BOXED WARNING
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 TOXICITY 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 neuro-muscular blockage and respiratory paralysis should be considered if neomycin is administered, especially to patients receiving anesthetics, neuro-muscular 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.
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NEWS HIGHLIGHTSMedia Articles Related to Neo-Fradin (Neomycin)
New Bowel Prep Approaches Evaluated By Researchers
Source: Colorectal Cancer News From Medical News Today [2009.10.27]
While there is little doubt concerning the effectiveness of colonoscopy procedures to detect colon cancer, a new study presented at the American College of Gastroenterology's 74th Annual Scientific Meeting in San Diego places new emphasis on the importance of adequate bowel preparation prior to procedure.
Published Studies Related to Neo-Fradin (Neomycin)
Parenteral aminosidine is not effective for Peruvian mucocutaneous leishmaniasis. [2007.06]
Few therapeutic options are available for mucocutaneous leishmaniasis (MCL). We conducted a randomized open trial to evaluate the efficacy, safety, and tolerance of parenteral aminosidine sulphate (AS) 14 mg/kg/d for 21 days compared with intravenous meglumine antimonate (MA) 20 mg/kg/d for 28 days in patients with moderate MCL in Cuzco, Peru...
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.
Randomized clinical trial of effect of synbiotics, neomycin and mechanical bowel preparation on intestinal barrier function in patients undergoing colectomy. [2007.05]
BACKGROUND:: The aim of this study was to investigate whether it is possible to modulate gut microflora and preserve intestinal barrier function during elective colorectal surgery by using combinations of oral antibiotics, synbiotics and mechanical bowel preparation (MBP)... CONCLUSION:: The combination of MBP, neomycin and synbiotics reduces the prevalence of faecal Enterobacteriaceae and bacterial translocation; however, this was not associated with a reduction in inflammatory response or septic morbidity in this study. Larger trials are needed before a change in practice can be recommended. Copyright (c) 2007 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
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.
Clinical Trials Related to Neo-Fradin (Neomycin)
Trial Comparing Neomycin to Rifaximin Plus Neomycin in the Treatment of Methane Positive Subjects With Constipation Predominant Irritable Bowel Syndrome (C-IBS) [Not yet 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
Scottsdale, AZ.
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.
Comparison of Combination Antibiotics Eyedrop to Artificial Tear in Hordeolum After Incision and Curettage [Recruiting]
To compare the effectiveness of combined antibiotic ophthalmic solution (neomycin sulfate,
polymyxin B sulfate and gramicidin) with placebo (artificial tear) in the treatment of
hordeolum after incision and curettage
Safety Study of 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. We want to see if we 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 we may
put a marker gene into them so we 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.
Topical Antibiotic Use In Chronic Rhinosinusitis A Double-Blinded, Randomized, Placebo Controlled Study [Recruiting]
Chronic rhinosinusitis is a pervasive and costly disease. Recent estimates describe over 20
million Americans suffering from this diagnosis at a cost of over $4. 3 billion per year.
Primary intervention consists of oral antibiotics and nasal steroid sprays. A role for
antifungal irrigation has also been proposed. Topical antibiotics are used by some
physicians, but there are few reports in the published literature describing their use and
establishing or refuting their efficacy.
Sykes in 1986 performed a randomized, prospective, double-blinded study with 50 patients
using topical nasal sprays with dexamethasone, tramazoline, and neomycin; dexamethasone and
tramazoline without antimicrobial; and placebo. Both of the treatment groups showed
improvement over placebo, but in those groups there was no significant difference in
response rates between those patients receiving neomycin and those who did not. There were
no adverse events reported. In the same year, Cuenant et al. reported success with
neomycin-tixocortol irrigations in the treatment of chronic rhinosinusitis.
Scheinberg and Otsuji and Vaughn and Carvalho describe their use of various nebulized
antimicrobials (including aminoglycosides) in patients with recurrent sinusitis. Both are
uncontrolled, retrospective studies showing improvement in symptom scores. Neither study
reported any major side effects. Leonard and Bolger describe a case report and review their
success with the use of topical Ceftazidime in 50 patients. Only one patient reported
stinging sensation during administration. They reported no problems with antibiotic
resistance.
Studies by Davidson et al. , and Moss and King describe the use of topical antibiotics for
sinusitis in patients with cystic fibrosis. They report improvement in sinusitis symptoms
and reduction of need for revision sinus surgery in patients treated with surgery followed
by topical intranasal tobramycin. They report no significant side effects.
Dudley described the use of topical gentamicin in a case report of a patient with atrophic
rhinitis. The patient had resolution of her complaints without any adverse symptoms. He
also describes a study by Thornell showing success with streptomycin nasal sprays and
reports work by Rubinstein demonstrating safe administration of gentamicin into the nose
without absorption by the nasal mucosa.
On balance, the literature describes topical antibiotics as a safe, but variably efficacious
treatment for chronic rhinosinusitis. There is a paucity of prospective, randomized,
blinded, and controlled studies. The purpose of this protocol is to describe a
scientifically rigorous study of the use of broad spectrum antibiotic nasal sprays for
chronic sinusitis.
The patient population for this study will consist of patients who have a history of
multiple sinus infections each year that require treatment with antibiotics. The patients in
this study will have had recurrent infections despite prior medical and surgical
intervention. They will fulfill the criteria for chronic rhinosinusitis without nasal
polyposis.
Treatment will include conventional treatment with oral antibiotics and a topical nasal
steroid. In addition, patients will be randomized to receive either topical antibiotics or
a vehicle placebo. The study will follow patients for a three month period.
Patients will be monitored for improvement in radiographic findings and quality of life
when compared to a randomized and double-blinded placebo group. The patient population
identified for inclusion in this study will also be evaluated for allergy and humoral and
innate immunodeficiency. Nasal lavage will be obtained from the study population and pre
and post-treatment comparisons will be performed.
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