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Dosing and Administration

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.

OTIPRIO Provides Intratympanic
Treatment in a Single Administration

Getting started with OTIPRIO

Things to know:

OTIPRIO is for intratympanic administration only

Store OTIPRIO at 2° to 8° C (36° to 46° F) and protect from light

Store in the original carton until dose preparation

After preparation, syringes can be kept at room temperature or in the refrigerator prior to administration

Keep syringes on their side

Discard syringes if not administered in 3 hours

OTIPRIO vial, alcohol pads, syringes, preparation needles, and administration needles

Materials you will need:

  • One vial of OTIPRIO (enough for 2 doses)
  • Two 1 mL luer lock syringes
  • Two 18-21G preparation needles
  • Two 20-24G, 2-3 inch blunt, flexible administration needles
  • Alcohol pads
  • OPTIONAL: Ice pack and drape to keep OTIPRIO vial cold

Preparation

KEEP COLD during preparation. If OTIPRIO thickens during preparation, place the vial back in refrigeration

SHAKE the vial for 5 to 8 seconds to mix well until a visually homogenous suspension is obtained. Always hold the vial by the aluminum seal to prevent gelation

WITHDRAW 0.3 mL of the suspension into the 1 mL syringe using an 18-21G preparation needle

REPLACE the 18-21G preparation needle with a 20-24G, 2-3 inch blunt, flexible administration needle

PRIME the needle, leaving a dose of 0.1 mL (0.1 cc)

REPEAT Using the same vial, prepare a second syringe for the other ear and dispose of the vial. Use a different syringe for each ear

Administration

COMPLETE myringotomy and suctioning of middle ear effusion

ADMINISTER 0.1 mL of OTIPRIO by using the 20-24G, 2-3 inch blunt, flexible administration needle

NEVER ADMINISTER OTIPRIO using the 18-21G preparation needle

DIRECTIONS FOR USE can be found in Figure 1 of the OTIPRIO Prescribing Information

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.