Ciprofloxacin otic solution for acute otitis externa treatment

Ciprofloxacin otic solution, 0.2% is a sterile, preservative-free antibiotic ear drop used to treat acute otitis externa caused by specific susceptible bacteria. It contains the fluoroquinolone ciprofloxacin, which works by interfering with bacterial DNA synthesis.

Ciprofloxacin otic solution, 0.2% is used for the treatment of acute otitis externa (swimmer's ear) due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus.

Ciprofloxacin hydrochloride

Ciprofloxacin is a fluoroquinolone antibiotic that kills bacteria by blocking the enzyme DNA gyrase, which bacteria need to replicate their DNA. This stops bacterial growth and helps clear the infection. It targets bacteria that cause ear infections but works differently than other antibiotics, which may be effective against resistant strains.

Adults and pediatric patients one year and older: Instill the entire content of one 0.25 mL single-dose container into the affected ear twice daily, about 12 hours apart, for 7 days.

Instructions for use:

• Wash hands before use.
• Warm the single-dose container by holding it in your hands for at least 1 minute to reduce dizziness from cold solution.
• Lie with the affected ear facing upward.
• Instill drops into the ear and maintain the position for at least 1 minute to help the medication penetrate the ear canal.
• Treat the opposite ear if needed by repeating the process.
• Discard used single-dose containers; do not reuse or save partial doses.

Use is contraindicated in individuals with a known history of hypersensitivity to ciprofloxacin.

Otic use only: Do not use ciprofloxacin otic solution for injection, inhalation, or eye drops.

Hypersensitivity: Discontinue immediately if a skin rash or any sign of allergic reaction occurs.

Overgrowth of nonsusceptible organisms: Prolonged use may lead to yeast or fungal infections in the ear; if this occurs, stop treatment and seek alternative therapy.

Lack of improvement: If no clinical improvement occurs after 7 days, cultures should be considered to guide further treatment.

The most common side effects reported (2-3% of patients) include:

• Pain at the application site
• Ear itching (pruritus)
• Fungal ear superinfection
• Headache

Pregnancy: Classified as Pregnancy Category C. Animal studies have not shown teratogenic effects, but human studies have not established safety. Exercise caution when used by pregnant women.

Lactation: Systemic ciprofloxacin is present in breast milk, but it is unknown for the otic solution. Consider discontinuing nursing or the drug based on clinical judgment.

Store unopened single-dose containers at 15°C to 25°C (59°F to 77°F). Keep unused containers in the protective pouch away from light. Discard containers immediately after use.