Source: FDA, National Drug Code (US) Revision Year: 2020
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
Molecular Weight 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);
Inactives: polycarbophil, mannitol, poloxamer 407, sodium chloride, edetate disodium dihydrate, sodium hydroxide and water for injection.
Preservative: benzalkonium chloride 0.01%
BESIVANCE is an isotonic suspension with an osmolality of approximately 290 mOsm/kg.
| Dosage Forms and Strengths |
|---|
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Ophthalmic suspension containing 6 mg/mL (0.6%) of besifloxacin. |
| How Supplied |
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BESIVANCE (besifloxacin ophthalmic suspension) 0.6% is supplied as a sterile ophthalmic suspension in a white low density polyethylene (LDPE) bottle with a controlled dropper tip and tan polypropylene cap. Tamper evidence is provided with a shrink band around the cap and neck area of the package.
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| Drug | Countries | |
|---|---|---|
| BESIVANCE | Brazil, Canada, Singapore, Turkey, United States |
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