Dexamethasone 1mg Information
Dexamethasone 1mg (Dexamethasone sodium phosphate) Description:
Dexamethasone Sodium Phosphate Ophthalmic Solution USP, is a sterile, topical steroid solution. The active ingredient is represented by the following structural formula:
CHFNaOP
Mol. wt. 516.41
Chemical Name: 9-fluoro-11β, 17-dihydroxy-16α-methyl-21-[phosphonooxy]pregna-1, 4-diene-3,20-dione disodium salt.
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. It is approximately three thousand times more soluble at 25°C than hydrocortisone.
Dexamethasone 1mg (Dexamethasone sodium phosphate) Clinical Pharmacology:
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 have been advanced.
Dexamethasone 1mg (Dexamethasone sodium phosphate) Indications And Usage:
For the treatment of the following conditions:
Dexamethasone 1mg (Dexamethasone sodium phosphate) Contraindications:
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 or auricular structures.
Hypersensitivity to any component of this product, including sulfites (see ).
Perforation of a drum membrane.
Dexamethasone 1mg (Dexamethasone sodium phosphate) 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 or ear, 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.
This product contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Dexamethasone 1mg (Dexamethasone sodium phosphate) Precautions:
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 )
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 solutions. (See )
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's advice concerning the continued use of the present multidose container.
One of the preservatives in dexamethasone sodium phosphate ophthalmic solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling dexamethasone sodium phosphate ophthalmic solution before they insert their lenses.
Pregnancy Category C.
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. Dexamethasone sodium phosphate ophthalmic solution 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.
Dexamethasone 1mg (Dexamethasone sodium phosphate) Adverse Reactions:
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.
Dexamethasone 1mg (Dexamethasone sodium phosphate) Dosage And Administration:
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.
If preferred, the aural canal may be packed with a gauze wick saturated with solution. Keep the wick moist with the preparation and remove from the ear after 12 to 24 hours. Treatment may be repeated as often as necessary at the discretion of the physician.
Dexamethasone 1mg (Dexamethasone sodium phosphate) How Supplied:
Dexamethasone Sodium Phosphate Ophthalmic Solution USP 0.1%, is supplied in a plastic squeeze bottle with a controlled drop tip in the following size: 5 mL - Prod. No. 04407
KEEP OUT OF REACH OF CHILDREN.
Tampa, FL 33637
©Bausch & Lomb Incorporated
9100200 9100300
Dexamethasone 1mg (Dexamethasone sodium phosphate) Package/label Principal Display Panel
NDC 0904-3006-05
Dexamethasone Sodium Phosphate Ophthalmic Solution USP, (Sterile)
0.1% Dexamethasone Phosphate Equivalent
FOR TOPICAL APPLICATION IN THE EYE OR EAR.
5 mL
MAJOR PHARMACEUTICALS
