Cortisone Acetate

General

Alternate-day Therapy

• If used for prolonged therapy, consider an alternate-day dosage regimen.a c

• Alternate-day therapy in which a single dose is administered every other morning is the dosage regimen of choice for long-term oral glucocorticoid treatment of most conditions.c This regimen provides relief of symptoms while minimizing adrenal suppression, protein catabolism, and other adverse effects.c

• If alternate-day therapy is preferred, only use a “short-acting” glucocorticoid that suppresses the HPA axis <1.5 days after a single oral dose (e.g., cortisone, hydrocortisone, prednisone, methylprednisolone).c

• Some conditions (e.g., rheumatoid arthritis, ulcerative colitis) require daily glucocorticoid therapy because symptoms of the underlying disease cannot be controlled by alternate-day therapy.c

Discontinuance of Therapy

• Following long-term therapy with pharmacologic dosages, very gradually withdraw systemic glucocorticoids until recovery of HPA-axis function occurs.a c e (See Adrenocortical Insufficiency under Cautions.)

• A steroid withdrawal syndrome consisting of lethargy, fever, myalgia, and arthralgia can develop following abrupt discontinuance.e Symptoms often occur without evidence of adrenal insufficiency (while plasma glucocorticoid concentrations were still high but were falling rapidly).e

• In one suggested regimen, decrease by 12.5–25 mg every 3–7 days until the physiologic dose (25 mg) is reached.c

• Other recommendations state that decrements usually should not exceed 12.5 mg every 1–2 weeks; in alternate-day therapy, decrements should not exceed 25 mg every 1–2 weeks.c

• When physiologic dosage (25 mg) is reached, substitute single 20-mg oral morning doses of hydrocortisone.c After 2–4 weeks, may decrease hydrocortisone dosage by 2.5 mg every week until a single morning dosage of 10 mg daily is reached.c

• If disease flares during withdrawal, increase dosage and withdraw more gradually.c

• If used for only brief periods (a few days) in emergency situations, may reduce and discontinue dosage quite rapidly.c

• For certain acute allergic conditions (e.g., contact dermatitis such as poison ivy), glucocorticoids may be administered short term (e.g., for 6 days).c Administer a high dose on the first day of therapy, then withdraw therapy by tapering the dosage over several days.c

• Exercise caution when transferring from systemic glucocorticoid to oral or nasal inhalation corticosteroid therapy.c

Administration

Oral Administration

Administer orally as tablets.a b e

To decrease gastric irritation, take immediately before, during, or after meals, or with food or milk.c e Some experts recommend antacids between meals to help prevent peptic ulcer formation.e

Dosage

Available as cortisone acetate; dosage expressed in terms of the salt.a

Individualize dosage carefully according to the diagnosis, severity, prognosis, probable duration of the disease, and patient response and tolerance.c e

After a satisfactory response is obtained, decrease dosage in small decrements to the lowest level that maintains an adequate clinical response, and discontinue the drug as soon as possible.a b c e

Long-term therapy should not be initiated without due consideration of its risks.c If necessary, administer in the smallest dosage possible.c Continual monitoring is recommended for signs that indicate dosage adjustment is necessary (e.g., remission or exacerbations of the disease, stress [surgery, infection, trauma]).a b c e

High or massive dosages may be required in the treatment of pemphigus, pemphigoid†, exfoliative dermatitis, bullous dermatitis herpetiformis, severe erythema multiforme, or mycosis fungoides.c Early initiation of systemic glucocorticoid therapy may be life-saving in pemphigus vulgaris and pemphigoid†.c Reduce dosage gradually to the lowest effective level, but discontinuance may not be possible.c

Pediatric Patients

Base pediatric dosage on severity of the disease and patient response rather than on strict adherence to dosage indicated by age, body weight, or body surface area.a

0.7–10 mg/kg daily or 20–300 mg/m2 daily in 4 divided doses.a

Adults

Initially, 25–300 mg daily.a b e

Special Populations

Hepatic Impairment

Cirrhosis: Lower dosage may be required; select dosage with caution.e (See Hepatic Impairment under Cautions.)

Renal Impairment

No specific dosage recommendations at this time.b e

Geriatric Patients

No specific dosage recommendations at this time.b e

Thyroid Conditions

Changes in thyroid status may necessitate adjustment of glucocorticoid dosage.c (See Special Populations under Pharmacokinetics.)

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.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name