- Antibacterial drugs
- OPHTHALMOLOGICAL DRUGS
- Pharmaceutical Form : Sterile Ophthalmic Suspension
- Composition : Each 1 ml contains: 5.12 mg of levofloxacin hemihydrate equivalent to 5 mg of levofloxacin
- Active Substance : Levofloxacin
LEVOFLOXACIN eye drops are indicated for the topical treatment of bacterial external ocular infections in patients ≥1 year of age caused by levofloxacin susceptible microorganisms.
This product is indicated in adults, children aged 1 year to 12 years and adolescents aged 12 to 18 years.
Commonly susceptible species:
Aerobic Gram-positive micro-organisms: Staphylococcus aureus (MSSA)*, Streptococcus pneumoniae, Streptococcus pneumoniae, Streptococcus pyogenes, Viridans group streptococci.
Aerobic Gram-negative micro-organisms: Escherichia coli, Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa
Other micro-organisms: Chlamydia trachomatis
Hypersensitivity to the active substance levofloxacin, to other quinolones or to any of the excipients, e.g. benzalkonium chloride.
WARNINGS AND PRECAUTIONS FOR USE:
LEVOFLOXACIN 5 mg/ml solution must not be injected sub-conjunctivally.
The solution should not be introduced directly into the anterior chamber of the eye.
Systemic fluoroquinolones have been associated with hypersensitivity reactions, even following a single dose. If an allergic reaction to levofloxacin occurs, discontinue the medication.
As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If worsening of infection occurs, or if a clinical improvement is not noted within a reasonable period, discontinue use and institute alternative therapy.
Patients with external bacterial ocular infections should not wear contact lenses.
LEVOFLOXACIN eye drops contain benzalkonium chloride, which may cause eye irritation.
The special warnings and precautions for use are the same in adults and children aged ≥1 year.
LEVOFLOXACIN eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
LEVOFLOXACIN5 mg/ml eye drops should be used during lactation only if the potential benefit justifies any potential risk to the nursing child.
Effects on ability to drive and use machines:
LEVOFLOXACIN has minor influence on the ability to drive and use machines.
If there are any transient effects on vision, the patient should be advised to wait until this clear before driving or operating machinery.
Approximately 10% of patients can be expected to experience adverse reactions. The reactions are usually graded as mild or moderate, are transient, and are generally restricted to the eye.
Immune system disorders:
Rare: Extra-ocular allergic reactions, including skin rash.
Very rare: Anaphylaxis.
Nervous system disorders:
Common: Ocular burning decreased vision and mucous strand.
Uncommon: Lid matting, chemosis, conjunctival papillary reaction, lid oedema, ocular discomfort, ocular itching, ocular pain, conjunctival injection, conjunctival follicles, ocular dryness, lid erythema, and photophobia.
Respiratory, thoracic and mediastinal disorders:
Very rare: Laryngeal oedema.
For all patients instill 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.
To prevent contaminating the dropper tip and 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 disorder and on the clinical and bacteriological course of infection. The usual treatment duration is 5 days.
LEVOFLOXACIN is not recommended for use in children below age 1 year due to a lack of data on safety and efficacy.
STORAGE CONDITIONS: Store at (15-25) ˚c
PACKAGING: 5 mL