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warnings and cautions
5 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.
warnings and cautions
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.
warnings and cautions
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.
6 ADVERSE REACTIONS The most common adverse reactions occurring in 1% of patients with XTORO were ear pruritus and nausea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fonseca Biosciences, LLC at 1-877-436-6732 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 618 patients were treated with XTORO in two Phase 3 clinical trials. The most frequently reported adverse reactions of those exposed to XTORO occurring at an incidence of 1% included ear pruritus and nausea.