Presentation

Gatiflox ES Sterile Eye Drops: Each ml contains Gatifloxacin Sesquihydrate INN equivalent to Gatifloxacin 5 mg.

Description

Gatiflox ES is an 8-methoxyfluoroquinolone anti-infective for the treatment of bacterial conjunctivitis. 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.

Indications

Gatiflox ES is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:

Aerobic Gram-Positive Bacteria:

Staphylococcus aureus

Staphylococcus epidermidis

Streptococcus mitis

Streptococcus oralis

Streptococcus pneumoniae

Aerobic Gram-Negative Bacteria:

Haemophilus influenzae

Dosage & Administration

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.

Side Effects

Most common adverse reactions were eye irritation, dysgeusia, increased lacrimation and eye pain.

Precautions

Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with this eye drops.

As with other anti-infectives, prolonged use of this eye drops may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy.

Use in Pregnancy & Lactation

Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women; it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is not known whether it is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Gatiflox? ES is administered to a lactating woman.

Drug Interaction

Specific drug interaction studies have not been conducted with Gatiflox? ES eye drops.

Over Dose

A topical overdose may be flushed from the eye(s) with warm water

Storage

? Store in cool & dry place, protected from light

? Keep out of the reach of children

? Do not use more than 4 weeks after opening

Commercial Pack

Gatiflox ES Sterile Eye Drops: Plastic dropper bottle containing 5 ml Sterile Eye Drops.