Flagyl ER (Metronidazole) - Summary

FLAGYL ER SUMMARY

Flagyl^® ER
metronidazole extended release tablets

Metronidazole is an oral synthetic antiprotozoal and antibacterial agent, 2-methyl-5-nitroimidazole-1-ethanol.

Flagyl ER 750 mg tablets are indicated in the treatment of women with Bacterial Vaginosis (BV).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Flagyl ER and other antibacterial drugs, Flagyl ER should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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NEWS HIGHLIGHTS

Published Studies Related to Flagyl ER (Metronidazole)

Efficacy of the standard quadruple therapy versus triple therapies containing proton pump inhibitor plus amoxicillin and clarithromycin or amoxicillin-clavulanic acid and metronidazole for Helicobacter pylori eradication in children. [2009.08]
CONCLUSION: Considering these data we suggest quadruple therapy as the first line of therapy for eradication of H. pylori infection in children in our geographic area (Iran).

Comparison of oral and vaginal metronidazole for treatment of bacterial vaginosis in pregnancy: impact on fastidious bacteria. [2009.06.10]
BACKGROUND: Bacterial vaginosis (BV) is a common condition that is associated with preterm birth and acquisition of complex communities of vaginal bacteria that include several fastidious species. Treatment of BV in pregnancy has mixed effects on the risk of preterm delivery, which some hypothesize is due to variable antibiotic efficacy for the fastidious bacteria. Both oral and intravaginal metronidazole can be used to treat bacterial vaginosis in pregnancy, but little is known about the impact of different routes of antibiotic administration on concentrations of fastidious vaginal bacteria... CONCLUSION: Both oral and vaginal metronidazole therapy in pregnant women result in a significant decrease in concentrations of most BV-associated anaerobic bacteria, with the exception that Leptotrichia, Sneathia and BVAB1 do not significantly decrease with vaginal metronidazole therapy. These data suggest that the route of antibiotic administration has a minor impact on bacterial eradication in pregnant women with BV. TRAIL REGISTRATION: This trial is registered with ClinicalTrials.gov, number NCT00153517.

Clinical efficacy of Saccharomyces boulardii and metronidazole compared to metronidazole alone in children with acute bloody diarrhea caused by amebiasis: a prospective, randomized, open label study. [2009.06]
The aim was to evaluate the efficacy of Saccharomyces boulardii (Sb) in addition to metronidazole in amebiasis. A prospective, randomized, open clinical trial was performed in 50 children presenting with acute bloody diarrhea caused by Entameba histolytica...

A randomized clinical trial to determine the efficacy of regimens containing clarithromycin, metronidazole, and amoxicillin among histologic subgroups for Helicobacter pylori eradication in a developing country. [2009.04]
BACKGROUND: Most treatments deemed effective for Helicobacter pylori eradication in developed countries are less effective in developing countries. Regimens containing clarithromycin, metronidazole, and amoxicillin seem efficacious despite antibiotic resistance, and may be a viable option in developing countries... CONCLUSIONS: Our results suggest that an eradication rate of > 85% can be achieved with 14-day clarithromycin, metronidazole, and amoxicillin and 10-day clarithromycin, amoxicillin, and omeprazole regimens in Pasto, Colombia. The regimens containing clarithromycin, metronidazole, and amoxicillin appear to be superior to the clarithromycin, amoxicillin, and omeprazole regimen for compliant participants and those with atrophic gastritis. Our findings provide treatment options for a population in a developing country with a high prevalence of H. pylori infections and antibiotic resistance.

Impact of quadruple regimen of clarithromycin added to metronidazole-containing triple therapy against Helicobacter pylori infection following clarithromycin-containing triple-therapy failure. [2009.04]
BACKGROUND: The establishment of an optimal second-line regimen for Helicobacter pylori infection is required. Although quadruple therapy should overcome resistance to either clarithromycin or metronidazole, the effects of a quadruple regimen in second-line therapy are unknown. This study aims to evaluate the efficacy of triple therapy composed of proton pump inhibitor/amoxicillin plus metronidazole with the combined additive effects of clarithromycin as a second-line quadruple therapy against H. pylori infection... CONCLUSIONS: In Japan, the RAMC regimen is thought to be a promising alternative strategy for second-line eradication of H. pylori infection.

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Clinical Trials Related to Flagyl ER (Metronidazole)

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.

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.

