Drug Catalog - Product Detail
METRONIDAZOLE VAGINAL GEL 0.75% 70GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00781-7077-87 | SANDOZ | 70 | 0.75% | GEL |
PACKAGE FILES
Generic Name
METRONIDAZOLE
Substance Name
METRONIDAZOLE
Product Type
HUMAN PRESCRIPTION DRUG
Route
VAGINAL
Application Number
ANDA077264
Description
DESCRIPTION Metronidazole vaginal gel USP, 0.75% 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 C 6 H 9 N 3 O 3 , a molecular weight of 171.16, and has the following structure: Metronidazole vaginal gel USP, 0.75% is a gelled, purified water solution, containing metronidazole at a concentration of 7.5 mg/g (0.75%). The gel is formulated at pH 5.5. The gel also contains carbopol 974P, edetate disodium, methylparaben, propylene glycol, propylparaben and sodium hydroxide. Each applicator full of 5 grams of vaginal gel contains approximately 37.5 mg of metronidazole. 5d5728bc-figure-01
How Supplied
HOW SUPPLIED Metronidazole vaginal gel USP, 0.75% is supplied in a 70 gram tube and packaged with 5 vaginal applicators. The NDC number for the 70 gram tube is 0781-7077-87. Store at 20° – 25°C (68° – 77°F) [see USP Controlled Room Temperature]. Protect from freezing.
Indications & Usage
INDICATIONS & USAGE Metronidazole vaginal gel USP, 0.75% 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
DOSAGE & ADMINISTRATION The recommended dose is one applicator full of metronidazole vaginal gel USP, 0.75% (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, metronidazole vaginal gel USP, 0.75% should be administered at bedtime.