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Fluoroquinolone drops useful in ear infection: few adverse effects.

MIAMI Beach -- Fluoroquinolones are often safe and effective against both acute otitis media in children with tympanostomy tubes and acute otitis externa, Dr. Ramzi Younis said at a pediatric update sponsored by Miami Children's Hospital.

Acute otitis media with tubal otorrhea and otitis externa are the culprits behind the majority of children's ear problems, especially in the summer, said Dr. Younis, chief of pediatric otolaryngology at the University of Miami. He shared an overview of these common conditions and strategies to balance effective management with concerns about antibiotic resistance.

* Otitis Externa. This severe infection of the outer ear, diagnosable by otoscopy, may be bacterial, fungal, eczematous, or viral. Clinical signs include erythema of the ear canal, purulent otorrhea, and pain on movement of the external ear. Diagnosis may be complicated by pus that obstructs the view, Dr. Younis noted Treatment includes cleaning and suctioning the ear, followed by topical therapy Oral therapy may be used if local cellulitis occurs.

* Acute otitis media with tubes. Placement of tympanostomy tubes is one of the most common childhood procedures to treat disease, Dr. Younis said. However, postoperative otorrhea is common as well. Clinical signs and symptoms include visible tube otorrhea, draining pus, and hearing loss. Causes include exposure to water and presence of an upper respiratory infection. Treatment of granuloma in the tubes may require topical antibiotics with steroids, and systemic antibiotics may be needed.

Topical drugs can be used to treat both of these conditions. Antibiotics often are needed to treat infections, but concerns about antibiotic resistance have supported the development and use of fluoroquinolones. Unlike aminoglycosides, which have the potential for ototoxicity, fluoroquinolones have been found safe and well tolerated, he said.

The latest incarnation of fluoroquinolone treatment is Ciprodex Otic, a suspension of ciprofloxacin and dexamethasone that was approved by the Food and Drug Administration in 2003. Dexamethasone was the steroid of choice for this mix, given its proven safety record and regular use to treat inflammations in children, and it appears to contribute significantly to the therapeutic effects, said Dr. Younis, a principal investigator and member of the speakers' bureau for Alcon Laboratories Inc., which produces the drug.

He said in an interview that Ciprodex Otic, when used in the dosages recommended by the manufacturer, has become his treatment of choice for otitis media in children since its FDA approval.

Dr. Younis cited laboratory studies in which Ciprodex Otic was superior to Cortisporin Otic in resolving acute otitis externa and eradicating bacteria, and was superior to ofloxacin in clinical efficacy against acute otitis media with tubal otorrhea (Pediatrics [online] 113[1], 2004; full/113/1/e40; and Laryngoscope 113[12]:2116-22, 2003).

In addition, he cited the low incidence of adverse effects from Ciprodex Otic based on data from 400 children with acute otitis media and tympanostomy tubes and 537 children with acute otitis externa. Among the children with acute otitis media and tympanostomy tubes, ear discomfort occurred in 3%, ear pain occurred in 2.3%, and the incidence of any other adverse event was 0.5% or less. Among the children with acute otitis externa, ear pruritus occurred in 1.5%, and the incidence of any other adverse event was 0.6% or less.

Ciprodex Otic suspension is approved for topical treatment of acute otitis media in children with tympanostomy tubes who are aged 6 months and older. In addition, it is indicated for topical treatment of acute otitis externa in pediatric, adult, and elderly patients.
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Title Annotation:Children's Health
Author:Splete, Heidi
Publication:Family Practice News
Geographic Code:1USA
Date:Apr 15, 2004
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