DIFLUCAN® TABLET, SUSPENSION Clinical Studies

(Fluconazole TABLET, SUSPENSION)

CLINICAL STUDIES

Cryptococcal meningitis

In a multicenter study comparing DIFLUCAN (200 mg/day) to amphotericin B (0.3 mg/kg/day) for treatment of cryptococcal meningitis in patients with AIDS, a multivariate analysis revealed three pretreatment factors that predicted death during the course of therapy: abnormal mental status, cerebrospinal fluid cryptococcal antigen titer greater than 1:1024, and cerebrospinal fluid white blood cell count of less than 20 cells/mm3. Mortality among high risk patients was 33% and 40% for amphotericin B and DIFLUCAN patients, respectively (p=0.58), with overall deaths 14% (9 of 63 subjects) and 18% (24 of 131 subjects) for the 2 arms of the study (p=0.48). Optimal doses and regimens for patients with acute cryptococcal meningitis and at high risk for treatment failure remain to be determined. (Saag, et al. N Engl J Med 1992; 326:83-9.)

Vaginal candidiasis

Two adequate and well-controlled studies were conducted in the U.S. using the 150 mg tablet. In both, the results of the fluconazole regimen were comparable to the control regimen (clotrimazole or miconazole intravaginally for 7 days) both clinically and statistically at the one month post-treatment evaluation.

The therapeutic cure rate, defined as a complete resolution of signs and symptoms of vaginal candidiasis (clinical cure), along with a negative KOH examination and negative culture for Candida (microbiologic eradication), was 55% in both the fluconazole group and the vaginal products group.

Fluconazole PO 150 mg tabletVaginal Product qhs × 7 days

Enrolled

448

422

Evaluable at Late Follow-up

347 (77%)

327 (77%)

Clinical cure

239/347 (69%)

235/327 (72%)

Mycologic eradication

213/347 (61%)

196/327 (60%)

Therapeutic cure

190/347 (55%)

179/327 (55%)

Approximately three-fourths of the enrolled patients had acute vaginitis (<4 episodes/12 months) and achieved 80% clinical cure, 67% mycologic eradication, and 59% therapeutic cure when treated with a 150 mg DIFLUCAN tablet administered orally. These rates were comparable to control products. The remaining one-fourth of enrolled patients had recurrent vaginitis (≥4 episodes/12 months) and achieved 57% clinical cure, 47% mycologic eradication, and 40% therapeutic cure. The numbers are too small to make meaningful clinical or statistical comparisons with vaginal products in the treatment of patients with recurrent vaginitis.

Substantially more gastrointestinal events were reported in the fluconazole group compared to the vaginal product group. Most of the events were mild to moderate. Because fluconazole was given as a single dose, no discontinuations occurred.

ParameterFluconazole POVaginal Products

Evaluable patients

448

422

With any adverse event

141 (31%)

112 (27%)

Nervous System

90 (20%)

69 (16%)

Gastrointestinal

73 (16%)

18 (4%)

With drug-related event

117 (26%)

67 (16%)

Nervous System

61 (14%)

29 (7%)

Headache

58 (13%)

28 (7%)

Gastrointestinal

68 (15%)

13 (3%)

Abdominal pain

25 (6%)

7 (2%)

Nausea

30 (7%)

3 (1%)

Diarrhea

12 (3%)

2 (<1%)

Application site event

0 (0%)

19 (5%)

Taste Perversion

6 (1%)

0 (0%)

Pediatric Studies

Oropharyngeal candidiasis

An open-label, comparative study of the efficacy and safety of DIFLUCAN (2 to 3 mg/kg/day) and oral nystatin (400,000 I.U. 4 times daily) was conducted in immunocompromised pediatric patients from 6 months to 13 years of age with oropharyngeal candidiasis. Clinical and mycological response rates were higher in pediatric patients treated with fluconazole.

Clinical cure at the end of treatment was reported for 86% of fluconazole-treated patients compared to 46% of nystatin treated patients. Mycologically, 76% of fluconazole treated patients had the infecting organism eradicated compared to 11% for nystatin treated patients.

FluconazoleNystatin
*
Subjects without follow-up cultures for any reason were considered nonevaluable for mycological response.

Enrolled

96

90

Clinical Cure

76/88 (86%)

36/78 (46%)

Mycological eradication*

55/72 (76%)

6/54 (11%)

The proportion of patients with clinical relapse 2 weeks after the end of treatment was 14% for subjects receiving DIFLUCAN and 16% for subjects receiving nystatin. At 4 weeks after the end of treatment, the percentages of patients with clinical relapse were 22% for DIFLUCAN and 23% for nystatin.

