Besifloxacin Ophthalmic

Besifloxacin eye drops may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• red, itchy, or irritated eyes
• eye pain
• blurred vision
• headache

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• rash
• hives
• itching
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs

Besifloxacin eye drops may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

If your eye infection does not improve, or if it becomes worse, check with your doctor.

Stop using besifloxacin and check with your doctor right away if you have a rash, itching, or red or swollen skin around the eye or eyelid. These may be symptoms of an allergic reaction.

Do not wear contact lenses while you are using besifloxacin to avoid further eye irritation.

Usual Adult Dose for Bacterial Conjunctivitis:

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

Use: For the treatment of bacterial conjunctivitis due to susceptible isolates of Aerococcus viridans, CDC coryneform group G, Corynebacterium pseudodiphtheriticum, C striatum, Haemophilus influenzae, Moraxella lacunata, M catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus, S epidermidis, S hominis, S lugdunensis, S warneri, Streptococcus mitis group, S oralis, S pneumoniae, S salivarius

Usual Pediatric Dose for Bacterial Conjunctivitis:

1 year or older: Instill 1 drop in the affected eye(s) 3 times a day, 4 to 12 hours apart, for 7 days.

Use: For the treatment of bacterial conjunctivitis due to susceptible isolates of A viridans, CDC coryneform group G, C pseudodiphtheriticum, C striatum, H influenzae, M lacunata, M catarrhalis, P aeruginosa, S aureus, S epidermidis, S hominis, S lugdunensis, S warneri, S mitis group, S oralis, S pneumoniae, S salivarius

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. US FDA pregnancy category: C

Animal studies have failed to reveal evidence of teratogenicity. Oral doses up to 1000 mg/kg/day (Cmax in rat dams about 20 mcg/mL, more than 45,000 times plasma levels in humans) were associated with maternal toxicity (reduced weight gain and food intake) and maternal mortality but not with visceral or skeletal malformations in rat pups; increased postimplantation loss and decreased fetal weight, fetal ossification, pup weight (compared to controls), and rate of neonate survival observed. The No Observed Adverse Effect Level for fetal and maternal toxicity was 100 mg/kg/day (Cmax 5 mcg/mL, more than 11,000 times plasma levels in humans). There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.