Besifloxacin

General

Pronunciation
(be si FLOX a sin)

Trade Name(s)

• Besifloxacin Hydrochloride
• BOL-303224-A
• SS734

• Antibiotic, Ophthalmic
• Antibiotic, Quinolone

Indications

Use: Labeled Indications
Treatment of bacterial conjunctivitis

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosing and Administration

Ophthalmic: Children ≥1 year and Adults: Bacterial conjunctivitis: Instill 1 drop into affected eye(s) 3 times/day (4-12 hours apart) for 7 days

General Administration
Ophthalmic: Wash hands before and after instillation. Shake bottle once prior to each administration. Avoid contaminating the applicator tip with affected eye(s).

Storage
Store between 15°C to 25°C (59°F to 77°F). Protect from light.

Dosage Forms/Strengths

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, ophthalmic [drops]:

Besivance™: 0.6% (5 mL) [contains benzalkonium chloride]

Interactions

There are no known significant interactions.

Adverse Reactions

1% to 2%:

Central nervous system: Headache

Ocular: Conjunctival redness (2%), blurred vision, irritation, pain, pruritus

Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, have occurred with systemic quinolone therapy. The spectrum of these reactions can vary widely; reactions may present as typical allergic symptoms (eg, itching, urticaria, rash, edema) after a single dose, or may manifest as severe idiosyncratic dermatologic (eg, Stevens-Johnson, toxic epidermal necrolysis), vascular (eg, vasculitis), pulmonary (eg, pneumonitis), renal (eg, nephritis), hepatic (eg, hepatic failure or necrosis), and/or hematologic (eg, anemia, cytopenias) events, usually after multiple doses. Prompt discontinuation of drug should occur if skin rash or other symptoms arise.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection. Discontinue use and initiate alternative therapy if superinfection occurs.

Special populations:

• Contact lens wearers: Contact lenses should not be worn during treatment of ophthalmic infections.

Dosage form specific issues:

• Ophthalmic solution: Do not inject ophthalmic solution subconjunctivally or introduce directly into the anterior chamber of the eye.

Pregnancy Risk Factor
C

Pregnancy Considerations
Oral besifloxacin has been shown to be fetotoxic in animal studies at doses that were also maternally toxic. Quinolone exposure during human pregnancy has been reported with other agents (refer to Ciprofloxacin, Ofloxacin, and Norfloxacin monographs). The low plasma concentrations of besifloxacin following ophthalmic use (<1.3 ng/mL in nonpregnant patients) should limit fetal exposure.

Lactation
Excretion in breast milk unknown/use caution

Patient and Family Education

Do not wear contact lenses while using this medication. Wash hands before applying; invert bottle and shake once before use. Remove cap and tilt head back; squeeze bottle gently and instill one drop into the affected eye(s). Avoid contaminating the tip; do not touch the tip with fingers or touch the tip to eye. You may experience eye redness or blurred vision. Discontinue immediately and contact prescriber if you experience a rash, pain, or allergic reaction.