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

Otiprio Now Available

For the treatment of acute otitis externa in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus

Staying Power

Thermosensitive liquid-to-gel technology

After administration to the external ear canal, OTIPRIO warms and transitions to a gel.

The first and only single‐dose ciprofloxacin otic suspension administered by a healthcare professional in an office setting

  • Study design: Phase 3, randomized, controlled, blinded, multicenter study in 262 pediatric and adult patients with unilateral or bilateral acute otitis externa
  • The primary endpoint was the proportion of patients with clinical response at Day 8
  • Clinical response was defined as the complete absence of signs and symptoms of acute otitis externa (i.e., tenderness, erythema, edema, and otorrhea as determined by the blinded assessor), and no concomitant systemic or topical antibacterial drug (given in the study ear) was taken for any reason at or prior to the study visit

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.

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