Dexamethasone is a synthetic fluorinated corticosteroid.
Dexamethasone or its sodium phosphate salt is applied topically to the eye or the ear. Potency of the sodium phosphate preparations is expressed in terms of dexamethasone phosphate. Care should be taken to avoid contamination of the tip of the ointment tube or dropper when the drug is used ophthalmically.
For use in the eye, 1 or 2 drops of dexamethasone ophthalmic suspension or dexamethasone sodium phosphate ophthalmic solution may be instilled into the conjunctival sac every hour during the day and every 2 hours during the night for initial therapy in severe cases. In mild or moderate inflammation or when a favorable response is attained in severe cases, dosage may be reduced to 1 drop every 4-8 hours. Alternatively, 1.25-2.5 cm of dexamethasone sodium phosphate ophthalmic ointment may be instilled into the conjunctival sac 3 or 4 times daily initially, and once or twice daily thereafter. The ointment also may be used at night in conjunction with daytime use of a suspension or solution to reduce the frequent applications required with the liquid dosage forms. If improvement does not occur within several days, the drug should be discontinued and other therapy begun. The duration of treatment depends on the type and severity of the disease and may range from a few days to several weeks; long-term therapy should be avoided. When the drug is discontinued, dosage should be gradually tapered to avoid exacerbation of the disease.
For application to the ear, the ear canal should be clean and dry. The pH of the preparation used must be neutral or acidic and should be used sparingly to prevent an accumulation of excess debris in the ear canal. No otic preparations of dexamethasone or its sodium phosphate salt are currently marketed in the US. However, 3 or 4 drops of dexamethasone sodium phosphate ophthalmic solution may be instilled into the ear canal 2 or 3 times daily. Alternatively, a gauze wick saturated with the solution may be packed into the aural canal, kept moist with the solution, and allowed to remain in the canal for 12-24 hours. This treatment may be repeated as needed. Duration of treatment may range from a few days to several weeks. After a favorable response is attained, dosage should be gradually reduced and the solution discontinued.
Dexamethasone is a synthetic fluorinated corticosteroid. Dexamethasone occurs as a white to practically white, odorless, crystalline powder and is practically insoluble in water and sparingly soluble in alcohol. Dexamethasone sodium phosphate occurs as a white or slightly yellow, crystalline powder that may have a slight odor of alcohol. Dexamethasone sodium phosphate is very hygroscopic and is freely soluble in water and slightly soluble in alcohol. The pH of dexamethasone ophthalmic suspension is 5-6. The pH of dexamethasone sodium phosphate ophthalmic solution is 6.6-7.8.
Dexamethasone sodium phosphate ophthalmic solution should be stored in tight, light-resistant containers.
Additional Information
For further information on chemistry, pharmacology, pharmacokinetics, uses, cautions, and dosage and administration of dexamethasone, see the EENT Corticosteroids General Statement 52:08.08. For systemic uses, see 68:04.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
---|---|---|---|---|
Ophthalmic | Ointment | Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, and Dexamethasone 0.1%* | ||
Alcon | ||||
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment | ||||
Suspension | Neomycin Sulfate 0.35% (of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per mL, and Dexamethasone 0.1%* | AK-Trol® (viscous) | ||
Maxitrol® (viscous) | Alcon | |||
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension | ||||
Ocu-Trol® | Ocumed |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
---|---|---|---|---|
Ophthalmic | Ointment | 0.3% Tobramycin and Dexamethasone 0.1% | Alcon | |
Suspension | 0.3% Tobramycin and Dexamethasone 0.1% | TobraDex® | Alcon |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
---|---|---|---|---|
Ophthalmic | Solution | 0.1% (of dexamethasone phosphate)* |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name