This preparation is indicated for steroid-responsive inflammatory conditions with involvement of bacteria, such as: blepharitis, scleritis, episcleritis, iritis, cyclitis, iridocyclitis, choroiditis, optic neuritis and chronic anterior uveitis. Also useful in disciform and interstitial keratitis, allergic corneal marginal ulcers, and corneal injury from chemical radiation or thermal burns.

Each ml sterile eye drops contains:

• Gatifloxacin 3 mg (as Gatifloxacin Sesquihydrate INN)
• Dexamethasone Phosphate 1 mg (as Dexamethasone Sodium Phosphate USP)

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. Through inhibiting this process, Gatifloxacin shows bactericidal activity. The action of Dexamethasone is to inhibit phospholipase A2, the first step in prostaglandin synthesis. It also inhibits the chemotactic infiltration of neutrophils into the site of inflammation. Its anti-inflammatory activity is 30 times greater and its overall therapeutic effectiveness 8-10 times greater than that of hydrocortisone. Like other glucocorticoids, it is anti-allergic, anti-exudative and anti-proliferative.

Instill 1-2 drops into the conjunctival sac 3 to 4 times daily.

There may be an interaction between Gatifloxacin and any of the following: antacids (containing aluminum, calcium, and magnesium), digoxin, probenecid, and vitamins (containing zinc, calcium, magnesium, or iron). Specific drug interaction studies have not been conducted with Dexamethasone.

Contraindicated in fungal disease of ocular structures, viral conjunctivitis, and hypersensitivity to any of the components of the formulation.

Frequently reported reactions related to Gatifloxacin include chemosis, redness, dry eye, itching, swelling of the eyelid, and reduced visual acuity. The reactions due to Dexamethasone are elevation of intraocular pressure, delayed wound healing, and posterior subcapsular cataract formation.

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

In Lactation: Gatifloxacin or Dexamethasone has not been measured in human milk, although it can be presumed to be excreted in human milk following topical administration. Caution should be exercised when the combination is administered to a nursing woman.

Pediatric Use: The safety in pediatric patients has not been established.

If the product is used for 10 days or more, intraocular pressure should be monitored routinely. Prolonged use of steroids may result in glaucoma or other ocular damage. It may exacerbate the severity of viral infections. Use cautiously in patients with a history of herpes simplex.

Use in children: Safety and effectiveness in pediatric patients have not been established.

Overdose through local or accidental oral administration is not likely. An overdose of this medication is unlikely to threaten life.

Ophthalmic steroid - antibiotic combined preparations

Store in a cool and dry place away from light. Keep out of reach of children. Do not touch the dropper tip to surfaces, as this may contaminate the solution. Do not use the medicine for more than one month after the first opening.