METROGEL-VAGINAL- metronidazole gel

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Medicis Pharmaceutical Corp

INN (الاسم الدولي):

METRONIDAZOLE

تركيب:

METRONIDAZOLE 7.5 mg in 1 g

طريقة التعاطي:

VAGINAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

METROGEL-VAGINAL 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. METROGEL-VAGINAL is contraindicated in patients with a prior history of hy

ملخص المنتج:

METROGEL-VAGINAL (metronidazole vaginal gel) 0.75% Vaginal Gel is supplied in a 70 gram tube and packaged with 5 vaginal applicators. The NDC number for the 70 gram tube is 99207-130-70. Store at controlled room temperature 15° to 30°C (59° to 86°F). Protect from freezing. In a randomized, single-blind clinical trial of non-pregnant women with bacterial vaginosis who received METROGEL-VAGINAL 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.

الوضع إذن:

New Drug Application

نشرة المعلومات

METROGEL-VAGINAL- METRONIDAZOLE GEL
Medicis Pharmaceutical Corp
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DIRECTIONS FOR USE
•
Filling the applicator
•
Remove cap and puncture metal seal on tube with the pointed tip of
cap. (See Figure 1)
•
Screw end of applicator onto tube. (See Figure 2)
•
Gently squeeze the tube from the bottom to fill applicator. Plunger
will stop when the
applicator is full. (See Figure 3)
•
Unscrew applicator and replace cap on tube.
•
Inserting the applicator
•
The applicator may be inserted while lying on your back with your
knees bent or in any
comfortable position.
•
Hold filled applicator by barrel, and gently insert into vagina as far
as it will comfortably go.
(See Figure 4)
•
Slowly press the plunger until it stops to deposit gel into vagina and
then withdraw the
applicator.
•
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 five days, or as directed by
physician.
WARNINGS:
•
If significant irritation develops from the use of this medication,
discontinue use and consult your
physician.
•
Do not use during pregnancy except under the supervision of a
physician.
•
Keep this and all medications out of reach of children.
•
For vaginal use only. Not for use in the eyes, on the skin or in the
mouth.
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.
Scottsdale, AZ 85256
129800
Rev 12/11
Revised: 8/2014
Document Id: c08e30fc-ad8b-4bc0-ab9f-644021a906bb
Set id: 94688946-19f1-4f46-903a-2e9c9b89b0f5
Version: 2
Effective Time: 20140812
Medicis Pharmaceutical Corp

خصائص المنتج

METROGEL-VAGINAL- METRONIDAZOLE GEL
MEDICIS PHARMACEUTICAL CORP
----------
METROGEL-VAGINAL
(METRONIDAZOLE VAGINAL GEL)
0.75% VAGINAL GEL
FOR INTRAVAGINAL USE ONLY
NOT FOR OPHTHALMIC, DERMAL, OR ORAL USE
DESCRIPTION
METROGEL-VAGINAL 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:
METROGEL-VAGINAL 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 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 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-