For what conditions are ciprofloxacin (Cipro)/dexamethasone ear drops most appropriate?

From the Guidelines

Ciprofloxacin/dexamethasone ear drops are most appropriate for treating acute tympanostomy tube otorrhea (TTO) in children, as they have been shown to achieve superior outcomes in clinical cure, bacterial eradication, and patient satisfaction compared to systemic oral antibiotics 1. The use of ciprofloxacin/dexamethasone ear drops in this context is supported by four RCTs that compared topical antibiotic eardrops with systemic oral antibiotics for treating acute TTO in children, with results showing that topical therapy achieved superior outcomes in some studies for clinical cure, bacterial eradication, and patient satisfaction 1. Some key points to consider when prescribing ciprofloxacin/dexamethasone ear drops include:

• The typical dosing regimen is 4 drops instilled into the affected ear(s) twice daily for 7-10 days 1.
• Caregivers should be advised to limit topical therapy to a single course of no more than 10 days 1.
• The ear canal should be cleaned of any debris or discharge before administering the drops to ensure proper distribution 1.
• Topical antibiotic therapy avoids adverse events associated with systemic antibiotics, including dermatitis, allergic reactions, gastrointestinal upset, oral thrush, and potential for increased antibiotic resistance 1. It is essential to note that ciprofloxacin/dexamethasone ear drops should only be used in patients with bacterial infections, and not in patients with viral or fungal ear infections, or hypersensitivity to either active ingredient 1.

From the FDA Drug Label

Ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below: Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa. Ciprofloxacin and dexamethasone otic suspension is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below: Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa. (1)

The most appropriate conditions to prescribe ciprofloxacin/dexamethasone ear drops are:

• Acute Otitis Externa (AOE) in:
  • Pediatric patients (age 6 months and older)
  • Adult patients
  • Elderly patients caused by Staphylococcus aureus and Pseudomonas aeruginosa 2, 2, 2.

From the Research

Conditions for Prescribing Ciprofloxacin/Dexamethasone Ear Drops

Ciprofloxacin/dexamethasone ear drops are most appropriate for the following conditions:

• Acute otitis externa (AOE) 3, 4, 5
• Acute otitis media in pediatric patients with tympanostomy tubes 4
• Otorrhea with tympanostomy tubes 6
• Chronic suppurative otitis media (CSOM) 6

Key Considerations

When prescribing ciprofloxacin/dexamethasone ear drops, consider the following:

• The presence of an intact tympanic membrane 5
• The potential for ototoxicity, although fluoroquinolone and dexamethasone containing drops have been shown to be non-ototoxic 6
• The need for frequent cleansing of the ear canal and avoidance of predisposing factors such as swimming in polluted waters or using cotton-tip applicators to clean the ear canal 7

Treatment Duration and Efficacy

• The typical treatment duration for ciprofloxacin/dexamethasone ear drops is 7-10 days 5
• Clinical cure rates and microbiologic eradication rates have been shown to be higher with ciprofloxacin/dexamethasone compared to other treatments 3, 4
• The addition of dexamethasone to ciprofloxacin has been shown to improve clinical cure rates and bacterial eradication rates 4, 6