besifloxacin ophthalmic (Rx)

1-10%

Blurred vision

Conjunctival redness

Eye irritation

Eye pain

Eye pruritus

Headache

Contraindications

None listed by the manufacturer

Cautions

May result in overgrowth of nonsusceptible organisms, including fungi

Avoid contact lenses during treatment of infections

Pregnancy

There are no available human data during pregnancy to inform any drug-associated risks; however, systemic exposure to besifloxacin from ocular administration is low; oral administration of besifloxacin to pregnant rats during organogenesis or during pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures

Lactation

There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production; however, systemic exposure to besifloxacin following topical ocular administration is low, and it is not known whether measurable levels of besifloxacin would be present in maternal milk following topical ocular administration

The developmental and health benefits of breastfeeding should be considered, along with mother’s clinical need for therapy, and any potential adverse effects on breastfed infant from treatment

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Bactericidal

Inhibits DNA-gyrase (a topoisomerase) in susceptible organisms, which in turn inhibits cell division.

Pharmacokinetics

Half-life: 7 hr