Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK
Hydrocortisone Tablets are indicated for replacement therapy in congenital adrenal hyperplasia in children.
Hydrocortisone Tablets are also used for the emergency treatment of severe bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema and anaphylaxis in adults and children.
Steroids should be used cautiously in the elderly, since adverse effects are enhanced in old age (see section 4.4).
When long term treatment is to be discontinued, the dose should be gradually reduced over a period of weeks or months, depending on dosage and duration of therapy (see section 4.4).
Undesirable effects may be minimised by using the lowest effective dose for the minimum period, and by administering the daily requirement as a single morning dose, or whenever possible, as a single morning dose on alternative days. Frequent patient review is required to titrate the dose against disease activity.
10-30 mg in divided doses is the normal daily requirement (see section 4.4).
In patients requiring replacement therapy, the daily dose should be given when practicable, in two doses. The first dose in the morning should be larger than the second dose in the evening, thus simulating the normal diurnal rhythm of cortisol secretion.
60-80 mg every 4-6 hours for 24 hours then gradually reduce the dose over several days.
For oral administration.
Reports of acute toxicity and/or deaths following hydrocortisone overdose are rare. No antidote is available.
Overdosage may cause nausea and vomiting, sodium and water retention, hyperglycaemia and occasional gastrointestinal bleeding.
Treatment need only be symptomatic although cimetidine (200-400 mg by slow intravenous injection every 6 hours) or ranitidine (50 mg by slow intravenous injection every 6 hours) may be administered to prevent gastrointestinal bleeding.
Amber glass bottle: 2 years.
PVC/aluminium foil blister pack: 1.5 years.
Do not store above 25°C.
Amber glass bottle with HDPE/polypropylene cap containing 100 tablets.
PVC/aluminium foil blister packs containing 30 tablets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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