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Fluconazole (Fluconazole) - Summary

 
 



FLUCONAZOLE SUMMARY

Fluconazole USP, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration.

Fluconazole Tablets USP are 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 conduct
Prophylaxis

Fluconazole Tablets USP are 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 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

Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers [Completed]

Bioavailability Study of Fluconazole Tablets 200 mg Under Fed Conditions [Completed]
The objective of this study was an open-label, randomized, 2-way crossover to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (DiflucanŽ) 200 mg fluconazole tablets under fed conditions.

Bioavailability Study of Fluconazole Tablets 200 mg Under Fasting Conditions [Completed]
The objective of this study was an open-label, randomized, 2-way crossover to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (DiflucanŽ) 200 mg fluconazole tablets under fasting conditions.

Safety Study of Fluconazole in Combination With Flucytosine for the Treatment of Early Cryptococcal Infection [Terminated]
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.

The Study Of Fluconazole For Vulvovaginal Candidiasis [Completed]
As for the indication of vulvovaginal candidiasis, a single oral administration of fluconazole 150 mg has been approved and is recommended by guidelines overseas. However in Japan oral therapy with antifungal triazole such as Fluconazole has not been approved, and topical therapies such as vaginal tablets, pessary and cream are used clinically. The purpose of this trial is to confirm the efficacy and safety of single oral administration of fluconazole 150 mg for the treatment of vulvovaginal candidiasis in Japanese patients.

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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

Based on a total of 5 ratings/reviews, Fluconazole has an overall score of 5.40. The effectiveness score is 6 and the side effect score is 6.80. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

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.

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Page last updated: 2013-02-10

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