Levofloxacin

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE 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) Dosage and administration 2 DOSAGE AND ADMINISTRATION Days 1 through 3: Instill one to two drops in the affected eye(s) every 30 minutes to 2 hours while awake and approximately 4 and 6 hours after retiring. Day 4 through treatment completion: Instill one to two drops in the affected eye(s) every 1 to 4 hours while awake. Days 1 through 3: Instill one to two drops in the affected eye(s) every 30 minutes to 2 hours while awake and approximately 4 and 6 hours after retiring. Day 4 through treatment completion: Instill one to two drops in the affected eye(s) every 1 to 4 hours while awake. (2) 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. Pregnancy 8.1 Pregnancy Pregnancy Category C Teratogenic Effects: Levofloxacin at oral doses of 810 mg/kg/day in rats caused decreased fetal body weight and increased fetal mortality. No teratogenic effect was observed when rabbits were dosed orally as high as 50 mg/kg/day, at which systemic exposure was estimated to be 250 times that observed at the maximum recommended human ophthalmic dose, or when dosed intravenously as high as 25 mg/kg/day, at which systemic exposure was estimated to be 120 times that observed at the maximum recommended human ophthalmic dose. There are, however, no adequate and well-controlled studies in pregnant women. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.