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Otorrhea occurs in 21 to 50% of all children with tympanostomy tubes in the United States. More than 1 million children annually undergo tubomyringotomy, constituting placement of more than 2 million tympanostomy tubes each year. The organisms typically responsible for otorrhea are the same as those that cause otitis media in very young children, including Streptococcus pneumonia, Haemophilus influenzae and Moraxella catarrhalis. Drainage from tympanostomy tubes in older children involves organisms that colonize the external auditory canal, the most common being Pseudomonas aeruginosa and Staphylococcus aureus. Ofloxacin (Floxin otic), a newer fluoroquinalone antibiotic, has several advantages over other agents available for the treatment of otorrhea caused by acute otitis media in patients with tympanostomy tubes. The twice daily dosing regimen encourages better patient adherence to therapy, which is likely to improve treatment efficacy. Ofloxacin has not been associated with ototoxicity in animal models or in children participating in the clinical trials. It provides coverages for a wide range of pathogens, including Pseudomonas sp., and is indicated for use in children > or =1 year old and currently approved for patients > or =12 years with chronic suppurative otitis media. Ofloxacin applied topically in children with tympanostomy tubes in place and purulent otorrhea is as efficacious as oral amoxicillin/clavulanate (Augmentin) therapy. Other currently available therapeutic options are discussed.
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The overall clinical response was cure in the clinically evaluable patients, demonstrated by resolution of OE signs and symptoms at the test of cure visit. The overall clinical-microbiological response was cure in the microbiologically evaluable patients demonstrated by both clinical cure and microbiological eradication.
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OE: Floxin otic and Cortisporin TC otic suspension were equally effective in eradicating the three major pathogens Pseudomonas aeruginosa, Proteus mirabilis and Staphylococcus aureus. CSOM: Ofloxacin otic was effective in an open label trial in uniform eradication of S. aureus, P. aeruginosa, Proteus mirabilis and Enterobacter spp. AOM-TT: Ofloxacin otic and amoxicillin/clavulanate (by mouth) were equivalent clinically; rates of eradication of initial pathogens were similar for Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis, but ofloxacin otic was superior in eradication of S. aureus and P. aeruginosa
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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.
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In each of the studies of OE, CSOM and AOM-TT, ofloxacin otic solution was effective in eradicating the bacterial pathogen from the site of infection: equivalent to Cortisporin for children with OE; superior to amoxicillin/clavulanate for patients with AOM-TT who had acute drainage; and effective in eradicating bacterial pathogens from the external canal of patients with CSOM.
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Fluoroquinolone antibiotics have rarely been associated with renal failure (1). However, temafloxacin, a member of this drug class, was voluntarily withdrawn from the U.S. market in 1992 after reports of renal failure and other adverse reactions (2). In this article, we report one of the first published cases of renal failure resulting from the administration of ofloxacin (Floxin, Ortho Pharmaceutical Corporation), one of the newest fluoroquinolone antibiotics.
For the clinically evaluable patients, equivalent cure rates were obtained between the once-daily ofloxacin-treated and four-times-daily neomycin sulfate/polymyxin B sulfate/hydrocortisone-treated patients (93.8% and 94.7%, respectively). For the clinically and microbiologically evaluable patients, the overall cure rates were 96.4% versus 97.1% for the ofloxacin-treated and neomycin sulfate/polymyxin B sulfate/hydrocortisone-treated patients, respectively. The eradication rates for the prevalent pathogen, Pseudomonas aeruginosa, were 98% versus 100% for ofloxacin-treated and neomycin sulfate/polymyxin B sulfate/hydrocortisone-treated patients, respectively. Decreases in pain severity were similar in both treatment groups. Statistical analyses were limited by the small numbers of patients in each treatment group.
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Our study demonstrates no clinical cochlear ototoxicity in children who received Cortisporin following ventilation tube placement. The cost differential for prescribing fluoroquinolone drops is significant.
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We describe a method for the highly efficient and precise targeted modification of gene trap loci in mouse embryonic stem cells (ESCs). Through the Floxin method, gene trap mutations were reverted and new DNA sequences inserted using Cre recombinase and a shuttle vector, pFloxin. Floxin technology is applicable to the existing collection of 24,149 compatible gene trap cell lines, which should enable high-throughput modification of many genes in mouse ESCs.
Otitis externa (OE) is an infection of the external auditory canal affecting children and adults and is associated with symptoms of local pain and tenderness. Twice-daily topical treatment with ofloxacin otic solution (0.3% [Floxin otic solution]) for 10 days has been reported to be as effective and well tolerated as neomycin sulfate/polymyxin B sulfate/hydrocortisone otic suspension (Cortisporin otic suspension) administered four times daily for 10 days.