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SYNACTHEN DEPOT AMPOULES is a brand name for Cosyntropin (also known as Tetracosactide). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Therapeutic use: 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.…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Therapeutic use:
Initially, daily doses of Synacthen Depot should be given but after approximately 3 days, intermittent doses may be given.
Adults:
Initially 1mg intramuscularly daily or 1mg every 12 hours in acute cases. 5mg every 2 to 3 days or 1mg per week. 5mg every 2 to 8 days. 25 to 1mg every 2 to 8 days.
Elderly:
There is no evidence to suggest that dosage should be different in the elderly.
Diagnostic use:
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.
Adults:
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.
Children:
No paediatric dosage has been established Elderly: There is no evidence to suggest that dosage should be different in the elderly. Method of administration Synacthen Depot is intended for intramuscular injection. The ampoule should be shaken before use.
Since Synacthen Depot stimulates the adrenal cortex to increase the output of glucocorticoids and mineralocorticoids, side effects associated with excessive adrenocorticotropic activity may be encountered, as well as those related to tetracosactide.
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).
4 Special warnings and precautions for use). Undesirable effects related to glucocorticoid and mineralocorticoid effects The undesirable effects related to glucocorticoid and mineralocorticoid effects are unlikely to be observed with short-term use of Synacthen Depot as a diagnostic tool, but may be reported when Synacthen Depot is used for therapeutic indications.
g. after trauma, surgery or illness; menstruation irregular, carbohydrate tolerance decreased, hyperglycaemia, manifestations of latent diabetes mellitus, hirsutism Metabolism and nutrition disorders: Hypokalaemia, calcium deficiency, sodium retention, fluid retention, increased appetite, hypokalaemic alkalosis Psychiatric disorders: Mental disorder1 Nervous system disorders: Convulsions, benign intracranial pressure increased with papilloedema usually after treatment, vertigo, headache Eye disorders: Intraocular pressure increased, glaucoma, posterior subcapsular cataracts, exophthalmoses.
). Acute psychoses, infectious diseases, Cushing’s syndrome, peptic ulcer, refractory heart failure, treatment of primary adrenocortical insufficiency and adrenogenital syndrome. Synacthen Depot must not be administered intravenously.
4 Special warnings and precautions for use Before using Synacthen Depot, the doctor should make every effort to find out whether the patient is suffering from, or has a history of, allergic disorders. In particular, he should enquire whether the patient has previously experienced adverse reactions to ACTH, Synacthen Depot or other drugs.
Synacthen Depot should only be administered under medical supervision. If local or systemic hypersensitivity reactions occur during or after an injection (for example, marked redness and pain at the injection site, urticaria, pruritus, flushing, faintness, severe malaise or dyspnoea), Synacthen Depot or other ACTH preparations must be discontinued and should be avoided in the future.
Hypersensitivity reactions tend to occur within 30 minutes of the 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 Depot 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 non-specific ulcerative colitis, diverticulitis, recent intestinal anastomosis, kidney failure, hypertension, thromboembolic tendencies, osteoporosis and myasthenia gravis. High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).
1 List of excipients. In view of the increased risk of anaphylactic reactions, Synacthen Depot should not be used in patients known to have asthma and/or other forms of allergy (see section
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Cardiac disorders:
Cardiac failure congestive Reversible cardiac hypertrophy may occur in isolated cases in infants and small children treated over a prolonged period with high doses Vascular disorders: Vasculitis necrotising, thromboembolism, hypertension Gastrointestinal disorders: Pancreatitis, peptic ulcer with possible perforation and haemorrhage, oesophagitis ulcerative, abdominal distension Skin and subcutaneous tissue disorders: Skin atrophy, petechiae, ecchymosis, erythema, hyperhidrosis, acne, skin hyperpigmentation Musculoskeletal and connective tissue disorders: Aseptic necrosis of femoral and humeral heads, spinal compression fractures, muscle atrophy, myopathy, osteoporosis, muscular weakness, pathological fracture of long bones, tendon rupture.
General disorders and administration site conditions:
Hypersensitivity reactions2, growth retardation, weight increase, impaired healing.
Investigations:
Nitrogen balance negative due to protein catabolism, suppression of skin test reactions. 4 Special warnings and precautions for use. 8 Undesirable effects (paragraph Undesirable effects related to tetracosactide). Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
The increased production of adrenal steroids may result in corticosteroid type effects: - Salt and water retention can occur and may respond to a low salt diet. g. euphoria, insomnia, mood swings, personality changes and severe depression, or even frank psychotic manifestations).
Existing emotional instability or psychotic tendencies may be aggravated - Use cautiously in patients with ocular herpes simplex owing to possible corneal perforation - Synacthen Depot may activate latent amoebiasis. It is therefore recommended that latent or active amoebiasis be ruled out before initiating therapy.
- If Synacthen Depot is indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary because the disease may be reactivated. During prolonged therapy, such patients should receive chemoprophylaxis.
g. glaucoma, cataracts). - Provided the dose is chosen to meet the individual's needs, Synacthen Depot is unlikely to inhibit growth in children. Nevertheless, growth should be monitored in children undergoing long-term treatment. In infants and children aged up to 5 years, reversible myocardial hypertrophy may occur in very rare cases following long-term treatment with high doses.
Therefore echocardiographic recordings should be made regularly. - Dosage adjustments may be necessary in patients being treated for diabetes or hypertension. An enhanced effect of tetracosactide acetate therapy may occur in patients with hypothyroidism and in those with cirrhosis of the liver.
In patients who suffer an injury or undergo surgery during or within one year after treatment, the associated stress should be managed by an increase in or resumption of treatment with Synacthen Depot. Additional use of rapidly acting corticosteroids may be required.
Use the lowest effective dose to control the condition under treatment. If the dose has to be reduced, this should be done gradually. Relative insufficiency of the pituitary-adrenal axis is induced by prolonged administration, and may persist for several months after stopping treatment, so appropriate adrenocortical therapy should be considered.
e. essentially ‘sodium- free’. Lack of diagnostic accuracy Post administration total plasma cortisol levels during Synacthen test might be misleading in some special clinical situations due to altered cortisol binding globulin levels.
These situations include patients on oral contraceptives, post operative patients, critical illness, severe liver disease, nephrotic syndrome. , salivary cortisol, free cortisol index, plasma free cortisol) can be used to assess the integrity of HPA axis.