Flagyl (Metronidazole) - Summary

FLAGYL SUMMARY

DESCRIPTION

Flagyl (metronidazole) is an oral synthetic antiprotozoal and antibacterial agent.

Flagyl (metronidazole) is indicated for the following:

Treatment of Anaerobic Infections

Metronidazole Injection, USP RTU® is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Metronidazole Injection, USP RTU® therapy. In a mixed aerobic and anaerobic infection, antibiotics appropriate for the treatment of the aerobic infection should be used in addition to Metronidazole Injection, USP RTU®.

Metronidazole Injection, USP RTU® is effective in Bacteroides fragilis infections resistant to clindamycin, chloramphenicol and penicillin.

Intra-Abdominal Infections, including peritonitis, intra-abdominal abscess and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species and Peptostreptococcus species.

Skin and Skin Structure Infections caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species and Fusobacterium species.

Gynecologic Infections, including endometritis, endomyometritis, tubo-ovarian abscess and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptostreptococcus species and Fusobacterium species.

Bacterial Septicemia caused by Bacteroides species including the B. fragilis group and Clostridium species.

Bone and Joint Infections, as adjunctive therapy, caused by Bacteroides species including the B. fragilis group.

Central Nervous System (CNS) Infections, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group.

Lower Respiratory Tract Infections, including pneumonia, empyema and lung abscess, caused by Bacteroides species including the B. fragilis group.

Endocarditis caused by Bacteroides species including the B. fragilis group.

Prophylaxis

The prophylactic administration of Metronidazole Injection, USP RTU® preoperatively, intraoperatively and postoperatively may reduce the incidence of postoperative infection in patients undergoing elective colorectal surgery which is classified as contaminated or potentially contaminated. Prophylactic use of Metronidazole Injection, USP RTU® should be discontinued within 12 hours after surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism(s) so that appropriate therapy may be given (see DOSAGE AND ADMINISTRATION).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection, USP RTU® and other antibacterial drugs, Metronidazole Injection, USP RTU® 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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FLAGYL NEWS HIGHLIGHTS

Published Studies Related to Flagyl (Metronidazole)

Ciprofloxacin or metronidazole for the treatment of perianal fistulas in patients with Crohn's disease: a randomized, double-blind, placebo-controlled pilot study. [2009.01]
BACKGROUND: Although metronidazole [generic for Flagyl] and ciprofloxacin are used to treat perianal Crohn's disease (CD), no placebo-controlled trials have been performed... CONCLUSION: Remission and response occurred more frequently in patients treated with ciprofloxacin but the differences were not significant in this pilot study. Ciprofloxacin was well tolerated.

A comparative study of the therapeutic effects of the Zataria multiflora vaginal cream and metronidazole vaginal gel on bacterial vaginosis. [2008.12]
Bacterial vaginosis (BV) is one of most prevalent complications among reproductive-aged women. Metromidazole prescription, which is considered as the first-line treatment of BV, is usually followed by a few side effects.

Intravaginally applied metronidazole is as effective as orally applied in the treatment of bacterial vaginosis, but exhibits significantly less side effects. [2008.12]
OBJECTIVE: Metronidazole [generic for Flagyl] is the drug of choice for the treatment of bacterial vaginosis (BV). However, so far the oral administration has not been clinically compared to the intravaginal application regarding efficacy, side effects and patient satisfaction in a scientific sound fashion... CONCLUSION: In this clinical trial the intravaginal application was as effective as the oral administration of metronidazole in treating BV. However, significantly less adverse events were reported after short-term intravaginal as compared to oral application (p=0.023) and probably led to a better patient compliance.

Therapy of metronidazole with azathioprine to prevent postoperative recurrence of Crohn's disease: a controlled randomized trial. [2008.10]
BACKGROUND & AIMS: More than 80% of Crohn's disease (CD) patients undergoing resection suffer recurrence of their disease. Therapy with aminosalicylates, antimetabolites, or antibiotics leads to a modest reduction in the incidence of recurrence. Goal: We sought to examine whether metronidazole [generic for Flagyl] for 3 months together with azathioprine (AZA) for 12 months is superior to metronidazole alone to reduce recurrence of postoperative CD in "high-risk" patients... CONCLUSIONS: Despite the enhanced risk of recurrence, the overall incidence of significant recurrence was rather low, probably owing to the metronidazole treatment that all patients received. Concomitant AZA resulted in lower endoscopic recurrence rates and less severe recurrences 12 months postsurgery, predicting a more favorable clinical outcome. This combined treatment seems to be recommendable to all operated CD patients with an enhanced risk for recurrence.

Clinical and microbiological benefits of systemic metronidazole and amoxicillin in the treatment of smokers with chronic periodontitis: a randomized placebo-controlled study. [2008.10]
AIM: The aim of this study was to evaluate the clinical and microbiological effects of scaling and root planing (SRP) alone or combined with metronidazole [generic for Flagyl] (MTZ) or with MTZ and amoxicillin (AMX) in the treatment of smokers with chronic periodontitis... CONCLUSION: Significant advantages are observed when systemic antibiotics are combined with SRP in the treatment of smokers with chronic periodontitis. The greatest benefits in clinical and microbiological parameters are achieved with the use of SRP+MTZ+AMX.

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Clinical Trials Related to Flagyl (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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FLAGYL PATIENT REVIEWS / RATINGS / COMMENTS

Flagyl review by 33 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		bacterial vaginosis
Dosage & duration:		One pill a day for 8 days taken once a day for the period of Eight days
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		My infection cleared up almost before the dosage was done. Has not come back.
Side effects:		Mild upset stomach.
Comments:		I took this once a day for eight days for a vaginal bacterial infection. I only had slight side effects of an upset stomach after taking the pill; probably because I had not eaten much on those days. My infection cleared up noticably before the treatement was through. I feel it was very effective.

Flagyl review by 39 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		bacterial infectoin
Dosage & duration:		one tablet twice a day taken twice a day for the period of 10 days
Other conditions:		none
Other drugs taken:		None
		Reported Results
Benefits:		not worth the cost of the side effects. Becasue I was so miserable, I discontinued the medication early and opted for a more conventional anti-biotic.
Side effects:		nausea, upset stomach, insomnia, and a general feeling sick. I felt like I was going to throw up if I so much as drank water, I got very tired and week but could not sleep due to constant dry heaving.
Comments:		I was told to take it so I did. the more I took the more miserable I got, until I called my doctor and said, I can not take this. I dont know if I am alergic or what but I cant and I wont take any more of it. it still took almost two days for the side effects to go away.

Flagyl review by 39 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		bacterial infectoin
Dosage & duration:		one tablet twice a day taken twice a day for the period of 10 days
Other conditions:		none
Other drugs taken:		None
		Reported Results
Benefits:		not worth the cost of the side effects. Becasue I was so miserable, I discontinued the medication early and opted for a more conventional anti-biotic.
Side effects:		nausea, upset stomach, insomnia, and a general feeling sick. I felt like I was going to throw up if I so much as drank water, I got very tired and week but could not sleep due to constant dry heaving.
Comments:		I was told to take it so I did. the more I took the more miserable I got, until I called my doctor and said, I can not take this. I dont know if I am alergic or what but I cant and I wont take any more of it. it still took almost two days for the side effects to go away.