METRONIDAZOLE gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E)

Available from:

Physicians Total Care, Inc.

INN (International Name):

METRONIDAZOLE

Composition:

METRONIDAZOLE 7.5 mg in 1 g

Administration route:

VAGINAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metronidazole Vaginal Gel 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. Metronidazole Vaginal Gel is contraindicated in patient

Product summary:

Metronidazole Vaginal Gel 0.75% is supplied in a 70 gram tube and packaged with 5 vaginal applicators. The NDC number for the 70 gram tube is 54868-6352-0. Store at controlled room temperature 15° to 30°C (59° to 86°F). Protect from freezing. Clinical Studies In a randomized, single-blind clinical trial of non-pregnant women with bacterial vaginosis who received Metronidazole Vaginal Gel 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. Rx only June 2008 Manufactured for Prasco Laboratories Mason, OH 45040 USA Manufactured by DPT Laboratories, Inc. San Antonio, TX 78215 128951-0608 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma        74146

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

METRONIDAZOLE - METRONIDAZOLE GEL
PHYSICIANS TOTAL CARE, INC.
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METRONIDAZOLE VAGINAL GEL, 0.75%
DESCRIPTION
Metronidazole Vaginal Gel is the intravaginal dosage form of the
synthetic antibacterial agent,
metronidazole, USP at a concentration of 0.75%. Metronidazole is a
member of the imidazole class of
antibacterial agents and is classified therapeutically as an
antiprotozoal and antibacterial agent.
Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. It
has a chemical formula of
C6H9N3O3, a molecular weight of 171.16, and has the following
structure:
Metronidazole Vaginal Gel is a gelled, purified water solution,
containing metronidazole at a
concentration of 7.5 mg/g (0.75%). The gel is formulated at pH 4.0.
The gel also contains carbomer
934P, edetate disodium, methyl paraben, propyl paraben, propylene
glycol, and sodium hydroxide.
Each applicator full of 5 grams of vaginal gel contains approximately
37.5 mg of metronidazole.
CLINICAL PHARMACOLOGY
NORMAL SUBJECTS:
Following a single, intravaginal 5 gram dose of metronidazole vaginal
gel (equivalent to 37.5 mg of
metronidazole) to 12 normal subjects, a mean maximum serum
metronidazole concentration of 237 ng/mL
was reported (range: 152 to 368 ng/mL). This is approximately 2% of
the mean maximum serum
metronidazole concentration reported in the same subjects administered
a single, oral 500 mg dose of
metronidazole (mean Cmax = 12,785 ng/mL, range: 10,013 to 17,400
ng/mL). These peak concentrations
were obtained in 6 to 12 hours after dosing with metronidazole vaginal
gel and 1 to 3 hours after dosing
with oral metronidazole.
The extent of exposure [area under the curve (AUC)] of metronidazole,
when administered as a single
intravaginal 5 gram dose of metronidazole vaginal gel (equivalent to
37.5 mg of metronidazole), was
approximately 4% of the AUC of a single oral 500 mg dose of
metronidazole (4977 ng-hr/mL and
approximately 125,000 ng-hr/mL, respectively).
Dose-adjusted comparisons of AUCs demonstrated that, on a mg to mg
comparison b