (fluconazole and flucytosine) is safe as compared with one medicine alone (fluconazole) for the treatment of an early infection with a fungus called cryptococcus.

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

Pharmacokinetics/Pharmacodynamics (PK/PD) of Fluconazole in Children on Extracorporeal Membrane Oxygenation (ECMO) [Recruiting]
Extracorporeal membrane oxygenation (ECMO) is a form of heart-lung bypass used to support children who suffer heart or lung failure until whatever illness caused that failure can be treated and reversed. While on ECMO, children are at increased risk of infection, including fungal infection. Treatment for fungal infection includes not only antifungal medications but also removal of any large intravenous (IV) lines. Since ECMO requires large IV lines, proper treatment of fungal infections would be difficult if not impossible. The investigators believe that giving prophylactic antifungal medication to all children on ECMO may prevent fungal infections from developing in the first place.

Fluconazole is an antifungal medication that works well against the most common fungal infections and has been shown to be safe in children. Unfortunately, the ECMO machine has the potential to significantly alter the drug levels of medications so the investigators do not know the proper dose of Fluconazole to give children on ECMO. Standard dosing of fluconazole is 12mg per kilogram of body weight given intravenously once daily. Based on preliminary data and modeling from other studies, the investigators think 25mg per kilogram given once weekly will achieve proper drug levels to prevent fungal infections. The investigators have obtained FDA approval to give this dose of fluconazole to children on ECMO who are enrolled in the study. Blood samples will be collected at specific times around the first and second fluconazole doses to describe the PK and drug extraction by the ECMO circuit.

Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight [Recruiting]
The most common etiology of infection-related death or neurodevelopmental impairment in neonates with birthweight <750 g is invasive candidiasis. Over 70% of the premature neonates who develop invasive candidiasis will die or suffer severe, permanent neurologic impairment. Fluconazole has been commonly used off-label in the neonatal intensive care unit, but definitive recommendations for its use in the nursery have been hampered by the limited number of well-designed trials. In neonates weighing <750 g, appropriate dosing is not known, definitive safety and long-term follow up trials have not been completed, and there have not been well-powered trials conducted to establish the efficacy of the product using mortality as part of the primary endpoint. Three recent proof-of-concept studies suggest that fluconazole will be safe and effective, and a recently completed pharmacokinetic study is providing data to give preliminary dosing guidance. The next logical step in drug development is proposed by this research: to conduct a pivotal trial to determine the safety and efficacy of fluconazole in premature neonates with 2-year neurodevelopmental follow-up assessment.

This will be accomplished by randomizing 360 neonates, with a birthweight <750g, at 20 centers, to twice weekly fluconazole (6 mg/kg) or placebo for the first 6 weeks of life. The primary efficacy endpoint will be Candida-free survival at study day 49. The research will establish definitive dosing, safety, and efficacy of fluconazole; it will also provide critical information on the effects of fluconazole on neurodevelopmental impairment and antifungal resistance.

Potential Impact:

Approximately 17,000 neonates are born <750 grams each year in the United States. Over 5000 will die or develop invasive Candida infections. Demonstrating safety and efficacy of fluconazole in preterm neonates will improve the survivability and long term outcomes for these neonates.

Study of Paroxetine and Fluconazole for the Treatment of HIV Associated Neurocognitive Disorder [Recruiting]
The purpose of this study is to see if paroxetine and fluconazole are safe and effective as a treatment for problems with memory, concentration, thinking, and judgment in people who are infected with HIV. Paroxetine is an antidepressant approved by the FDA to treat major depression. Fluconazole is an antifungal medication approved by the FDA to treat fungal infections.

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Reports of Suspected Diflucan (Fluconazole) Side Effects

Hyperkalaemia (10),  Drug Interaction (10),  Renal Disorder (10),  Drug Ineffective (9),  Interstitial Lung Disease (8),  Nausea (8),  Renal Impairment (7),  Fall (6),  Death (6),  Blood Pressure Decreased (6), more >>

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 17 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Candida caused yeast infection
Dosage & duration:		150 (dosage frequency: 1 time) for the period of 1 day
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		The yeast stopped coming out in chunks, but was more watery like... Still yeast tho so I wasn't pleased...
Side effects:		Didn't have any side effects
Comments:		I had sex the day after I took the pill with my only partner. I had sex wit him with the yeast infection before I took the pill so if I gave it to him, he probably gave it back to me :( the doc gave me a pill for him and for me. He took his after we had sex. Which was the day after I took mine... Is this y I still hav it? I thought it took days to work that's y I had sex

Diflucan review by 17 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Candida caused yeast infection
Dosage & duration:		150 (dosage frequency: 1 time) for the period of 1 day
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		The yeast stopped coming out in chunks, but was more watery like... Still yeast tho so I wasn't pleased...
Side effects:		Didn't have any side effects
Comments:		I had sex the day after I took the pill with my only partner. I had sex wit him with the yeast infection before I took the pill so if I gave it to him, he probably gave it back to me :( the doc gave me a pill for him and for me. He took his after we had sex. Which was the day after I took mine... Is this y I still hav it? I thought it took days to work that's y I had sex