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«The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official ...»

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Despite some inherent bias found in all studies including those sponsored and/or funded by pharmaceutical manufacturers, the studies in this therapeutic class review were determined to have results or conclusions that do not suggest systematic error in their experimental study design. While the potential influence of manufacturer sponsorship/funding must be considered, the studies in this review have also been evaluated for validity and importance.

Very little comparative literature of good quality is available. Due to the differences in international bacterial susceptibility, only studies performed in the United States were considered. Most studies were performed in a single-masked manner.

ciprofloxacin/dexamethasone (Ciprodex) and ofloxacin (Floxin Otic) In a multicenter trial of 599 children (ages six months to 12 years) with acute otitis media with otorrhea through tympanostomy tubes (AOMT), patients were randomized to receive either ciprofloxacin/dexamethasone four drops twice daily for seven days or ofloxacin five drops twice daily for ten days.66 In the observer-masked trial, clinical signs and symptoms of AOMT were evaluated at clinic visits on days one, three, 11, and 18 (test of cure). Pathogens included Streptococcus pneumoniae (16.8 percent), S. aureus (13 percent), P. aeruginosa (12.7 percent), Haemophilus influenzae (12.4 percent), Staphylococcus epidermidis (10.2 percent), and Moraxella catarrhalis (4.1 percent). Clinical cure rates at the test-of-cure visit were better in the ciprofloxacin/dexamethasone group (90 versus 78 percent; p=0.0025). Microbiologic success was 92 percent for the ciprofloxacin/dexamethasone group and 81.8 percent for the ofloxacin group (p=0.0061). Fewer treatment failures were seen with ciprofloxacin/dexamethasone (4.4 percent) than ofloxacin (14.1 percent). Both treatments had similar adverse event profiles.

ciprofloxacin/dexamethasone (Ciprodex) and neomycin/polymyxin B/hydrocortisone A randomized, observed-masked trial enrolled 468 patients over one year of age with acute otitis externa and intact tympanic membranes to compare the efficacy and safety of seven-day treatment with ciprofloxacin/dexamethasone and neomycin/polymyxin B/hydrocortisone.67 Patients were randomized to ciprofloxacin 0.3%/dexamethasone 0.1% suspension given as three to four drops twice daily or neomycin 0.35%/polymyxin B 10,000 IU/mL/hydrocortisone 1% otic suspension given as three to four drops three times daily. Patients with positive cultures (n=396) had a clinical cure rate at day 18 of 90.9 percent with the ciprofloxacin/dexamethasone product versus 83.9 percent with the neomycin combination product (p=0.0375). Microbiological cure rates were also significantly higher in the ciprofloxacin/dexamethasone group (94.7 versus 86 percent; p=0.0057). Both treatments were well tolerated.

–  –  –

ciprofloxacin (Cetraxal) and neomycin/polymyxin B/hydrocortisone Due to a lack of other studies, this observer-blinded study has been included. To compare efficacy and safety, a multicenter, observer-blinded study of 630 patients with acute otitis externa was conducted.68 Patients were randomized to receive either ciprofloxacin 0.2% twice daily or neomycin/polymyxin B/hydrocortisone otic solution three times daily for seven days.

Clinical cure was achieved at the end of a seven-day treatment in 70 percent for the ciprofloxacin-treated group versus 60.5 percent for the neomycin/polymyxin B/hydrocortisone group. Ciprofloxacin was shown to be noninferior to neomycin/polymyxin B/hydrocortisone.

The clinical cure rate for patients with baseline cultures showing P. aeruginosa was 87.5 percent in the ciprofloxacin group and 78.6 percent in the neomycin/polymyxin B/hydrocortisone group. In patients with baseline cultures showing S. aureus, the clinical cure rate was 72.7 percent for the ciprofloxacin group and 75.9 percent for the neomycin/polymyxin B/hydrocortisone group.

ciprofloxacin/hydrocortisone (Cipro HC) and neomycin/polymyxin B/hydrocortisone (Cortisporin) plus systemic amoxicillin A randomized, multicenter, active-control, observer-blind, non-inferiority trial of 206 adult and children patients with acute otitis externa compared ciprofloxacin/hydrocortisone with neomycin/polymyxin B/hydrocortisone plus systemic amoxicillin for clinical equivalence.69 Patients received either ciprofloxacin/hydrocortisone otic three drops twice daily for seven days or neomycin/polymyxin B/hydrocortisone two drops (child) or four drops (adult) plus systemic amoxicillin 250 mg three times daily for 10 days. The primary efficacy variable was response to therapy seven days after treatment ended (test of cure). The study demonstrated clinical noninferiority of ciprofloxacin/hydrocortisone group when compared to neomycin/polymyxin B/hydrocortisone plus amoxicillin. Response to therapy for ciprofloxacin/hydrocortisone was

95.71 percent versus 89.83 percent for neomycin/polymyxin B/hydrocortisone plus amoxicillin.

