Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Synacthen Ampoules 250 micrograms
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Tetracosactide acetate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Synacthen Ampoules belongs to a group of medicines called pituitary hormones and analogues. The pituitary gland is a small gland inside the brain which controls many other glands in the body, including the thyroid and adrenal glands. The pituitary gland produces hormones which send chemical messages to various parts of the body and affect many bodily functions such as blood pressure, blood sugar levels, growth and menstrual cycle. The adrenal glands are found on top of the kidneys and make the body's natural steroids which can affect blood pressure and the way the body handles the sugars, protein and fats absorbed from food. They also make adrenaline which controls the body's response to different types of stress.
Synacthen Ampoules is used as a test to find out if the pituitary and adrenal glands are working normally.
What you need to know before you take it
Synacthen Ampoules You should not be given Synacthen Ampoules if:
- you are allergic (hypersensitive) to adrenocorticotropic hormone (ACTH), tetracosactide acetate or any of the other ingredients of Synacthen Ampoules (listed in Section 6)
- you suffer from any allergies, including allergies to any medicines
- you suffer from asthma
- you suffer from any serious mood or mental health disorders
- you have currently got any infections
- you suffer from any known hormone problems, e.g. Cushing's syndrome or Addison's disease (over or under active adrenal glands)
- you have an ulcer in your stomach or small intestine
- you suffer from any serious heart disease
- it is for the treatment of primary adrenocortical insufficiency or adrenocongenital syndrome (where your adrenal glands are not working properly) If any of the above applies to you, or if you are not sure, speak to your doctor or nurse before you are given Synacthen Ampoules. Warnings and Precautions Before you are given Synacthen Ampoules tell your doctor or nurse if:
- you suffer from high blood pressure
- you suffer from thromboembolism (blood vessel blocked by a blood clot)
- you suffer from myasthenia gravis (extreme muscle weakness)
- you suffer from osteoporosis (thinning of the bones)
- you suffer from an inflammation of the bowel (e.g. ulcerative colitis or diverticulitis)
- you have been recently vaccinated
- you have a severe liver disease (cirrhosis)
- you have a reduced immune system
- you are pregnant, think you might be pregnant or are breast feeding
- you have ocular herpes simplex (viral infection of the eye)
- you have kidney problems. Other medicines and Synacthen Ampoules Tell your doctor or nurse if you are taking/using or have recently taken/used any of the following medicines as they may interfere with Synacthen Ampoules:
- medicines to control high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan)
• • • •
medicines to control diabetes such as insulin or metformin corticosteroids (medicines used to treat inflammatory conditions in your body such as asthma or arthritis) medicines to control convulsions (fits) such as valproate, phenytoin, clonazepam, nitrazepam, phenobarbital or primidone medicines to control conception (birth control).
It may be necessary to change the dose or in some cases to stop the medicine. Please tell your doctor or nurse if you are taking or have recently taken/used any other medicines, including medicines obtained without a prescription. Pregnancy, breast-feeding and fertility If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine. Your doctor will discuss with you the potential risk of using Synacthen during pregnancy. Synacthen Ampoules should be given with caution to women who are breast-feeding. Driving and using machines If you feel dizzy or get blurred vision after you have been given Synacthen Ampoules, do not drive or operate machinery until these effects have worn off. Important information about some of the ingredients of Synacthen Ampoules Synacthen Ampoules contains less than 1 mmol sodium (23mg) per 1mg, i.e. is essentially 'sodium-free'.
How to take it
Synacthen Ampoules Your treatment with Synacthen Ampoules will take place in a hospital, under the supervision of a doctor. The doctor will be monitoring your progress carefully during your treatment with Synacthen Ampoules. The liquid will be drawn up into a syringe and injected into a muscle or vein by your doctor or nurse. You will be given a single injection of Synacthen Ampoules. You will have two blood samples taken, one before the injection of Synacthen Ampoules and the other 30 minutes after injection. These blood samples will show whether your adrenal glands are functioning as well as they should. Adults including elderly patients will be given 250 micrograms (one ampoule). Children will be given a lower dose based on their age and weight.
What to do if you think you have received more Synacthen Ampoules than you should As this medicine is given to you in hospital, it is very unlikely that an overdose will happen. If anyone receives this medicine by accident, tell the hospital accident and emergency department or a doctor immediately. Show any left over medicines or the empty packet to the doctor. If you forget to take Synacthen Ampoules As a doctor or nurse is giving you this medicine, you are unlikely to miss a dose. If you have any worries, tell a doctor or nurse. 4. Possible side effects Like all medicines, Synacthen Ampoules can cause side effects, although not everyone gets them. Serious side effects:
- Anaphylactic shock or severe allergic reaction (symptoms may include redness or pain at the injection site, rash, itching, hives or flushing, dizziness, feeling or being sick, difficulty breathing, and swelling of the face, lips, tongue or other parts of the body, feeling very unwell). This tends to be more severe in people, who suffer from allergies (especially asthma). For these reasons, you should be monitored carefully for 30 minutes after the injection. If you have had an allergic reaction, you should never be treated with Synacthen Ampoules or similar medicines again.
