CORTATE

What it is

CORTATE is a tablet formulation of cortisone acetate available in two strengths: 5 mg and 25 mg. Cortisone acetate is a mineralocorticoid and glucocorticoid. Naturally occurring glucocorticoids such as cortisone are used as replacement therapy in adrenocortical deficiency states and for their potent anti-inflammatory effects in disorders of many organ systems.

Approved indications

CORTATE is indicated for: — Addison's disease — Allergic disorders including status asthmaticus — Angioneurotic oedema, serum sickness and drug sensitisation — Periarteritis nodosa — Disseminated lupus erythematosus — Giant cell arteritis

Dosing overview

Dosage requirements are variable and must be individualised on the basis of the disease and the response of the patient. An initial dose of 25 mg once every 6 hours for an adult may be used, with the daily dosage reduced by 10 to 20 mg every few days once remission is achieved until an optimum maintenance dose results. Acute and severe sensitivity or anaphylactic states may require much larger doses.

Key safety warnings

A risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used, since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment. During prolonged corticosteroid therapy, adrenal suppression and atrophy may occur. Duration of treatment and dosage appear to be important factors in determining suppression of the pituitary adrenal axis. In some patients, the production of hydrocortisone in response to stress may be insufficient, and death may result. Therefore, withdrawal of corticosteroids should always be gradual. Abrupt withdrawal of corticosteroid therapy may precipitate acute adrenal insufficiency. The risk of gastrointestinal ulceration or hemorrhage is increased when alcohol is used concurrently with glucocorticoids. The possibility of development of osteoporosis should be an important consideration in initiating and managing corticosteroid therapy, especially in post menopausal women. Corticosteroids may mask some signs of infection, and there may be decreased resistance and inability to localise infection when corticosteroids are used. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. Prolonged use may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

Contraindications

CORTATE is contraindicated in hypersensitivity to cortisone acetate or any ingredients listed in the product information, and in uncontrolled infections.

PBS listing

CORTATE 5 mg tablets are listed on the PBS with a restriction status and an ex-manufacturer price of A$6.82. CORTATE 25 mg tablets are listed on the PBS with a restriction status and an ex-manufacturer price of A$11.59.

Regulatory history

CORTATE was first registered on the Australian Register of Therapeutic Goods on 21 October 1991, with both the 5 mg and 25 mg tablet strengths listed under licence category RE.