Ofloxacin Otic Solution for Treatment of Otitis Externa in Children and Adults

Jones, Ronald N.; Milazzo, Jack; Seidlin, Mindell

doi:10.1001/archotol.1997.01900110047007

Cited by 55 publications

(36 citation statements)

References 11 publications

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“…The efficacy of neomycin-polymixin B-hydrocortisone has been shown in clinical studies to have cure rates ranging from 87% to 97%. 7,8 Efficacy in published reports has also remained consistent over the past 2 decades. 7 However, there are some limitations.…”

Section: Treatmentmentioning

confidence: 58%

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Otitis Externa Review

Beers¹,

Abramo²

2004

Pediatric Emergency Care

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TARGET AUDIENCEPhysicians, nurse practitioners, and physician assistants who evaluate and care for children with minor illnesses.Specialists including pediatricians, emergency physicians, pediatric emergency physicians, family practitioners, otolaryngologists, pediatric nurse practitioners, and nurses working in school or camp setting will find this information particularly useful. LEARNING OBJECTIVESAfter completion of this article, the reader will be able to: 1. Define the pathogenesis and microbiology of otitis externa. 2. Describe the presenting sign and symptoms in children with infections of the external ear, as well as the complications. 3. Discuss the therapeutic options, including topical antibiotic drugs, anti-inflammatory agents, and the use of mechanical interventions (wick, ear plugs). DEFINITIONO titis externa (OE), also known as ''swimmer's ear''or ''tropical ear,'' is a disease process that includes infection or inflammation of the external ear canal. It can range from mild inflammation to a very severe disease process known as necrotizing otitis externa. It is caused by a break in the normal skin/cerumen protective barrier in the external ear canal usually under the conditions of elevated humidity and warmer temperature.Three clinical stages of OE have been described: preinflammatory, acute inflammatory, and chronic. The preinflammatory stage results from moisture or local trauma in the ear canal. The skin becomes edematous, obstructing the glands. This process predisposes the ear to further trauma. The acute inflammatory stage of OE can be classified into mild, moderate, and severe stages. In the mild acute inflammatory stage, the canal is erythematous and edematous, and develops clear odorless secretions. Moderate acute inflammatory OE has increased edema and pain, and the secretions become seropurulent. Severe inflammatory OE is intensely painful and involves a lumen that is obstructed with draining secretions and debris. It is often accompanied with periauricular edema and adenopathy. If the infection spreads to surrounding tissues, the condition is known as necrotizing OE. Finally, chronic OE is defined as a single episode lasting longer than 4 weeks or 4 or more episodes in 1 year. 1

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Section: Treatmentmentioning

confidence: 58%

“…7,8 Efficacy in published reports has also remained consistent over the past 2 decades. 7 However, there are some limitations. First of all, there is a high incidence of adverse effects from components of this combination drug.…”

Section: Treatmentmentioning

confidence: 58%

Otitis Externa Review

Beers¹,

Abramo²

2004

Pediatric Emergency Care

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“…Of the 14 articles, 11 articles were included in the meta-analysis [5,8,[10][11][12][13][14][15][16][17][18]. One article was excluded because the subjects included in the study were patients with otitis externa [19]. Another article was excluded because the study was an uncontrolled clinical trial [20], and the last one was a review and a report of a single site that participated in a multi-center trial already included [21].…”

Section: Literature Searchmentioning

confidence: 99%

A Systematic Review of the Effectiveness of Ofloxaxin Otic Solution for the Treatment of Suppurative Otitis Media

Abes¹,

Espallardo²,

Tong³

et al. 2003

ORL

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The objectives of the study were to determine the effectiveness and incidence of adverse events of ofloxacin otic solution for suppurative otitis media compared with other treatments. All randomized controlled trials and nonrandomized comparative clinical trials published from 1966 to 2000 using ofloxacin otic solution as one of the interventions were reviewed and data were extracted and analyzed. Eleven clinical trials (9 randomized and 2 nonrandomized) enrolling 1,484 adults and children were finally included in the analysis. Five studies employed clear concealment procedure in the allocation of treatment whereas evaluation of outcome was at least single-blinded in 6 trials. The probability of overall cure rate was higher with 0.3% ofloxacin otic solution than with other topical or systemic antibiotics in 9 of the studies analyzed (OR = 2.67; 95% CI = 2.04, 3.50). Resolution of secondary outcome parameters evaluated at least 1 week after treatment was higher with 0.3% ofloxacin otic solution: resolution of otalgia (4 trials; OR = 2.41; 95% CI = 1.2, 4.82); resolution of otorrhea (11 trials; OR = 2.78; 95% CI = 2.12, 3.65), and bacterial eradication rate (6 trials; OR = 3.86; 95% CI = 2.54, 5.87). A subgroup analysis of 4 studies comparing ofloxacin otic solution with antibiotic- and steroid-containing otic solution showed a higher cure rate for ofloxacin otic solution (OR = 2.73; 95% CI = 1.52, 4.90). Another subgroup analysis on 3 studies comparing ofloxacin otic solution with oral systemic antibiotics showed higher resolution of otorrhea with ofloxacin otic solution (OR = 2.78; 95% CI = 2.12, 3.65). Of 4 studies with data on adverse events, the probability of adverse events was lower with ofloxacin otic solution than with other topical antibiotics (OR = 0.28; 95% CI = 0.19, 0.42). Subgroup analysis showed that 0.3% ofloxacin otic solution showed better results in terms of overall cure rate, resolution of otorrhea, otalgia, bacterial eradication rate and incidence of adverse events. Whether due to chronic suppurative otitis media (CSOM) or draining tympanostomy tube, the overall cure rate (CSOM OR = 4.86; with tympanostomy tube OR = 2.13) and resolution of otorrhea (CSOM OR = 4.42; with tympanostomy tube OR = 1.66) were likewise in favor of 0.3% ofloxacin otic solution. The studies included in this meta-analysis showed generally homogenous results in all clinical and laboratory outcomes analyzed, except for the evaluation of adverse events. The authors conclude that 0.3% ofloxacin otic solution is better than other otic antibiotic drops and other oral antibiotics in terms of overall cure rate and resolution of secondary outcome parameters. Estimates on the beneficial effects of ofloxacin otic solution are limited to the period of study included in this review.

