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Questions & Answers
Side Effects & Adverse Reactions
Do not insert any part of the aerosol container directly into the anus. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F. Because Cortifoam® is not expelled, systemic hydrocortisone absorption may be greater from Cortifoam® than from corticosteroid enema formulations. If there is not evidence of clinical or proctologic improvement within two or three weeks after starting Cortifoam® therapy, or if the patient's condition worsens, discontinue the drug.
Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS).
Corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.
Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.
Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.
Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Cortifoam® is indicated as adjunctive therapy in the topical treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas.
There is currently no drug history available for this drug.
Cortifoam® (hydrocortisone acetate rectal aerosol) 10% Rectal Foam contains hydrocortisone acetate 10% in a base containing propylene glycol, emulsifying wax, polyoxyethylene-10-stearyl ether, cetyl alcohol, methylparaben, propylparaben, trolamine, purified water and inert propellants: isobutane and propane.
Each application delivers approximately 900 mg of foam containing 80 mg of hydrocortisone (90 mg of hydrocortisone acetate).
The molecular weight of hydrocortisone acetate is 404.50. It is designated chemically as pregn-4-ene-3,20-dione,21-(acetyloxy)-11,17-dihydroxy-,(11β)-. The empirical formula is C23H32O6 and the structural formula is:
Hydrocortisone acetate, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is insoluble in water (1 mg/100 mL) and slightly soluble in alcohol and chloroform.