Besifloxacin

Besifloxacin is a fluoroquinolone antibacterial [see Microbiology (12.4) ] .

• 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.ICD-10: H10.9

• None. None.contraindicated

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 )

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.

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 .

8.1 Pregnancy Risk Summary There are no available human data for the use of BESIVANCE during pregnancy to inform any drug-associated risks; however, systemic exposure to besifloxacin from ocular administration is low [see Clinical Pharmacology (12.3) ]. Oral administration of besifloxacin to pregnant rats during organogenesis or during the prenatal and postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures [see Data]. Data Animal Data In an embryofetal development study in rats, the administration of besifloxacin at oral doses up to 1,000 mg/kg/day during organogenesis was not associated with visceral or skeletal malformations in rat fetuses, although this dose was associated with maternal toxicity (reduced body weight gain and food consumption) and maternal mortality. Increased post-implantation loss, decreased fetal body weights, and decreased fetal ossification were also observed. At this dose, the mean C max in the rat dams was approximately 20 mcg/mL, approximately 46,500 times the mean plasma concentrations measured in humans at the recommended human ophthalmic dose (RHOD). The No Observed Adverse Effect Level (NOAEL) for this embryofetal development study was 100 mg/kg/day (C max , 5 mcg/mL, approximately 11,600 times the mean plasma concentrations measured in humans at the RHOD).

Metabolism

Plasma concentrations of besifloxacin were measured in adult patients with suspected bacterial conjunctivitis who received BESIVANCE bilaterally three times a day (16 doses total). Following the first and last dose, the maximum plasma besifloxacin concentration in each patient was less than 1.3 ng/mL.

• May 28, 2009NDANDA022308Bausch And Lomb

1. 1Eye Pain10110%
2. 2Vision Blurred818.4%
3. 3Eye Irritation798.2%
4. 4Off Label Use788.1%
5. 5Hypersensitivity687.1%
6. 6Ocular Hyperaemia596.1%
7. 7Cardiac Disorder505.2%
8. 8Chronic Kidney Disease424.4%
9. 9Drug Ineffective353.6%
10. 10Photophobia353.6%
11. 11Impaired Healing343.5%
12. 12Foreign Body Sensation In Eyes333.4%
13. 13Corneal Oedema303.1%
14. 14Cataract293.0%
15. 15Condition Aggravated282.9%

The 10 most recently updated of 22 ClinicalTrials.gov registrations naming Besifloxacin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Besifloxacin in Bacterial Keratitis
  Completed · Interventional · 32 enrolled · McGill University Health Centre/Research Institute of the McGill University Health Centre
  NCT02497365updated 2023-10-19
• Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification
  Completed · Phase 4 · Interventional · 120 enrolled · Frank A. Bucci, Jr., M.D.
  NCT01296191updated 2020-12-22
• A Comparison of Prophylactic Antibacterial Efficacy of Besivance vs. VIGAMOX Prior to Cataract Surgery
  Completed · Phase 4 · Interventional · 60 enrolled · Bucci Laser Vision Institute
  NCT01296542updated 2020-12-08
• Swiss PACK-CXL Multicenter Trial for the Treatment of Infectious Keratitis
  Completed · Phase 3 · Interventional · 35 enrolled · University Hospital, Geneva
  NCT02717871updated 2020-10-20
• Effect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery
  Completed · Phase 1 · Interventional · 60 enrolled · Instituto de Oftalmología Fundación Conde de Valenciana
  NCT04542759updated 2020-09-09
• Study of Ocular Penetration of Topically Administered Fluoroquinolones
  Completed · Phase 4 · Interventional · 50 enrolled · Johns Hopkins University
  NCT00924729updated 2017-10-24
• Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children
  Completed · Phase 1 · Interventional · 24 enrolled · Rutgers, The State University of New Jersey
  NCT01431170updated 2016-07-14
• A Comparison of Three Fluoroquinolone Topical Eyedrops in the Treatment of Infectious Corneal Ulcers.
  Terminated · Phase 2 · Interventional · 2 enrolled · Cornea Consultants Of Nashville
  NCT01928693updated 2015-08-13
• Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis
  Completed · Phase 2 · Interventional · 270 enrolled · Bausch & Lomb Incorporated
  NCT00622908updated 2015-03-24
• A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis
  Completed · Phase 3 · Interventional · 1,161 enrolled · Bausch & Lomb Incorporated
  NCT00348348updated 2015-03-24

Frequently asked questions

How does Besifloxacin work?

Besifloxacin is a fluoroquinolone antibacterial [see Microbiology (12.4) ] .

What is Besifloxacin used for?

According to FDA labeling, Besifloxacin carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Besifloxacin?

Besifloxacin is classified as Fluoroquinolones, Quinolone Antimicrobial, DNA Gyrase Inhibitors, Topoisomerase 4 Inhibitors, Decreased DNA Integrity, Decreased DNA Replication, Decreased Transcription to RNA.

What are the brand names for Besifloxacin?

Besifloxacin is marketed under brand names including Besivance.

What are the contraindications for Besifloxacin?

Besifloxacin labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.