AHFS Class:

• Corticosteroids 52:08.08

Generic Name(s):

• Hydrocortisone

• Hydrocortisone Acetate

• Colistin and Neomycin Sulfates and Hydrocortisone Acetate

• Hydrocortisone and Acetic Acid

• Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone

• Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Acetate

• Neomycin and Polymyxin B Sulfates and Hydrocortisone

• Oxytetracycline Hydrochloride and Hydrocortisone Acetate

• Polymyxin B Sulfates and Hydrocortisone

Hydrocortisone is a corticosteroid secreted by the adrenal cortex.

Hydrocortisone or its acetate ester is applied topically to the eye or ear. For ophthalmic or otic use, hydrocortisone and hydrocortisone acetate currently are commercially available only in fixed-combination preparations.

Care should be taken to avoid contamination of the tip of the ointment tube or dropper of the solution or suspension when the drug is used ophthalmically.

Ophthalmic

For use in the eye in fixed combination with neomycin sulfate and polymyxin B sulfate, the usual dosage of ophthalmic suspensions containing hydrocortisone is 1 or 2 drops applied to the affected eye every 3 or 4 hours, or more frequently if necessary depending on the severity of the condition. When the ophthalmic ointment containing hydrocortisone in fixed combination with bacitracin zinc, neomycin sulfate, and polymyxin B sulfate is used, a small amount of the ointment is instilled into the conjunctival sac every 3 or 4 hours depending on the severity of the condition. The usual dosage of ophthalmic suspensions containing hydrocortisone acetate in fixed combination with oxytetracycline hydrochloride is 1 or 2 drops applied to the affected eye 3 times daily.

Ophthalmic ointments also may be used at night in conjunction with daytime use of a solution or suspension to reduce the frequent applications required with the liquid dosage form. The lowest effective concentration should be used and, 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.

Otic

For application to the ear, the ear canal should be clean and dry, and the pH of the otic preparation must be neutral or acidic. Otic preparations should be used sparingly to prevent an accumulation of excess debris in the ear canal.

For use in the ear in fixed combination with colistin, neomycin, and/or polymyxin B), 4 or 5 drops of otic solutions or suspensions containing hydrocortisone or hydrocortisone acetate may be instilled into the ear canal 3 or 4 times daily in adults; because of the smaller capacity of the ear canal, 3 drops 3 or 4 times daily is suggested for infants and children. Alternatively, a gauze wick saturated with the solution or suspension may be packed into the ear canal, kept moist with solution or suspension (e.g., every 4 hours), and allowed to remain in the canal for 12-24 hours; the wick should be replaced at least every 24 hours. Alternatively, 3 drops of otic suspensions containing hydrocortisone in fixed combination with ciprofloxacin may be instilled into the ear canal twice daily in adults and children.

Duration of treatment may range from a few days to several weeks.

Chemistry and Stability

Chemistry

Hydrocortisone is a corticosteroid secreted by the adrenal cortex. For ophthalmic and otic use, hydrocortisone and its acetate salt currently are commercially available only in fixed-combination preparations. Hydrocortisone and hydrocortisone acetate occur as white to practically white, odorless, crystalline powders. Hydrocortisone is very slightly soluble in water and sparingly soluble in alcohol. Hydrocortisone acetate is insoluble in water and slightly soluble in alcohol.

Stability

Hydrocortisone and hydrocortisone acetate ophthalmic and otic preparations should be stored according to the manufacturers' recommendations on the labeling.

Additional Information

For further information on chemistry, pharmacology, pharmacokinetics, uses, cautions, and dosage and administration of hydrocortisone, see the EENT Corticosteroids General Statement 52:08.08. For systemic and other topical uses, see 68:04 and 84:06.08, respectively. The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.