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Besifloxacin is an 8-chloro fluoroquinolone with an N-1 cydopropyl group. The compound has activity 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.
Besibac 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.
Dosage And Administration
Instill one drop in the affected eye(s) 3 times a day for 7 days.
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.
Hypersensitivity to the active ingredient or any component of this formulation.
No such information found. Topical Ophthalmic Use Only
Besifloxacin for topical ophthalmic use only, and should not be injected subconjunctivally , nor should it be introduced directly into the anterior chamber of the eye. Use in Specific Populations Use in Pregnancy: Pregnancy Category C. Nursing Mothers: Besifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Besifloxacin administered to a nursing mother. Pediatric Use: The safety and effectiveness of Besifloxacin in infants below one year of age have not been established. The efficacy of Besifloxacin in treating bacterial conjunctivitis in pediatric patients one year or older has been demonstrated in controlled clinical trials. Geriatric Use: No overall differences in safety and effectiveness have been observed between elderly and younger patients.
No data are available regarding the over dose of Besifloxacin.
Store at room temperature, protect from light and moisture. It is desirable that the contents should not be used more than four weeks after first opening of the bottle. Shake well before use.
5 ml sterile ophthalmic suspension in a plastic dropper bottle.