Manufacturer:

Bausch & Lomb Pharmaceuticals

Pharmacological Class:

Quinolone

Active Ingredient(s):

Besifloxacin 0.6%; oph. susp; contains benzalkonium chloride.

Indication(s):

Susceptible bacterial conjunctivitis.

Pharmacology:

Besifloxacin is a fluoroquinolone with activity against a variety of gram (+) and gram (-) bacteria. Like others in its class, it works by inhibiting bacterial DNA gyrase, which is necessary for replication, transcription, and repair of bacterial DNA, and topoisomerase IV, which is necessary for the partitioning of chromosomal DNA during cell division. It has a different mode of action than that of the aminoglycosides, macrolides, and β-lactam antibiotics, and may therefore provide coverage against pathogens that are resistant to these other antibiotics.

This product is indicated to treat 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 hominus, Staphylococcus lugdunensis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, and Streptococcus salivarius.

As with other anti-infectives, prolonged use of besifloxacin may result in overgrowth of non-susceptible organisms, inlcuding fungi. If super-infection occurs, discontinue use and institute alternative therapy. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment and increase the likelihood that bacteria will develop resistance and will not be treatable by besifloxacin or other antibacterial drugs in the future.

Besivance is for topical ophthalmic use only, and should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.

Clinical Trials:

A randomized, double-masked, vehicle-controlled clinical trial was conducted in which patients with bacterial conjunctivitis were dosed with besifloxacin 0.6% ophthalmic suspension three times daily for 5 days. In this trial, besifloxacin was shown to be superior to vehicle in clinical resolution (45% vs. 33%, respectively). Microbiological outcomes showed a statistically significant eradication rate for causative pathogens for besifloxacin compared to vehicle (91% vs. 60%, respectively).

Legal Classification:

Rx

Adults & Children:

<1yr: not recommended. ≥1year: 1 drop in affected eye(s) 3 times daily (4–12 hrs apart) for 7 days. Shake bottle once before use.

Precaution(s):

Remove contact lenses during therapy or if symptomatic. Pregnancy (Cat.C). Nursing mothers.

Adverse Reaction(s):

Conjunctival redness, blurred vision, eye pain/pruritus/irritation, headache; superinfection (discontinue and treat).

Notes:

Avoid contaminating the applicator tip with material from the eye, fingers, or other source. Wash hands thoroughly prior to use. Invert closed bottle and shake once before each use. Remove cap with bottle still in the inverted position. Tilt head back, and with bottle inverted, gently squeeze bottle to instill one drop into the affected eye(s).

How Supplied:

Susp—5mL

Last Updated:

7/16/2009