ciprofloxacin hydrochloride + fluocinolone acetonide: clinical use

Prescribing considerations

• Confirm acute otitis externa or acute otitis media with a tympanostomy tube and that bacterial infection is likely.
• Consider local susceptibility and antimicrobial stewardship principles.
• Use below 6 months only exceptionally after individual benefit–risk assessment because clinical experience is insufficient.
• Reassess persistent symptoms. Persistent or recurrent otorrhoea warrants evaluation for an underlying condition.
• Stop at the first sign of hypersensitivity. Consider superinfection if symptoms worsen or fungal or bacterial features develop.

Contraindications and cautions

• Hypersensitivity to ciprofloxacin, another quinolone, fluocinolone acetonide or an excipient.
• Viral external-ear infection, including varicella or herpes simplex.
• Fungal ear infection.

Monitoring

• Clinical response and persistent or recurrent otorrhoea.
• Hypersensitivity or overgrowth of non-susceptible bacteria, yeasts or fungi.
• Blurred vision or other visual disturbance; consider ophthalmological assessment.

Clinical pharmacology

Ciprofloxacin is bactericidal through inhibition of bacterial DNA gyrase and topoisomerase IV. Fluocinolone acetonide has anti-inflammatory, antipruritic and vasoconstrictive effects. Plasma concentrations after ear administration were absent or negligible.

Formulation and product differences

• The product is a clear aqueous ear-drop solution in single-dose LDPE containers.
• Containers are held in a light-protective foil pouch and should be used immediately after opening.

Ear drops

Route: Otic

Strengths: 3 mg/mL + 0.25 mg/mL