Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Atnahs Pharma UK Ltd., Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, UK
Synacthen Depot should normally only be used for short-term therapy in conditions for which glucocorticoids are indicated in principle, for example, in ulcerative colitis and Crohn’s disease, juvenile rheumatoid arthritis, or as adjunct therapy in patients with rheumatoid arthritis and osteoarthrosis. Synacthen Depot may be particularly useful in patients unable to tolerate oral glucocorticoid therapy or in patients where normal therapeutic doses of glucocorticoids have been ineffective.
As a diagnostic aid for the investigation of adrenocortical insufficiency.
Initially, daily doses of Synacthen Depot should be given but after approximately 3 days, intermittent doses may be given.
Initially 1mg intramuscularly daily or 1mg every 12 hours in acute cases. After the acute symptoms of the disease have disappeared, treatment may be continued at a dose of 1mg every 2 to 3 days; in patients who respond well, the dosage may be reduced to 0.5mg every 2 to 3 days or 1mg per week.
Premature babies or neonates (less than 1 month): Due to the presence of benzyl alcohol, Synacthen Depot is contraindicated in premature babies and in neonates (less than one month). (See section 4.3 Contraindications).
Children aged 3 to 5 years: Initially 0.25 to 0.5mg intramuscularly daily; the maintenance dose is 0.25 to 0.5mg every 2 to 8 days.
Children aged 5 to 12 years: nitially 0.25 to 1mg intramuscularly daily; the maintenance dose is 0.25 to 1mg every 2 to 8 days.
There is no evidence to suggest that dosage should be different in the elderly.
In cases of suspected adrenocortical insufficiency, where the 30-minute diagnostic test with Synacthen ampoules (see Synacthen Ampoules 250 mcg Summary of Product Characteristics) has yielded inconclusive results or where it is desired to determine the functional reserve of the adrenal cortex, a 5-hour test with Synacthen Depot may be performed.
This test is based on measurement of the plasma cortisol concentration before and exactly 30 minutes, 1, 2, 3, 4 and 5 hours after an intramuscular injection of 1mg Synacthen Depot. If adrenocortical function is normal, baseline plasma cortisol (normally >200 nmol/L) doubles in the first hour and then continues to rise slowly, as follows:
Hourly cortisol levels:
| Time | nmol/L |
|---|---|
| 1st hour | 600–1250 nmol/L |
| 2nd hour | 750–1500 nmol/L |
| 3rd hour | 800–1550 nmol/L |
| 4th hour | 950–1650 nmol/L |
| 5th hour | 1000–1800 nmol/L |
If plasma cortisol rises more slowly than indicated above, this may be the result of Addison’s disease, secondary adrenocortical insufficiency due to a disorder of hypothalamo-pituitary function, or overdose of corticosteroids.
A 3-day test with Synacthen Depot may be used to differentiate between primary and secondary adrenocortical insufficiency.
All the plasma samples should be stored in a refrigerator until plasma cortisol level estimation.
No paediatric dosage has been established.
There is no evidence to suggest that dosage should be different in the elderly.
Synacthen Depot is intended for intramuscular injection. The ampoule should be shaken before use.
Overdosage may lead to fluid retention and signs of excessive adrenocorticotropic activity (Cushing’s Syndrome). In such cases, Synacthen Depot should either be withdrawn temporarily, given in lower doses or the interval between injections should be prolonged (e.g. 5 to 7 days).
There is no known antidote. Treatment should be symptomatic.
2 years.
Protect from light. Store in a refrigerator (2 to 8°C).
Synacthen Depot comes in cardboard boxes of 1 ampoule and 10 ampoules.
Not all pack sizes may be marketed.
The ampoule should be shaken before use.
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