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“…Topical ofloxacin was chosen as the comparator for this study because of its reported efficacy and safety in ear infections, including AOMT, 16,17 CSOM, 18 and acute otitis externa. 19 …”

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confidence: 99%

Topical Ciprofloxacin/Dexamethasone Otic Suspension Is Superior to Ofloxacin Otic Solution in the Treatment of Children With Acute Otitis Media With Otorrhea Through Tympanostomy Tubes

Roland

Kreisler²,

Reese³

et al. 2004

Pediatrics

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ABSTRACT. Objective. To determine the efficacy and safety of topical ciprofloxacin/dexamethasone otic suspension compared with ofloxacin otic solution in the treatment of acute otitis media with otorrhea through tympanostomy tubes (AOMT) in pediatric patients.Methods. This multicenter, prospective, randomized, observer-masked, parallel-group study was conducted at 39 sites in 599 children aged >6 months to 12 years with an AOMT episode of <3 weeks' duration. The mean age of patients was 2.5 years (standard deviation: 2.37 years). Patients received either ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension 4 drops twice daily for 7 days or ofloxacin 0.3% otic solution 5 drops twice daily for 10 days. Clinical signs and symptoms of AOMT were evaluated at clinic visits on days 1 (baseline), 3 (on therapy), 11 (end of therapy), and 18 (test of cure). A patient diary was used to measure time to cessation of otorrhea. Principal pretherapy pathogens included Streptococcus pneumoniae (16.8%), Staphylococcus aureus (13.0%), Pseudomonas aeruginosa (12.7%), Haemophilus influenzae (12.4%), S epidermidis (10.2%), and Moraxella catarrhalis (4.1%).Results. Ciprofloxacin/dexamethasone is superior to ofloxacin for clinical cure (90% vs 78%) and microbiologic success (92% vs 81.8%) at the test-of-cure visit, produces fewer treatment failures (4.4% vs 14.1%), and results in a shorter median time to cessation of otorrhea (4 days vs 6 days). Ciprofloxacin/dexamethasone treatment is also superior to improvement in clinical response by visit, absence of otorrhea by visit, and reduction of otorrhea volume by visit. Both topical otic preparations are safe and well tolerated in pediatric patients. No change in speech recognition threshold or decrease in hearing from baseline, based on audiometric testing, was noted with either regimen.Conclusion. Topical ciprofloxacin/dexamethasone treatment is superior to topical ofloxacin in the treatment of AOMT. Pediatrics 2004;113:e40 -e46. URL: http://www. pediatrics.org/cgi/content/full/113/1/e40; ciprofloxacin, dexamethasone, ofloxacin, otorrhea, AOM, tympanostomy tubes.ABBREVIATIONS. AOMT, acute otitis media with otorrhea through tympanostomy tubes; CSOM, chronic suppurative otitis media; TOC, test of cure; ITT, intention-to-treat.T he most common surgery performed in children for treatment of recurrent otitis media with effusion is the insertion of a tympanostomy tube into the eardrum. 1 However, otorrhea is a common complication after their insertion. The vast majority (90%-95%) of cases of acute otitis media with otorrhea through tympanostomy tubes (AOMT) occur in children aged 1 to 12 years, and typically 2 to 6 episodes of AOMT are experienced. 2,3 Topical ciprofloxacin is an effective and safe therapy for AOMT 4,5 and chronic suppurative otitis media (CSOM). 6 -8 Bacteria commonly isolated from patients with AOMT include Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, and Pseudomonas aeruginosa. 3 Because of the inflammatory response indu...

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Ofloxacin Otic Solution for Treatment of Otitis Externa in Children and Adults

Cited by 55 publications

References 11 publications

Otitis Externa Review

Otitis Externa Review

A Systematic Review of the Effectiveness of Ofloxaxin Otic Solution for the Treatment of Suppurative Otitis Media

Topical Ciprofloxacin/Dexamethasone Otic Suspension Is Superior to Ofloxacin Otic Solution in the Treatment of Children With Acute Otitis Media With Otorrhea Through Tympanostomy Tubes

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