GYNAZOLE-1 2 % Vaginal Cream
Generic Name: BUTOCONAZOLE NITRATE
Brand Name: gynazole 1
- Substance Name(s):
- BUTOCONAZOLE NITRATE
WARNINGS
This cream contains mineral oil.
Mineral oil may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms; therefore, use of such products within 72 hours following treatment with GYNAZOLE•1® Butoconazole Nitrate Vaginal Cream USP, 2% is not recommended.
Recurrent vaginal yeast infections, especially those that are difficult to eradicate, can be an early sign of infection with the human immunodeficiency virus (HIV) in women who are considered at risk for HIV infection.
DESCRIPTION
GYNAZOLE • 1® Butoconazole Nitrate Vaginal Cream USP, 2% contains butoconazole nitrate 2%, an imidazole derivative with antifungal activity.
Its chemical name is (±)-1-[4-(p-chlorophenyl)-2- [(2,6-dichlorophenyl) thio]butyl] imidazole mononitrate, and it has the following chemical structure: Butoconazole nitrate is a white to off-white crystalline powder with a molecular weight of 474.79.
It is sparingly soluble in methanol; slightly soluble in chloroform, methylene chloride, acetone, and ethanol; very slightly soluble in ethyl acetate; and practically insoluble in water.
It melts at about 159°C with decomposition.
GYNAZOLE • 1® Butoconazole Nitrate Vaginal Cream USP, 2% contains 2% butoconazole nitrate in a cream of edetate disodium, glyceryl monoisostearate, methylparaben, mineral oil, polyglyceryl-3 oleate, propylene glycol, propylparaben, colloidal silicon dioxide, sorbitol solution, purified water, and microcrystalline wax.
Chemical Structure.jpg
CLINICAL STUDIES
Vulvovaginal Candidiasis: Two studies were conducted that compared 2% butoconazole nitrate cream with clotrimazole tablets.
There were 322 enrolled patients, 161 received 2.0% butoconazole vaginal cream and 161 patients inserted the 500-mg clotrimazole vaginal tablet.
At the second follow-up visit (30 days post-therapy), 118 patients in the butoconzole group and 116 in the clotrimazole group were evaluable for efficacy analysis, respectively.
All of these patients had infection caused by Candida albicans.
The efficacy of the study drugs was assessed by evaluating clinical, mycologic and therapeutic cure rates, which are summarized in Table 1.
The therapeutic cure was defined as complete resolution of signs and symptoms of vaginal candidiasis (clinical cure) along with a negative KOH examination and negative culture for Candida spp.
(microbiologic eradication) at the long term follow-up (30 days).
The therapeutic cure rate was 67% in the butoconazole group and 61% in the clotrimazole group.
Table 1.jpg
HOW SUPPLIED
GYNAZOLE•1® Butoconazole Nitrate Vaginal Cream USP, 2% is available in cartons containing one single-dose prefilled disposable applicator (NDC 45802-396-01).
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Avoid heat above 30°C (86°F)
INDICATIONS AND USAGE
GYNAZOLE • 1® Butoconazole Nitrate Vaginal Cream USP, 2% is indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida).
The diagnosis should be confirmed by KOH smears and/or cultures (see CLINICAL STUDIES).
Note: GYNAZOLE • 1® Butoconazole Nitrate Vaginal Cream USP, 2% is safe and effective in non-pregnant women; however, the safety and effectiveness of this product in pregnant women has not been established (see PRECAUTIONS – Pregnancy).
PEDIATRIC USE
Pediatric Use – Safety and effectiveness in children have not been established.
PREGNANCY
Pregnancy:
NUSRING MOTHERS
Nursing Mothers – It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when butoconazole nitrate is administered to a nursing woman.
DOSAGE AND ADMINISTRATION
The recommended dose of GYNAZOLE • 1® Butoconazole Nitrate Vaginal Cream USP, 2% is one applicatorful of cream (approximately 5 grams of the cream) intravaginally.
This amount of cream contains approximately 100 mg of butoconazole nitrate.