Simulect IV Infusion

Besifloxacin ophthalmic suspension is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:

• Corynebacterium pseudodiphtheriticum
• Corynebacterium striatum
• Haemophilus influenzae
• Moraxella lacunata
• Staphylococcus aureus
• Staphylococcus epidermidis
• Staphylococcus hominis
• Staphylococcus lugdunensis
• Streptococcus mitis group
• Streptococcus oralis
• Streptococcus pneumoniae
• Streptococcus salivarius

Efficacy for this organism was studied in fewer than 10 infections.

Besifloxacin acts against Gram positive and Gram negative bacteria due to the inhibition of both bacterial DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme required for replication, transcription and repair of bacterial DNA. Topoisomerase IV is an essential enzyme required for partitioning of the chromosomal DNA during bacterial cell division.

Adults and children (1 year of age and older): Instill one drop in the affected eye(s) 3 times a day for 7 days.

Pediatric Use: The safety and effectiveness of Besifloxacin in infants below one year of age have not been established.

No such information found. Topical ophthalmic use only

Hypersensitivity to the active ingredient or any component of this formulation.

The most frequently reported ocular adverse event was conjunctival redness, reported in approximately 2% of patients. Other adverse events reported in patients receiving Besifloxacin occurring in approximately 1-2% of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache.

Pregnancy Category C. No adequate and well-controlled studies are established in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is not known whether Besifloxacin is secreted in human milk or not. Caution should be exercised when Besifloxacin is administered to a nursing mother.

This drug is for topical ophthalmic use only and should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. To prevent contamination do not touch the tip of the dropper to eye, eyelid or any surface of the affected eye. Patients should not wear contact lenses during the course of therapy with this drug. Shake well before use.

No data are available regarding the over dose of Besifloxacin.

Ophthalmic antibacterial drugs

Store in a cool, dry place and protected from light. Keep out of the reach of children. Discard the container 4 weeks after opening.