scholarly journals Butoconazole Nitrate

2020 ◽  
Author(s):  
Keyword(s):  
Butoconazole Nitrate

scholarly journals An Evaluation of Butoconazole Nitrate 2% Site Release®Vaginal Cream (Gynazole-1®) Compared to Fluconazole 150 mg Tablets (Diflucan®) in the Time to Relief of Symptoms in Patients With Vulvovaginal Candidiasis

2005 ◽  
Vol 13 (4) ◽  
pp. 197-206 ◽  
Author(s):  
Larry S. Seidman ◽  
Campbell K. Skokos
Keyword(s):  
Single Dose ◽  
Treatment Group ◽  
Adverse Events ◽  
Median Time ◽  
The United States ◽  
Vulvovaginal Candidiasis ◽  
Reinfection Rate ◽  
Vaginal Cream ◽  
Butoconazole Nitrate ◽  
Site Release

Background.It is estimated that as many as 13 million cases of vulvovaginal infection occur in the United States annually, the majority of which are the result ofCandida albicansinfection. The symptoms of vulvovaginal infections are often painful and distressing to the patient. The objective of this study was to compare the time to symptomatic relief of vulvovaginal candidiasis (VVC) with butoconazole nitrate 2% Site Release®vaginal cream (Gynazole-1®) and oral fluconazole 150 mg tablets (Diflucan®).Methods.This randomized, open-label, parallel study evaluated 181 female patients with moderate to severe symptoms of VVC. Patients were randomized to single-dose therapy with either butoconazole nitrate 2% Site Release®vaginal cream or fluconazole. The primary outcome measure was the time to onset of first relief of symptoms. Secondary measures included the time to overall relief of symptoms and the reinfection rate over the first 30 days following treatment. The overall safety of both products was investigated through the collection of adverse event reports.Results.The median time to first relief of symptoms occurred at 17.5 h for butoconazole patients as compared to 22.9 h for fluconazole patients (p< 0.001). The time at which 75% of patients experienced first relief of symptoms was 24.5 h versus 46.3 h for butoconazole and fluconazole, respectively (p< 0.001). By 12- and 24-h post-treatment, 44.4% and 72.8% of patients in the butoconazole treatment group reported first relief of symptoms versus 29.1% and 55.7% of patients in the fluconazole group (p= 0.044 andp= 0.024 respectively). In patients experiencing first relief of symptoms within 48 h of dosing, the median time to first relief of symptoms in the butoconazole treatment group was significantly shorter at 12.9 h compared to 20.7 h for the fluconazole treatment group (p= 0.048). There were no significant differences between the two groups with respect to time to total relief of symptoms or reoccurrence of infection within 30 days of treatment. Butoconazole therapy was shown to have fewer reported adverse events, including drug-related adverse events, than fluconazole therapy. Vulvovaginal pruritis and vulvovaginal burning were the most common drug-related adverse events attributed to butoconazole. Headache, diarrhea, nausea, upset stomach and skin sensitivity were the most common drugrelated adverse events attributable to fluconazole.Conclusions.Single-dose butoconazole nitrate 2% Site Release®vaginal cream provides statistically significant improvement in time to first relief of symptoms in the treatment of VVC compared to fluconazole. There is no difference between these two treatments with respect to total relief of symptoms or reinfection rate. Although there was no significant difference in the incidence of adverse events judged by the investigator to be treatment-related, butoconazole treatment did result in fewer patients experiencing adverse events than fluconazole.

