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About the Middle Ear

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.

Otitis Media With Effusion

Anatomy of the ear

 

Anatomy of the Ear
Adapted from Rosenfeld et al. Otolaryngol Head Neck Surg.
2013;149(suppl 1):S1-S35.

Otitis media with effusion (OME) is the presence of inflammation and a collection of fluid in the middle ear space without signs or symptoms of acute otitis media.3

Ear tube surgery: facts and figures

 

 


References:

  1. Kogan MD, Overpeck MD, Hoffman HJ, Casselbrant ML. Factors associated with tympanostomy tube insertion among preschool-aged children in the United States. Am J Pub Health. 2000;90:245-250.
  2. IMS Custom Analysis, TTP Market, Integrated Health Plan Real World Data, October 2013.
  3. Rosenfeld RM, Schwartz SR, Pynnonen MA, et al. Clinical practice guideline: tympanostomy tubes in children—executive summary. Otolaryngol Head Neck Surg. 2013;149(1):8-16.
  4. Kay DJ, Nelson M, Rosenfeld RM. Meta-analysis of tympanostomy tube sequelae. Otolaryngol Head Neck Surg. 2001;124:374-380.

 

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.