Pharmacy Prior Authorization Criteria

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.

Ciprodex (ciprofloxacin and dexamethasone otic suspension)

• For diagnosis of Acute Otitis Media
  Indicated in pediatric patients (age 6 months and older) with tympanostomy tubes for the treatment of infections caused by susceptible isolates of Staphylococcus aureus, Streptococcus, pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.

• For diagnosis of Acute Otitis Externa
  Indicated in pediatric (age 6 months and older), adult and elderly patients for the treatment of infections caused by susceptible isolates of Staphylococcus aureus and Pseudomonas aeruginosa.

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

Brand Ciprodex

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
AND
• Trial and failure (of a minimum 7-day supply) within the past 180 days, or intolerance to generic ciprofloxacin-dexamethasone otic suspension

P & T Revisions

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

References

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.
4. Ciprodex Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. November 2020.

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Revision History

• 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

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