Besivance Generic Name & Formulations
Store at 15°C to 25°C (59°F to 77°F). Protect from light.
Besivance is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:
CDC coryneform group G
Streptococcus mitis group
Besivance Dosage and Administration
Adults and Children
Besivance Boxed Warnings
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.
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.
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.
No overall differences in safety and effectiveness have been observed between elderly and younger patients.
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.
The average elimination half-life of besifloxacin in plasma following multiple dosing was estimated to be 7 hours.
Besivance Adverse Reactions
Besivance 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 Patient Counseling
Avoid contaminating the applicator tip.
Do not wear contact lenses during therapy.
Invert bottle and shake once before each use.