Properties
What is it?
Levofloxacin Composition Each 5 ml contains 25 mg USP Levofloxacin. Therapeutic Indications Levofloxacin 5 mg/ml eye drops are indicated for the local treatment of bacterial eye infections in patients aged ≥1 year caused by microorganisms susceptible to levofloxacin (see sections 4.4 and 5.1). Levofloxacin 5 mg/ml is indicated in adults, children aged ≥1 to 12 years, and adolescents aged 12 to 18 years. Official instructions for the appropriate use of antibacterial agents should be taken into account. Dosage For the patient, while awake, instill one to two drops into the affected eye(s) every two hours, 8 times a day, for the first two days, then four times a day, for 3 to 5 days. If other topical ophthalmic medications are used, an interval of at least 15 minutes must be observed between instillations. To avoid contamination of the dropper tip and the solution, the dropper tip should not come into contact with the eyelids or surrounding areas. The duration of treatment depends on the severity of the disease and the clinical and bacteriological course of the infection. Usually, the duration of treatment is 5 days. Safety and efficacy for the treatment of corneal ulcers and neonatal ophthalmia have not been established. Levofloxacin 5 mg/ml is not recommended for use in children under 1 year of age due to lack of safety and efficacy data. Pediatric Population Dosage is the same in adults and children ≥1 year of age. The safety and efficacy of Levofloxacin 5 mg/ml have been established in children aged ≥1 year. The safety and efficacy of Levofloxacin 5 mg/ml in children under 1 year of age have not yet been established. Data are not available. Use in the Elderly No dose adjustment is required. Method of Administration For ocular use. Special Precautions for Storage: Store below 30°C. Protect from light and moisture. Keep all medicines out of reach of children. After first opening the bottle: use within 28 days and store at 2-8°C.
