Ciprofloxacin + Dexamethasone

Acute and chronic keratitis and conjunctivitis of an infectious, allergic but non-viral nature. It is also indicated in chronic anterior uveitis, scleritis, episcleritis, myositis and corneal injury from chemical radiation or thermal burns, or penetration of foreign bodies. Post-operative management of cataract, glaucoma, and strabismus. The use of combination with an anti-infective component is indicated where the risk of superficial ocular infection is high.

This is a sterile ophthalmic solution containing Dexamethasone- a corticosteroid and Ciprofloxacin-a quinolone derivative for topical administration to the eyes.

Dexamethasone reduces prostaglandin synthesis by inhibiting the enzyme phospholipase A2. Also, Dexamethasone inhibits the chemotactic infiltration of neutrophils into the site of inflammation.

Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organisms, possessing the greatest antibacterial activity of all quinolones. The bactericidal action of Ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA.

1 drop into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every two hours.

Specific drug interaction studies have not been conducted with ophthalmic Ciprofloxacin and Dexamethasone.

Known hypersensitivity to any ingredient of the product. Herpes simplex and other viral conditions, mycosis, glaucoma, newborn babies, fungal diseases of ocular structures.

Frequently reported adverse reactions are transient ocular burning or discomfort. Other reported reactions include photophobia, conjunctivitis/keratitis, Periocular/facial edema, foreign body sensation, blurred vision, tearing, dryness, and eye pain. Elevation of IOP with development of glaucoma, and delayed wound healing may rarely occur. Stinging, redness, itching are common in eye.

It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical administration of corticosteroids would result in sufficient systemic absorption to produce detectable quantities in human milk. So caution should be exercised when the combination is administered to a nursing woman.

Prolonged use may result in overgrowth of non-susceptible organisms including fungi; in ocular hypertension, damage to the optic nerve, defects in visual acuity and posterior subcapsular cataract formation may occur. Patients wearing contact lenses must not use the drops during the time the lenses are worn. Avoid contaminating with the tip with material from fingers or other sources.

Not known and not likely.

Store at room temperature, protect from light. It is desirable that the contents should not be used more than one month after first opening of the bottle.