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For the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement

Important Safety Information and Indications

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

OTIPRIO is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO.

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IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

OTIPRIO is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO.

WARNINGS AND PRECAUTIONS

Potential for Microbial Overgrowth: OTIPRIO may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur, institute alternative therapy.

ADVERSE REACTIONS

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%).

USE IN SPECIFIC POPULATIONS

Pediatric Use: The safety and effectiveness of OTIPRIO in infants below six months of age have not been established.

Indications and Usage

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.