Drug Reference
Besifloxacin
Fluoroquinolones
Rx only
Fact box
- Therapeutic class
- Fluoroquinolones
- Action class
- Quinolone Antimicrobial
- Chemical class
- Quinolones
- Habit forming
- No
- Availability
- Prescription (Rx)
Brand names
Besivance
Available as
6 MG/ML · Ophthalmic Suspension
FDA label sections are from openFDA and may not reflect the most recent labeling — confirm against the current DailyMed label.
Uses
1 INDICATIONS AND USAGE 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. BESIVANCE ® (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 )
How it works
12.1 Mechanism of Action Besifloxacin is a fluoroquinolone antibacterial [see Microbiology (12.4) ] .
How to use / dosing
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 )
Side effects
6 ADVERSE REACTIONS 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 .
Safety advice
Conservative summary derived from FDA labeling — defaults to “consult your doctor” unless the label is explicit. Not a substitute for your clinician’s advice.
PregnancyConsult your doctor
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). 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.
BreastfeedingConsult your doctor
…8.2 Lactation Risk Summary There are no data on the presence of BESIVANCE in human milk, the effects on the breastfed infant, or the effects on milk production.…
AlcoholNo information
No specific information in the FDA label.
DrivingNo information
No specific information in the FDA label.
KidneyNo information
No specific information in the FDA label.
LiverNo information
No specific information in the FDA label.
Warnings & precautions
5 WARNINGS AND PRECAUTIONS 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.
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Pediatric use
8.4 Pediatric Use The safety and effectiveness of BESIVANCE in infants below one year of age have not been established. The efficacy of BESIVANCE in treating bacterial conjunctivitis in pediatric patients one year or older has been demonstrated in controlled clinical trials [see Clinical Studies (14)]. There is no evidence that the ophthalmic administration of quinolones has any effect on weight-bearing joints, even though systemic administration of some quinolones has been shown to cause arthropathy in immature animals.
⚑ About half of pediatric medication use is off-label and not described in FDA labels — absence of pediatric information does not mean a medicine is unused or unsafe in children. Confirm with your clinician.
Current FDA labels (DailyMed)
Authoritative sources
Reference only — not clinical advice. Verify against current FDA labeling and consult a licensed provider. About half of pediatric drug use is off-label and is not reflected in FDA labels; absence of pediatric information does not mean a medicine is unused or unsafe in children.