Tag 5Ml

Gatifloxacin eye drops is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:

• Aerobic Gram-Positive Bacteria: Corynebacterium propinquum, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis, Streptococcus pneumoniae
• Aerobic Gram-Negative Bacteria: Haemophilus influenzae.

Ophthalmic antibacterial drugs

The antibacterial action of gatifloxacin results from inhibition of DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division. The mechanism of action of fluoroquinolones including gatifloxacin is different from that of aminoglycoside, macrolide, and tetracycline antibiotics. Therefore, gatifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to gatifloxacin. There is no crossresistance between gatifloxacin and the aforementioned classes of antibiotics. Cross resistance has been observed between systemic gatifloxacin and some other fluoroquinolones. Resistance to gatifloxacin in vitro develops via multiple-step mutations.

0.3% eye drops-

The recommended dosage regimen for the treatment of bacterial conjunctivitis is:

• Days 1 and 2: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times daily.
• Days 3 through 7: Instill one drop up to 4 times daily while awake.

0.5% eye drops-

Patients 1 year of age or older: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times on Day 1. Instill one drop two to four times daily in the affected eye(s) while awake on Days 2 through 7.

Specific drug interaction studies have not been conducted with gatifloxacin eye drops. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving systemic cyclosporine concomitantly.

Gatifloxacin eye drops is contraindicated in patients with a history of hypersensitivity to Gatifloxacin, to other quinolones, or to any of the components in this medication. Gatiflox 0.3% eye drops should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.

The most frequently reported adverse events in the overall study population were conjunctival irritation, increased lacrimation etc.

Pregnancy Category C. Because there are no adequate and well-controlled studies in pregnant women, Gatifloxacin 0.3% eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Gatifloxacin is administered to a nursing woman.