Flagyl (Metronidazole) - Summary

FLAGYL SUMMARY

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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NEWS HIGHLIGHTS

Published Studies Related to Flagyl (Metronidazole)

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 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.

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

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Reports of Suspected Flagyl (Metronidazole) Side Effects

Drug Hypersensitivity (39),  Nausea (23),  Vomiting (20),  Diarrhoea (17),  Abdominal Pain (15),  Urticaria (15),  Confusional State (14),  Pyrexia (14),  NO Adverse Event (14),  Clostridium Difficile Colitis (13), more >>

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 43 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		gum infection
Dosage & duration:		400 mg tablets taken 2 or 3 daily for the period of 5 days
Other conditions:		no other health problems
Other drugs taken:		nil
		Reported Results
Benefits:		the side effects put me in hospital and not able to work for weeks. the gum infection cleared up but this took second place to the concerns during hospitalisation. i did not bounce back to my usual good health after.
Side effects:		irritated heartbeat, palpatations, breathlessness, dizziness, anxiety, flue like symptoms, extreme fatigue, tingling, pain in arm
Comments:		prescribed tablets by Dentist for gum infection. i was told i should take antibiotics but nothing about how it works or side effects. i took the tablets until finished while feeling worse, breathless, dizzy, pain left arm and fatigue but put it down to body fighting gum infection. the day after i finished the full course of tablets i couldn't breath and ready to pass out and went to Doctors and was taken to hospital with heart complications. I have no health problems until now.