Sterile Eye Drops is indicated for steroid responsive ocular inflammatory conditions with involvement of bacteria like blepharitis, scleritis, episcleritis, iritis, cyclitis, iridocyclitis, choroiditis, optic neuritis and chronic anterior uveitis, disciform and interstitial keratitis, allergic corneal marginal ulcers, corneal injury from chemical radiation or thermal burns.
Therapeutic Class Ophthalmic steroid - antibiotic combined preparations
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 in patients who are hypersensitive to any of the components of this preparation. Precaution For ophthalmic use only. If the product is used for 10 days or more, intraocular pressure should be monitored routinely
Mild burning, chemosis, redness may occur.
Pregnancy: There are no adequate and well-controlled studies in pregnant women. Dexon-G should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation: Caution should be exercised when Dexon-G is administered to a nursing mother.
Overdose through local or accidental oral administration is not likely. An overdose of this medication is unlikely to threaten life.
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.
Each ml sterile eye drops contains-
Gatifoxacin 3 mg (as Gatifoxacin Sesquihydrate INN)
Dexamethasone Phosphate 1 mg (as Dexamethasone Sodium Phosphate USP).