Both groups had a median time to end of pain of six days.

ofloxacin (Floxin Otic) and neomycin/polymyxin B/hydrocortisone (Cortisporin)

Adults and children with otitis externa were randomized to receive ofloxacin otic solution ten drops or five drops twice daily, respectively, or neomycin/polymyxin B/hydrocortisone otic solution four drops or three drops four times daily for ten days.70 A total of 314 adults and 287 children were enrolled. In the investigator-blinded study, the overall clinical response was a cure rate of 97 percent of ofloxacin-treated children and 95 percent of neomycin combinationtreated children (p=NS). The overall clinical response was cure in 82 percent of ofloxacintreated adults and 84 percent of neomycin combination-treated adults (p=NS). There were no differences in the incidence of any adverse events between treatment arms.





A double-blind study enrolled 52 patients with active chronic suppurative otitis media (CSOM).

Patients were randomized to receive treatment for two weeks with either topical ofloxacin or neomycin/polymyxin B/hydrocortisone.71 At the conclusion of the study, microbiologic eradication was noted in 81 percent and 75 percent of patients, respectively (p=NS). Clinical cure rates were 89 percent for ofloxacin and 79 percent for neomycin/polymyxin B/hydrocortisone (p=NS). In the study, ofloxacin had better coverage against Staphylococcus aureus (93 percent versus 68 percent), Staphylococcus epidermidis (83 percent versus 73 percent) and Pseudomonas aeruginosa (100 percent versus 86 percent). The adverse events were similar in each group.

–  –  –

Summary Otic antibiotics provide an alternative to systemic oral medication in the treatment of acute otitis media in children with tympanostomy tubes and are effective treatments for acute otitis externa.

Since many AOMT patients have received multiple antibiotics prior to getting tympanostomy tube placement, higher rates of antibiotic resistance may be noted in these patients. Due to the high levels of antibiotic achieved, the use of broad spectrum fluoroquinolones may overcome some of the bacterial resistance. While the addition of a corticosteroid may be of benefit in reducing inflammation, some consider the use of corticosteroids unnecessary.

The safety and efficacy of topical fluoroquinolones for the treatment of ear infections in children and adults is well documented.

References Ciprodex Otic [package insert]. Fort Worth, TX; Alcon Laboratories; 2004.

Cipro HC Otic [package insert]. Fort Worth, TX; Alcon Laboratories; 2006.

Coly-mycin S [package insert]. Rochester, MI; JHP Pharmaceuticals; February 2008.

Cortisporin Otic [package insert]. Bristol, TN; Monarch Pharmaceuticals; April 2003.

Cortisporin TC [package insert]. Rochester, MI; JHP Pharmaceuticals; February 2008.

Floxin Otic [package insert]. Montvale NJ; Daiichi Pharmaceutical; November 2006.

Ruohola A, Meurman O, Nikkari S. Microbiology of acute otitis media in children with tympanostomy tubes: prevalences of bacteria and viruses. Clin Infect Dis. 2006; 43(11):1417-22.

Rosenfeld RM, Brown L, Cannon CR, et al for the American Academy of Otolaryngology--Head and Neck Surgery Foundation.

Clinical practice guideline: acute otitis externa. Otolaryngol Head Neck Surg. 2006; 134(4 Suppl):S4-23.

Sander R. Otitis externa: a practice guide to treatment and prevention. Am Fam Physician. 2001; 63:927-936,941-942.

Rosenfeld RM, Singer M, Wasserman JM, et al. Systematic review of topical antimicrobial therapy for acute otitis externa.

Otolaryngol Head Neck Surg. 2006; 134(suppl):S24-48.

Rosenfeld RM, Brown L, Cannon CR, et al for the American Academy of Otolaryngology--Head and Neck Surgery Foundation.

Clinical practice guideline: acute otitis externa. Otolaryngol Head Neck Surg. 2006;134(4 Suppl):S4-23.

