Dexamethasone sodium phosphate ophthalmic

MAXIDEX® (dexamethasone sodium phosphate) is an adrenocortical steroid prepared as a sterile ophthalmic ointment. The active ingredient is represented by the chemical structure:

Established Name

Dexamethasone Sodium Phosphate

Chemical Name

Pregn-4-ene-3,20-dione,9-fluoro-11,17-dihydroxy-16-methyl-21-(phos phonoxy)-, dis odium s alt, (11β,16α)-.

Each gram contains:

Active: Dexamethasone Sodium Phosphate equivalent to Dexamethasone Phosphate 0.5 mg (0.05%)
Inactive: Mineral Oil.

White Petrolatum. DM-00

The following adverse reactions have been reported: glaucoma with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infections from pathogens including herpes simplex, and perforation of the globe. Rarely, filtering blebs have been reported when topical steroids have been used following cataract surgery. Rarely, stinging or burning may occur.

Prolonged use may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Prolonged use may suppress the host response an thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection. If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Employment of corticosteroid medication in the treatment of herpes simplex other than epithelial herpes simplex keratitis, in which it is contraindicated, requires great caution; periodic slit-lamp microscopy is essential.

Dexamethasone sodium phosphate suppresses the inflammatory response to a variety of agents and it probably delays or slows healing. No generally accepted explanation of these steroid properties has been advanced.

Do not touch tube tip to any surface, as this may contaminate the contents.