METRONIDAZOLE gel

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Oceanside Pharmaceuticals

INN (Medzinárodný Name):

METRONIDAZOLE

Zloženie:

METRONIDAZOLE 7.5 mg in 1 g

Spôsob podávania:

VAGINAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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). 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 patients with a prior history of hypersensitivity to metronidazole, parabens, other ingredients of the formulation, or other nitroimidazole derivatives.

Prehľad produktov:

Metronidazole Vaginal Gel, 0.75% is supplied in a 70 g tube and packaged with 5 vaginal applicators. The NDC number for the 70 g tube is 68682-455-70. 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. Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: DPT Laboratories, Inc., San Antonio, TX 78215 USA © 2020 Bausch Health Companies Inc. or its affiliates Rev. 10/2020 9432505 Metronidazole Vaginal Gel, 0.75% DIRECTIONS FOR USE 1.  Filling the applicator 2.  Inserting the applicator 3. Care of the applicator If physician prescribes twice-a-day dosing: • After use, pull the plunger out of the barrel. (See Figure 5) • Wash both plunger and barrel in warm soapy water and rinse thoroughly. • To reassemble applicator, gently push plunger back into barrel. IMPORTANT For once-a-day dosing, apply one applicator full at bedtime. For twice-a-day dosing, apply one applicator full each morning and evening for 5 days, or as directed by physician. WARNINGS Store at room temperature. Avoid exposure to extreme heat or cold. See end of carton and bottom of tube for lot number and expiration date. Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: DPT Laboratories, Inc. San Antonio, TX 78215 USA © 2020 Bausch Health Companies Inc. or its affiliates Rev. 10/2020 9432505

Stav Autorizácia:

New Drug Application Authorized Generic

Súhrn charakteristických

METRONIDAZOLE- METRONIDAZOLE GEL
OCEANSIDE PHARMACEUTICALS
----------
METRONIDAZOLE VAGINAL GEL, 0.75%
FOR INTRAVAGINAL USE ONLY
NOT FOR OPHTHALMIC, DERMAL, OR ORAL USE
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
C H N O , 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, methylparaben, propylparaben, 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 g 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 administered as a single
intravaginal 5 g 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