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Metrogel Vaginal (Metronidazole Vaginal) - Summary

 
 



SUMMARY

MetroGel-Vaginal®
(metronidazole vaginal gel)
0.75% Vaginal Gel

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.

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.


See all Metrogel Vaginal indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Metrogel Vaginal (Metronidazole Vaginal)

Bacterial Vaginosis
Source: MedicineNet Gonorrhea In Women Specialty [2013.10.18]
Title: Bacterial Vaginosis
Category: Diseases and Conditions
Created: 11/7/2001 1:44:00 PM
Last Editorial Review: 10/18/2013 4:20:17 PM

What is Bacterial Vaginosis?
Source: MedicineNet metronidazole Specialty [2013.10.18]
Title: What is Bacterial Vaginosis?
Category: Doctor's Views
Created: 5/2/2005 12:00:00 AM
Last Editorial Review: 10/18/2013 12:00:00 AM

more news >>

Published Studies Related to Metrogel Vaginal (Metronidazole Vaginal)

Clinical and microbiological benefits of metronidazole alone or with amoxicillin as adjuncts in the treatment of chronic periodontitis: a randomized placebo-controlled clinical trial. [2011.09]
AIM: To evaluate the effects of the adjunctive use of metronidazole (MTZ) or MTZ+amoxicillin (AMX) in the treatment of generalized chronic periodontitis (ChP)... CONCLUSION: The adjunctive use of MTZ+AMX offers short-term clinical and microbiological benefits, over SRP alone, in the treatment of non-smokers subjects with generalized ChP. The added benefits of MTZ were less evident. (c) 2011 John Wiley & Sons A/S.

Helicobacter pylori eradication with a capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline given with omeprazole versus clarithromycin-based triple therapy: a randomised, open-label, non-inferiority, phase 3 trial. [2011.03.12]
BACKGROUND: Helicobacter pylori is associated with benign and malignant diseases of the upper gastrointestinal tract, and increasing antibiotic resistance has made alternative treatments necessary. Our aim was to assess the efficacy and safety of a new, single-capsule treatment versus the gold standard for H pylori eradication... INTERPRETATION: Quadruple therapy should be considered for first-line treatment in view of the rising prevalence of clarithromycin-resistant H pylori, especially since quadruple therapy provides superior eradication with similar safety and tolerability to standard therapy. FUNDING: Axcan Pharma Inc. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

Tinidazole vs metronidazole for the treatment of bacterial vaginosis. [2011.03]
OBJECTIVE: The purpose of this study was to compare the efficacy of 2 different doses of tinidazole with metronidazole for the treatment of bacterial vaginosis and to compare the side effects of the drugs... CONCLUSION: There were no differences in cure rates between metronidazole and either of the tinidazole dosing regimens that were studied. In addition, there were no important differences in the side-effect profiles of metronidazole and tinidazole. Copyright (c) 2011 Mosby, Inc. All rights reserved.

Clinical efficacy of Saccharomyces boulardii or metronidazole in symptomatic children with Blastocystis hominis infection. [2011.03]
Although many Blastocystis infections remain asymptomatic, recent data suggest it also causes frequent symptoms. Therapy should be limited to patients with persistent symptoms and a complete workup for alternative etiologies...

The effects of an investigational antimalarial agent, NIPRD-AM1 on the single dose pharmacokinetics of metronidazole in healthy human volunteers. [2011.01]
The effect of concurrent administration of a novel phytomedicine, NIPRD-AM1 used for the treatment of malaria on the pharmacokinetics of metronidazole was investigated in healthy volunteers. The study was a completely randomized one, crossover involving administration of single dose metronidazole tablets (200 mgx2) concomitantly with NIPRD-AM1 capsules (250 mgx2) to 11 healthy volunteers...

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Clinical Trials Related to Metrogel Vaginal (Metronidazole Vaginal)

An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1% [Completed]
The purpose of this study is to determine the cosmetic appearance of metronidazole gel (MetroGel®) 1% with commonly marketed facial foundations.

A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis [Recruiting]
Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly in people who have taken potent antibiotics. When C. difficile multiplies within the colon, it produces two toxins that cause inflammation and resultant abdominal pain, fever and diarrhea. Current treatment of mild to moderate disease is with immediate release metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed a delayed release form of metronidazole to release just before the colon to increase the concentration of antibiotic in the colon to improve the effectiveness of metronidazole treatment and potentially to allow less whole body exposure to the antibiotic.

This study will measure the amount of metronidazole in the blood and stool of patients with C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing the antibiotic as designed, immediately before the colon.

Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease [Recruiting]
The purpose of this study is to evaluate effectiveness of 2 months antibiotic course of Azithromycin combined with Metronidazole compared with 2 months antibiotic course of Metronidazole alone.

Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment [Completed]
What is the difference between the use of one drug (Oral Metronidazole) versus the use of this same drug combined with another drug (Rifampin) in treatment of bacteria and infection-associated diarrhea in patients? This infection is an important cause of morbidity and mortality in both the community and hospitals, and the leading cause of hospital and chronic facility-acquired diarrhea. Research is important for the treatment of this infection. Patient care with use of two medication treatment regimens will be studied.

Do Motion Metrics Lead to Improved Skill Acquisition on Simulators? [Recruiting]
Emphasizing the growing popularity of motion metrics are the majority of available virtual reality simulators and some newer hybrid models that offer motion tracking for performance assessment. A popular hybrid model (PROMIS) allows training with regular laparoscopic instruments in a box-trainer while automatically recording task duration and movement efficiency (pathlength and smoothness) that are immediately offered as feedback to trainees.

Despite the increasing availability of simulators that track motion, our knowledge of the impact those metrics have on trainee learning is severely limited. We do not know if it is more important to use speed, accuracy, motion efficiency or a combination thereof for performance assessment and how these metrics impact skill transfer to the OR.

Based on sound educational principles we have developed a proficiency-based laparoscopic suturing simulator curriculum. This curriculum focuses on deliberate and distributed practice, provides trainees with augmented feedback and sets expert-derived performance goals based on time and errors. We have previously demonstrated that this curriculum leads to improved operative performance of trainees compared to controls.

To measure operative performance and determine transferability, we will use a live porcine Nissen fundoplication model. Instead of placing actual patients at risk, the porcine model is preferable for this purpose as it offers objective metrics (targets are established, distances measured, knots are disrupted for slippage scoring), complete standardization, and allows multiple individuals to be tested on the same day.

We hypothesize that proficiency-based simulator training in laparoscopic suturing to expert-derived levels of speed and motion will result in better operative performance compared to participants training to levels of speed or motion alone. The study is powered to detect an at least 10% performance difference between the groups.

Specific Aims

1. Compare whether any performance differences between the groups persist long-term

2. Assess whether the groups demonstrate differences in safety in the operating room by comparing the inadvertent injuries in the animal OR between the groups

3. Identify the training duration required by novices to reach proficiency in laparoscopic suturing based on speed, motion efficiency, or a combination of these metrics

4. Identify any baseline participant characteristics that may predict individual metric-specific performance

more trials >>


Page last updated: 2013-10-18

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