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Acute otitis externa: Treatment of acute otitis externa (AOE) with or without an otowick, caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus in patients ≥1 year of age
There are no contraindications listed in the manufacturers labeling.
Acute otitis externa: Otic: Four drops into affected ear(s) twice daily for 7 days. Note: For use with an otowick, the first dose can be doubled (8 drops).
Refer to adult dosing.
Acute otitis externa: Children ≥1 year and Adolescents: Otic: Refer to adult dosing.
There are no dosage adjustments provided in the manufacturer 's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer 's labeling. However, dosage adjustment unlikely due to low systemic absorption.
For otic use only. Prior to use, warm suspension by holding container in hands for 1 to 2 minutes. Shake bottle well before each use. Patient should lie down with affected ear upward; maintain the position for 60 seconds after installation. Pump tragus 4 times to ensure penetration of medication. Repeat if necessary for the opposite ear.
Store at 2 ‚ °C to 25 ‚ °C (36 ‚ °F to 77 ‚ °F). Do not freeze.
There are no known significant interactions.
Concerns related to adverse effects:
- Hypersensitivity reactions: Allergic reactions may occur. Discontinue use if an allergic reaction occurs.
- Superinfection: Prolonged use may result in fungal or bacterial superinfection. If superinfection occurs, discontinue use and institute appropriate alternative therapy.
- Tendon inflammation/rupture: There have been reports of tendon inflammation and/or rupture with systemic quinolone antibiotics. Exposure following otic administration is substantially lower than with systemic therapy. Discontinue at first sign of tendon inflammation or pain.
Other warnings/precautions:
- Appropriate use: For otic use only. Instilling cold otic suspension may cause dizziness; prior to administration, warm container by holding in hands for 1 to 2 minutes.
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Adverse events were observed in animal reproduction studies following oral administration. Following otic administration, systemic absorption is low.
Finafloxacin is a DNA gyrase inhibitor, and also inhibits topoisomerase IV. DNA gyrase (topoisomerase II) is an essential bacterial enzyme that maintains the superhelical structure of DNA. DNA gyrase is required for DNA replication and transcription, DNA repair, recombination, and transposition.