Besifloxacin Hydrochloride

Antibacterial; 8-chloro fluoroquinolone.1

Bacterial Ophthalmic Infections

Topical treatment of conjunctivitis caused by Aerococcus viridans, CDC coryneform group G, Corynebacterium pseudodiphtheriticum, C. striatum, Haemophilus influenzae, Moraxella catarrhalis, M. lacunata, Pseudomonas aeruginosa, Staphylococcus aureus, S. epidermidis, S. hominis, S. lugdunensis, S. warneri, Streptococcus mitis group, S. oralis, S. pneumoniae, or S. salivarius.1 2 3 5

Many cases of mild, acute bacterial conjunctivitis resolve spontaneously without anti-infective therapy.6 17 18 19 Although topical ophthalmic anti-infectives may shorten time to resolution and reduce severity and risk of complications,6 17 18 19 avoid indiscriminate use of topical anti-infectives.6 17

Treatment of acute bacterial conjunctivitis generally is empiric;6 17 18 use of a broad-spectrum topical ophthalmic antibacterial usually recommended.6 17 18 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.6 17 18

Contraindications

• Manufacturer states none known.1

Warnings/Precautions

Sensitivity Reactions

Although besifloxacin is not used systemically, consider that hypersensitivity reactions have been reported with systemic quinolones, even following a single dose.1

Immediately discontinue at first sign of rash or hypersensitivity reaction.1

Administration Precautions

For topical ophthalmic use only;1 not for injection into the eye.1

Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms (e.g., fungi).1

If superinfection occurs, discontinue besifloxacin ophthalmic suspension and institute appropriate therapy.1

Patient Monitoring

Whenever clinical judgment dictates, examine patient with the aid of magnification (e.g., slit lamp biomicroscopy) and, if appropriate, fluorescein staining.1 2

Contact Lenses

Do not wear contact lenses during treatment with besifloxacin ophthalmic suspension or if any signs or symptoms of bacterial conjunctivitis are present.1

Specific Populations

Category C.1

Data not available regarding use of besifloxacin 0.6% ophthalmic suspension in pregnant women.1

Although not measured in human milk, presumed to be distributed into human milk.1

Use with caution in nursing women.1

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

No overall differences in safety and efficacy relative to younger adults.1

Common Adverse Effects

Conjunctival redness.1

No formal drug interaction studies using besifloxacin 0.6% ophthalmic suspension.1

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.