Besivance

Ophthalmological Anti-infectives

For topical ophthalmic administration only.
Wash hand prior to use.
Remove contact lenses prior to use.
Prior to administration, invert the closed bottle and shake once.
Remove the cap while the bottle is in the inverted position and administer one drop into the affected eye(s).
Do not rinse the dropper after use; keep container tightly closed.
Use one bottle per patient; do not share ophthalmic drops.

blurred vision / Early / 1.0-2.0
conjunctival hyperemia / Early / 2.0-2.0
superinfection / Delayed / Incidence not known

ocular irritation / Rapid / 1.0-2.0
ocular pruritus / Rapid / 1.0-2.0
ocular pain / Early / 1.0-2.0
headache / Early / 1.0-2.0

Besivance

Rx

Ophthalmic suspension use to treat bacterial conjunctivitis.

Instill 1 drop in the affected eye(s) 3 times daily, 4 to 12 hours apart, for 7 days.

Specific guidelines for dosage adjustment in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustment in renal impairment are not available; it appears that no dosage adjustments are needed.

There are no drug interactions associated with Besifloxacin products.

Besivance Ophthalmic Susp: 0.6%

3 drops/eye/day.

3 drops/eye/day.

3 drops/eye/day.

3 drops/eye/day.

Safety and efficacy have not been established.

Besifloxacin is a fluoroquinolone that is bactericidal against Gram-positive and Gram-negative organisms. It inhibits bacterial DNA gyrase, which is required for replication, transcription, and repair of bacterial DNA. It also inhibits bacterial topoisomerase IV, which is necessary for the partitioning of the chromosomal DNA during bacterial cell division. In vitro data have demonstrated cross-resistance between besifloxacin and other fluoroquinolones.

Besifloxacin is applied topically to the eye. Systemic absorption is minimal. The mean elimination half-life after multiple doses was estimated to be 7 hours.

Ophthalmic Route
Systemic absorption of besifloxacin is minimal. Serum concentrations were measured in adults with suspected bacterial conjunctivitis receiving besifloxacin bilaterally three times daily (16 doses total). After both the first and last dose, maximum serum concentrations were less than 1.3 ng/mL with a mean Cmax of 0.37 ng/mL on day 1 and 0.43 ng/mL on day 6.

No adequate and well-controlled studies with besifloxacin have been conducted in pregnant women and its ability to cause fetal harm or affect reproductive capacity is unknown. In animal studies, the No Observed Adverse Effect Level (NOAEL) for embryo-fetal development was 100 mg/kg/day (Cmax 5 mcg/mL or greater than 11,000-times the mean serum concentration measured in humans). Low serum concentrations have been observed during ophthalmic administration (e.g., less than 1.3 ng/mL). To minimize the amount of drug that reaches systemic circulation, apply pressure over the tear duct by the corner of the eye for 1 minute after each administration. The manufacturer recommends that besifloxacin be used during pregnancy only if the potential benefits to the mother outweigh the potential risk to the fetus.

There are no data on the presence of besifloxacin in human milk, the effects on the breastfed infant, or the effects on milk production. It is not known whether measurable concentrations of besifloxacin would be present in maternal milk after topical ocular administration; however, systemic exposure after ocular administration is low. The low maternal serum concentrations (less than 1.3 ng/mL) suggest exposure to a nursing infant would likely be clinically insignificant. To minimize the amount of drug that reaches systemic circulation and breast milk, apply pressure over the tear duct by the corner of the eye for 1 minute after each administration. The manufacturer suggests caution when administering to lactating women. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-fed infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.