Neomycin and Polymyxin B Sulfates
Solution for Irrigation, USP
NOT FOR INJECTION
Neomycin and Polymyxin B Sulfates Solution for Irrigation is a concentrated sterile antibiotic solution to be diluted for urinary bladder irrigation. Each mL contains neomycin sulfate equivalent to 40 mg neomycin base, 200,000 units polymyxin B sulfate, and Water for Injection, inactive ingredient: sulfuric acid. The 20-mL multiple dose vial contains, in addition to the above, 1 mg methylparaben (0.1%) added as a preservative. Neomycin sulfate, an antibiotic of the aminoglycoside group, is the sulfate salt of neomycin B and C produced by Streptomyces fradiae It has a potency equivalent to not less than 600 mcg of neomycin per mg.
Neomycin and Polymyxin B Sulfates Solution for Irrigation is indicated for short-term use (up to 10 days) as a continuous irrigant or rinse in the urinary bladder of abacteriuric patients to help prevent bacteriuria and gram-negative rod septicemia associated with the use of indwelling catheters.
Since organisms gain entrance to the bladder by way of, through, and around the catheter, significant bacteriuria is induced by bacterial multiplication in the bladder urine, in the mucoid film often present between catheter and urethra, and in other sites. Urinary tract infection may result from the repeated presence in the urine of large numbers of pathogenic bacteria. The use of closed systems with indwelling catheters has been shown to reduce the risk of infection. A three-way closed catheter system with constant neomycin-polymyxin B bladder rinse is indicated to prevent the development of infection while using indwelling catheters.
If uropathogens are isolated, they should be identified and tested for susceptibility so that appropriate antimicrobial therapy for systemic use can be initiated.
Clinical Trials Related to Neomycin and Polymyxin b Sulfates (Neomycin / Polymyxin b Irrigation)
Trial Comparing Neomycin to Rifaximin Plus Neomycin in the Treatment of Methane Positive Subjects With Constipation Predominant Irritable Bowel Syndrome (C-IBS) [Recruiting]
In this study the investigators aim to compare the efficacy of neomycin to a combination of
rifaximin and neomycin in the treatment of C-IBS subjects with methane on their breath test.
This study will be conducted in collaboration with Dr. John DiBaise at the Mayo Clinic in
Efficacy of the Combination Bismuth + Neomycin + Procaine in the Treatment of Recurrent Aphthous Ulceration [Not yet recruiting]
To evaluate the efficacy of the product Bismu-Jet ® (bismuth tartrate and sodium, neomycin
sulfate and procaine hydrochloride) produced by EMS S / A compared to placebo in reducing
the signs and symptoms resulting from UAR in patients of both sexes, with age over 12 years.
Role of Methane in Glycemic Control [Recruiting]
The purpose of this study is to determine how certain types of bacteria in the human gut may
affect weight gain, and contribute to the development of diabetes.
The investigators initial studies have shown that gut bacteria that produce methane may
directly affect weight gain. These bacteria, called methanogens, produce methane gas as a
byproduct, which can be detected through breath testing. Methane can slow the passage of
food through the intestines, which would allow extra time for uptake and absorption of
nutrients and calories, and might contribute to weight gain. The investigators have also
found that people who have increased levels of methane-producing bacteria in their
intestines also have higher levels of glucose in their blood. Therefore, control of how the
body responds to insulin and uses glucose may be altered in methane-producing individuals.
This research study is designed to test the investigational use of the drugs neomycin and
rifaximin that have been approved by the U. S Food and Drug Administration (FDA). While
neomycin is FDA-approved for treating skin infections, preparing the bowel for surgery, and
hepatic encephalopathy (a condition that occurs when a damaged liver cannot remove the
toxins that a healthy liver normally would), and rifaximin is FDA-approved for treating
travelers' diarrhea, they are not yet approved to be used together for the treatment of
methanogens or obesity.
Simplified Selective Digestive Tract Decontamination for the Prevention of Intensive Care Unit Acquired Infections [Not yet recruiting]
A simplified graded gut decontamination protocol combined with rigorous bi-weekly screening
and appropriate bacterial prophylaxis, will lead to a 25% reduction in the acquisition of
blood stream infections and to a 25% reduction in lower airway colonization with multi drug
resistant organisms. There will be no concomitant rise in gram-positive or fungal infection
or a surgency of new resistance patterns.
Safety Study of Epstein Barr Virus (EBV) Specific Cytotoxic T-Cells to Treat Relapsed EBV-Positive Lymphoma, [Recruiting]
Some patients with Hodgkin or non-Hodgkin Lymphoma show evidence of infection with the virus
that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their
diagnosis of Lymphoma. EBV is often found in the cancer cells suggesting that it may play a
role in causing Lymphoma. The cancer cells infected by EBV are very clever because they are
able to hide from the body's immune system and escape destruction. The investigators want to
see if they can grow special white blood cells, called T cells, that have been trained to
kill EBV infected cells and then give them back to the patient. To find out how long these
cells last the investigators may put a marker gene into them so they can track them. Gene
marking is optional in this study. Eligible patients can participate without the gene
marking if they choose.
The purpose of this study is to find the largest safe dose of EBV specific cytotoxic T
cells, to learn what the side effects are and to see whether this therapy might help
patients with Hodgkin disease and non-Hodgkins Lymphoma.
Page last updated: 2007-05-04