METRONIDAZOLE gel

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

REMEDYREPACK INC.

INN (International Adı):

METRONIDAZOLE

Kompozisyon:

METRONIDAZOLE 7.5 mg in 1 g

Uygulama yolu:

VAGINAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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. 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 USP, 0.75% is contraindicated in patients with a prior history of hypersensitivity to metronidazole, parabens, other ingredients of the formulation, or other nitroimidazole derivatives.

Ürün özeti:

Metronidazole vaginal gel USP, 0.75% is supplied in a 70 gram tube and packaged with 5 vaginal applicators. NDC: 70519-0539-00 PACKAGING: 1 in 1 CARTON. 70 g in 1 TUBE WITH APPLICATOR Store at 20° – 25°C (68° – 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

METRONIDAZOLE- METRONIDAZOLE GEL
REMEDYREPACK INC.
----------
METRONIDAZOLE VAGINAL GEL USP, 0.75%
RX ONLY
FOR INTRAVAGINAL USE ONLY
NOT FOR OPHTHALMIC, DERMAL, OR ORAL USE
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
H
N
O
, 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.
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 C
= 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
6
9
3
3
max
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/m