Diflucan

[Fluconazole]

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.

Text Continues Below

---

Fluconazole PO 150 mg tablet Vaginal Product qhs x 7 days Enrolled 448 422
Evaluable at Late Follow-up 347 (77%) 327 (77%) Clinical cure 239/ 347 (69%) 235/ 327 (72%)
Mycologic erad. 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.

Parameter Fluconazole PO Vaginal 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%)

Page:  << Prev | 1 | 2 | 3 | 4 | 5 | Next >>