Dexamethasone Sodium Phosphate Solution label

Dexamethasone Sodium Phosphate Solution

Dexamethasone Sodium Phosphate Solution Recall

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Side Effects & Adverse Reactions

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.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

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 punctuate 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.

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History

There is currently no drug history available for this drug.

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Other Information

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 is 9-fluoro-11 β, 17-dihydroxy-16α-methyl-21- (phosphonooxy)pregna-1,4-diene-3,20-dione disodium salt and has the following structural formula:

Chemical Structure

Each mL contains: Active:dexamethasone sodium phosphate equivalent to 1mg (0.1%) dexamethasone phosphate. Preservative:benzalkonium chloride 0.01%. Inactives:monobasic sodium phosphate, sodium chloride, dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate and/or dibasic sodium phosphate to adjust pH (6.6 to 7.8) and water for injection.

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Dexamethasone Sodium Phosphate Solution Recall
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Dexamethasone Sodium Phosphate Solution Manufacturers

  • Rebel Distributors Corp
    Dexamethasone Sodium Phosphate Solution | Rebel Distributors Corp
    No Recall

    Dexamethasone Sodium Phosphate Solution | Rebel Distributors Corp

    Dexamethasone Sodium Phosphate Solution | Rebel Distributors Corp

    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 treatment.

    Eye

    Instill one or two drops of solution into the conjunctival sac every hour during the day and every two hours during the night as initial therapy. When a favorable response is observed, reduce dosage to one drop every four hours. Later, further reduction in dosage to one drop three or four times daily may suffice to control symptoms.

    Ear

    Clean the aural canal thoroughly and sponge dry. Instill the solution directly into the aural canal. A suggested initial dosage is three or four drops two or three times a day. When a favorable response is obtained, reduce dosage gradually and eventually discontinue.

    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.

  • Physicians Total Care, Inc.
    Dexamethasone Sodium Phosphate Solution | Physicians Total Care, Inc.
    No Recall

    Dexamethasone Sodium Phosphate Solution | Physicians Total Care, Inc.

    Dexamethasone Sodium Phosphate Solution | Physicians Total Care, Inc.

    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 treatment.

    Eye

    Instill one or two drops of solution into the conjunctival sac every hour during the day and every two hours during the night as initial therapy. When a favorable response is observed, reduce dosage to one drop every four hours. Later, further reduction in dosage to one drop three or four times daily may suffice to control symptoms.

    Ear

    Clean the aural canal thoroughly and sponge dry. Instill the solution directly into the aural canal. A suggested initial dosage is three or four drops two or three times a day. When a favorable response is obtained, reduce dosage gradually and eventually discontinue.

    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.

  • Dispensing Solutions, Inc.
    Dexamethasone Sodium Phosphate Solution | Dispensing Solutions, Inc.
    No Recall

    Dexamethasone Sodium Phosphate Solution | Dispensing Solutions, Inc.

    Dexamethasone Sodium Phosphate Solution | Dispensing Solutions, Inc.

    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 treatment.

    Eye: Instill one or two drops of solution into the conjunctival sac every hour during the day and every two hours during the night as initial therapy. When a favorable response is observed, reduce dosage to one drop every four hours. Later, further reduction in dosage to one drop three or four times daily may suffice to control symptoms.

    Ear: Clean the aural canal thoroughly and sponge dry. Instill the solution directly into the aural canal. A suggested initial dosage is three or four drops two or three times a day. When a favorable response is obtained, reduce dosage gradually and eventually discontinue. 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.

  • Sandoz Inc
    Dexamethasone Sodium Phosphate Solution | Sandoz Inc
    No Recall

    Dexamethasone Sodium Phosphate Solution | Sandoz Inc

    Dexamethasone Sodium Phosphate Solution | Sandoz Inc

    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 treatment.

    Eye: Instill one or two drops of solution into the conjunctival sac every hour during the day and every two hours during the night as initial therapy. When a favorable response is observed, reduce dosage to one drop every four hours. Later, further reduction in dosage to one drop three or four times daily may suffice to control symptoms.

    Ear: Clean the aural canal thoroughly and sponge dry. Instill the solution directly into the aural canal. A suggested initial dosage is three or four drops two or three times a day. When a favorable response is obtained, reduce dosage gradually and eventually discontinue.

    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.

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