Medication Monitor

Generic Name (Trade Name—Company)
March 9, 2018

Ciprofloxacin otic suspension 6%

First single-dose antibiotic approved for acute otitis externa

FDA has approved ciprofloxacin otic suspension 6% for treatment of acute otitis externa (AOE) resulting from Pseudomonas aeruginosa and Staphylococcus aureus in patients aged 6 months and older.

It is the first single-dose antibacterial approved by the FDA for treating AOE.

This sterile, preservative-free agent is administered as a single-dose by a health professional. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed.

For AOE, the agent is a single 0.2 mL (12 mg) administered to the external ear canal of each affected ear.

In a single Phase III trial, the agent demonstrated statistically significant clinical response, defined as the complete absence of signs and symptoms of AOE (i.e., tenderness, erythema, edema, and otorrhea) compared with sham.

For bilateral otitis media with effusion, the agent is administered during ear tube surgery as a single 0.1 mL (6 mg) intratympanic administration into each affected ear, following suctioning of the middle ear effusion. 

In two Phase III trials, a single intraoperative administration of the agent demonstrated a statistically significant reduction in the cumulative proportion of study treatment failures compared with tubes alone.