Besifloxacin

INDICATIONS AND USAGE BESIVANCE ® (besifloxacin ophthalmic suspension) 0.6% is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: Aerococcus viridans* CDC coryneform group G Corynebacterium pseudodiphtheriticum* Corynebacterium striatum* Haemophilus influenzae Moraxella catarrhalis* Moraxella lacunata* Pseudomonas aeruginosa* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus hominis* Staphylococcus lugdunensis* Staphylococcus warneri* Streptococcus mitis group Streptococcus oralis Streptococcus pneumoniae Streptococcus salivarius* *Efficacy for this organism was studied in fewer than 10 infections. BESIVANCE ® (besifloxacin ophthalmic suspension) 0.6% is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: Aerococcus viridans *, CDC coryneform group G, Corynebacterium pseudodiphtheriticum*, Corynebacterium striatum*, Haemophilus influenzae, Moraxella catarrhalis*, Moraxella lacunata*, Pseudomonas aeruginosa*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis*, Staphylococcus lugdunensis*, Staphylococcus warneri*, Streptococcus mitis group , Streptococcus oralis, Streptococcus pneumoniae, Streptococcus salivarius* *Efficacy for this organism was studied in fewer than 10 infections. ( 1 )

DOSAGE AND ADMINISTRATION Invert closed bottle and shake once before use. Instill one drop in the affected eye(s) 3 times a day, 4 to 12 hours apart for 7 days. Instill one drop in the affected eye(s) 3 times a day, 4 to 12 hours apart for 7 days. ( 2 )

WARNINGS AND PRECAUTIONS Not for Injection into the Eye ( Error! Hyperlink reference not valid. ) Growth of Resistant Organisms with Prolonged Use ( Error! Hyperlink reference not valid. ) 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 BESIVANCE. ( 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 BESIVANCE (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 BESIVANCE.

CONTRAINDICATIONS None. None. ( 4 )

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 BESIVANCE 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 BESIVANCE 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 BESIVANCE 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 .

Mechanism of Action Besifloxacin is a fluoroquinolone antibacterial [see Microbiology (12.4) ] .