Metronidazole (Metronidazole Vaginal)

Trade Name : metronidazole vaginal

Perrigo New York Inc

GEL

Strength 7.5 mg/g

METRONIDAZOLE Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Metronidazole (Metronidazole Vaginal) which is also known as metronidazole vaginal and Manufactured by Perrigo New York Inc. It is available in strength of 7.5 mg/g per ml. Read more

Metronidazole (Metronidazole Vaginal) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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FOR INTRAVAGINAL USE ONLY
NOT FOR OPHTHALMIC, DERMAL, OR ORAL USE

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 CHNO, 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 974P, 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.

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-adjusted comparisons of AUCs demonstrated that, on a mg to mg comparison basis, the absorption of metronidazole, when administered vaginally, was approximately half that of an equivalent oral dosage.
Patients with Bacterial Vaginosis
Following single and multiple 5 gram doses of metronidazole vaginal gel to 4 patients with bacterial vaginosis, a mean maximum serum metronidazole concentration of 214 ng/mL on day 1 and 294 ng/mL (range: 228 to 349 ng/mL) on day five were reported. Steady state metronidazole serum concentrations following oral dosages of 400 to 500 mg BID have been reported to range from 6,000 to 20,000 ng/mL.
Microbiology
The intracellular targets of action of metronidazole on anaerobes are largely unknown. The 5-nitro group of metronidazole is reduced by metabolically active anaerobes, and studies have demonstrated that the reduced form of the drug interacts with bacterial DNA. However, it is not clear whether interaction with DNA alone is an important component in the bactericidal action of metronidazole on anaerobic organisms.
Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis.
(See .)
Standard methodology for the susceptibility testing of the potential bacterial vaginosis pathogens, , spp., and , has not been defined. Nonetheless, metronidazole is an antimicrobial agent active against most strains of the following organisms that have been reported to be associated with bacterial vaginosis:
Bacteroides
Gardnerella vaginalis
Mobiluncus
Peptostreptococcus

Metronidazole Vaginal Gel is indicated in the treatment of bacterial vaginosis (formerly referred to as vaginitis, vaginitis, nonspecific vaginitis, vaginitis, or anaerobic vaginosis).
NOTE:n- Lactobacillus n- Gardnerella
Other pathogens commonly associated with vulvovaginitis, e.g., , , , , and 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.

Convulsive Seizures and Peripheral Neuropathy
Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with oral or intravenous metronidazole. The appearance of abnormal neurologic signs demands the prompt discontinuation of metronidazole vaginal gel therapy. Metronidazole vaginal gel should be administered with caution to patients with central nervous system diseases.
Psychotic Reactions
Psychotic reactions have been reported in alcoholic patients who were using oral metronidazole and disulfiram concurrently.
Metronidazole vaginal gel should not be administered to patients who have taken disulfiram within the last two weeks.

Metronidazole Vaginal Gel affords minimal peak serum levels and systemic exposure (AUCs) of metronidazole compared to 500 mg oral metronidazole dosing. Although these lower levels of exposure are less likely to produce the common reactions seen with oral metronidazole, the possibility of these and other reactions cannot be excluded presently. Data from well-controlled trials directly comparing metronidazole administered orally to metronidazole administered vaginally are not available.

Clinical Trials
There were no deaths or serious adverse events related to drug therapy in clinical trials involving 800 non-pregnant women who received metronidazole vaginal gel.
In a randomized, single-blind clinical trial of 505 non-pregnant women who received metronidazole vaginal gel once or twice a day, 2 patients (one from each regimen) discontinued therapy early due to drug-related adverse events. One patient discontinued drug because of moderate abdominal cramping and loose stools, while the other patient discontinued drug because of mild vaginal burning. These symptoms resolved after discontinuation of drug.
Medical events judged to be related, probably related, or possibly related to administration of metronidazole vaginal gel once or twice a day were reported for 195/505 (39%) patients. The incidence of individual adverse reactions were not significantly different between the two regimens. Unless percentages are otherwise stipulated, the incidence of individual adverse reactions listed below was less than 1%:
Reproductive:
Vaginal discharge (12%),
Symptomatic cervicitis/vaginitis (10%),
Vulva/vaginal irritative symptoms (9%),
Pelvic discomfort (3%).
Gastrointestinal:
Gastrointestinal discomfort (7%),
Nausea and/or vomiting (4%),
Unusual taste (2%),
Diarrhea/loose stools (1%),
Decreased appetite (1%),
Abdominal bloating/gas; thirsty, dry mouth.
Neurologic:
Headache (5%),
Dizziness (2%),
Depression.
Dermatologic:
Generalized itching or rash.
Other:
Unspecified cramping (1%),
Fatigue,
Darkened urine.
In previous clinical trials submitted for approved labeling of metronidazole vaginal gel the following was also reported:
Laboratory:
Increased/decreased white blood cell counts (1.7%).
Other Metronidazole Formulations
Other effects that have been reported in association with the use of formulations of metronidazole include skin irritation, transient skin erythema, and mild skin dryness and burning. None of these adverse events exceeded an incidence of 2% of patients.
Metronidazole Vaginal Gel affords minimal peak serum levels and systemic exposure (AUC) of metronidazole compared to 500 mg oral metronidazole dosing. Although these lower levels of exposure are less likely to produce the common reactions seen with oral metronidazole, the possibility of these and other reactions cannot be excluded presently.
The following adverse reactions and altered laboratory tests have been reported with the use of metronidazole:
Cardiovascular
Central Nervous Systemn- WARNINGS
Gastrointestinal
Genitourinary
Hematopoietic
Hypersensitivity Reactions
Renal
To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or .

There is no human experience with overdosage of metronidazole vaginal gel. Vaginally applied metronidazole gel, 0.75% could be absorbed in sufficient amounts to produce systemic effects. (See )

The recommended dose is one applicator full of Metronidazole Vaginal Gel (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 should be administered at bedtime.

Metronidazole Vaginal Gel, 0.75% is supplied in a 70 gram tube and packaged with 5 vaginal applicators.
The NDC number for the 70 gram tube is 45802-139-70.
Store at controlled room temperature 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F). 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.
Rx only
Made in Israel
Manufactured By Perrigo
Yeruham, Israel
Distributed by
Perrigou00ae
Allegan, MI 49010 u2022 www.perrigo.com
Rev 08-18
0N900RCJ1

Filling the applicator
Inserting the applicator
Care of the applicator
If physician prescribes twice-a-day dosing:
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:
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.
Made in Israel
Manufactured By Perrigo
Yeruham, Israel
Distributed By
Perrigou00ae
Allegan, MI 49010 u2022 www.perrigo.com
Rev 08-18
0N900 RC J1

Rx Only
Metronidazole Vaginal Gel 0.75% with 5 applicators
FOR INTRAVAGINAL USE ONLY.
(NOT FOR OPHTHALMIC, DERMAL, OR ORAL USE.)
NET WT 70 g

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Metronidazole (Metronidazole Vaginal)

Trade Name : metronidazole vaginal

GEL

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Metronidazole (Metronidazole Vaginal)

Trade Name : metronidazole vaginal

GEL

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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