METRONIDAZOLE gel

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

NuCare Pharmaceuticals,Inc.

Οδός χορήγησης:

VAGINAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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)

Περίληψη προϊόντος:

Metronidazole vaginal gel USP, 0.75% is supplied in a 70 gram tube and packaged with 5 vaginal applicators. The NDC 68071-5009-7 box of 70g Store at 20° – 25°C (68° – 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

METRONIDAZOLE- METRONIDAZOLE GEL
NUCARE PHARMACEUTICALS,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
125,00