Gynazole-1 (Cream)

Gynazole-1 (Cream)

Following vaginal administration of butoconazole nitrate vaginal cream, 2% to 3 women, 1.7% (range 1.3-2.2%) of the dose was absorbed on average. Peak plasma levels (13.6-18.6 ng radioequivalents/mL of plasma) of the drug and its metabolites are attained between 12 and 24 hours after vaginal administration.<br/>Microbiology: The exact mechanism of the antifungal action of butoconazole nitrate is unknown; however, it is presumed to function as other imidazole derivatives via inhibition of steroid synthesis. Imidazoles generally inhibit the conversion of lanosterol to ergosterol, resulting in a change in fungal cell membrane lipid composition. This structural change alters cell permeability and, ultimately, results in the osmotic disruption or growth inhibition of the fungal cell. Butoconazole nitrate is an imidazole derivative that has fungicidal activity in vitro against Candida spp. and has been demonstrated to be clinically effective against vaginal infections due to Candida albicans. Candida albicans has been identified as the predominant species responsible for vulvovaginal candidasis.

Gynazole-1 (butoconazole nitrate) vaginal cream, 2% is available in cartons containing one single-dose prefilled disposable applicator. 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). U.S. Patent Nos. 4,078,071, 4,551,148, 4,636,202 and 5,266,329 Manufactured for Ther-Rx Corporationby KV Pharmaceutical Co.St. Louis, MO 63044 Gynazole-1 (butaconazole nitrate) Vaginal Cream, 2%In one prefilled disposable applicator Using the Gynazole-1 Prefilled Disposable Applicator3 Easy Steps: Step 1: Preparing the Applicator Peel back the protective foil and remove the prefilled applicator. Applicator is designed to be used with the tip in place. Do not remove the tip; do not use the applicator if the tip has been removed. Do not warm applicator before using. While holding the applicator firmly, pull the ring back to fully extend the plunger (See Figure 2). Step 2: Inserting the Applicator Gently insert the applicator into the vagina as far as it will comfortably go (See Figure 3). Step 3: Applying the Cream Push the plunger to release the cream (See Figure 4). Remove the empty applicator from the vagina and throw it away. Important Instructions: P4249-1 01/05

dailymed-ingredient:colloidal_silicon_dioxide, dailymed-ingredient:edetate_disodium, dailymed-ingredient:glyceryl, dailymed-ingredient:methylparaben, dailymed-ingredient:microcrystalline_wax, dailymed-ingredient:mineral_oil, dailymed-ingredient:monoisostearate, dailymed-ingredient:polyglyceryl-3_oleate, dailymed-ingredient:propylene_glycol, dailymed-ingredient:propylparaben, dailymed-ingredient:sorbitol_solution, dailymed-ingredient:water

Gynazole-1 (Cream)

Gynazole-1 (butoconazole nitrate) vaginal cream, 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 . Note: Gynazole-1 is safe and effective in non-pregnant women; however, the safety and effectiveness of this product in pregnant women has not been established .

http://www4.wiwiss.fu-berlin.de/dailymed/resource/routeOfAdministration/Vaginal