Approved May 28, 2009

BESIFLOXACIN HYDROCHLORIDE
(FDA Category 1S)

BESIVANCE(R) (Bausch and Lomb), a 0.6% ophthalmic suspension, is an fluoroquinolone antibiotic with activity against grampositive and gram-negative bacteria.

DOSING INFORMATION: For the treatment of bacterial conjunctivitis in adults and pediatric patients 1 year of age or older, instill 1 drop to affected eye(s) three times daily (separate doses by 4 to 12 hr) for 7 days.

PHARMACOKINETICS: Following the first and the last dose of besifloxacin 0.6% ophthalmic suspension administered bilaterally three times daily (total of 16 doses) in adult patients with suspected bacterial conjunctivitis, the Cmax in each patient was less than 1.3 ng/mL. The mean Cmax reported on day 1 was 0.37 ng/mL and was 0.43 ng/mL on day 6. Following multiple dosing, the average elimination half-life is approximately 7 hr.

CAUTIONS: No specific contraindications have been determined. The ophthalmic suspension is for topical ophthalmic use only and should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye. Avoid wearing contact lenses during course of therapy. Prolonged use may result in superinfection with non-susceptible organisms, including fungi. The most common adverse event is conjunctival redness.

FDA APPROVED INDICATIONS: Besifloxacin hydrochloride 0.6% ophthalmic suspension is indicated for the treatment of bacterial conjunctivitis in patients aged 1 year or older.