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(description)

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 290 mOsm/kg.

Clinical pharmacology

CLINICAL PHARMACOLOGY

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 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
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.

Indications and usage 

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.

Contraindications

None

Precautions

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™

Adverse reactions

The most common adverse event reported in 2% of patients treated with Besivance™ was conjunctival redness.

Dosage and administration 

Instill one drop in the affected eye(s) 3 times a day, four to twelve hours apart for 7 days.

How supplied

7.5 mL size bottle filled with 5 mL of besifloxacin ophthalmic suspension, 0.6%

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
NDC 24208-446-05

Storage: Store at 15°- 25°C (59° - 77°F). Protect from Light.
Invert closed bottle and shake once before use.
Rx Only

Reference

Package Insert data: 
Manufactured by: Bausch & Lomb Incorporated
Tampa, Florida 33637
©Bausch & Lomb Incorporated

U.S. Patent No. 6,685,958
U.S. Patent No. 6,699,492
U.S. Patent No. 5,447,926

Besivance™ is a trademark of Bausch & Lomb Incorporated

*DuraSite is a trademark of InSite Vision Incorporated
April 2009

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

Disclaimer

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