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warnings and cautions
5 WARNINGS AND PRECAUTIONS Not for Injection into the Eye ( 5.1 ) Growth of Resistant Organisms with Prolonged Use ( 5.2 ) Avoidance of Contact Lenses: Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with besifloxacin ophthalmic suspension. ( 5.3 ) 5.1 Not for Injection into the Eye 5.2 Growth of Resistant Organisms with Prolonged Use As with other anti-infectives, prolonged use of besifloxacin ophthalmic suspension 0.6% may result in overgrowth of non-susceptible organisms, including fungi. If super-infection 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 Lenses Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with besifloxacin ophthalmic suspension.
6 ADVERSE REACTIONS 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 clinical practice. The data described below reflect exposure to besifloxacin ophthalmic suspension in approximately 1,000 patients between 1 and 98 years old with clinical signs and symptoms of bacterial conjunctivitis. The most frequently reported ocular adverse reaction was conjunctival redness, reported in approximately 2% of patients. Other adverse reactions reported in patients receiving besifloxacin ophthalmic suspension occurring in approximately 1-2% of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache. The most common adverse reaction reported in 2% of patients treated with besifloxacin ophthalmic suspension was conjunctival redness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.