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Medications›Antibiotic›Besivance

Besivance®

GoodRx

Besifloxacin 0.6% · ophthalmic suspension

Antibiotic

Approved uses

Bacterial conjunctivitis

1 drop in the affected eye(s) TID, 4 to 12 hours apart, x 7 days.

FDA label, Indications and Usage and Dosage and Administration; trials: Karpecki P, DePaolis M, Hunter JA, et al. Clin Ther. 2009;31(3):514-526; McDonald MB, Protzko EE, Brunner LS, et al. Ophthalmology. 2009;116(9):1615-1623.e1 (doi 10.1016/j.ophtha.2009.05.014).

OFF-LABELNot in the FDA label for this product

Bacterial keratitis

No labeled keratitis regimen. In the cited series dosing varied; most patients ended on 4 or more times daily and median treatment duration was 15 days, the same in the moxifloxacin comparison arm.

Retrospective safety · n=142

No randomized trial. Retrospective multicenter safety surveillance across 10 US centers (142 patients treated with this drug, 85 with moxifloxacin 0.5% for perspective) reported a single adverse event, mild superficial punctate keratitis, with similar treatment outcomes between groups; regimens varied and many patients received additional topical antibacterials, and the authors state a prospective trial is needed to isolate the drug's contribution.

Schechter BA, Parekh JG, Trattler W. Besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial keratitis: a retrospective safety surveillance study. J Ocul Pharmacol Ther. 2015;31(2):114-121 (Epub 2014 Nov 19). Dosing frequency and duration as summarized in Mah FS, Sanfilippo CM. Ophthalmol Ther. 2016;5(1):1-20 (doi 10.1007/s40123-016-0046-6).

Contraindications

Other Antibiotic drugs

Amoxil®
Augmentin®
AzaSite®
Bacitracin Ointment
Bactrim®
Ceclor®
Ciloxan® Ointment
Ciprofloxacin

Browse all medications All Antibiotic drugs

None listed in the labeling.

Available Forms

5 mL bottle, 0.6% suspension, 6 mg/mL

Mechanism of Action

Fluoroquinolone antibacterial; bactericidal through inhibition of both bacterial DNA gyrase and topoisomerase IV, a target set distinct from aminoglycosides, macrolides and beta-lactams. In vitro resistance requires multiple-step mutations and arises at a frequency below one in a billion, though in vitro cross-resistance with some other fluoroquinolones has been demonstrated.

Warnings & Precautions

Topical ophthalmic use only: Not for injection into the eye.
Resistant organism overgrowth: Prolonged use may cause overgrowth of non-susceptible organisms including fungi; discontinue and start alternative therapy if super-infection occurs.
Contact lens wear: Not appropriate with signs or symptoms of bacterial conjunctivitis, and not during the treatment course.

Common Side Effects

Ocular: Conjunctival redness about 2%, the most frequent reaction across roughly 1,000 treated patients aged 1 to 98.
Ocular, 1% to 2%: Blurred vision, eye pain, eye irritation, eye pruritus.
Systemic, 1% to 2%: Headache.

Pregnancy & Lactation

Pregnancy: No human data; systemic exposure after ocular dosing is low, and oral dosing in pregnant rats through organogenesis and the prenatal-postnatal period produced no adverse embryofetal or offspring effects at clinically relevant systemic exposures.

Lactation: No data on presence in human milk, effects on the breastfed infant or effects on milk production; systemic exposure after topical ocular use is low.

Pediatric Use

Not established below 1 year; efficacy demonstrated in controlled clinical trials at 1 year and older.

Besivance (Besifloxacin 0.6%) | EyeKnow O.D.