From the FDA Drug Label
The recommended dosage regimen for the treatment of chronic suppurative otitis media with perforated tympanic membranes in patients 12 years and older is: Ten drops (0.5 mL, 1. 5 mg ofloxacin) instilled into the affected ear twice daily for fourteen days. The patient should lie with the affected ear upward, before instilling the drops The tragus should then be pumped 4 times by pushing inward to facilitate penetration into the middle ear.
For a broken tympanic membrane, the preferred treatment is antibiotic ear drops, specifically ofloxacin (OTIC) ear drops, as indicated in the dosage regimen for chronic suppurative otitis media with perforated tympanic membranes 1.
- The dosage is ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear twice daily for fourteen days.
- It is essential to follow the administration instructions to facilitate penetration of the drops into the middle ear.
From the Research
For a broken tympanic membrane, the preferred treatment is typically oral antibiotics rather than antibiotic ear drops, as evidenced by the most recent and highest quality study 2.
Key Considerations
- Oral antibiotics such as amoxicillin (500mg three times daily for 7-10 days) or amoxicillin-clavulanate (875mg twice daily for 7-10 days) are generally recommended if infection is present or suspected.
- Antibiotic ear drops are usually avoided because they can potentially be ototoxic (damaging to the inner ear) when they pass through the perforation into the middle ear, as shown in a study comparing the effects of ciprofloxacin/dexamethasone and ofloxacin on tympanic membrane perforation healing 3.
- Most tympanic membrane perforations heal spontaneously within 1-3 months without specific treatment beyond controlling infection and keeping the ear dry.
- Patients should avoid getting water in the affected ear during the healing process and can use a cotton ball lightly coated with petroleum jelly as a water barrier during showering.
Rationale for Preference
The preference for oral antibiotics over antibiotic ear drops is based on the potential for ototoxicity and the delayed healing associated with certain antibiotic ear drops, such as ciprofloxacin/dexamethasone, as demonstrated in studies 4, 2, 5.
Important Studies
- A study published in 2018 found that ototopical quinolones delay rat tympanic membrane healing in a drug-specific manner, with ciprofloxacin having a greater impact than ofloxacin 2.
- Another study from 2007 showed that exposure to ciprofloxacin/dexamethasone, but not ofloxacin, prolongs tympanic membrane healing 5.
Clinical Implications
The use of oral antibiotics is recommended over antibiotic ear drops for the management of a broken tympanic membrane, due to the potential risks associated with antibiotic ear drops and the effectiveness of oral antibiotics in controlling infection and promoting healing 2. If the perforation doesn't heal within 3 months or if it's very large, surgical repair (tympanoplasty) might be necessary.