Introduction

Antibacterial; 8-methoxy fluoroquinolone.

Uses for Gatifloxacin (EENT)

Bacterial Ophthalmic Infections

Topical treatment of bacterial conjunctivitis caused by susceptible Staphylococcus aureus, S. epidermidis, Streptococcus mitis group, S. oralis, S. pneumoniae, or Haemophilus influenzae.

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.

Gatifloxacin (EENT) Dosage and Administration

Administration

Ophthalmic Administration

Apply 0.5% ophthalmic solution topically to the eye.

For topical ophthalmic use only; do not inject directly into anterior chamber of the eye. (See Administration Precautions under Cautions.)

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

Dosage

Pediatric Patients

Bacterial Ophthalmic Infections

Conjunctivitis

Children ≥1 year of age: Instill 1 drop of 0.5% solution in the affected eye(s) every 2 hours while awake (up to 8 times daily) on day 1, then 1 drop 2–4 times daily while awake on days 2 through 7.

Adults

Bacterial Ophthalmic Infections

Conjunctivitis

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

Contraindications

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

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity

Hypersensitivity reactions, including anaphylactic reactions, angioedema (e.g., pharyngeal, laryngeal, or facial edema), dyspnea, urticaria, and itching, reported in patients receiving gatifloxacin ophthalmic solution. Stevens-Johnson syndrome reported rarely.

Hypersensitivity reactions have occurred following a single dose.

Immediately discontinue at first sign of rash or hypersensitivity reaction.

Administration Precautions

For topical ophthalmic use only.

Corneal endothelial cell injury may occur if gatifloxacin ophthalmic solution is introduced directly into anterior chamber of the eye.

Superinfection

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

If superinfection occurs, discontinue gatifloxacin 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 during treatment with gatifloxacin ophthalmic solution or if any signs or symptoms of bacterial conjunctivitis are present.

Specific Populations

Pregnancy

Data not available regarding use of gatifloxacin 0.5% ophthalmic solution in pregnant women.

Lactation

Distributed into milk in rats after oral administration; not known whether distributed into human milk following topical application to the eye.

Consider benefits of breast-feeding and importance of the drug to the woman; also consider potential adverse effects on the breast-fed child from the drug or underlying maternal condition.

Pediatric Use

Safety and efficacy not established in children <1 year of age.

Geriatric Use

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

Common Adverse Effects

Worsening of conjunctivitis, eye irritation, dysgeusia, eye pain.

Administration

Ophthalmic Administration

Apply 0.5% ophthalmic solution topically to the eye.

For topical ophthalmic use only; do not inject directly into anterior chamber of the eye. (See Administration Precautions under Cautions.)

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

Dosage

Pediatric Patients

Bacterial Ophthalmic Infections

Conjunctivitis

Children ≥1 year of age: Instill 1 drop of 0.5% solution in the affected eye(s) every 2 hours while awake (up to 8 times daily) on day 1, then 1 drop 2–4 times daily while awake on days 2 through 7.

Adults

Bacterial Ophthalmic Infections

Conjunctivitis

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