| Initial U.S. Approval: 2009
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:
Preservative: benzalkonium chloride 0.01%
Besivance™ is an isotonic suspension with an osmolality of approximately 290 mOsm/kg.
| CLINICAL PHARMACOLOGY
Mechanism of Action
The mechanism of action of fluoroquinolones, including besifloxacin, is different from that of aminoglycoside, macrolide, and β-lactam 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 fluoroquinolones.
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
| 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 bacteria:
CDC coryneform group G
Corynebacterium pseudodiphtheriticum*, Corynebacterium striatum*, Haemophilus influenzae, Moraxella lacunata*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis*, Staphylococcus lugdunensis*, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, Streptococcus salivarius*
*Efficacy for this organism was studied in fewer than 10 infections.
| WARNINGS AND PRECAUTIONS
Topical Ophthalmic Use Only.
Growth of Resistant Organisms with Prolonged Use.
Avoidance of Contact Lenses. Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with Besivance™
|The most common adverse event reported in 2% of patients treated with Besivance™ was conjunctival redness.|
|Instill one drop in the affected eye(s) 3 times a day, four to twelve hours apart for 7 days.|
| 7.5 mL size bottle filled with 5 mL of besifloxacin ophthalmic suspension, 0.6%
HOW SUPPLIED/STORAGE AND HANDLING
5 mL in 7.5 mL bottle
Storage: Store at 15°- 25°C (59° - 77°F). Protect from Light.
| Package Insert data:
Manufactured by: Bausch & Lomb Incorporated
Tampa, Florida 33637
©Bausch & Lomb Incorporated
U.S. Patent No. 6,685,958
Besivance™ is a trademark of Bausch & Lomb Incorporated
*DuraSite is a trademark of InSite Vision Incorporated
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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