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Initial U.S. Approval: 2009 DESCRIPTION
Besivance™ (besifloxacin ophthalmic suspension) 0.6%, is a sterile
ophthalmic suspension of besifloxacin formulated with DuraSite®* (polycarbophil,
edetate disodium dihydrate and sodium chloride). Each mL of Besivance™
contains 6.63 mg besifloxacin hydrochloride equivalent to 6 mg
besifloxacin base. It is an 8-chloro fluoroquinolone anti-infective for
topical ophthalmic use.
Besifloxacin hydrochloride is a white to pale yellowish-white powder.
Each mL Contains:
Active: besifloxacin 0.6% (6 mg/mL);
Preservative: benzalkonium chloride 0.01%
Inactives: polycarbophil, mannitol, poloxamer 407, sodium chloride,
edetate disodium dihydrate, sodium hydroxide and water for injection.
Besivance™ is an isotonic suspension with an osmolality of approximately
Mechanism of Action
Besifloxacin is a fluoroquinolone antibacterial.
Besifloxacin is an 8-chloro fluoroquinolone with a N-1 cyclopropyl
group. The compound has activity against Gram-positive and Gram-negative
bacteria due to the inhibition of both bacterial DNA gyrase and
topoisomerase IV. DNA gyrase is an essential enzyme required for
replication, transcription and repair of bacterial DNA. Topoisomerase IV
is an essential enzyme required for partitioning of the chromosomal DNA
during bacterial cell division. Besifloxacin is bactericidal with
minimum bactericidal concentrations (MBCs) generally within one dilution
of the minimum inhibitory concentrations (MICs).
The mechanism of action of fluoroquinolones, including besifloxacin, is
different from that of aminoglycoside, macrolide, and
antibiotics. Therefore, besifloxacin may be active against pathogens
that are resistant to these antibiotics and these antibiotics may be
active against pathogens that are resistant to besifloxacin. In vitro
studies demonstrated crossresistance between besifloxacin and some
In vitro resistance to besifloxacin develops via multiple-step mutations
and occurs at a general frequency of < 3.3 x 10-10 for Staphylococcus
aureus and < 7 x 10-10 for Streptococcus pneumoniae.
Besifloxacin has been shown to be active against most isolates of the
following bacteria both in vitro and in conjunctival infections treated
in clinical trials as described in the INDICATIONS AND USAGE section:
CDC coryneform group G
Streptococcus mitis group
*Efficacy for this organism was studied in fewer than 10 infections.
INDICATIONS AND USAGE
Besivance™ (besifloxacin ophthalmic suspension) 0.6%, is a
quinolone antimicrobial indicated for the treatment of bacterial
conjunctivitis caused by susceptible isolates of the following
7.5 mL size bottle filled with 5 mL of besifloxacin ophthalmic
HOW SUPPLIED/STORAGE AND HANDLING
Besivance™ (besifloxacin ophthalmic suspension) 0.6%, is
supplied as a sterile ophthalmic suspension in a white low
density polyethylene (LDPE) bottle with a controlled dropper tip
and tan polypropylene cap. Tamper evidence is provided with a
shrink band around the cap and neck area of the package.
5 mL in 7.5 mL bottle
Storage: Store at 15°- 25°C (59° - 77°F). Protect from Light.
Invert closed bottle and shake once before use.