SYNACTHEN AMPOULES

Adults:

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 250micrograms (1ml) Synacthen. 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. 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.

Elderly:

There is no evidence to suggest that dosage should be different in the elderly.

Undesirable effects may be related to tetracosactide or to the stimulation of glucocorticoids and mineralocorticoid secretion during the use of Synacthen. The following undesirable effects have been derived from post-marketing experience via spontaneous cases reports and literature cases.

Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known. Undesirable effects are listed according to system organ classes in MedDRA.

Within each system organ class, undesirable effects are presented in order of decreasing seriousness. Table 1. Undesirable effects (frequency not known) related to tetracosactide Immune system disorders: Hypersenstivity* Endocrine disorders: Adrenal haemorrhage *Tetracosactide can provoke hypersensitivity reactions, which tend to be more severe (anaphylactic shock) in patients susceptible to, allergies (especially asthma).

Hypersensitivity reactions may include skin reactions at the injection site, dizziness, nausea, vomiting, urticaria, pruritus, flushing, malaise, dyspnoea, angioneurotic oedema and Quincke's oedema. The undesirable effects related to glucocorticoid and mineralocorticoid effects are unlikely to be observed with short-term use of Synacthen as a diagnostic tool, but may be reported when Synacthen is used in therapeutic indications.

Should information be required on the side effects reported with therapeutic use of tetracosactide acetate, see Synacthen Depot Ampoules 1 mg/ml Summary of Product Characteristics. Table 2 Undesirable effects (frequency not known) related to glucocorticoid and mineralocorticoid effects Infections and infestations Abscess.

g. 4. Special warnings and precautions for use and Table 1 Undesirable effects related to tetracosactide. Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorisation of the medicinal product is important.

), acute psychosis, infectious diseases, peptic ulcer, refractory heart failure, Cushing’s syndrome, treatment of primary adrenocortical insufficiency and adrenocongenital syndrome. 3 “Contra-indications”). In particular, he should enquire whether the patient has previously experienced adverse reactions to ACTH, Synacthen or other drugs.

g. consultants). If local or systemic hypersensitivity reactions occur after the injection (for example, marked redness and pain at the injection site, urticaria, pruritus, flushing, faintness, severe malaise or dyspnoea), Synacthen or other ACTH preparations must be discontinued and should be avoided in the future.

Hypersensitivity reactions tend to occur within 30 minutes of an injection. The patient should therefore be kept under observation during this time. Preparation should be made in advance to combat any anaphylactic reaction that may occur after an injection of Synacthen.

In the event of a serious anaphylactic reaction, the patient should be treated appropriately with adrenaline and steroids. Synacthen Ampoules should not be used in the presence of active infectious or systemic diseases, when the use of live vaccine is contemplated or in the presence of a reduced immune response, unless adequate disease specific therapy is being given.

Use with care in patients with hypertension and thromboembolic tendencies. Use cautiously in patients with ocular herpes simplex owing to possible corneal perforation. g. euphoria, insomnia, mood swings, personality changes and severe depression, or even frank psychotic manifestations).

g. g. glaucoma, cataracts) • Dosage adjustments may be necessary in patients being treated for diabetes or hypertension • If Synacthen is used in any of the following conditions, the risks of treatment should be weighed against the possible benefits: ulcerative colitis, diverticulitis, recent intestinal anastomosis, kidney failure, hypertension, predisposition to thromboembolism, osteoporosis, myasthenia gravis.

1 List of excipients. g. asthma) (see Section