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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity and anaphylaxis have been reported with systemic use of levofloxacin. (5.1) Prolonged use may result in the overgrowth of non- susceptible organisms, including fungi. (5.2) Patients should not wear contact lenses if they have signs or symptoms of corneal ulcer. (5.3) 5.1 Hypersensitivity Reactions In patients receiving systemically administered quinolones, including levofloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema, (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria and itching. If an allergic reaction to levofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated. 5.2 Growth of Resistant Organisms with Prolonged Use As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and where appropriate, fluorescein staining. 5.3 Avoidance of Contact Lens Wear Patients should be advised not to wear contact lenses if they have signs and symptoms of corneal ulcer.
6 ADVERSE REACTIONS The most frequently reported adverse reactions in the overall study population were headache and a taste disturbance following instillation. These reactions occurred in approximately 8 to 10% of patients. Adverse reactions occurring in approximately 1 to 2% of patients included decreased/blurred vision, diarrhea, dyspepsia, fever, infection, instillation site irritation/discomfort, ocular infection, nausea, ocular pain/discomfort, and throat irritation. Other reported ocular reactions occurring in less than 1% of patients included chemosis, corneal erosion, diplopia, floaters, hyperemia, lid edema, and lid erythema. The most frequently reported adverse reactions in the overall study population were headache and a taste disturbance following instillation. These reactions occurred in approximately 8 to 10% of patients. (6) To report SUSPECTED ADVERSE REACTIONS,contact BPI Labs LLC at (727)471-0850 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.