Ofloxacin Otic Solution Regimen
Dosing by Indication and Age
For otitis externa, administer ofloxacin otic solution 0.3% once daily for 7 days: 5 drops (0.25 mL) for children 6 months to 12 years, and 10 drops (0.5 mL) for patients ≥13 years. 1
Otitis Externa
- Pediatric patients (6 months to 13 years): 5 drops (0.25 mL, 0.75 mg ofloxacin) into the affected ear once daily for 7 days 1
- Patients ≥13 years: 10 drops (0.5 mL, 1.5 mg ofloxacin) into the affected ear once daily for 7 days 1
- Clinical cure rates are excellent: 95% in children and 88% in adolescents/adults, with 68% of patients cured within 7 days 2
Acute Otitis Media with Tympanostomy Tubes
- Pediatric patients (1 to 12 years): 5 drops (0.25 mL, 0.75 mg ofloxacin) into the affected ear twice daily for 10 days 1
- The tragus should be pumped 4 times by pushing inward to facilitate penetration into the middle ear 1
Chronic Suppurative Otitis Media with Perforated Tympanic Membranes
- Patients ≥12 years: 10 drops (0.5 mL, 1.5 mg ofloxacin) into the affected ear twice daily for 14 days 1
- The tragus should be pumped 4 times by pushing inward to facilitate middle ear penetration 1
Administration Technique
Proper instillation technique is critical for therapeutic success:
- Warm the bottle by holding it in the hand for 1-2 minutes before instillation to avoid dizziness from cold solution 1
- Patient should lie with the affected ear upward during instillation 1
- Maintain this position for 5 minutes after instillation to facilitate penetration into the ear canal 1
- For middle ear infections (tympanostomy tubes or perforated membranes), pump the tragus 4 times after instillation 1
Clinical Evidence Supporting Once-Daily Dosing
The once-daily regimen for otitis externa represents a significant advancement over older regimens:
- Once-daily ofloxacin is as effective as neomycin/polymyxin B/hydrocortisone given 4 times daily, with equivalent cure rates of 93.8% vs 94.7% 3
- Mean adherence to once-daily therapy is 98%, suggesting better patient acceptance than more frequent dosing regimens 2
- Microbiological eradication rates are 96% overall, with 98% eradication of Pseudomonas aeruginosa 2, 3
Safety Profile
Ofloxacin otic solution has an excellent safety profile with minimal adverse events:
- Adverse events occur in only 3% of patients and are typically mild 2
- Most common adverse events: pruritus (2%), increased earache (<1%), and application-site reactions (<1%) 2
- Bitter taste occurs in 5% of patients, primarily those with non-intact tympanic membranes 4
- No ototoxicity has been documented in clinical studies, unlike aminoglycoside-containing preparations 4, 5
Critical Caveats
Age restrictions: Ofloxacin otic solution is approved for use in patients ≥6 months of age 1
Systemic absorption: Topical otic administration produces minimal systemic absorption, avoiding systemic fluoroquinolone adverse effects 4, 5
Resistance: Despite extensive clinical use since the late 1980s, resistance emergence is rare, with only two documented strains of Pseudomonas aeruginosa showing decreased susceptibility 5