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Tetracosactide parenteral


Suspension and solution for injection containing tetracosactide acetate

Drugs List

  • SYNACTHEN 250microgram/1ml injection
  • SYNACTHEN DEPOT 1mg/1ml injection
  • tetracosactide 1mg/1ml injection suspension
  • tetracosactide 250microgram/1ml injection
  • Therapeutic Indications


    Diagnostic use
    Investigation of adrenocortical insufficiency

    Therapeutic use
    1 mg/1 ml depot injection only
    For short term therapy of conditions where glucocorticoids are indicated particularly in patients intolerant of oral glucocorticoid therapy or where normal therapeutic doses have been ineffective:
    Crohn's disease
    Ulcerative colitis
    Juvenile rheumatoid arthritis
    Adjunctive therapy in patients with rheumatoid arthritis
    Adjunctive therapy in patients with osteoarthritis

    Unlicensed Uses

    Treatment of infantile spasms.



    Therapeutic use
    Intramuscular administration of the 1mg/1ml injection suspension only.

    Initial treatment: 1mg daily or every 12 hours in acute cases.
    Once acute symptoms have abated: 1mg every two to three days.
    Patients responding well: 500micrograms every two to three days or 1mg per week.

    Diagnostic use
    This test is based on the plasma cortisol concentration before and at defined periods after administration of tetracosactide.

    All plasma samples should be refrigerated until plasma cortisol level estimation.

    30 minute test
    Determine the plasma cortisol concentration at baseline and at 30 minutes after intramuscular or intravenous injection of 250micrograms/1ml tetracosactide solution for injection. Adrenocortical function is regarded as normal if the rise in plasma cortisol concentration is at least 200nmol/litre (70micrograms/litre).

    5 hour test
    If the result of the 30 minute test is inconclusive or the functional reserve of the adrenal cortex needs to be determined a 5 hour test can be carried out by intramuscular injection of the 1mg/1ml injection suspension. Plasma cortisol concentration should be determined at baseline and at 30 minutes, 1, 2, 3, 4 and 5 hours post injection. Adrenal cortisol concentration can be considered normal if the plasma cortisol concentration increases 2 fold in the first hour and continues to rise slowly as follows:

    600nmol/l to 1250nmol/l in the first hour.
    750nmol/l to 1500nmol/l by the second hour.
    800nmol/l to 1550nmol/l by the third hour.
    950nmol/l to 1650nmol/l by the fourth hour.
    1000nmol/l to 1800nmol/l by the fifth hour.

    Slower concentration rises may indicate Addison's disease, secondary adrenocortical insufficiency due to a disorder of the hypothalamo-pituitary function or corticosteroid overdosage.

    3 day test
    A 3 day test may then be performed using the 1mg/1ml injection suspension to differentiate between primary and secondary adrenocortical insufficiency.


    Children under 1 month should not be administered the 1mg/1ml injection suspension due to the presence of benzyl alcohol in the suspension for injection.

    Therapeutic uses
    Intramuscular administration of the 1mg/1ml injection suspension only.
    Children aged 12 to 18 years
    (See Dosage; Adult)
    Children aged 5 to 12 years
    Initial dose: 250micrograms to 1mg daily.
    Maintenance dose: 250micrograms to 1mg every two to eight days.
    Children aged 3 to 5 years
    Initial dose: 250micrograms to 500micrograms daily.
    Maintenance dose: 250micrograms to 500micrograms every two to eight days.

    Diagnostic use
    30 minute test
    For use with the 250microgram/1ml solution only.
    An intravenous dose of 250micrograms/1.73 square metre body surface area has been suggested.
    For accurate dosage, consult standard body surface area tables.

    The following alternative dosing schedule may be suitable:
    By intramuscular or intravenous injection (250microgram/1ml solution)
    Standard dose test: 145micrograms/metre squared (up to a maximum of 250micrograms) as a single dose.
    Low dose test (unlicensed): 300nanograms/metre squared as a single dose (may be diluted in sodium chloride 0.9% to 250nanograms/ml).

