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Author: Admin | 2025-04-28
Ciprodex is approved for the treatment of ear infections, acute otitis media, and acute otitis externa.The FDA approved ciprofloxacin 0.3% and dexamethasone 0.1% sterile otic suspension (Ciprodex) in 2003 for the treatment of ear infections, acute otitis media, and acute otitis externa.1 The product combines ciprofloxacin, a fluoroquinolone antibiotic, with dexamethasone, an anti-inflammatory corticosteroid. Generic products became available as of 2020.2Ciprofloxacin/dexamethasone is indicated to treat acute otitis media caused by Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa in pediatric patients age 6 months and older with tympanostomy tubes.1 Health care providers most commonly prescribe antibacterial agents for children with otitis media, or middle ear infections, in the United States.3Providers may insert tympanostomy tubes in the eardrum to allow fluid drainage within the inner ear of patients with recurrent ear infections.4 Ciprofloxacin/dexamethasone is also indicated to treat acute otitis externa caused by the most common pathogens, Staphylococcus aureus and Pseudomonas aeruginosa in adult and pediatric patients 6 months of age and older.1,5Otitis externa, also known as swimmer’s ear, is an outer ear canal infection.5Clinical Studies1When researchers compared treatments of acute otitis media with tympanostomy tubes in a clinical trial, ciprofloxacin/dexamethasone administered 2 times daily for 7 days clinically cured 86% of patients compared to 79% for ofloxacin 0.3% solution administered 2 times daily for 10 days. For patients with positive cultures, ciprofloxacin/dexamethasone had a 90% cure rate compared to 79% for ofloxacin.Microbiological eradication rates were 91% for ciprofloxacin/dexamethasone compared to 82% for ofloxacin.Researchers conducted 2 clinical trials for acute otitis externa. Ciprofloxacin/dexamethasone administered twice daily for 7 days clinically cured 87% and 94% of patients compared to 84% and 89% of patients treated with neomycin 0.35%, polymyxin B 10,000 units/mL, and hydrocortisone 1.0% (neo/poly/HC) otic suspension.For patients with positive cultures, ciprofloxacin/dexamethasone had 86% and 92% cure rates, respectively, compared to 84% and 89%, respectively, for neo/poly/HC. Microbiological eradication rates were 85% and 92%, respectively, for ciprofloxacin/dexamethasone compared to 85% and 85%, respectively, for neo/poly/HC.Mechanism of Action1Ciprofloxacin is a fluoroquinolone antibacterial agent. Ciprofloxacin works as a bactericide by interfering with DNA gyrase, an enzyme essential for the synthesis of bacterial DNA.Dexamethasone, a corticosteroid, suppresses inflammation that often accompanies bacterial infection. Dexamethasone inhibits multiple inflammatory cytokines resulting in decreased edema, redness, and pruritus.Dosage and Administration1Pharmacists should counsel patients to shake the bottle well immediately before use. Patients can warm the suspension by holding the bottle in the hands for
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