Presentation

Gatiflox Sterile Eye Drops: Gatiflox 0.3% eye drops is a sterile ophthalmic solution. Each ml eye drop contains Gatifloxacin Sesquihydrate INN equivalent to Gatifloxacin 3 mg.

Description

Gatiflox 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.

Indications

Gatiflox 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.

Dosage & Administration

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.

Adverse Reactions

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

Pediatric Use: Safety and effectiveness in infants below the age of one year have not been established.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Side Effects

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

Precautions

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.

Use in Pregnancy & Lactation

In Pregnancy: Because there are no adequate and well-controlled studies in pregnant women, Gatiflox 0.3% eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In 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.

Drug Interaction

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

Over Dose

An overdose of this medication is unlikely to threaten life.

Storage

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

Commercial Pack

Gatiflox Sterile Eye Drops: 5 ml sterile solution in plastic dropper bottle.