Cortisone is an active pharmaceutical ingredient in the Glucocorticoids group (H02AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
CAOfficial regulatory label· Contraindications· revised March 22, 2025[1]
Tuberculosis, whether active or healed, is usually an absolute contraindication to steroid therapy. However, cortisone may be a life-saving measure to control the acute toxicity of overwhelming infection. It must be accompanied by specific antituberculosis therapy.
Should other infections exist, cortisone may be employed if the condition indicating its use is sufficiently severe. Appropriate antibiotic therapy must be given as well, usually in substantially larger doses than customary. Ocular herpes simplex and acute psychoses also are usually absolute contraindications to steroid therapy.
Relative contraindications are diverticulitis; fresh intestinal anastomosis; active or latent peptic ulcer; renal insufficiency; hypertension; thromboembolic tendencies; osteoporosis; diabetes mellitus; psychotic tendencies; acute or chronic infections including fungus and viral diseases; especially chickenpox and vaccinia; myasthenia gravis; and diminished cardiac reserve or congestive heart failure other than that due to acute rheumatic carditis.
[1]Health Canada (DPD) · 00280437 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Pregnancy is a relative contraindication to corticosteroid therapy, particularly during the first trimester, because fetal abnormalities have been observed in experimental animals. If it is necessary to give corticosteroids during pregnancy, the newborn infant should be watched closely for signs of hypoadrenalism and appropriate therapy should be instituted if such signs are present.
When any of these conditions exist, the risks of corticosteroid therapy must be weighed against the possible benefits. Intrasynovial and soft tissue injections should not be made into infected areas. PRECAUTIONS Cortisone should be given only with full cognizance of the characteristic activity of, and the varied responses to adrenocortical hormones.
Average and large doses can cause elevation of blood pressure, salt and water retention, and increased potassium and calcium excretion. Dietary salt restriction and potassium supplementation may be necessary. Salt and water retention is frequently followed by spontaneous diuresis on continued administration of cortisone.
In some instances, however, salt and water retention may be pronounced and occasionally may develop suddenly. Rarely, congestive heart failure, peripheral or pulmonary edema, ascites, or increased arterial pressure may develop if therapy is continued despite signs of fluid retention.
Hypokalemia can be detected early in the course of treatment by paying careful attention PrCORTISONE ACETATE Product Information Page 5 of 9 to the patient's symptoms and, if necessary, by doing an electrocardiogram, and by determining the CO2 combining power, and blood potassium and chloride levels.
It may possibly be avoided by a low sodium, high potassium diet. If any changes indicating metabolic alkalosis are noted, cortisone should be reduced or stopped, and potassium chloride administered. Diuretics may provoke a further dangerous loss of potassium.
Potassium salts must be avoided or undertaken with great caution in the presence of renal impairment or cardiac decompensation. Although hypokalemia is a relatively uncommon complication, it may occur quite suddenly. , 80 mg per day.
Important It is of importance to keep in mind that the tissues may be low in potassium even when blood potassium levels appear to be adequate. Since spontaneous remission of some diseases, such as rheumatoid arthritis, may occur during pregnancy, every effort should be made to avoid hormone treatment in pregnancy.
Corticosteroids may mask the signs of infection and enhance dissemination of the infecting organism. All patients receiving these substances should be watched for evidence of intercurrent infection. Should infection occur, vigorous, appropriate anti- infective therapy should be initiated.
Abrupt cessation of steroids should be avoided if possible because of the danger of superimposing adrenocortical insufficiency on the infectious process. Prolonged hormone therapy usually causes a reduction in the activity and size of the adrenal cortex.
Relative adrenocortical insufficiency upon discontinuation of therapy may be avoided by gradual reduction of dosage. A potentially critical degree of insufficiency may persist asymptomatically, however, for some time even after gradual discontinuation.
Therefore, if a patient is subjected to significant stress, such as surgery, trauma, or serious illness, while being treated or within 1 year (occasionally up to 2 years) after treatment has been terminated, hormone therapy should be augmented or reinstituted and continued for the duration of the stress and immediately following it.
Since mineralocorticoid secretion may be impaired, salt and/or desoxycorticosterone may be required conjunctively. It is preferable to use a soluble hormone preparation during immediate preoperative and postoperative periods. Corticosteroid therapy may cause hyperacidity or peptic ulcer.
Therefore, an ulcer regimen including an antacid is recommended as a prophylactic measure during prolonged therapy. Since appearance of peptic ulcer may be asymptomatic until PrCORTISONE ACETATE Product Information Page 6 of 9 perforation or hemorrhage occurs, X-rays should be taken when treatment is prolonged or when there is gastric distress, and when changes are noted an ulcer regimen is recommended.
Cortisone, like other glucocorticoids, may aggravate diabetes mellitus so that higher insulin dosage may become necessary, or it may precipitate manifestations of latent diabetes mellitus. When systemic adrenocorticosteroid preparations are used in the presence of glaucoma, intraocular pressure should be measured frequently, and optic nerve heads and visual fields observed.
Continued supervision of the patient after cessation of corticosteroids is essential, since there may be a […]
This is not medical advice. Consult a qualified healthcare professional.