WHA

Ciprofloxacin-Containing Otic Agents

Indications for Prior Authorization

Cetraxal (ciprofloxacin otic solution)
  • For diagnosis of Acute Otitis Externa
    Indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus.

Criteria

Brand Cetraxal

Step Therapy

Length of Approval: 12 Month(s)

  • Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
    • AND
  • Trial and failure (of a minimum 10-day supply) within the past 180 days, contraindication, or intolerance to generic ofloxacin otic solution

  • Guideline ID
    GL-378213

  • Formulary
    premium

  • Effective date
    Nov 1, 2025

  • P&T approval date
    May 21, 1999

P & T Revisions

2025-09-04, 2024-07-03, 2023-07-28, 2023-07-06, 2022-07-07, 2021-09-28, 2021-06-18, 2021-05-20, 2021-03-01, 2020-06-01

  1. Jones RN, Milazzo J, Seidlin M. Ofloxacin otic solution for treatment of otitis externa in children and adults. Arch Otolaryngol Head Neck Surg 1997;123:1193-200.
  2. Cetraxal Prescribing Information. The RiteDose Corporation. Columbia, SC. December 2017.
  3. Rosenfeld RM, Schwartz SR, Cannon CR, et al. Clinical practice guideline: acute otitis externa. Otolaryngol Head Neck Surg. 2014;150(1):S1-S24.
  • 2025-09-04: 2025 Annual Review - Removed EHB formulary and removed Ciprodex and associated criteria (product obsolete date 9/15/25)
  • 2024-07-03: Annual review: No updates required.
  • 2023-07-28: Retired ST on generic ciprofloxacin otic agent.
  • 2023-07-06: Annual review: No updates required.
  • 2022-07-07: Annual review: Updated criteria and background.
  • 2021-09-28: Annual Review: no change
  • 2021-06-18: Annual Review: no change
  • 2021-05-20: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-03-01: Added Brand Ciprodex otic suspension to ST program and renamed program to "Ciprofloxacin-Containing Otic Agents."
  • 2020-06-01: Annual Review