Besivance
(Besifloxacin)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.
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Besivance Prescribing Information
BESIVANCE
®(besifloxacin ophthalmic suspension) 0.6% is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:
CDC coryneform group G
*Efficacy for this organism was studied in fewer than 10 infections.
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.
Ophthalmic suspension containing 6 mg/mL (0.6%) of besifloxacin.
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
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. The mean besifloxacin Cmaxwas 0.37 ng/mL on Day 1 and 0.43 ng/mL on Day 6. The average elimination half-life of besifloxacin in plasma following multiple dosing was estimated to be 7 hours.
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
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
maxin 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).
In a prenatal and postnatal development study in rats, the NOAELs for both fetal/neonate and maternal toxicity were 100 mg/kg/day. At 1,000 mg/kg/day, pups weighed significantly less than controls and had a reduced neonatal survival rate. Attainment of developmental landmarks and sexual maturation was delayed, although surviving pups from this dose group that were reared to maturity did not demonstrate deficits in behavior, including activity, learning and memory, and their reproductive capacity appeared normal.
None.
- 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 Avoidance of Contact LensesPatients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with BESIVANCE.