Indications And Usage
METROGEL-VAGINAL is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).
NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells.
Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.
METROGEL-VAGINAL (metronidazole vaginal gel) 0.75% Vaginal Gel is supplied in a 70 gram tube and packaged with 5 vaginal applicators.
The NDC number for the 70 gram tube is 0089-0200-25.
Store at controlled room temperature 15° to 30°C (59° to 86°F). Protect from freezing.
In a randomized, single-blind clinical trial of non-pregnant women with bacterial vaginosis who received METROGEL-VAGINAL daily for 5 days, the clinical cure rates for evaluable patients determined at 4 weeks after completion of therapy for the QD and BID regimens were 98/185 (53%) and 109/190 (57%), respectively.
|Manufactured for||Manufactured by|
|3M Pharmaceuticals||DPT Laboratories, Inc.|
|Northridge, CA 91324||San Antonio, TX 78215||622901||3M Pharmaceuticals|