Find DIFLUCAN® TABLET, SUSPENSION medical information:

Find DIFLUCAN® TABLET, SUSPENSION medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

DIFLUCAN® TABLET, SUSPENSION Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

Clinical Studies

CLINICAL STUDIES

Cryptococcal meningitis

In a multicenter study comparing DIFLUCAN (200 mg/day) to amphotericin B (0.3 mg/kg/day) for treatment of cryptococcal meningitis in patients with AIDS, a multivariate analysis revealed three pretreatment factors that predicted death during the course of therapy: abnormal mental status, cerebrospinal fluid cryptococcal antigen titer greater than 1:1024, and cerebrospinal fluid white blood cell count of less than 20 cells/mm3. Mortality among high risk patients was 33% and 40% for amphotericin B and DIFLUCAN patients, respectively (p=0.58), with overall deaths 14% (9 of 63 subjects) and 18% (24 of 131 subjects) for the 2 arms of the study (p=0.48). Optimal doses and regimens for patients with acute cryptococcal meningitis and at high risk for treatment failure remain to be determined. (Saag, et al. N Engl J Med 1992; 326:83-9.)

Vaginal candidiasis

Two adequate and well-controlled studies were conducted in the U.S. using the 150 mg tablet. In both, the results of the fluconazole regimen were comparable to the control regimen (clotrimazole or miconazole intravaginally for 7 days) both clinically and statistically at the one month post-treatment evaluation.

The therapeutic cure rate, defined as a complete resolution of signs and symptoms of vaginal candidiasis (clinical cure), along with a negative KOH examination and negative culture for Candida (microbiologic eradication), was 55% in both the fluconazole group and the vaginal products group.

Fluconazole PO 150 mg tabletVaginal Product qhs × 7 days

Enrolled

448

422

Evaluable at Late Follow-up

347 (77%)

327 (77%)

Clinical cure

239/347 (69%)

235/327 (72%)

Mycologic eradication

213/347 (61%)

196/327 (60%)

Therapeutic cure

190/347 (55%)

179/327 (55%)

Approximately three-fourths of the enrolled patients had acute vaginitis (<4 episodes/12 months) and achieved 80% clinical cure, 67% mycologic eradication, and 59% therapeutic cure when treated with a 150 mg DIFLUCAN tablet administered orally. These rates were comparable to control products. The remaining one-fourth of enrolled patients had recurrent vaginitis (≥4 episodes/12 months) and achieved 57% clinical cure, 47% mycologic eradication, and 40% therapeutic cure. The numbers are too small to make meaningful clinical or statistical comparisons with vaginal products in the treatment of patients with recurrent vaginitis.

Substantially more gastrointestinal events were reported in the fluconazole group compared to the vaginal product group. Most of the events were mild to moderate. Because fluconazole was given as a single dose, no discontinuations occurred.

ParameterFluconazole POVaginal Products

Evaluable patients

448

422

With any adverse event

141 (31%)

112 (27%)

Nervous System

90 (20%)

69 (16%)

Gastrointestinal

73 (16%)

18 (4%)

With drug-related event

117 (26%)

67 (16%)

Nervous System

61 (14%)

29 (7%)

Headache

58 (13%)

28 (7%)

Gastrointestinal

68 (15%)

13 (3%)

Abdominal pain

25 (6%)

7 (2%)

Nausea

30 (7%)

3 (1%)

Diarrhea

12 (3%)

2 (<1%)

Application site event

0 (0%)

19 (5%)

Taste Perversion

6 (1%)

0 (0%)

Pediatric Studies

Oropharyngeal candidiasis

An open-label, comparative study of the efficacy and safety of DIFLUCAN (2 to 3 mg/kg/day) and oral nystatin (400,000 I.U. 4 times daily) was conducted in immunocompromised pediatric patients from 6 months to 13 years of age with oropharyngeal candidiasis. Clinical and mycological response rates were higher in pediatric patients treated with fluconazole.

Clinical cure at the end of treatment was reported for 86% of fluconazole-treated patients compared to 46% of nystatin treated patients. Mycologically, 76% of fluconazole treated patients had the infecting organism eradicated compared to 11% for nystatin treated patients.

FluconazoleNystatin
*
Subjects without follow-up cultures for any reason were considered nonevaluable for mycological response.

Enrolled

96

90

Clinical Cure

76/88 (86%)

36/78 (46%)

Mycological eradication*

55/72 (76%)

6/54 (11%)

The proportion of patients with clinical relapse 2 weeks after the end of treatment was 14% for subjects receiving DIFLUCAN and 16% for subjects receiving nystatin. At 4 weeks after the end of treatment, the percentages of patients with clinical relapse were 22% for DIFLUCAN and 23% for nystatin.

Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5Pm ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.