Gatifloxacin + Dexamethasone

This preparation is indicated for steroid responsive infammatory 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, corneal injury from chemical radiation or thermal burns.

Each ml sterile eye drops contains-

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

The antibacterial action of Gatifoxacin 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 Gatifoxacin shows bactericidal activity. The action of Dexamethasone is to inhibit the phospholipase A2, the frst step in prostaglandin synthesis. Also, inhibits the chemotactic infltration of neutrophils into the site of infammation. Its anti-infammatory activity is 30 times greater and its overall therapeutic efectiveness 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 Gatifoxacin and any of the followings: Antacids (containing aluminum, calcium, and magnesium), digoxin, probenecid, vitamins (containing zinc, calcium, magnesium, or iron). Specifc 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 Gatifoxacin include chemosis, redness, dry eye, itching, swelling of the eyelid & 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 beneft justifes the potential risk to the fetus.

In Lactation: Gatifoxacin 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, intra ocular pressure should be monitored routinely. Prolonged use of steroid may result in glaucoma or other ocular damage. It may exacerbate severity of viral infections. Use cautiously in patients with 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 since this may contaminate the solution. After one month of the frst opening do not use the medicine of dropper.