    Infantile spasms (unlicensed)
    Children aged 1 month to 2 years
    Initial dose: 500micrograms on alternate days. Titrate to response.

    Patients with Renal Impairment

    Caution should be observed when administering tetracosactide acetate to these patients.

    Patients with Hepatic Impairment

    Caution should be observed when administering tetracosactide acetate to patients with cirrhosis of the liver.

    Additional Dosage Information

    Relative insufficiency of the pituitary-adrenal axis is induced by prolonged administration, and may persist for several months after treatment has stopped, therefore appropriate adrenocortical therapy should be considered.

    Patients who suffer stress associated with injury or surgery within 1 year of treatment with tetracosactide should be managed by an increase in or resumption of treatment with tetracosactide depot injection. Additional use of rapidly acting corticosteroids may be required. Use the lowest effective dose. If the dose has to be reduced, this should be done gradually.


    Tetracosactide solution for injection 250 micrograms/1 ml: for intravenous or intramuscular administration.

    Tetracosactide suspension for injection 1 mg/1 ml: for intramuscular administration only.


    Allergic disposition (for example, asthma)
    Active peptic ulcer
    Cardiac failure
    Acute psychosis
    Cushing's disease
    Adrenogenital syndrome
    Infectious diseases
    Children under 1 month
    Hypersensitivity to benzyl alcohol

    Precautions and Warnings

    Tetracosactide may cause hypersensitivity reactions. It is therefore important to obtain patient history of allergic disorders before administering tetracosactide. Only administer under medical supervision and, for diagnostic use, under supervision of senior medical staff. It is important to monitor the patient for at least 30 minutes after administration as the majority of hypersensitivity reactions occur during this period. In the event of a serious anaphylactic reaction adrenaline and corticosteroid should be administered.

    Discontinue and avoid future use if a serious anaphylactic reaction or other hypersensitivity reaction (redness/pain at the injection site, urticaria, pruritis, flushing, faintness, severe malaise or dyspnoea) occurs during or after an injection.

    Do not administer tetracosactide treatment in the presence of an infective or systemic disease, when the use of a live vaccine may be required or if the immune system is compromised, unless satisfactory specific disease therapy is being given.

    Relative insufficiency of the pituitary-adrenal axis is induced by prolonged administration, and may persist for several months after treatment has stopped, therefore appropriate adrenocortical therapy should be considered.
    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 tetracosactide. Additional use of rapidly acting corticosteroids may be required. Use the lowest effective dose to control the condition. If the dose has to be reduced, this should be done gradually.

    Children aged 1 month to 12 years.


    Additional precautions for therapeutic use
    Tetracosactide should be administered with caution to patients with the following conditions:
    Non-specific ulcerative colitis
    Recent intestinal anastomosis,
    Renal insufficiency,
    Thromboembolic tendencies,
    Myasthenia gravis,
    Ocular Herpes simplex.

    The effect of tetracosactide may be enhanced in patients with hypothyroidism or cirrhosis of the liver.

    A increase in the production of adrenal steroids may result in corticosteroid type effects:
    Salt and water retention (may respond to a low salt diet) Potassium supplementation may be required during long term therapy. Daily weight records may highlight any fluid retention.
    Psychological disturbances may be aggravated or triggered.
    Latent infections may become active (e.g. tuberculosis, amoebiasis). Monitor patients with tuberculin reactivity. Consider prophylactic anti-tuberculosis therapy if appropriate.
    Ocular effects (glaucoma, cataracts) may occur.
    Growth inhibition in children (unlikely if appropriate dose is administered correctly). Nevertheless, growth should be monitored in children undergoing long term treatment.
    Reversible myocardial hypertrophy in rare cases following high doses in children up to 5 years. Echocardiographs readings should be taken regularly in order to detect any changes in the heart.
    Dosage adjustments of concurrent therapy may be required for diabetics or patients with hypertension.

