Ocudex Ophthalmic Solution

Ocudex ophthalmic solution or ointment is indicated for the treatment of

• Allergic non-infectious blepharitis and conjunctivitis
• Non-infectious keratitis, punctate keratitis, disciform keratitis (provided the corneal surface is intact)
• Inflammation of the anterior uvea (iritis, iridocyclitis )
• Scleritis, episcleritis and myositis
• Post-operative management of cataract, strabismus & other ocular surgeries.

Dexamethasone is a cortisone derivative whose high activity due to the presence of methyl group in the 16-alpha position and of a fluorine atom in the 9-alpha position. The result is that 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. Therapeutic concentrations of Dexamethasone are found in both the cornea and aqueous humor 15-30 minutes after local application of single drop of 0.1% solution. These concentrations persist for 4-6 hours. The action of Dexamethasone is to inhibit the phospholipase A2, the first step in prostaglandin synthesis. Also, Dexamethasone inhibits the chemotactic infiltration of neutrophils into the site of inflammation.

Dexamethasone ophthalmic solution: Instill 1 drop into the conjunctival sac 3-5 times per day. Acute cases: up to 1 drop every hour if necessary.

Dexamethasone ophthalmic ointment: Apply a small amount into the conjunctival sac 3-4 times per day. Slowly close your eyes without blinking. Keep your eyes closed for 1 to 2 minutes. Minimize the dose when desired improvement is observed.

Specific drug interaction studies have not been conducted with Ocudex.

Injuries and ulcerating processes of the cornea, particularly those of bacterial or viral origin (herpes simplex, vaccinia), purulent infections of the conjunctiva and eyelids, tuberculosis, mycosis, glaucoma.

In predisposed patients, application of corticosteroids for a period of several weeks may cause a reversible rise in intraocular pressure. Pressure measurements at regular intervals are therefore essential.

Animal experiments with dexamethasone have shown adverse effect on the fetus. However, no control human studies are available. Dexamethasone ophthalmic preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Corticosteroids may mask, activate or aggravate an infection of the eye. If no improvement is seen after a few days application, other form of treatment should be used. Do not touch dropper tip to any surface as this may contaminated the ophthalmic solution or ointment.

Overdose through local or accidental oral administration is 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.