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| |  Topical Solution Addresses Parents' Concerns With Ear Infections FORT LEE, NJ -- February 19, 1998 -- Daiichi Pharmaceutical Corp. has launched Floxin(R) Otic, which marks the first time in over two decades that a new antibiotic ear drop has been approved by the United States Food and Drug Administration. The arrival of Floxin Otic will aid in the treatment of approximately five million people in the U.S. suffering from specific middle and outer ear infections. Floxin Otic will be particularly beneficial to children one to 12 years of age with tympanostomy tubes who develop middle ear infections (acute otitis media with tympanostomy tubes) and patients 12 years and older who suffer from middle ear infections associated with perforated eardrums (chronic suppurative otitis media). For these two groups, Floxin Otic stands alone as the first and only drug approved for their treatment. The drop may be used alone without oral antibiotic therapy. This may help to alleviate some parental concerns over the frequent use of oral antibiotics in their children. In addition the twice-daily dosing of Floxin Otic allows for greater flexibility in co-ordinating daily applications avoiding school and work hours. Of the approximately five million people annually who suffer from ear infections that can be treated with Floxin Otic, about four million suffer from swimmer's ear, or outer ear infections (medically referred to as otitis externa). This infection generally occurs during the summer months. Topical treatment is standard therapy for outer ear infections. Floxin Otic is the first twice-daily topical therapy approved for the treatment of these infections and, with its near neutral pH level, it may minimise the patient's discomfort. It is the first new topical solution in 20 years approved by the FDA for treatment of outer ear infections. The most commonly reported adverse reactions in clinical trials in otitis externa patients treated with Floxin Otic: pruritis (four percent) application site reaction (three percent); dizziness (one percent); and vertigo (once percent); in acute otitis media patients with tympanostomy tubes and in CSOM patients with perforated membranes treated with Floxin Otic: taste perversion (seven percent); earache, pruritis, paraesthesia, rash and dizziness (all one percent). Floxin Otic is contraindicated in patients with a history of hypersensitivity to ofloxacin, other quinolones, or other ingredients of the medication, and should be discontinued at the first sign of allergic reaction. Patients who have not improved after one week of treatment should be evaluated by their doctor.
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