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Dexamethasone Sodium Phosphate

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Description

Dexamethasone Sodium Phosphate

Dexamethasone Sodium Phosphate is used to treat inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe (conjunctivitis, keratitis, iritis, and cyclitis).  Made by Bausch & Lomb.

This medication requires a prescription from your veterinarian.

Dexamethasone Sodium Phosphate 0.1% Ophthalmic solution is a drug labeled for human use that is used extra-label in the treatment of ocular and periocular inflammatory conditions in veterinary patients.

Dexamethasone sodium phosphate ophthalmic solution is a clear, colorless to pale yellow topical steroid solution for ophthalmic or otic administration.

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 in water at 25°C than hydrocortisone.

Dexamethasone Sodium Phosphate

Dexamethasone Sodium Phosphate (structural formula)

C22H28FNa2O8P

Mol. wt. 516.41

Chemical Name: 9-fluoro-11β, 17-dihydroxy-16α-methyl-21-[phosphonooxy]pregna-1,4-diene-3, 20-dione disodium salt.

Each mL contains: Active: Dexamethasone Sodium Phosphate [equivalent to 1 mg (0.1%) Dexamethasone Phosphate]. Inactives:Sodium Citrate, Sodium Borate, Creatinine, Polysorbate 80, Edetate Disodium Dihydrate, Purified Water. Hydrochloric Acid may be added to adjust pH (6.6- 7.8). Preservatives Added: Sodium Bisulfite 0.1%, Phenylethyl Alcohol 0.25%, Benzalkonium Chloride 0.02%.

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 has been advanced.

INDICATIONS AND USAGE

For the treatment of the following conditions:

Ophthalmic: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.

Otic: Steroid responsive inflammatory conditions of the external auditory meatus, such as allergic otitis externa, selected purulent and nonpurulent infective otitis externa when the hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.

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 WARNINGS).

Perforation of a drum membrane.

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 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 PRECAUTIONS, 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 solutions, 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 PRECAUTIONS, General).

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