WARNINGS : SYSTEMIC ABSORPTION OF NEOMYCIN OCCURS FOLLOWING ORAL ADMINISTRATION AND TOXIC REACTIONS MAY OCCUR. Patients treated with neomycin should be under close clinical observation because of the potential toxicity associated with their use. NEUROTOXICITY (INCLUDING OTOTOXICITY) AND NEPHROTOXICITY FOLLOWING THE ORAL USE OF NEOMYCIN SULFATE HAVE BEEN REPORTED, EVEN WHEN USED IN RECOMMENDED DOSES. THE POTENTIAL FOR NEPHROTOXICITY, PERMANENT BILATERAL AUDITORY OTOTOXICITY AND SOMETIMES VESTIBULAR TOXOCITY IS PRESENT IN PATIENTS WITH NORMAL RENAL FUNCTION WHEN TREATED WITH HIGHER DOSES OF NEOMYCIN AND/OR FOR LONGER PERIODS THAN RECOMMENDED. Serial, vestibular and audiometric tests, as well as tests of renal function, should be performed (especially in high-risk patients). THE RISK OF NEPHROTOXICITY AND OTOTOXICITY IS GREATER IN PATIENTS WITH IMPAIRED RENAL FUNCTION. Ototoxicity is often delayed in onset and patients developing cochlear damage will not have symptoms during therapy to warn them of developing eighth nerve destruction and total or partial deafness may occur long after neomycin has been discontinued.
Neuromuscular blockage and respiratory paralysis have been reported following the oral use of neomycin. The possibility of the occurrence of neuromuscular blockage and respiratory paralysis should be considered if neomycin is administered, especially to patients receiving anesthetics, neuromuscular blocking agents such as tubocurarine, succinylcholine, decamethonium, or in patients receiving massive transfusions of citrate anticoagulated blood. If blockage occurs, calcium salts may reverse these phenomena but mechanical respiratory assistance may be necessary.
Concurrent and/or sequential systemic, oral or topical use of other aminoglycosides, including paromomycin and other potentially nephrotoxic and/or neurotoxic drugs such as bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin and viomycin, should be avoided because the toxicity may be additive.
Other factors which increase the risk of toxicity are advanced age and dehydration.
The concurrent use of neomycin with potent diuretics such as ethacrynic acid or furosemide should be avoided, since certain diuretics by themselves may cause ototoxicity. In addition, when administered intravenously, diuretics may enhance neomycin toxicity by altering the antibiotic concentration in serum and tissue.
Neomycin Sulfate Tablets, USP, for oral administration, contain neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomyces fradiae.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Neomycin Sulfate Tablets USP and other antibacterial drugs, Neomycin Sulfate Tablets USP 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.
Suppression of intestinal bacteria
Neomycin sulfate tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, eg, preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base (see DOSAGE AND ADMINISTRATION).
Hepatic coma (portal-systemic encephalopathy
Neomycin sulfate has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.
Published Studies Related to Neomycin
A comparison of ciprofloxacin/dexamethasone with neomycin/polymyxin/hydrocortisone for otitis externa pain. [2007.05]
Ciprofloxacin 0.3%/dexamethasone 0.1% (CIP/DEX) and neomycin 0.35%(polymyxin B 10,000 IU/mL/hydrocortisone 1.0% (NPH) were compared for relief of pain in patients with acute otitis externa. Patients received 7 d of treatment with CIP/DEX twice daily or NPH 3 times daily... Overall, these results support greater pain relief attained over the first 3 d in patients with acute otitis externa treated with CIP/DEX compared with NPH and a rapid reduction in severe pain after initiation of treatment.
Prospective randomised single-blind controlled trial of glacial acetic acid versus glacial acetic acid, neomycin sulphate and dexamethasone spray in otitis externa and infected mastoid cavities. [2006.12]
OBJECTIVES: The literature reports the merits of antibacterial, antibiotic and steroid agents in treating otological infections but no controlled clinical trial has directly compared 2% glacial acetic acid (EarCalm; Stafford-Miller Ltd, Brentford, UK) against 2% glacial acetic acid, 0.1% dexamethasone and 3250 U/ml of neomycin sulphate (Otomize; Stafford-Miller Ltd) in the treatment of otitis externa and infected mastoid cavities... CONCLUSION: Glacial acetic acid, dexamethasone and neomycin sulphate is significantly more effective in treating otitis externa when compared with glacial acetic acid. This effect failed to be significant in the infected mastoid cavities group. We therefore recommend that in conjunction with aural toilet, antibiotic/steroid combination is more effective than an antibacterial agent for otitis externa. Larger numbers of infected mastoid cavities are required to be studied.
Ofloxacin otic drops vs neomycin-polymyxin B otic drops as prophylaxis against early postoperative tympanostomy tube otorrhea. [2006.12]
OBJECTIVES: To evaluate the incidence of tympanostomy tube (TT) sequelae, tube otorrhea, and tube obstruction immediately postoperatively in patients receiving TT for otitis media and to compare patients receiving postoperative otic drops with controls... CONCLUSIONS: Nonpatency and otorrhea are the most frequent sequelae immediately following TT placement. Few studies have compared different treatment regimens in a randomized controlled trial. These results demonstrate that otic drops clearly provide benefit postoperatively in preventing TT plugging and otorrhea but primarily in patients who have middle ear fluid at the time of TT placement. In addition, consideration of drop choice should be based on patient tolerance and medication safety profiles.
Once-daily ofloxacin otic solution versus neomycin sulfate/polymyxin B sulfate/hydrocortisone otic suspension four times a day: a multicenter, randomized, evaluator-blinded trial to compare the efficacy, safety, and pain relief in pediatric patients with otitis externa. [2006.09]
CONCLUSION: In the treatment of OE in children, once-daily ofloxacin otic solution was as effective and safe as neomycin sulfate/polymyxin B sulfate/hydrocortisone otic suspension given four times daily. The two treatments provide rapid and comparable pain relief; however, ofloxacin otic solution does not have the risk of ototoxicity associated with neomycin and provides effective pain relief without adjunctive steroids.
Prophylaxis of irinotecan-induced diarrhea with neomycin and potential role for UGT1A1*28 genotype screening: a double-blind, randomized, placebo-controlled study. [2006.09]
OBJECTIVE: Delayed-type diarrhea is a common side effect of irinotecan and is associated with a bacterial-mediated formation of the active irinotecan metabolite SN-38 from its glucuronide conjugate in the intestine. Based on a pilot study, we hypothesized that concomitant administration of the antibiotic neomycin would diminish exposure of the gut to SN-38 and ameliorate the incidence and severity of diarrhea... CONCLUSION: Our results do not suggest a major role for neomycin as prophylaxis for irinotecan-induced delayed-type diarrhea. It is suggested that the UGT1A1*28 genotype status could be used as a screening tool for a priori prevention of irinotecan-induced delayed-type diarrhea.
Clinical Trials Related to Neomycin
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: 2007-10-18