Product Description.:
MAXIDEX? 0.1% (dexamethasone ophthalmic suspension) is an adrenocortical steroid prepared as a sterile topical ophthalmic suspension.
Each mL contains: Active: dexamethasone 0.1%. Preservative: benzalkonium chloride 0.01%. Vehicle: hypromellose 0.5%. Inactives: sodium chloride, dibasic sodium phosphate, polysorbate 80, edetate disodium, citric acid and/or sodium hydroxide (to adjust pH), purified water.
INDICATIONS AND USAGE
Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
CONTRAINDICATIONS
Contraindicated in epithelial herpes simplex (dendritic keratitis), vaccinia, varicella, and most other viral diseases of the cornea and conjunctiva tuberculosis of the eye fungal disease of ocular structures and in those persons who have shown hypersensitivity to any component of this preparation.
WARNINGS
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 and 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.
PRECAUTIONS
General
FOR TOPICAL OPHTHALMIC USE ONLY. The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing.
Information for Patients
Do not touch dropper tip to any surface, as this may contaminate the contents. The preservative in MAXIDEX? (dexamethasone ophthalmic suspension), benzalkonium chloride, may be absorbed by soft contact lenses. MAXIDEX? (dexamethasone ophthalmic suspension) should not be administered while wearing soft contact lenses.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of MAXIDEX? (dexamethasone ophthalmic suspension).