Lieberthal AS, Ganiats TG, Cox EO, et al for the American Academy of Pediatrics and the American Academy of Family Physicians. Clinical Practice Guidelines: Diagnosis and Management of Acute Otitis Media. Pediatrics. 2004; 113(5):1451-1465.

Parry D, et al. Middle Ear, Chronic Suppurative Otitis, Medical Treatment. http://emedicine.medscape.com/article/859501overview. updated Jul 7, 2009. Accessed December 7, 200.

Dohar J. Eardrops for Otorrhoea. In: Alper CM, Bluestone C, Dohar JE, Mandel EM, Casselbrant ML eds. Advanced Therapy of Otitis Media. Hamilton: BC Decker Publications, 2004;pp. 246-53.

Weber PC, et al. The development of antibiotic resistant organisms with the use of ototopical medications. Otolaryngol Head Neck Surg. 2004; 130(3 Suppl):S89-94.

Wai TK, Tong MC. A benefit-risk assessment of ofloxacin otic solution in ear infection. Drug Saf. 2003; 26(6):405-20.

Cipro HC Otic [package insert]. Fort Worth, TX; Alcon Laboratories; 2006.

Cetraxal [package insert Ridgeland, MS; Wraser Pharmaceuticals; April 2009.

Floxin Otic [package insert]. Montvale NJ; Daiichi Pharmaceutical; November 2006.

Ciprodex Otic [package insert]. Fort Worth, TX; Alcon Laboratories; 2004.

Cipro HC Otic [package insert]. Fort Worth, TX; Alcon Laboratories; 2006.

Ciprodex Otic [package insert]. Fort Worth, TX; Alcon Laboratories; 2004.

Floxin Otic [package insert]. Montvale NJ; Daiichi Pharmaceutical; November 2006.

Cipro HC Otic [package insert]. Fort Worth, TX; Alcon Laboratories; 2006.

Cortisporin Otic [package insert]. Bristol, TN; Monarch Pharmaceuticals; April 2003.

Cortisporin TC [package insert]. Rochester, MI; JHP Pharmaceuticals; February 2008.

Coly-mycin S [package insert]. Rochester, MI; JHP Pharmaceuticals; February 2008.

Cetraxal [package insert]. Columbia, SC; Ritedose Corporation; April 2009.

Ciprodex Otic [package insert]. Fort Worth, TX; Alcon Laboratories; 2004.

Cipro HC Otic [package insert]. Fort Worth, TX; Alcon Laboratories; 2006.

Floxin Otic [package insert]. Montvale NJ; Daiichi Pharmaceutical; November 2006.

Cortisporin Otic [package insert]. Bristol, TN; Monarch Pharmaceuticals; April 2003.

Cortisporin TC [package insert]. Rochester, MI; JHP Pharmaceuticals; February 2008.

Coly-mycin S [package insert]. Rochester, MI; JHP Pharmaceuticals; February 2008.

Cetraxal [package insert]. Ridgeland, MS; Wraser Pharmaceuticals; April 2009.

Cetraxal [package insert]. Ridgeland, MS; Wraser Pharmaceuticals; April 2009.

Ciprodex Otic [package insert]. Fort Worth, TX; Alcon Laboratories; 2004.

Cipro HC Otic [package insert]. Fort Worth, TX; Alcon Laboratories; 2006.

Floxin Otic [package insert]. Montvale NJ; Daiichi Pharmaceutical; November 2006.

Coly-mycin S [package insert]. Rochester, MI; JHP Pharmaceuticals; February 2008.

–  –  –

Cortisporin TC [package insert]. Rochester, MI; JHP Pharmaceuticals; February 2008.

Cortisporin Otic [package insert]. Bristol, TN; Monarch Pharmaceuticals; April 2003.

Cetraxal [package insert]. Ridgeland, MS; Wraser Pharmaceuticals; April 2009.

Ciprodex Otic [package insert]. Fort Worth, TX; Alcon Laboratories; 2004.

Floxin Otic [package insert]. Montvale NJ; Daiichi Pharmaceutical; November 2006.

Cortisporin Otic [package insert]. Bristol, TN; Monarch Pharmaceuticals; April 2003.

Cortisporin TC [package insert]. Rochester, MI; JHP Pharmaceuticals; February 2008.

Coly-mycin S [package insert]. Rochester, MI; JHP Pharmaceuticals; February 2008.

Coly-mycin S [package insert]. Rochester, MI; JHP Pharmaceuticals; February 2008.



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