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Metrogel Vaginal

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MetroGel Vaginal

INDICATIONS

METROGEL-VAGINAL (metronidazole) 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.

DOSAGE AND ADMINISTRATION

The recommended dose is one applicator full of METROGEL-VAGINAL (metronidazole) (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, METROGEL-VAGINAL (metronidazole) should be administered at bedtime.

HOW SUPPLIED

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.

January 2003, Manufactured for: 3M Pharmaceuticals, Northridge, CA 91324. Manufactured by: DPT Laboratories, Inc., San Antonio, TX 78215.

Last reviewed on RxList: 4/20/2009
This monograph has been modified to include the generic and brand name in many instances.

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