INFORMATION FOR HEALTH PROFESSIONALS
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Cortisone 5mg tablet: White, round, biconvex tablet having a diameter of 7.94mm and a breakline.
Cortisone 25mg tablet: White, round, flat tablet having a diameter of 9.5mm and a breakline.
Cortisone is a glucocorticoid secreted by the adrenal cortex. It exhibits anti-inflammatory immunosuppressant and mineralo-corticoid properties inhibiting the clinical manifestations of disease in a wide range of disorders.
Cortisone acetate is well absorbed after oral administration and the cortisone is rapidly metabolised in the liver to its active metabolite hydrocortisone.
The biological half-life of cortisone is only about 30 minutes.
The biological half-life of hydrocortisone is about 100 minutes.
Replacement therapy in Addisons disease or chronic adrenocortical insufficiency secondary to hypopituitarism.
As replacement therapy: The normal requirement is 12.5 - 50mg daily (usually 25mg in the morning and 12.5mg at night to mimic the circadian rhythm of the body).
Cortisone is contraindicated in patients with: peptic ulcer, osteoporosis, psychoses or severe psychoneuroses. Cortisone is usually contraindicated in the presence of acute infection, unless the patient is on long term cortisone whereupon the dose should be increased to counteract the increased stress of the infection.
Extreme caution should be exercised in the presence of congestive heart failure, diabetes mellitus, infectious disease, chronic renal failure and uraemia, and quiescent tuberculosis.
Abrupt withdrawal of cortisone after chronic use may precipitate acute adrenal insufficiency as a result of the suppression of corticotrophin at the anterior pituitary. Symptoms of adrenal insufficiency include malaise, muscle weakness, mental changes, muscle and joint pain, desquamation of the skin, dyspnoea, anorexia, nausea and vomiting, fever, hypoglycaemia, hypotension and dehydration.
The withdrawal symptoms may simulate a clinical relapse of the disease for which the patient is undergoing treatment. Withdrawal of cortisone should always be gradual, the rate depending upon the individual patients response, the dose and duration of therapy.
Corticosteroid induced elevation of blood pressure, salt and water retention and increased potassium excretion are possible with high doses of cortisone. Like all corticosteroids, cortisone increases calcium excretion.
Administration of live virus vaccines including smallpox is contraindicated in patients receiving immunosuppressive doses of dexamethasone since the expected serum antibody response may not be obtained. Immunisation procedures may, however, be undertaken in patients who are receiving corticosteroids as replacement therapy.
The administration of cortisone may mask some signs of infection or allow new infections to develop. Decreased resistance and inability to localise infection may be noted.
It has been observed that in cerebral malaria, the use of corticosteroids was associated with prolongation of coma and a higher incidence of pneumonia and gastrointestinal bleeding. Corticosteroids may activate latent amoebiasis, therefore, it is recommended that latent or active amoebiasis be ruled out before initiating corticosteroid treatment in any patient who has spent time in the tropics or has unexplained diarrhoea.
Prolonged corticosteroid use may produce posterior, sub-capsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi or viruses.
The use of cortisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis. The cortisone must be used in conjunction with an appropriate antituberculosis regimen.
Patients with hypothyroidism and cirrhosis manifest an enhanced effect if given corticosteroids.
Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.
The use of corticosteroids may cause psychic derangements ranging from euphoria, insomnia, mood swings, personality changes and severe depression to frank psychotic manifestations.
Corticosteroids should be used with caution in non-specific ulcerative colitis if there is a probability of impending perforation, abscess or other pyogenic infection.
Steroids may increase or decrease motility and number of spermatozoa in some patients.
Use in Pregnancy and Lactation: Since adequate information on the effects of cortisone on the developing child is not known, use in pregnancy or in women of child-bearing potential requires that the possible benefit of cortisone to the mother be weighed against the potential hazards to the mother and/or foetus.
Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects. Mothers should, therefore, be advised not to nurse if corticosteroids are required.
Patients who have received high or prolonged doses of cortisone should be given supplementary corticosteroids to overcome periods of stress caused by anaesthesia, surgery or trauma.
The use of cortisone may cause disturbance of electrolyte balance with retention of sodium and water and increased excretion of potassium. There may be disturbances of some aspects of metabolism including gluconeogenesis, calcium balance that may lead to osteoporosis and hyperglycaemia. Tissue repair and healing may be delayed, with an associated increase in the liability for infection.
Prolonged administration of cortisone may result in suppression of corticotrophin secretion and atrophy of the adrenal cortex. Large doses of hydrocortisone may produce symptoms typical of Cushing's disease.
Except for allergy the adverse effects listed have been associated with prolonged therapy and/or high doses:
Adrenal suppression
Allergy
Blood/vascular disorders:
Development of diabetes mellitus
Effects on bones and joints:
Effects on eyes:
Effects on growth:
Effects on heart:
Effects on muscle:
Effects on skin:
Effects on gastrointestinal tract:
Fluid and electrolyte disturbances:
Mental effects:
Metabolic effects:
Other effects:
Concurrent administration of barbiturates, phenylbutazone, phenytoin or rifampicin may reduce the effects of corticosteroids. The action of anti-coagulants may be reduced by corticosteroids.
Excessive potassium loss may occur if corticosteroids are administered concurrently with a potassium-depleting diuretic such as the thiazides or frusemide.
Adverse effects related to cortisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the cortisone dose should be reduced gradually.
Store at room temperature. Protect from light and moisture and keep out of reach of children.
Prescription Medicine.
Cortisone 5mg and 25mg tablets are available in quantities of 100 and 500.
Cortisone acetate is: 17α,21-dihydroxy-pregn-4-ene-3,11,20-trione 21 acetate. It has a molecular formula and weight of C23H30O6 and 402.5 respectively.
Other ingredients of the tablets are: Lactose, Talc, Magnesium Stearate, Maize Cornflour and Polyvinylpyrrolidinone K-30.
Douglas Pharmaceuticals Ltd
PO Box 45-027
Auckland 8
Ph: (09) 835-0660
Fax: (09) 835-0665
29 December 1998