From the Guidelines
Ofloxacin ear drops can be safely used in cases of perforated tympanic membrane, but with caution, due to its low ototoxicity compared to other antibiotics, as recommended by the 2014 clinical practice guideline on acute otitis externa 1. When administering ofloxacin ear drops, the patient should lie with the affected ear upward for 5 minutes after application to ensure proper distribution. It's crucial to use a sterile dropper and avoid touching the ear canal or outer ear with the dropper tip to prevent contamination. The recommended dosage is typically 5 drops in the affected ear twice daily for 7 to 10 days.
Key Considerations
- Ofloxacin is effective against many bacteria that cause ear infections, including those in the middle ear that may be more accessible due to the perforation.
- Patients should be monitored for signs of vertigo, tinnitus, or hearing changes, which could indicate adverse effects.
- While using ofloxacin, it's essential to keep the ear dry by avoiding swimming and using earplugs when showering.
- Most perforations heal on their own within a few months, but persistent cases may require surgical intervention.
- If symptoms worsen or don't improve after the full course of treatment, further evaluation by an otolaryngologist is recommended, as stated in the 2008 clinical practice guideline on cerumen impaction 1.
Rationale
The 2014 guideline on acute otitis externa 1 provides a recommendation based on reasoning from first principles and exceptional circumstances, suggesting the use of non-ototoxic topical preparations, such as ofloxacin, in cases of perforated tympanic membrane. Although the evidence quality is graded as C, and the level of confidence in the evidence is medium, the guideline's recommendation is based on a preponderance of benefit over harm. Therefore, ofloxacin ear drops are a suitable option for treating ear infections in patients with a perforated tympanic membrane, with proper precautions and monitoring.
From the FDA Drug Label
Subjects with Acute Otitis Media with Tympanostomy Tubes (AOM TT) and Subjects with Chronic Suppurative Otitis Media (CSOM) with Perforated Tympanic Membranes In phase III clinical trials which formed the basis for approval, the following treatment-related adverse events occurred in 1% or more of the 656 subjects with non-intact tympanic membranes in AOM TT or CSOM treated twice-daily with ofloxacin otic solution:
The effect of Ofloxacin on a perforated tympanic membrane is not explicitly stated in terms of benefits, but the following adverse events were reported in subjects with non-intact tympanic membranes:
- Taste Perversion (7%)
- Earache (1%)
- Pruritus (1%)
- Paraesthesia (1%)
- Rash (1%)
- Dizziness (1%) Other treatment-related adverse reactions reported in subjects with non-intact tympanic membranes included otorrhagia (0.6%) 2.
From the Research
Effect of Ofloxacin on Perforated Tympanic Membrane
- Ofloxacin otic solution has been shown to be effective in the treatment of chronic suppurative otitis media in patients with perforated tympanic membranes, with a clinical cure rate of 75 to 91% 3.
- A systematic review and meta-analysis found that ofloxacin ear drops significantly increased the rate of tympanic membrane closure and reduced healing time in patients with traumatic tympanic membrane perforations 4.
- A clinical trial found that ofloxacin otic solution was effective in resolving the signs and symptoms of chronic suppurative otitis media in patients with perforated tympanic membranes, with a clinical cure rate of 91% 5.
- A study comparing the healing outcomes of large traumatic tympanic membrane perforations treated with ofloxacin otic solution, gelatin sponge patch, and spontaneous healing found that ofloxacin otic solution had a higher closure rate and shorter mean time to closure 6.
- Another study found that ofloxacin did not delay tympanic membrane healing, whereas ciprofloxacin/dexamethasone did 7.
Adverse Effects and Tolerability
- Ofloxacin otic solution has been shown to be well tolerated, with adverse events such as bitter taste and pruritus being mild to moderate and occurring in less than 2% of patients 3.
- The incidence of adverse events with ofloxacin otic solution was similar to that with other ototopical preparations and significantly less than that with oral amoxicillin/clavulanic acid 3.
Comparison with Other Treatments
- Ofloxacin otic solution has been compared to other treatments such as neomycin/polymixin B/hydrocortisone preparations and oral amoxicillin/clavulanic acid, and has been found to be as effective or more effective in some cases 3, 5.
- A study comparing the healing outcomes of large traumatic tympanic membrane perforations treated with ofloxacin otic solution, gelatin sponge patch, and spontaneous healing found that ofloxacin otic solution had a higher closure rate and shorter mean time to closure than gelatin sponge patch and spontaneous healing 6.