Besibac Eye Drops
Besifloxacin 0.6%
 Besibac Eye Drops

Each ml contains: Active: Besifloxacin Hydrochloride INN equivalent to Besifloxacin 6 mg
Preservative: Benzalkonium Chloride 0.1 mg.

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Besibac ophthalmic suspension, is a sterile ophthalmic suspension of Besifloxacin. It is an 8-chloro fluoroquinolone anti-infective for topical ophthalmic use.

Clinical Pharmacology
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 Cmax 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.


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.

Side Effects

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.

Drug Interactions

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
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.

Over Dosage

No data are available regarding the over dose of Besifloxacin.

Pharmaceutical Precautions

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.

Commercial Pack

5 ml sterile ophthalmic suspension in a plastic dropper bottle.