Following are the changes to the SPC:
Section 4.4
Corticosteroid effects may be enhanced in patients with hypothyroidism or decreased in hyperthyroid patients.
Section 4.5
Replaced by the following:
Amphotericin B injection and potassium-depleting agents: Patients should be observed for hypokalemia.
Anticholinesterases: Effects of anticholinesterase agents may be antogonised.
Anticoagulants, oral: Corticosteroids may potentiate or decrease anticoagulant action. Patients receiving oral anticoagulants and corticosteroids should therefore be closely monitored.
Antidiabetics: Corticosteroids may increase blood glucose; diabetic control should be monitored, especially when corticosteroids are initiated, discontinued, or changed in dosage.
Antihypertensives, including diuretics: corticosteroids antagonise the effects of antihypertensives and diuretics. The hypokalaemic effect of diuretics, including acetazolamide, is enhanced.
Anti-tubercular drugs: Isoniazid serum concentrations may be decreased.
Cyclosporin: Monitor for evidence of increased toxicity of cyclosporin when the two are used concurrently.
Digitalis glycosides: Co-administration may enhance the possibility of digitalis toxicity.
Oestrogens, include oral contraceptives: Corticosteroid half-life and concentration may be increased and clearance decreased.
Hepatic Enzyme Inducers (e.g. aminoglutethemide, barbiturates, carbamazepine, phenytoin, primidone, rifabutin, rifampicin): There may be increased metabolic clearance of Florinef. Patients should be carefully observed for possible diminished effect of steroid, and the dosage should be adjusted accordingly.
Human growth hormone: The growth-promoting effect may be inhibited.
Ketoconazole: Corticosteroid clearance may be decreased, resulting in increased effects.
Nondepolarising muscle relaxants: Corticosteroids may decrease or enhance the neuromuscular blocking action.
Nonsteroidal anti-inflammatory agents (NSAIDS): Corticosteroids may increase the incidence and/or severity of GI bleeding and ulceration associated with NSAIDS. Also, corticosteroids can reduce serum salicylate levels and therefore decrease their effectiveness. Conversely, discontinuing corticosteroids during high-dose salicylate therapy may result in salicylate toxicity. Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinaemia.
Thyroid drugs: Metabolic clearance of adrenocorticoids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in adrenocorticoid dosage.
Vaccines: Neurological complications and lack of antibody response may occur when patients taking corticosteroids are vaccinated. (See 4.4 Special Warnings and Special Precautions for Use.)
Section 4.8
Added:
Hypersensitivity: Anaphylatic reactions, angiodema, rash, pruritus and urticaria, particularly where there is a history of drug allergies.
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