Full Prescribing Info
Each ml of ophth susp contains besifloxacin hydrochloride INN equivalent to besifloxacin 6 mg.
Excipients/Inactive Ingredients: Preservative: Sodium perborate BP 0.01%. Vehicle: HPMC USP 0.45%.
Pharmacology: Besifloxacin is an 8-chlorofluoroquinolone with a 3-aminohexahydro-azepinyl substituent at C-7 which shows antibacterial activity by inhibiting the bacterial enzyme DNA gyrase and topoisomerase IV.
Besiflox Sterile Ophthalmic Suspension is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerobic Gram-Positive Bacteria: Corynebacterium pseudodiphtheriticum, Corynebacterium striatum, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis, Staphylococcus lugdunensis, Streptococcus mitis, Streptococcus pneumoniae, Streptococcus oralis, Streptococcus salivarius, CDC coryneform group G. Aerobic Gram-Negative Bacteria: Moraxella lacunata. It is also indicated for the treatment of blepharitis, surgical prophylaxis & keratitis.
Dosage/Direction for Use
For bacterial conjunctivitis & blepharitis: Instill 1 drop in the affected eye(s) 3 times a day for 7 days. For keratitis: Instill higher doses in the affected eye(s) as per needed or directed by the physicians. For surgical prophylaxis: Instill 1 drop in the affected eye(s) every 10 minutes for a total 4 doses beginning 1 hour before cataract surgery.
Special Precautions
For topical ophthalmic use only and should not be injected subconjunctivally and should not be introduced directly into the anterior chamber of the eye. Prolonged use may result in overgrowth of non-susceptible organisms, including fungi like with other anti-infectives. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.
Use in children: Safety and effectiveness in infants below the age of 1 year have not been established.
Use in elderly patients: No overall clinical differences in safety or effectiveness have been observed between elderly and younger patients.
Use In Pregnancy & Lactation
Pregnancy: Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Besifloxacin should be used during pregnancy only if the benefit justifies the potential risk to the fetus.
Lactation: Besifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. So, caution should be exercised when Besifloxacin is administered to a nursing woman.
Side Effects
Reported side effect is conjunctival redness. Other side effects are blurred vision, eye irritation, eye pain, eye pruritus and headache.
Store below 30°C and protect from light. Discard 30 days after opening.
MIMS Class
Eye Anti-Infectives & Antiseptics
ATC Classification
S01AE08 - besifloxacin ; Belongs to the class of quinolone antiinfectives. Used in the treatment of eye infections.
Ophth susp 6 mg/mL x 5 mL x 1's.
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