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Dexamethasone sodium phosphate is 9-fluoro-11(beta),17-dihydroxy-16(alpha) -methyl-21-(phosphonooxy)pregna-1,4-diene-3,20-dione disodium salt. Its empirical formula is C 22 H 28 FNa 2 O 8 P and its structural formula is:
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Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic. Dexamethasone is a synthetic analog of naturally occurring glucocorticoids (hydrocortisone and cortisone). Dexamethasone sodium phosphate is a water soluble, inorganic ester of dexamethasone. Its molecular weight is 516.41.
Sterile Ophthalmic Ointment DECADRON* Phosphate (Dexamethasone Sodium Phosphate) is a topical steroid ointment containing dexamethasone sodium phosphate equivalent to 0.5 mg (0.05%) dexamethasone phosphate in each gram. Inactive ingredients: white petrolatum and mineral oil.
Dexamethasone sodium phosphate is an inorganic ester of dexamethasone.
*Registered trademark of MERCK & CO., INC.
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.
For the treatment of the following conditions:
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 conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical or thermal burns, or penetration of foreign bodies.
Epithelial herpes simplex keratitis (dendritic keratitis).
Acute infectious stages of vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva.
Mycobacterial infection of the eye.
Fungal diseases of ocular structures.
Hypersensitivity to a component of the medication.
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.
General
The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing.
There have been reports of bacterial keratitis associated with the use of multiple dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. (See PRECAUTIONS , Information for Patients . )
Information for Patients
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures.
Patients should also be instructed that ocular preparations, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated preparations. (See PRECAUTIONS , General . )
Patients should also be advised that if they develop an intercurrent ocular condition (e.g., trauma, ocular surgery or infection), they should immediately seek their physician' advice concerning the continued use of the present multidose container.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of Ophthalmic Ointment DECADRON Phosphate.
Pregnancy
Pregnancy Category C. Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose.
In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate. In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc.
There are no adequate or well-controlled studies in pregnant women. Ophthalmic Ointment DECADRON Phosphate should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.
Nursing Mothers
Topically applied steroids are absorbed systemically. Therefore, because of the potential for serious adverse reactions in nursing infants from dexamethasone sodium phosphate, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Glaucoma with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, 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.
The duration of treatment will vary with the type of lesion and may extend from a few days to several weeks, according to therapeutic response. Relapses, more common in chronic active lesions than in self-limited conditions, usually respond to retreatment.
Apply a thin coating of ointment three or four times a day. When a favorable response is observed, reduce the number of daily applications to two, and later to one a day as a maintenance dose if this is sufficient to control symptoms.
Ophthalmic Ointment DECADRON Phosphate is particularly convenient when an eye pad is used. It may also be the preparation of choice for patients in whom therapeutic benefit depends on prolonged contact of the active ingredients with ocular tissues.
No. 7615--0.05% Sterile Ophthalmic Ointment DECADRON Phosphate is a clear unctuous ointment and is supplied as follows:
NDC 0006-7615-04 in 3.5 g tubes
(6505-00-961-5508 0.05% 3.5 g).
7612332 Issued October 1996
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