Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Atnahs Pharma UK Ltd., Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, UK
Diagnostic test for the investigation of adrenocortical insufficiency.
This preparation of Synacthen is intended for administration for diagnostic purposes only as a single intramuscular or intravenous dose; it is not to be used for repeated therapeutic administration.
The 30-minute Synacthen diagnostic test: This test is based on measurement of the plasma cortisol concentration immediately before and exactly 30 minutes after an intramuscular or intravenous injection of 250 micrograms (1ml) Synacthen. Adrenocortical function can be regarded as normal if the post-injection rise in plasma cortisol concentration increases by 200 nmol/litre (70 micrograms/litre), i.e. if the value 30 minutes after injection is >500 nmol/litre (180 micrograms/litre), adrenocortical function is regarded as normal.
All the plasma samples should be stored in a refrigerator until plasma cortisol level estimation.
Where the 30-minute test has yielded inconclusive results, or where it is desired to determine the functional reserve of the adrenal cortex, a 5-hour test can be performed with Synacthen Depot (see separate Summary of Product Characteristics). Furthermore, a 3-day test with Synacthen Depot may be used to differentiate between primary and secondary adrenocortical insufficiency.
An intravenous dose of 250micrograms/1.73m² body surface area has been suggested. Thus for children aged 5 to 7 years, approximately half the adult dose will be adequate. For more accurate dosing of other ages, standard body surface area tables should be consulted.
There is no evidence to suggest that dosage should be different in the elderly.
Overdosage is unlikely to be a problem when the product is used as a single dose for diagnostic purposes.
4 years.
Synacthen should be protected from light and stored in a refrigerator (2-8°C).
The ampoules are colourless glass Ph.Eur type I.
Synacthen Ampoules comes in cardboard boxes of 1 ampoule and 5 ampoules of 1 ml.
Not all pack sizes may be marketed.
Any unused product or waste material should be disposed of in accordance with local requirements.
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