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Flagyl ER (Metronidazole) - Summary

 
 



WARNING

Metronidazole has been shown to be carcinogenic in mice and rats (see PRECAUTIONS). Unnecessary use of the drug should be avoided. Its use should be reserved for conditions described in the INDICATIONS AND USAGE section below.

 

FLAGYL ER SUMMARY

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 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.

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Clinical Trials Related to Flagyl ER (Metronidazole)

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.

Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients [Recruiting]

Efficacy and Safety Study of Metronidazole, Nystatin and Dexamethasone Combination Therapy in Bacterial and Fungal Vaginal Infections [Not yet recruiting]

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.

more trials >>


Page last updated: 2014-11-30

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