Fluconazole (Fluconazole) - Summary

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:

1. Vaginal candidiasis (vaginal yeast infections due to Candida).
2. 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.
3. 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.

NEWS HIGHLIGHTS

Published Studies Related to 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

more studies >>

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

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.

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 Evaluating Efficiency and Tolerance of High-dose Fluconazole Associated With Flucytosine as Induction Therapy for Cryptococcal Meningitis Associated With HIV in Burundi [Recruiting]
The aim of the trial is to demonstrate that in a sub-Saharan African country, Burundi, the association of:

1. Oral treatment : high dose of fluconazole (1600mg/d) associated with flucytosine (100 mg/kg/j) as induction therapy

2. lumbar punctures to control intracranial pressure

3. early introduction of HAART (highly active antiretroviral therapy ) (at day 15 after anti-cryptococcoses initiation).

can decrease mortality rate below 40% at 10 weeks.

This is a non randomized open label pilot study, with standardized management of cryptococcoses meningitis and follow-up in Burundi. A total of 61 patients will be enrolled.

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.

more trials >>

Reports of Suspected Fluconazole Side Effects

Drug Interaction (79),  Pyrexia (53),  Septic Shock (37),  Neutropenia (36),  Hepatotoxicity (34),  Drug Rash With Eosinophilia and Systemic Symptoms (34),  Blood Bilirubin Increased (28),  Drug Ineffective (28),  Renal Failure Acute (28),  Thrombocytopenia (27), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

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 63 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		systemic fungus
Dosage & duration:		400 mg taken 1 x per day for the period of one month at the recommended dose
Other conditions:		bacterial skin infection
Other drugs taken:		none while on the recommended dose
		Reported Results
Benefits:		lessening of fungus
Side effects:		inflamed liver, upset stomach
Comments:		I was to take 400 mg daily, but could not handle that. After letting the drug dissipate out of my system, I resumed it at very low doses (25-125 mg daily) plus herbal and homeopathic remedies. This finally, after several months, got rid of the fungus.