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For the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement
OTIPRIO is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO.
Potential for Microbial Overgrowth: OTIPRIO may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur, institute alternative therapy.
Adverse reactions (incidence at least 3%) that occurred in two Phase 3 trials with OTIPRIO vs sham were: nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and rhinorrhea (3% vs 2%).
Pediatric Use: The safety and effectiveness of OTIPRIO in infants below six months of age have not been established.
OTIPRIO™ (ciprofloxacin otic suspension) 6% is a fluoroquinolone antibacterial indicated for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement.
Please see full Prescribing Information.