Levofloxacin

Levofloxacin ophthalmic solution is indicated for the treatment of corneal ulcer caused by susceptible strains of the following bacteria: Gram-positive bacteria: Corynebacterium species Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumonia Viridans group streptococci* Gram-negative bacteria: Pseudomonas aeruginosa Serratia marcescens* * Efficacy for this organism was studied in fewer than 10 infections Levofloxacin ophthalmic solution is a topical quinolone anti-microbial indicated for the treatment of corneal ulcer caused by susceptible strains of the following bacteria: Corynebacterium species * Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumonia Viridans group streptococci* Pseudomonas aeruginosa Serratia marcescens* *Efficacy for this organism was studied in fewer than 10 infections.

(1)

Levofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components in this medication. Levofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components in this medication. (4)

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)

5.1Hypersensitivity 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.