Introduction

Antibacterial; 8-methoxy fluoroquinolone.

Uses for Moxifloxacin (EENT)

Bacterial Ophthalmic Infections

Topical treatment of bacterial conjunctivitis caused by susceptible gram-positive bacteria, including Staphylococcus (S. aureus, S. arlettae, S. capitis, S. epidermidis, S. haemolyticus, S. hominis, S. saprophyticus, S. warneri ), Streptococcus (S. mitis, S. parasanguinis, S. pneumoniae, viridans streptococci ), Enterococcus faecalis, Aerococcus viridans, Corynebacterium (C. macginleyi), Micrococcus luteus, or Propionibacterium acnes.

Topical treatment of bacterial conjunctivitis caused by susceptible gram-negative bacteria, including Acinetobacter lwoffii, Escherichia coli, Haemophilus influenzae, H. parainfluenzae, or Klebsiella pneumoniae.

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 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.

Chlamydial Ophthalmic Infections

Has been used for topical treatment of conjunctivitis caused by Chlamydia trachomatis.

Systemic anti-infectives are recommended for treatment of conjunctivitis caused by C. trachomatis. Although topical anti-infectives have been used concomitantly, concomitant use of topical anti-infectives not considered necessary.

Moxifloxacin (EENT) Dosage and Administration

Administration

Ophthalmic Administration

Apply 0.5% ophthalmic solution topically to the eye.

For topical ophthalmic use only; do not inject subconjunctivally and do not introduce directly into anterior chamber of the eye.

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

Dosage

Available as moxifloxacin hydrochloride; dosage expressed in terms of moxifloxacin.

Pediatric Patients

Bacterial Ophthalmic Infections

Conjunctivitis

Moxeza 0.5% ophthalmic solution in pediatric patients ≥4 months of age: Instill 1 drop in the affected eye(s) 2 times daily for 7 days.

Vigamox 0.5% ophthalmic solution in pediatric patients ≥1 year of age: Instill 1 drop in the affected eye(s) 3 times daily for 7 days.

Chlamydial Ophthalmic Infections

Conjunctivitis

Moxeza 0.5% ophthalmic solution in pediatric patients ≥4 months of age: Instill 1 drop in the affected eye(s) 2 times daily for 7 days.

Vigamox 0.5% ophthalmic solution in pediatric patients ≥1 year of age: Instill 1 drop in the affected eye(s) 3 times daily for 7 days.

Adults

Bacterial Ophthalmic Infections

Conjunctivitis

Moxeza 0.5% ophthalmic solution: Instill 1 drop in the affected eye(s) 2 times daily for 7 days.

Vigamox 0.5% ophthalmic solution: Instill 1 drop in the affected eye(s) 3 times daily for 7 days.

Chlamydial Ophthalmic Infections

Conjunctivitis

Moxeza 0.5% ophthalmic solution: Instill 1 drop in the affected eye(s) 2 times daily for 7 days.

Vigamox 0.5% ophthalmic solution: Instill 1 drop in the affected eye(s) 3 times daily for 7 days.

Contraindications

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

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity

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

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

Serious acute hypersensitivity reactions may require immediate emergency treatment; administer oxygen and airway management as clinically indicated.

Superinfection

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

If superinfection occurs, discontinue moxifloxacin 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 moxifloxacin 0.5% ophthalmic solution in pregnant women; use only if potential benefits to the woman justify potential risks to fetus.

Lactation

Distribution into human milk following topical application to the eye not studied; presumed to be distributed into human milk.

Use with caution in nursing women.

Pediatric Use

Moxeza 0.5% ophthalmic solution: Safety and efficacy not established in pediatric patients <4 months of age.

Vigamox 0.5% ophthalmic solution: Safety and efficacy not established in pediatric patients <1 year of age.

Geriatric Use

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

Common Adverse Effects

Moxeza 0.5% ophthalmic solution: Eye irritation, pyrexia, conjunctivitis.

Vigamox 0.5% ophthalmic solution: Conjunctivitis, decreased visual acuity, ocular dryness, keratitis, ocular discomfort/pain/pruritus, ocular hyperemia, subconjunctival hemorrhage, tearing, fever, increased cough, infection, otitis media, pharyngitis, rash, rhinitis.

Administration

Ophthalmic Administration

Apply 0.5% ophthalmic solution topically to the eye.

For topical ophthalmic use only; do not inject subconjunctivally and do not introduce directly into anterior chamber of the eye.

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

Dosage

Available as moxifloxacin hydrochloride; dosage expressed in terms of moxifloxacin.

Pediatric Patients

Bacterial Ophthalmic Infections

Conjunctivitis

Moxeza 0.5% ophthalmic solution in pediatric patients ≥4 months of age: Instill 1 drop in the affected eye(s) 2 times daily for 7 days.

Vigamox 0.5% ophthalmic solution in pediatric patients ≥1 year of age: Instill 1 drop in the affected eye(s) 3 times daily for 7 days.

Chlamydial Ophthalmic Infections

Conjunctivitis

Moxeza 0.5% ophthalmic solution in pediatric patients ≥4 months of age: Instill 1 drop in the affected eye(s) 2 times daily for 7 days.

Vigamox 0.5% ophthalmic solution in pediatric patients ≥1 year of age: Instill 1 drop in the affected eye(s) 3 times daily for 7 days.

Adults

Bacterial Ophthalmic Infections

Conjunctivitis

Moxeza 0.5% ophthalmic solution: Instill 1 drop in the affected eye(s) 2 times daily for 7 days.

Vigamox 0.5% ophthalmic solution: Instill 1 drop in the affected eye(s) 3 times daily for 7 days.

Chlamydial Ophthalmic Infections

Conjunctivitis

Moxeza 0.5% ophthalmic solution: Instill 1 drop in the affected eye(s) 2 times daily for 7 days.

Vigamox 0.5% ophthalmic solution: Instill 1 drop in the affected eye(s) 3 times daily for 7 days.