Butoconazole Nitrate

1988 ◽  
Vol 9 (3) ◽  
pp. 122-124
Author(s):  
Demetris M. Tatum ◽  
Mark Eggleston
Keyword(s):  
Butoconazole Nitrate

Vulvovaginal Candidosis: Comparison of 3-Day Treatment with 2% Butoconazole Nitrate Cream and 6-Day Treatment with 1% Clotrimazole Cream

1988 ◽  
Vol 16 (5) ◽  
pp. 367-375 ◽  
Author(s):  
A. J. Hajman
Keyword(s):  
Day Treatment ◽  
Clinical Signs ◽  
Signs And Symptoms ◽  
Response To Treatment ◽  
Adverse Experiences ◽  
Vaginal Secretions ◽  
Vulvovaginal Candidosis ◽  
Clinical Signs And Symptoms ◽  
Butoconazole Nitrate ◽  
Single Blind

Sixty-three women with laboratory confirmed diagnoses of vulvovaginal candidosis were enrolled into this randomized, single-blind, parallel comparison of treatment with 2% butoconazole nitrate cream for 3 days and 1% clotrimazole cream for 6 days. Approximately 1 week after treatment ended both medications had substantially relieved vulvovaginal discharge, itching, burning, erythema and swelling. Both fungal cultures and potassium hydroxide stained preparations of vaginal secretions were negative for 93.3% of the butoconazole nitrate-treated patients. Comparable results for clotrimazole-treated patients were 80.6% and 77.4%, respectively. Both treatments improved the clinical signs and symptoms of candidosis. More butoconazole nitrate-treated patients (53.3%) had a ‘very good’ clinical response to treatment than clotrimazole-treated patients (38.7%). None of these differences was statistically significant, nor were statistically significant differences found between the percentages of patients considered clinically, microbiologically, or therapeutically cured in each group. No adverse experiences were associated with either treatment. Thus, the 3-day butoconazole nitrate regimen was considered as efficacious and safe as the 6-day clotrimazole regimen.

A new vaginal antifungal agent – Butoconazole nitrate

1985 ◽  
Vol 64 (3) ◽  
pp. 241-244 ◽  
Author(s):  
Jan B. Jacobson ◽  
Aleksander J. Hajman ◽  
JØRgen Wiese ◽  
Per Gandrup ◽  
Sven Forsström
Keyword(s):  
Antifungal Agent ◽  
Butoconazole Nitrate

The synthesis and antifungal activity of the enantiomers of butoconazole nitrate

1993 ◽  
Vol 4 (7) ◽  
pp. 1521-1526 ◽  
Author(s):  
David M. Rotstein ◽  
Keith A.M. Walker
Keyword(s):  
Antifungal Activity ◽  
Butoconazole Nitrate

scholarly journals Effect of Butoconazole Nitrate 2% Vaginal Cream and Miconazole Nitrate 2% Vaginal Cream Treatments in Patients with Vulvovaginal Candidiasis

1996 ◽  
Vol 4 (6) ◽  
pp. 323-328
Author(s):  
Myra A. Lappin ◽  
Doris C. Brooker ◽  
Carol A. Francisco ◽  
Joan Dorfman
Keyword(s):  
Potassium Hydroxide ◽  
Signs And Symptoms ◽  
Vulvovaginal Candidiasis ◽  
Vaginal Cream ◽  
Miconazole Nitrate ◽  
Symptom Scores ◽  
Cure Rates ◽  
Lost To Follow Up ◽  
Butoconazole Nitrate

In a multicenter, randomized, invesgtigator-blind, parallel study, 398 patients were dispensed topical butoconazole nitrate 2% cream for 3 days (n = 199) or miconazole nitrate 2% cream for 7 days (n = 199) for vaginal use. Efficacy analyses included 254 patients with culture-confirmedCandida(119 butoconazole and 135 miconazole users). Of the 398 patients issued study medication, 9 were lost to follow-up. Therefore, safety analyses included 389 patients (197 butoconazole and 192 miconazole users). Evaluations upon admission and approximately 8 and 30 days post-treatment includedCandidacultures, potassium hydroxide (KOH) wet mounts, and vulvovaginal examinations, with rating of vulvovaginal signs and symptoms using a 4-point scale. Rates of clinical cure (based on sign/symptom scores), microbiologic cure (based on cultures and wet mounts), and therapeutic cure (both clinical and microbiologic cures) were assessed and were to be similar between the regimens. Therapeutic cure rates were 57.8% and 61.4% for butoconazole and miconazole, respectively. Three-day butoconazole treatment was as safe and effective as 7-day miconazole therapy in treating vulvovaginal candidiasis.

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