Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
Levofloxacin 5 mg/ml eye drops are indicated for the topical treatment of bacterial external ocular infections in patients ≥1 year of age caused by levofloxacin susceptible microorganisms (see also sections 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Levofloxacin is indicated in adults, children aged ≥1 to 12 years and adolescents aged 12 to 18 years.
For all patients instil one to two drops in the affected eye(s) every two hours up to 8 times per day while awake for the first two days and then four times daily on days 3 through 5.
If different topical ocular medications are used concomitantly, at least a 15-minute interval is required between instillations.
The duration of treatment depends on the severity of the disorder and on the clinical and bacteriological course of infection. The usual treatment duration is 5 days.
Safety and efficacy in the treatment of corneal ulcer and ophthalmia neonatorum has not been established.
No adjustment of dosage is required.
The posology is the same in adults and children aged ≥1 year.
The safety and efficacy of Levofloxacin in children aged ≥1 year have been established.
Levofloxacin is not recommended for use in children below age 1 year due to a lack of data on safety and efficacy.
The safety and efficacy of Levofloxacin in children aged <1 year have not yet been established.
No data are available.
Ocular use.
To prevent contaminating the dropper tip and solution, the dropper tip should not come into contact with the eyelids or surrounding areas.
The total amount of levofloxacin in a bottle of eye drops is too small to induce toxic effects after an accidental oral intake. If considered necessary, the patient can be observed clinically and supportive measures can be undertaken. After a local overdose with Levofloxacin 5 mg/ml eye drops, the eyes can be flushed with clean (tap) water at room temperature.
Actions to be taken in case of overdose are the same in adults and in children aged ≥1 year.
Unopened bottle: 3 years.
After first opening the bottle: 4 weeks.
Unopened bottle: This medicinal product does not require any special storage conditions.
Opened bottle: Do not store above 25°C. Keep bottle in the outer carton in order to protect from light.
White LDPE 5 ml bottle with a white LDPE dropper and a white high density polyethylene (HDPE)/LDPE tamper-evident seal cap.
Pack size: one bottle in a cardboard box.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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