Gatigen Ophthalmic Solution

Gatigen 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.

Gatifloxacin eye drops is an 8-methoxyfluoroquinolone anti-infective for topical ophthalmic use. 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. It appears that the C-8-methoxy moiety contributes to enhanced activity and lower selection of resistant mutants of gram-positive bacteria compared to the nonmethoxy C-8 moiety.

Gatifloxacin 0.3%: 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.

Gatifloxacin 0.5%:  Patients 1 year of age or older:

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

Specific drug interaction studies have not been conducted with Gatigen eye drops.

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. Gatifloxacin 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.

Because there are no adequate and well-controlled studies in pregnant women, Gatifloxacin eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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.

Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis. Avoid contaminating the applicator tip with material from the eye, fingers or other source.

An overdose of this medication is unlikely to threaten life.

Ophthalmic antibacterial drugs

Protect from light. Store in cool & dry place; keep out of the reach of children. Do not use more than 4 weeks after opening.