FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Besivance® (besifloxacin ophthalmic suspension) 0.6%, is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:
Aerococcus viridans*
CDC coryneform group G
Corynebacterium pseudodiphtheriticum*
Corynebacterium striatum*
Haemophilus influenzae
Moraxella catarrhalis*
Moraxella lacunata*
Pseudomonas aeruginosa
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus hominis*
Staphylococcus lugdunensis*
Staphylococcus warneri*
Streptococcus mitis group
Streptococcus oralis
Streptococcus pneumoniae
Streptococcus salivarius*
*Efficacy for this organism was studied in fewer than 10 infections.
History
There is currently no drug history available for this drug.
Other Information
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.
C19H21ClFN3O3•HCl
Mol Wt 430.30
Chemical Name:(+)-7-[(3R)-3-aminohexahydro-1H-azepin-1-yl]-8-chloro-1- cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride.
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.
Sources
Pulmozyme Manufacturers
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Genentech, Inc.
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