Sequential Vaccinations in Prostate Cancer Patients [Active, not recruiting]
This study will evaluate, in two parts, the safety and effectiveness of vaccinations against prostate cancer in patients with disease that has recurred or metastasized (spread beyond the primary site) following standard treatment. The vaccine consists of three parts, or ingredients. Part 1 is derived from the vaccinia virus, which has been used for many years against smallpox. Part 2 is made from a related virus called fowlpox. Two kinds of human DNA are put inside some of the vaccinia and fowlpox viruses-one produces PSA protein, which is made by prostate cancer cells; the other produces various proteins called Tricom that enhance immune activity. Part 3 of the vaccine involves a protein called Sargramostin (also called granulocyte-macrophage colony stimulating factor, or GM-CSF), which boosts the immune system. An experimental form of Sargramostin, in which the human DNA for GM-CSF is put inside the fowlpox virus, is included in the regimen. Stage 1 of the study will examine the safety of the vaccine and Stage 2 will examine its ability to produce an immune response against tumor cells.

Patients 18 years of age or older with recurrent or metastatic prostate cancer may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood and urine tests, and imaging studies, including computed tomography (CT) of the chest, abdomen and pelvis. Candidates for Stage 2 will have a blood test to determine tissue type (human leukocyte antigen, or HLA) type. Only patients with HLA-A2 type may participate in Stage 2. Patients who are allergic to eggs may not participate in either part.

Part 1 - Safety Study

Patients in Part 1 receive different combinations and dosages of vaccines. The specific vaccine and dosage for an individual is determined by his or her time of entry in the study. The first group of 3 to 6 patients receive fowlpox vaccine; group 2 patients receive vaccinia and fowlpox; group 3, vaccinia, fowlpox and Sargramostin; group 4, vaccinia and fowlpox, and group 5, vaccinia and fowlpox. All vaccines are injected under the skin. Patients receiving the vaccinia and fowlpox vaccines have injections of one or the other once every 4 weeks for 3 months. Patients receiving Sargramostin in addition to fowlpox and vaccinia vaccines receive the Sargramostin injections daily for 4 days, starting with the day of each vaccine injection.

Part 2 - Immune Response Study

Patients in Part 2 are randomly assigned to one of four treatment groups, consisting of different combinations or doses of vaccines to test the effects of the vaccines on the immune system. The course of treatment is similar to that in Part 1. To obtain sufficient numbers of immune system cells to measure immune response, patients undergo lymphapheresis-a procedure for collecting lymphocytes (a type of white blood cell)-on days 1 and 85 of the study. For this procedure, whole blood is collected through a needle in an arm vein and circulated through a machine that separates it into its components. The lymphocytes are removed, and the rest of the blood is returned to the patient through the same needle. For patients who do not have good arm veins, lymphocytes are collected through a central line-a temporary catheter (plastic tube) that is placed in a large vein in the neck or under the collarbone. Patients whose disease remains stable and who tolerate the treatments well may continue to receive the vaccines every 12 weeks. Patients are monitored closely throughout treatment with monthly blood tests and with x-ray studies-including bone scans and CT scans of the abdomen and pelvis-every 85 days.

BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) Study [Recruiting]
Bacterial vaginosis (BV), the world's most common vaginal infection, continues to cost patients time, energy, comfort and money. BV is associated with increased incidence of sexually transmitted infections (including HIV), spontaneous abortion, pre-term labour, post-surgical infections, and endometritis. Current treatment for those women symptomatic for BV includes both oral and intravaginal antibiotics, such as metronidazole, which have success rates of 70-80 % at 1 month after treatment. These treatments also have high recurrence rates (49-66 % at one year after treatment) and side effects (10-20 % of women) that include secondary vaginal infection with candida. Intravaginal boric acid has been used for >100 years for the treatment of vaginal infections and is quite commonly prescribed today as a treatment for BV. It is cheap, easily accessible, easy to use, and is an effective treatment of other vaginal infections, such as candida. To date, there are no clinical trials studying the effectiveness of boric acid in the treatment of BV.

Objectives: To determine whether boric acid is at least as effective and as safe as metronidazole for treating women with symptomatic BV, our study will compare intravaginal boric acid to the current standard intravaginal treatment, metronidazole, and to a placebo. Our goal is to expand women's options for the treatment of BV. Hypothesis: Boric acid is an effective treatment of bacterial vaginosis as compared to placebo. Boric acid is at least as effective and as safe in the treatment of bacterial vaginosis as compared to metronidazole.

A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-Abdominal Infections in Adults [Completed]

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