Besivance

— THERAPEUTIC CATEGORIES —
  • Ocular infections
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Besivance Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Besifloxacin 0.6%; oph susp; contains benzalkonium chloride.

    Pharmacological Class

    Quinolone.

    How Supplied

    Susp—5mL

    Storage

    Store at 15°C to 25°C (59°F to 77°F). Protect from light.

    Manufacturer

    Bausch & Lomb Inc.

    Besivance Indications

    Indications

    Susceptible bacterial conjunctivitis.

    Indications

    Besivance 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

    Besivance Dosage and Administration

    Adults and Children

    <1yr: not established. ≥1yr: 1 drop in affected eye(s) 3 times daily (4–12hrs apart) for 7 days. Shake bottle once before use.

    Besivance Contraindications

    Not Applicable

    Besivance Boxed Warnings

    Not Applicable

    Besivance Warnings/Precautions

    Warnings/Precautions

    Not for inj into the eye. Avoid contact lenses during therapy or if symptomatic.  Prolonged use may result in overgrowth of nonsusceptible organisms. Pregnancy. Nursing mothers.

    Pregnancy Considerations

    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.

    Nursing Mother Considerations

    There are no data on the presence of Besivance in human milk, the effects on the breastfed infant, or the effects on milk production. Consider benefits for mother vs potential risks to infant. Systemic exposure following topical ocular administration is low.

    Pediatric Considerations

    The safety and effectiveness of Besivance in infants less than 1 year of age have not been established. There is no evidence that the ophthalmic administration of quinolones has any effect on weight-bearing joints.

    Geriatric Considerations

    No overall differences in safety and effectiveness have been observed between elderly and younger patients.

    Besivance Pharmacokinetics

    Absorption

    Following the first and last dose, the maximum plasma besifloxacin concentration in each patient was less than 1.3ng/mL. The mean besifloxacin Cmax was 0.37 ng/mL on day 1 and 0.43ng/mL on day 6.

    Elimination

    The average elimination half-life of besifloxacin in plasma following multiple dosing was estimated to be 7 hours.

    Besivance Interactions

    Not Applicable

    Besivance Adverse Reactions

    Adverse Reactions

    Conjunctival redness, blurred vision, eye pain/pruritus/irritation, headache; superinfection (discontinue and treat).

    Besivance Clinical Trials

    Clinical Trials

    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 vehicle in patients with bacterial conjunctivitis. 

    Clinical resolution was achieved in 45% (n=90/198) for the Besivance-treated group vs 33% (n=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% (n=181/198) for the Besivance-treated group vs 60% (n=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.

    Besivance Note

    Not Applicable

    Besivance Patient Counseling

    Patient Counseling

    Avoid contaminating the applicator tip.

    Do not wear contact lenses during therapy.

    Invert bottle and shake once before each use.

    Cost Savings Program

    Besivance Savings Program

    Images

    • Latest News Your top articles for Wednesday

    • Haymarket Medical NetworkTop Picks

    • Loading...

      Continuing Medical Education (CME/CE) Courses

      Show More