Besivance

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE 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. Besifloxacin ophthalmic suspension 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. ( 1 ) Dosage and administration 2 DOSAGE 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. Instill one drop in the affected eye(s) 3 times a day, 4 to 12 hours apart for 7 days. ( 2 ) Warnings and cautions 5 WARNINGS AND PRECAUTIONS Not for Injection into the Eye ( 5.1 ) Growth of Resistant Organisms with Prolonged Use ( 5.2 ) 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 besifloxacin ophthalmic suspension. ( 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 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 besifloxacin ophthalmic suspension. Pregnancy 8.1 Pregnancy Risk Summary There are no available human data for the use of besifloxacin ophthalmic suspension 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). 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.