Introduction

Antibacterial; fluoroquinolone; levorotatory isomer of ofloxacin.

Uses for levoFLOXacin (EENT)

Bacterial Ophthalmic Infections

Topical treatment of bacterial conjunctivitis caused by susceptible Staphylococcus aureus, S. epidermidis, Streptococcus pneumoniae, groups C, F, and G streptococci, viridans streptococci, Corynebacterium, Acinetobacter lwoffii, Haemophilus influenzae, or Serratia marcescens.

Many cases of mild, acute bacterial conjunctivitis resolve spontaneously without anti-infective therapy. Although topical ophthalmic anti-infectives may shorten time to resolution and reduce severity and risk of complications, avoid indiscriminate use of topical anti-infectives.

Treatment of acute bacterial conjunctivitis generally is empiric; use of a broad-spectrum topical ophthalmic antibacterial usually recommended. In vitro staining and/or cultures of conjunctival material may be indicated in diagnosis and management of recurrent, severe, or chronic purulent conjunctivitis or when acute conjunctivitis does not respond to initial empiric topical treatment.

levoFLOXacin (EENT) Dosage and Administration

Administration

Ophthalmic Administration

Apply 0.5% ophthalmic solution topically to the eye.

For topical ophthalmic use only.

Avoid contaminating applicator tip with material from eye, fingers, or other source.

Dosage

Pediatric Patients

Bacterial Ophthalmic Infections

Conjunctivitis

Children ≥6 years of age: Instill 1–2 drops of 0.5% solution in affected eye(s) every 2 hours while awake (up to 8 times daily) on days 1 and 2, then 1–2 drops every 4 hours while awake (up to 4 times daily) on days 3 through 7.

Adults

Bacterial Ophthalmic Infections

Conjunctivitis

Instill 1–2 drops of 0.5% solution in affected eye(s) every 2 hours while awake (up to 8 times daily) on days 1 and 2, then 1–2 drops every 4 hours while awake (up to 4 times daily) on days 3 through 7.

Contraindications

• Hypersensitivity to levofloxacin, other quinolones, or any ingredient in the formulation.

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions reported with systemic fluoroquinolones, including systemic levofloxacin; these reactions may occur with first dose. Some hypersensitivity reactions reported with systemic fluoroquinolones have been accompanied by cardiovascular collapse, hypotension or shock, seizures, loss of consciousness, angioedema (e.g., laryngeal, pharyngeal, facial), airway obstruction, dyspnea, urticaria, and itching.

Immediately discontinue levofloxacin ophthalmic solution at first sign of rash or hypersensitivity reaction.

Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.

If superinfection occurs, discontinue levofloxacin ophthalmic solution and institute appropriate therapy.

Patient Monitoring

Whenever clinical judgment dictates, examine patient with the aid of magnification (e.g., slit lamp biomicroscopy) and, if appropriate, fluorescein staining.

Contact Lenses

Do not wear contact lenses if any signs or symptoms of bacterial conjunctivitis are present.

Specific Populations

Pregnancy

Category C.

Data not available regarding use of levofloxacin 0.5% ophthalmic solution in pregnant women; use only if potential benefits to the woman justify potential risks to fetus.

Lactation

Since ofloxacin is distributed into human milk, levofloxacin (levorotatory isomer of ofloxacin) is presumed to be distributed into human milk.

Use with caution in nursing women.

Pediatric Use

Safety and efficacy not established in children <6 years of age.

Geriatric Use

No overall differences in safety and efficacy relative to younger adults.

Common Adverse Effects

Transient decrease in vision, transient ocular burning, ocular pain or discomfort, foreign body sensation, photophobia, headache, fever, pharyngitis.

Administration

Ophthalmic Administration

Apply 0.5% ophthalmic solution topically to the eye.

For topical ophthalmic use only.

Avoid contaminating applicator tip with material from eye, fingers, or other source.

Dosage

Pediatric Patients

Bacterial Ophthalmic Infections

Conjunctivitis

Children ≥6 years of age: Instill 1–2 drops of 0.5% solution in affected eye(s) every 2 hours while awake (up to 8 times daily) on days 1 and 2, then 1–2 drops every 4 hours while awake (up to 4 times daily) on days 3 through 7.

Adults

Bacterial Ophthalmic Infections

Conjunctivitis

Instill 1–2 drops of 0.5% solution in affected eye(s) every 2 hours while awake (up to 8 times daily) on days 1 and 2, then 1–2 drops every 4 hours while awake (up to 4 times daily) on days 3 through 7.