    Pregnancy and Lactation


    Tetracosactide is contraindicated in pregnancy and should only be used if considered to be essential and the benefits outweigh the risks.

    At the time of writing there is limited published information regarding the use of tetracosactide during pregnancy. Animal studies are insufficient with respect to reproductive toxicity. Schaefer 2007 states that inadvertent use is not grounds for pregnancy termination or for invasive diagnostic procedures.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Use tetracosactide with caution in breastfeeding.

    It is unknown whether tetracosactide is excreted in breast milk. The UK drugs in Lactation Advisory Service considers tetracosactide to be safe to use in breastfeeding. Tetracosactide is a synthetic analogue of adrenocorticotropic hormone (ACTH), ACTH is a normal component of breast milk, therefore tetracosactide is likely to be excreted in breast milk. However, due to the drug's properties it is anticipated that it will not be absorbed from the infant's GI tract.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Effects on Ability to Drive and Operate Machinery

    As tetracosactide therapy can result in dizziness, patients should be warned of the potential hazards of driving or operating machinery.

    Side Effects

    During diagnostic or therapeutic use, hypersensitivity reactions may be manifested in the following ways:
    Anaphylactic shock
    Skin reactions (injection site)
    Angioneurotic oedema
    Quincke's oedema
    Adrenal haemorrhage

    During therapeutic use, general adverse of effects of glucocorticoids maybe seen including:
    Muscle weakness
    Muscular atrophy
    Steroid myopathy
    Loss of muscle mass
    Vertebral compression fractures
    Aseptic necrosis of femoral and humeral heads
    Pathological fracture of long bones
    Tendon rupture
    Peptic ulceration with possible perforation and haemorrhage
    Abdominal distension
    Ulcerative oesophagitis
    Impaired wound healing
    Skin atrophy
    Increased sweating
    Suppression of skin test reactions
    Skin pigmentation
    Increased intracranial pressure with papilloedema (pseudotumour cerebri)
    Psychiatric changes
    Sodium retention
    Fluid retention
    Potassium loss
    Hypokalaemic alkalosis
    Calcium loss
    Menstrual irregularities
    Cushing's syndrome
    Growth suppression in children
    Secondary adrenocortical and pituitary unresponsiveness particularly in times of stress (trauma, surgery or illness)
    Decreased carbohydrate tolerance
    Manifestations of latent diabetes mellitus
    Posterior subcapsular cataracts
    Increased intraocular pressure
    Corneal perforation
    Negative nitrogen balance due to protein catabolism
    Necrotising vasculitis
    Congestive heart failure
    Reversible myocardial hypertrophy
    Increased susceptibility to infection
    Weight gain
    Increased appetite

    Effects on Laboratory Tests

    Post administration total plasma cortisol levels during treatment with tetracosactide may be misleading in some clinical situations due to altered cortisol binding globulin levels. These situations include patients on oral contraceptives, post operative patients, critical illness, severe liver disease, and nephrotic syndrome. In these circumstances, use alternative parameters (e.g. salivary cortisol, free cortisol index, plasma free cortisol) to assess the integrity of the HPA axis.


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Shelf Life and Storage

    Protect from light.

    Store in a refrigerator (2 to 8 degrees C).

    Further Information

    Last Full Review Date: August 2014

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London..

    Summary of product characteristic: Synacthen Depot Ampoules 1mg/ml from Alliance Pharmaceuticals Ltd. Revised May 2014.

    Summary of product characteristic: Synacthen Ampoules 250 micrograms/ml from Alliance Pharmaceuticals Ltd. Revised June 2014.

    NICE Evidence Services Available at: Last accessed: 01 September 2017.

    UK Drugs in Lactation Advisory Service.
    Available at:
    Last accessed: August 13, 2014

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