Femstat 3 (butoconazole nitrate 2%)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved December 1995

Specific Treatments:

vaginal yeast infections

General Information

Femstat 3 is an over-the-counter treatment (OTC) for vaginal yeast infections. While other OTC vaginal yeast infection medications require 7 days of treatment, Femstat 3 vaginal cream will be the first 3-day treatment brand available without a prescription.

Femstat 3 contains the antifungal agent butoconazole nitrate, which was developed specifically for the local treatment of vaginal yeast infections.

Femstat 3 should be used vaginally by nonpregnant women and girls age 12 and over.

Femstat 3 will be available in a 5-gram prefilled disposable applicator, with three applicators packaged together as a treatment regimen. Recommended dosage is one applicatorful each day for three consecutive days, preferably at bedtime.

Clinical Results

Since its introduction in prescription form in 1986, more than 13 million women worldwide have been treated with butoconazole nitrate for vaginal yeast infections. The safety of prescription butoconazole nitrate has been established in 45 clinical trials and eight years of postmarketing experience in the U.S. and abroad. These clinical studies included 3,267 subjects treated with butoconazole nitrate; 1,735 subjects treated with other antifungal agents; and 287 subjects treated with a placebo. In these 45 studies, the drug-related incidence of local adverse events, such as burning and itching, was consistent with the market leader, Monistat 7.

Two well-controlled clinical studies conducted in support of the Rx-to-OTC switch application demonstrated that the 3-day regimen with butoconazole nitrate 2% cream in over 300 subjects was as safe and effective as the 7-day regimen of miconazole nitrate 2% cream (Monistat 7) for the treatment of vulvovaginal candidiasis when evaluated at 8 and 30 days post-treatment. The efficacy of butoconazole nitrate in a 3-day regimen was also established in clinical studies conducted in support of the original prescription product. These NDA studies included more than 1,300 subjects, nearly 900 of whom were treated with butoconazole nitrate 2% cream.

Additional Information

Between 1980 and 1990, the incidence of vulvovaginal candidiasis nearly doubled in the United States., with an annual occurrence of 13 million cases. OTC vaginal yeast infection products are intended for use by women who have previously been diagnosed by a physician as having a vaginal yeast infection and who are experiencing the same symptoms again. Nonprescription Femstat 3 is the result of the prescription-to-OTC switch of the prescription products, Femstat and Femstat Prefill.

First-time sufferers should see a doctor. Femstat 3 should not be used if experiencing abdominal pain, fever, or foul-smelling discharge. A physician should be contacted immediately. If the infection isn't gone in three days, there may be a condition other than a yeast infection or the use of more medication may be needed. A doctor should be consulted. If symptoms return within two months or if women think they have been exposed to the HIV virus that causes AIDS, a doctor should be consulted immediately. Recurring infections may be a sign of pregnancy or a serious condition, such as AIDS or diabetes. Product should not be used if a woman is pregnant or thinks she may be pregnant, has diabetes, a positive HIV test or AIDS. Condoms or diaphragms should not be relied upon to prevent sexually transmitted diseases or pregnancy while using this product. This product may damage condoms and diaphragms and may cause them to fail. Another method of birth control should be used to prevent pregnancy while using this product. Femstat 3 should not be used with tampons. This product should not be used in girls under 12 years of age.