finafloxacin 3 MG/ML Otic Suspension

INDICATIONS AND USAGE XTORO® is indicated for the treatment of acute otitis externa (AOE) with or without an otowick, caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus in patients age 1 year and older. XTORO® is a quinolone antimicrobial indicated for the treatment of acute otitis externa (AOE) caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus . ( 1 )

DOSAGE AND ADMINISTRATION Instill four drops into the affected ear(s) twice daily for seven days. For patients requiring use of an otowick, the initial dose can be doubled (to 8 drops), followed by 4 drops instilled into the affected ear twice daily for seven days. Important administration instructions include: Warm the suspension by holding the bottle in the hand for one or two minutes prior to dosing in order to avoid dizziness which may result from the instillation of a cold suspension. Shake bottle well before use. Lie with the affected ear upward, instill the drops, and maintain the position for 60 seconds to facilitate penetration of the drops into the ear canal. Repeat if necessary for the opposite ear. Instill four drops in the affected ear(s) twice daily for seven days. For patients requiring use of an otowick, the initial dose can be doubled (to 8 drops), followed by 4 drops instilled into the affected ear twice daily for seven days. ( 2 )

WARNINGS AND PRECAUTIONS Prolonged use of this product may lead to overgrowth of nonsusceptible organisms. Discontinue use if this occurs. ( 5.1 ) Allergic reactions may occur in patients with a history of hypersensitivity to finafloxacin, to other quinolones, or to any of the components in this medication. Discontinue use if this occurs. ( 5.2 ) 5.1 Growth of Resistant Organisms with Prolonged Use As with other antibacterial preparations, prolonged use of XTORO may lead to overgrowth of nonsusceptible organisms, including yeast and fungi. If this occurs, discontinue use and institute alternative therapy. 5.2 Allergic Reactions Allergic reactions to XTORO may occur in patients with a history of hypersensitivity to finafloxacin, to other quinolones, or to any of the components in this medication. If this occurs, discontinue use and institute alternative therapy. 5.1 Growth of Resistant Organisms with Prolonged Use As with other antibacterial preparations, prolonged use of XTORO may lead to overgrowth of nonsusceptible organisms, including yeast and fungi. If this occurs, discontinue use and institute alternative therapy. 5.2 Allergic Reactions Allergic reactions to XTORO may occur in patients with a history of hypersensitivity to finafloxacin, to other quinolones, or to any of the components in this medication. If this occurs, discontinue use and institute alternative therapy.

CONTRAINDICATIONS None. None. ( 4 )

Mechanism of Action Finafloxacin is a fluoroquinolone antimicrobial [see Microbiology ( 12.4 )] .