OTIPRIO (ciprofloxacin otic suspension) 6% marketed by ALK-Abello Inc. and Otonomy Inc.



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Indications & 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
Dosage & Administration

·         OTIPRIO is for intratympanic or otic administration by a healthcare professional only.

·         OTIPRIO is intended for single-patient use with up to two doses available in each vial.

·         For bilateral otitis media with effusion, administer OTIPRIO as a single intratympanic administration of one 0.1 mL (6 mg) dose into each affected ear, following suctioning of the middle ear effusion.

·         For acute otitis externa, administer OTIPRIO as a single 0.2 mL (12 mg) administration to the affected ear(s).

·         See Full Prescribing Information for directions for OTIPRIO dose preparation. 

Dosage Forms and Strengths

Otic Suspension: Each OTIPRIO vial contains 1 mL of 6% (60 mg/mL) ciprofloxacinotic suspension. 

Contraindications

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

Warnings & Precautions

Potential for Microbial Overgrowth: OTIPRIO may result in overgrowth of non-susceptible bacteria and fungi. 

Adverse Reactions

Otitis Media with Effusion: The most frequently occurring adverse reactions (with an incidence rate greater than 3%) were nasopharyngitis and irritability.

Acute Otitis Externa: The most frequently occurring adverse reactions (with an incidence rate of at least 2%) were: ear pruritus, headache, otitis media and ear discomfort. 

To report SUSPECTED ADVERSE REACTIONS, contact Otonomy at 1-800-826-6411 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


OTIPRIO is being marketed by ALK-Abello. Inc. and Otonomy. Inc.

©2020 Otonomy, Inc. All rights reserved.
OTIPRIO is a registered trademark of Otonomy, Inc.

OTI0242.1220

       

Click here for full Prescribing Information for OTIPRIO

Indications and Important Safety Information


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