Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 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 beige polypropylene cap. Tamper evidence is provided with a shrink band around the cap and neck area of the package. NDC 24208-446-05 5 mL in 7.5 mL bottle Storage: Store at 15°C to 25°C (59°F to 77°F). Protect from light.; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 24208-446-05 BAUSCH + LOMB Besivance ® (besifloxacin ophthalmic Suspension) 0.6% Rx only Sterile FOR TOPICAL OPHTHALMIC USE ONLY 5 mL 9553305 AB44507 carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING 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 beige polypropylene cap. Tamper evidence is provided with a shrink band around the cap and neck area of the package. NDC 24208-446-05 5 mL in 7.5 mL bottle Storage: Store at 15°C to 25°C (59°F to 77°F). Protect from light.
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 24208-446-05 BAUSCH + LOMB Besivance ® (besifloxacin ophthalmic Suspension) 0.6% Rx only Sterile FOR TOPICAL OPHTHALMIC USE ONLY 5 mL 9553305 AB44507 carton
Overview
BESIVANCE ® (besifloxacin ophthalmic suspension) 0.6% is a sterile ophthalmic suspension of besifloxacin formulated with DuraSite ® † (polycarbophil, edetate disodium dihydrate, sodium chloride, sodium hydroxide, and water for injection). 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. C 19 H 21 ClFN 3 O 3 •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. Besifloxacin hydrochloride structural formula
Indications & Usage
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. BESIVANCE ® (besifloxacin ophthalmic suspension) 0.6% is a quinolone antimicrobial 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. ( 1 )
Dosage & Administration
Invert closed bottle and shake once before use. Instill one drop in the affected eye(s) 3 times a day, 4 to 12 hours apart for 7 days. Instill one drop in the affected eye(s) 3 times a day, 4 to 12 hours apart for 7 days. ( 2 )
Warnings & Precautions
Not for Injection into the Eye ( Error! Hyperlink reference not valid. ) Growth of Resistant Organisms with Prolonged Use ( Error! Hyperlink reference not valid. ) Avoidance of Contact Lenses: Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with BESIVANCE. ( 5.3 ) 5.1 Not for Injection into the Eye 5.2 Growth of Resistant Organisms with Prolonged Use As with other anti-infectives, prolonged use of BESIVANCE (besifloxacin ophthalmic suspension) 0.6% may result in overgrowth of non-susceptible organisms, including fungi. If super-infection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining. 5.3 Avoidance of Contact Lenses Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with BESIVANCE.
Contraindications
None. None. ( 4 )
Adverse Reactions
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure to BESIVANCE in approximately 1,000 patients between 1 and 98 years old with clinical signs and symptoms of bacterial conjunctivitis. The most frequently reported ocular adverse reaction was conjunctival redness, reported in approximately 2% of patients. Other adverse reactions reported in patients receiving BESIVANCE occurring in approximately 1-2% of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache. The most common adverse reaction reported in 2% of patients treated with BESIVANCE was conjunctival redness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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