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

Safety

Important Safety Information and Indications

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

OTIPRIO (ciprofloxacin otic suspension) 6% is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO

Adverse Reactions Observed With OTIPRIO Incidence of adverse reactions from Phase 3 trials were similar in both treatment arms

 

  • *Tubes alone arm: patients received an administration of air (sham) during ear tube placement.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATONS

OTIPRIO (ciprofloxacin otic suspension) 6% 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 non-susceptible bacteria and fungi. If such infections occur, institute alternative therapy.

ADVERSE REACTIONS

Bilateral otitis media with effusion clinical trials: Adverse reactions (incidence at least 3%) with OTIPRIO vs sham were: nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and rhinorrhea (3% vs 2%).

Acute otitis externa clinical trial: Adverse reactions (incidence at least 2%) with OTIPRIO vs sham were: ear pruritus (2% vs 2%), headache (2% vs 1%), otitis media (2% vs 1%), and ear discomfort (2% vs 0%).

USE IN SPECIFIC POPULATIONS

Pediatric Use: The safety and effectiveness of OTIPRIO in infants below six months of age have not been established for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement and acute otitis externa.

INDICATIONS AND USAGE

OTIPRIO (ciprofloxacin otic suspension) 6% is a fluoroquinolone antibacterial indicated for:

  • The treatment of pediatric patients (6 months of age and older) with bilateral otitis media with effusion undergoing tympanostomy tube placement
  • The treatment of acute otitis externa in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus