The makers of Ciprodex and Floxin see things differently.
"The FDA label for products containing aminoglycosides such as Cortisporin indicate the potential risk when there is an open tympanic membrane," said Paul Cockrum, Pharm.D., manager of clinical market support for Alcon Inc., which manufactures Ciprodex. "So if a physician prescribes this product, then he is open to potential liability.
Both Floxin (ofloxacin otic solution 0.3%) and Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1% sterile otic suspension) have recently been approved for the treatment of acute otitis externa in children as young as age 6 months.
Overall, the data suggest that efficacy of Floxin and Ciprodex drops in treating acute otitis externa in children is greater than 90%, compared with about 80% for the generics such as Cortisporin (neomycin, polymyxin B sulfates, and hydrocortisone otic solution), and about 70% for astringents such as acetic acid, isopropyl alcohol, or hydrogen peroxide.
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.
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.
With its user-friendly platform, the site offers digital access to information on treatments for two extremely common childhood ailments: Ciprodex
Otic (ciprofloxacin 0.3% and dexamethasone 0.1%), for acute otitis externa and acute otitis media in pediatric patients with tymponostomy tubes; and Moxeza Solution, (moxifloxacin HCI ophthalmic solution) 0.5%, for bacterial conjunctivitis caused by susceptible strains.
Pharmacokinetics of topical Ciprodex
otic suspension in pediatric and adolescent patients after tympanostomy tube surgery.
He also 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.
The Food and Drug Administration approved Ciprodex
Otic for topical treatment of acute otitis media in children (aged 6 months and older) with tympanostomy tubes (AOMT).
Otic topical drops have been approved for patients 6 months of age and older.