Brand Name
Besivance
Generic Name
Besifloxacin
View Brand Information FDA approval date: May 28, 2009
Classification: Quinolone Antimicrobial
Form: Suspension
What is Besivance (Besifloxacin)?
BESIVANCE ® 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 ® 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.
Approved To Treat
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Brand Information
Besivance (Besifloxacin)
1INDICATIONS AND USAGE
BESIVANCE
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 mitisgroup
Streptococcus oralis
Streptococcus pneumoniae
Streptococcus salivarius*
*Efficacy for this organism was studied in fewer than 10 infections.
2DOSAGE AND 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.
3DOSAGE FORMS AND STRENGTHS
Ophthalmic suspension containing 6 mg/mL (0.6%) of besifloxacin.
4CONTRAINDICATIONS
None.
5ADVERSE 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.
6DESCRIPTION
BESIVANCE
C
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.
7CLINICAL STUDIES
In a randomized, double-masked, vehicle-controlled, multicenter clinical trial, in which patients 1-98 years of age were dosed 3 times a day for 5 days, BESIVANCE was superior to its vehicle in patients with bacterial conjunctivitis. Clinical resolution was achieved in 45% (90/198) for the BESIVANCE-treated group versus 33% (63/191) for the vehicle-treated group (difference 12%, 95% CI 3% - 22%). Microbiological outcomes demonstrated a statistically significant eradication rate for causative pathogens of 91% (181/198) for the BESIVANCE-treated group versus 60% (114/191) for the vehicle-treated group (difference 31%, 95% CI 23% - 40%). Microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.
8HOW SUPPLIED/STORAGE AND HANDLING
BESIVANCE
- NDC24208-446-05 5 mL in 7.5 mL bottle
Storage:
Store at 15°C to 25°C (59°F to 77°F). Protect from light.
Store at 15°C to 25°C (59°F to 77°F). Protect from light.
9PATIENT COUNSELING INFORMATION
Handling the Container
Advise patients to avoid contaminating the applicator tip with material from the eye, fingers or other source.
Advise patients to avoid contaminating the applicator tip with material from the eye, fingers or other source.
Use with Contact Lenses
Advise patients not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with BESIVANCE.
Advise patients not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with BESIVANCE.
Dosing Instructions
Patients should be instructed to invert closed bottle (upside down) and shake once before each use.
Patients should be instructed to invert closed bottle (upside down) and shake once before each use.
Distributed by:
Bausch & Lomb Americas Inc.
Bridgewater, NJ 08807 USA
Bausch & Lomb Americas Inc.
Bridgewater, NJ 08807 USA
Manufactured by:
Bausch & Lomb Incorporated
Tampa, FL 33637 USA
Bausch & Lomb Incorporated
Tampa, FL 33637 USA
Patented. See
BESIVANCE is a trademark of Bausch & Lomb Incorporated or its affiliates.
© 2022 Bausch & Lomb Incorporated or its affiliates
†DuraSite is a trademark of Sun Pharma Global FZE.
9142709 (folded)
10PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC24208-446-05
BAUSCH + LOMB
Besivance
(besifloxacin ophthalmic
Suspension) 0.6%
Rx only
Sterile
Sterile
FOR TOPICAL OPHTHALMIC
USE ONLY
USE ONLY
5 mL
9553305
AB44507