Description

A sterile ophthalmic suspension each ml contains:

Active: Dexamethasone 0.1%.
Vehicle: Hydroxypropyl Methylcellulose 0.5%.
Preservative: Benzalkonium Chloride 0.01 %.

A sterile ophthalmic ointment each gram contains:

Active: Dexamethasone 0.1%.
Inactive: Mineral Oil, White Petrolatum.

Action

Dexamethasone is a potent synthetic corticosteroid. It has been demonstrated by animal and human studies based on oral application to possess approximately six to seven times the potency of prednisolone and at least 30 times the potency of cortisone. The potency of this compound is accomplished by the addition of a methyl radical and a fluorine atom to the prednisolone radical.

Indications

Isopto-Maxidex® is indicated in the management of conditions generally responsive to corticosteroids such as:

Certain inflammatory eye conditions of the anterior segment-acute and chronic anterior uveitis, iridocyclitis, iritis, and cyclitis, herpes zoster ophthalmicus.
Certain external diseases such as phlyctenular kerato-conjunctivitis: nonpurulent conjunctivitis, including vernal, allergic, catarrhal. It is very effective where allergy is a main factor.
Recurrent marginal ulceration of toxle or allergic etiology.
Thermal and chemical burns.
Post-operatively to reduce inflammatory reactions.

Contraindications

Contraindicated in acute Herpes simplex, vaccina, varicella, and most other viral diseases of the cornea and conjunctiva, tuberculosis; fungal disease; acute purulent untreated infections which, like other diseases caused by micro-organisms, may be masked or enhanced by the presence of the steroid.

Warnings

Intensive or prolonged topical corticosteroid therapy is a possible factor in the formation of posterior subcapsular cataracts.

Although topical steroids have not been reported to have an adverse effect on pregnancy, the safety of their use in pregnancy has not absolutely been established. Therefore, it is advisable not to use this product for long-term treatments on pregnant patients.

Precautions

During the course of therapy, if the inflammatory reaction does not respond within a reasonable period, other forms of therapy should be instituted.
A few individuals may be sensitive to one or more of the components of this product. If any reaction indicating sensitivity is observed, discontinue use.
The extensive use of steroids may cause systemic side effects; and ocular herpes simplex has occurred in patients under systemic or local corticosteroid therapy for other conditions.

Adverse Reactions

Extended use of topical steroids may cause increased intraocular pressure in certain individuals. It is advisable that intraocular pressure be checked frequently.

In those diseases causing thinning of the cornea, perforation has been known to occur with the use of topical steroids.

Dosage And Administration

Isopto-Maxidex® suspension

Topical application: (One or two drops in the conjunctival sac).

SEVERE OR ACUTE INFLAMMATION: Every 30 to 60 minutes as initial therapy, reducing the dosage when favorable response is observed to every two to four hours. Further reduction may be made to one drop three or four times daily if sufficient to control inflammation. If favorable response is not obtained in three to four days, additional systemic or conjunctival therapy may be indicated.

CHRONIC INFLAMMATION: Every three to six hours, or as frequently as necessary.

ALLERGIES OR MINOR INFLAMMATION: Every three to four hours until the desired response is obtained.

Isopto-Maxidex Oinment

Apply ribbon of ointment into the conjunctival sac(s) up to four times daily. When a favorable response is observed, dosage may be reduced gradually to once a day application for several days.

How Supplied

Suspension in 5 ml and 15 ml sterile Drop-tainer® package. Each ml contains 1 mg of Dexamethasone. Ointment in 3.5 g ophthalmic tube.