From the Guidelines
For otitis externa with a potentially perforated tympanic membrane (TM), the safest medication is a non-ototoxic topical preparation, such as ciprofloxacin/dexamethasone otic drops (Ciprodex). This recommendation is based on the principle of minimizing harm, as stated in the clinical practice guideline for acute otitis externa 1. The guideline emphasizes the importance of using non-ototoxic preparations when there is a known or suspected perforation of the tympanic membrane.
When selecting a medication, it is crucial to consider the potential risks of ototoxicity, as some medications can cause permanent hearing loss if they enter the middle ear through a perforation. Ciprofloxacin is a preferred option because it is not ototoxic, making it safe for use in patients with a potentially perforated TM 1.
Key considerations for treatment include:
- Using a non-ototoxic topical preparation to minimize the risk of harm
- Avoiding aminoglycoside-containing drops, such as neomycin, which can cause permanent hearing loss if they reach the middle ear through a perforation
- Avoiding alcohol-based preparations, which can cause severe pain in a perforated eardrum
- Considering the use of an ear wick if the ear canal is severely swollen, to deliver the medication effectively
- Generally, oral antibiotics are unnecessary unless there's extension beyond the ear canal or in immunocompromised patients.
The typical regimen for ciprofloxacin/dexamethasone otic drops is 4 drops in the affected ear twice daily for 7 days. Before application, gently clean the ear canal of debris if possible, and have the patient lie with the affected ear upward for 1-2 minutes after instillation. This approach prioritizes the patient's safety and minimizes the risk of complications, while also providing effective treatment for otitis externa 1.
From the FDA Drug Label
Ofloxacin otic solution, 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus. Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa, and Staphylococcus aureus.
The best medication to use for otitis externa that is safe if the tympanic membrane (TM) is perforated is ofloxacin (OTIC), as it is indicated for the treatment of otitis externa and chronic suppurative otitis media with perforated tympanic membranes 2, 2.
- The recommended dosage regimen for otitis externa is:
- For pediatric patients (from 6 months to 13 years old): Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear once daily for seven days.
- For patients 13 years and older: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear once daily for seven days.
- For chronic suppurative otitis media with perforated tympanic membranes in patients 12 years and older, the recommended dosage regimen is: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear twice daily for fourteen days.
From the Research
Otitis Externa Treatment with Perforated Tympanic Membrane
- The treatment of otitis externa with a perforated tympanic membrane requires careful consideration of the potential risks and benefits of different medications 3, 4.
- Ofloxacin otic solution 0.3% has been shown to be effective in the treatment of otitis externa, with a clinical cure rate of over 80% in adults and over 95% in children 3.
- This medication is also safe to use in patients with perforated tympanic membranes, as it is not associated with ototoxicity 3, 4.
- In fact, ofloxacin otic solution 0.3% is the first ototopical agent approved for use in patients with non-intact tympanic membranes, providing a valuable advantage over current treatment alternatives 3.
- Other studies have also demonstrated the efficacy of ofloxacin in treating otitis externa, including a study that found it to be as effective as ciprofloxacin otic and polymyxin/neomycin plus hydrocortisone in children under 12 years of age 4.
Safety and Efficacy of Ofloxacin
- The safety and efficacy of ofloxacin have been extensively studied, with results showing that it is well tolerated and effective in treating otitis externa, even in patients with perforated tympanic membranes 3, 4, 5.
- A systematic review and meta-analysis found that ofloxacin ear drops were effective in reducing healing time and increasing the rate of tympanic membrane closure in patients with traumatic tympanic membrane perforations 5.
- Another study found that treatment with clotrimazole solution was safe in managing otomycosis with tympanic membrane perforation, although this study did not specifically examine the use of ofloxacin 6.
Comparison to Other Treatments
- Ofloxacin otic solution 0.3% has been compared to other treatments for otitis externa, including topical neomycin/polymixin B/hydrocortisone preparations and oral amoxicillin/clavulanic acid 3.
- The results of these studies suggest that ofloxacin is a safe and effective treatment option for otitis externa, even in patients with perforated tympanic membranes 3, 4.