Besivance®
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.
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.
Contraindications
None listed in the labeling.
Available Forms5 mL bottle, 0.6% suspension, 6 mg/mL
Mechanism of ActionFluoroquinolone 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 & LactationPregnancy: 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 UseNot established below 1 year; efficacy demonstrated in controlled clinical trials at 1 year and older.