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Besiflox

Besiflox

Besifloxacin Hydrochloride

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.

Product Details

Presentation

Besiflox Sterile Ophthalmic Suspension: Each ml contains Besifloxacin Hydrochloride equivalent to Besifloxacin INN 6 mg.

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.

Indication

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: Moroxella lacunata. It is also indicated for the treatment of blepharitis, surgical prophylaxis & keratitis.

Dosage & Administration

For bacterial conjunctivitis & blepharitis: Instill 1 drop in the affected eye(s) 3 times a day for 7 days. 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. For keratitis: Instill higher doses in the affected eye(s) as per needed or directed by the physicians.

Contraindications

None

Warning & 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-invectives. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.

Side effects

Reported side effect is conjunctival redness. Other side effects are blurred vision, eye irritation, eye pain, eye pruritus and headache.

Use in special groups

Use in 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.
Use in 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.
Use in children: Safety and effectiveness in infants below the age of one 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.

Packing

Besiflox Sterile Ophthalmic Suspension: Each plastic dropper bottle contains 5 ml sterile ophthalmic suspension.

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