Levofloxacin eye drops are indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerobic Gram-positive bacteria: Corynebacterium species, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus groups C and F, Streptococcus group G, and viridans group streptococci.

Aerobic Gram-negative bacteria: Acinetobacter lwoffii, Haemophilus influenzae, and Serratia marcescens. 

Levofloxacin eye drops may also be beneficial in the treatment of other ocular infections, including bacterial corneal ulcer, blepharitis, hordeolum, and perioperative ocular conditions. Levofloxacin ear drops are indicated for the treatment of otitis externa and otitis media caused by susceptible strains of the following bacteria: Staphylococcus, Streptococcus, Pneumococcus, Moraxella (Branhamella) catarrhalis, Klebsiella pneumoniae, Enterobacter, Serratia, Haemophilus influenzae, Pseudomonas aeruginosa, and Acinetobacter.

Levofloxacin eye drops are a sterile topical ophthalmic solution. Levofloxacin is a synthetic, broad-spectrum, third-generation fluoroquinolone antibiotic with bactericidal activity against a wide range of Gram-positive and Gram-negative ocular pathogens. It exerts its antibacterial effect by inhibiting bacterial topoisomerase IV and DNA gyrase, enzymes essential for DNA replication, transcription, repair, and recombination.

0.5% Eye Drops: Adults and children aged 1 year and older:

• Days 1 and 2: Instill 1–2 drops into the affected eye(s) every 2 hours while awake, up to 8 times daily.
• Days 3 to 7: Instill 1–2 drops into the affected eye(s) every 4 hours while awake, up to 4 times daily.

1.5% Eye Drops: Adults and children aged 6 years and older:

• Days 1 to 3: Instill 1–2 drops into the affected eye(s) every 30 minutes to 2 hours while awake, and approximately 4 and 6 hours after bedtime.
• Day 4 until completion of treatment: Instill 1–2 drops into the affected eye(s) every 1 to 4 hours while awake.

1.5% Ear Drops: The usual dose is 6–10 drops into the affected ear twice daily. After administration, the patient should keep the ear filled with the solution for about 10 minutes. The dosage frequency may be adjusted according to the severity of symptoms and clinical response.

Children below 1 year of age: The safety and effectiveness of levofloxacin in children under 1 year of age have not been established.

Specific drug interaction studies have not been conducted with levofloxacin eye drops. However, systemic administration of certain quinolones has been reported to increase plasma concentrations of theophylline, interfere with the metabolism of caffeine, and potentiate the effects of oral anticoagulants such as warfarin and its derivatives.

Levofloxacin is contraindicated in patients with known hypersensitivity to levofloxacin, other quinolones, or any component of this formulation.

Side effects have been reported in approximately 1–3% of patients. These may include transient blurred vision, fever, foreign body sensation, headache, temporary ocular burning, ocular pain or discomfort, pharyngitis, and photophobia. In less than 1% of patients, allergic reactions, eyelid edema, ocular dryness, and ocular itching have been reported.

Pregnancy Category C. Levofloxacin should be used during pregnancy only when the potential benefit justifies the potential risk to the fetus. It is not known whether levofloxacin is excreted in human milk. Therefore, caution should be exercised when levofloxacin eye drops are administered to a nursing mother.

Prolonged use may lead to the overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, treatment should be discontinued and appropriate alternative therapy should be initiated.

4-Quinolone preparation.

Protect the eye drops from light. Store in a cool, dry place at a temperature below 25°C. Keep out of the reach of children.