Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands
Corticosteroid.
For use as replacement therapy in primary, secondary or acute adrenocortical insufficiency.
Pre-operatively, and during serious trauma or illness in patients with known adrenal insufficiency or doubtful adrenocortical reserve.
Dosage must be individualized according to the response of the individual patient. The lowest possible dosage should be used.
Patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness, and the effect of stress (e.g., surgery, infection, trauma). During stress it may be necessary to increase the dosage temporarily.
If the drug is to be stopped after more than a few days of treatment, it should be withdrawn gradually.
In chronic adrenocortical insufficiency, a dosage of 20-30 mg a day is usually recommended, sometimes together with 4-6 g of sodium chloride or 50-300 micrograms of fludrocortisone daily. When immediate support is mandatory, one of the soluble adrenocortical corticosteroid preparations (e.g., dexamethasone sodium phosphate), which may be effective within minutes after parenteral administration, can be life-saving.
In chronic adrenocortical insufficiency, the dosage should be approximately 0.4 to 0.8 mg/kg/day in two or three divided doses, adjusted to the needs of the individual child.
Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious consequences of the common side effects of corticosteroids in old age, especially osteoporosis, diabetes, hypertension, susceptibility to infection and thinning of the skin.
Anaphylactic and hypersensitivity reactions may be treated with adrenaline, positive-pressure artificial respiration and aminophylline. The patient should be kept warm and quiet.
Treatment is probably not indicated for reactions due to chronic poisoning unless the patient has a condition that would render him unusually susceptible to ill effects from corticosteroids. In this case, symptomatic treatment should be instituted as necessary.
3 years.
Store below 25°C. Store in the original package.
Blister packs of opaque PVC lidded with aluminium foil containing 30 tablets, presented in an outer carton.
No special requirements.
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