SUMMARY
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.
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NEWS HIGHLIGHTSMedia Articles Related to Metrogel Vaginal (Metronidazole Vaginal)
Bacterial Vaginosis
Source: MedicineNet metronidazole cream Specialty [2016.10.25]
Title: Bacterial Vaginosis
Category: Diseases and Conditions
Created: 11/7/2001 12:00:00 AM
Last Editorial Review: 10/25/2016 12:00:00 AM
What is Bacterial Vaginosis?
Source: MedicineNet metronidazole cream Specialty [2014.12.09]
Title: What is Bacterial Vaginosis?
Category: Doctor's Views
Created: 5/2/2005 12:00:00 AM
Last Editorial Review: 12/9/2014 12:00:00 AM
Published Studies Related to Metrogel Vaginal (Metronidazole Vaginal)
Efficacy and safety of metronidazole for pulmonary multidrug-resistant
tuberculosis. [2013]
Pulmonary lesions from active tuberculosis patients are thought to contain
persistent, nonreplicating bacilli that arise from hypoxic stress... Newer nitroimidazoles with both aerobic and
anaerobic activity, now in clinical trials, may increase the sterilizing potency
of future treatment regimens.
Randomised clinical trial: vancomycin or metronidazole in patients with primary
sclerosing cholangitis - a pilot study. [2013]
in patients with PSC... CONCLUSIONS: Both vancomycin and metronidazole demonstrated efficacy; however,
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 Trials Related to Metrogel Vaginal (Metronidazole Vaginal)
A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis [Completed]
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.
Penicillin and Metronidazole in Treatment of Peritonsillar Abscess [Completed]
Treatment of peritonsillar abscess varies. To study whether broad spectrum antibiotics are
required in addition to abscess drainage we perform a prospective, double blind,
placebo-controlled, randomised study on 200 adult patients with peritonsillar abscess. 100
patients are given penicillin and metronidazole and 100 patients get penicillin and placebo.
Recovery and recurrence and analyzed.
A Study to Assess the Levels of CAZ-AVI and Metronidazole in the Blood When Given Together and Separately [Completed]
The purpose of the study is to assess whether there is any pharmacokinetic interactions
between CAZ-AVI and metronidazole.
Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis [Completed]
The purpose of this study was to demonstrate comparable efficacy, safety, and tolerability
of Teva Pharmaceuticals USA's generic formulation of Metronidazole Vaginal Gel, 0. 75% and 3M
Pharmaceuticals' MetroGel-Vaginal® metronidazole vaginal gel, 0. 75% to establish clinical
equivalence in the treatment of bacterial vaginosis.
Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies [Recruiting]
Abnormal vaginal flora is a risk factor for preterm labor. Therefore, in high risk
pregnancies for preterm labor the diagnosis and treatment of abnormal flora is indicated.
Clindamycin and metronidazole given orally are both acceptable treatments in these cases.
The purpose of this study is to compare the effectiveness of Clindamycin Vs metronidazole
for the treatment of abnormal vaginal flora in high risk pregnancies. For this purpose,
pregnant women who are considered high risk for preterm labor and were diagnosed with
abnormal vaginal flora will be randomly treated either with clindamycin or metronidazole.
Eradication of the abnormal flora and adverse effects will be monitored and compared
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Page last updated: 2016-10-25
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