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

For state-mandated plans in Illinois or other states where applicable: Step therapy requirements do NOT apply. Beginning January 1, 2026, step therapy requirements or use of the authorization of alternative covered medications in a manner that effectively creates a step therapy requirement will not be imposed.

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-486386

  • Formulary
    Premium

  • Effective date
    Jan 1, 2026

  • P&T approval date
    May 21, 1999

P & T Revisions

1970-01-01, 2025-12-18, 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.
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 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