Besibac Ophthalmic Suspension

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.

Plasma concentrations of Besifloxacin were measured in adult patients with suspected bacterial conjunctivitis who received Besifloxacin bilaterally three times a day (16 doses total). Following the first and last dose, the maximum plasma Besifloxacin concentration in each patient was less than 1.3 ng/ml. The mean Besifloxacin C max was 0.37 ng/ml on day 1 and 0.43 ng/ml on day 6. The average elimination half-life of Besifloxacin in plasma following multiple dosing was estimated to be 7 hours.

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. 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 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 Besibac 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. 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.

Besibac 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 Besibac. Shake well before use.

Ophthalmic antibacterial drugs

Store at room temperature, protect from light and moisture. It is desirable that the contents should not be used more than one month after first opening of the bottle. Shake well before use.