- bleeding into the adrenal gland (small glands above the kidneys) which may result in sudden stomach or back pain, weakness, fainting, loss of appetite and feeling or actually being sick
- blood clot (symptoms may include pain, swelling, redness, warmth and tenderness in the area of the clot depending on location in the body)
- blood in your stools
- blood in your urine
- blood in your vomit. If you experience any of these at any time, tell your doctor straight away or go immediately to the nearest hospital accident and emergency department. Side effects which may occur with Synacthen Ampoules include the following: • • • •
allergic reaction with skin irritation and swelling menstrual (period) problems swelling of the face (moon face) increased thirst
• • • •
diabetes mellitus (increased sugar levels in your blood and urine) fluid retention sodium retention low levels of potassium which can
• • • • • • • • • • • • • • • •
• • •
mood changes or fits decreased or blurred vision high blood pressure heart problems which can cause shortness of breath or ankle swelling inflammation of the blood vessels (sometimes with a rash, arthritis or kidney failure) inflammation of the pancreas which causes severe stomach and back pain feeling or actually being sick general feeling of being unwell acne, other skin problems or unusual bruising muscle cramps or pain, muscle weakness pain in back, hips, arms, shoulders or legs itching poor healing of wounds increased chance of infection abscess increase in the number of white blood cells which can cause bleeding, fever, infection or inflammation unusual increase in hair growth on body or face thinning of the skin may affect the results of skin prick test reactions
• • • • • • • • • • • • • •
• •
cause muscle weakness, muscle twitching or abnormal heart beat or low levels of calcium which can cause muscle cramps, stomach cramps or spasms. Your doctor may want to take a blood test to measure your blood levels of potassium or calcium increased appetite headache protrusion of the eye-balls in their sockets glaucoma/blurred vision a feeling of dizziness or "spinning" stomach pain or a bloated stomach inflammation of the gullet (food pipe) small, round, dark red spots on the skin bruising facial flushing darkening or lightening of skin colour increased sweating bone thinning and fractures of the bones ruptured tendon, the symptoms of which include severe pain, inability to use the affected arm or leg and rapid bruising at the site slowing of the rate of growth in children weight increase.
Reporting of suspected adverse reactions If you get any side effects, talk to your doctor or nurse. This includes any
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme by connecting to the following website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Synacthen Ampoules
Synacthen Ampoules will be stored in the hospital pharmacy. Keep out of the sight and reach of children. Do not use Synacthen Ampoules after the expiry date which is stated on the ampoule and the carton. The expiry date refers to the last day of that month after EXP. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer require. These measures will help protect the environment.
Contents of the pack and other information
What Synacthen Ampoules contains Synacthen Ampoules contains the active ingredient tetracosactide (as acetate) 250 micrograms per ampoule. The other ingredients are acetic acid, sodium acetate, sodium chloride and water for injections. What Synacthen Ampoules looks like and contents of the pack Synacthen is a clear, colourless sterile liquid that comes in a 1ml (millilitre) clear glass ampoule. Synacthen Ampoules comes in packs of 1 ampoule and 5 ampoules. Not all pack sizes may be marketed. Marketing Authorisation Holder: Atnahs Pharma UK Limited, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, UK Manufacturer: Waymade Plc, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom Atnahs Pharma UK Limited, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom The information in this leaflet applies only to Synacthen Ampoules. If you have any questions or you are not sure about anything, ask your doctor or a nurse.
This leaflet was last revised in: October 2024 SYNACTHEN is a registered trademark of Novartis AG and is used under licence by Atnahs Pharma UK Ltd. © Atnahs Pharma UK Ltd
<———————————————————————————————————-> The following information is intended for medical or healthcare professionals only: 1. Dosage Indication Adults:
Method of administration This preparation of Synacthen Ampoules 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 Ampoules 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 Ampoules. Adrenocortical function can be regarded as normal if the post-injection rise in plasma cortisol concentration increased by 200nmol/litre (70 micrograms/litre), i.e. if the value 30 minutes after injection is >500nmol/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.
Children:
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.
Elderly:
There is no evidence to suggest that dosage should be different in the elderly.
2. Disposal Any unused product or waste material should be disposed of in accordance with local requirements. 3. Overdose Overdosage is unlikely to be a problem when the product is used as a single dose for diagnostic purposes. 4. Storage Synacthen should be protected from light and stored in a refrigerator (2 – 8°C).
Frequently asked questions about Synacthen Ampoules 250 micrograms
How do I take Synacthen Ampoules 250 micrograms?
Synacthen Ampoules 250 micrograms comes as injection containing 250mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Synacthen Ampoules 250 micrograms?
The active substance in Synacthen Ampoules 250 micrograms is tetracosactide acetate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Synacthen Ampoules 250 micrograms, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Synacthen Ampoules 250 micrograms without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: tetracosactide acetate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Diagnostic test for the investigation of adrenocortical insufficiency.
4.2. Posology and method of administration
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 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.
Children: 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.
Elderly: There is no evidence to suggest that dosage should be different in the elderly.
4.3. Contraindications
Known hypersensitivity to tetracosactide and/or ACTH or to any of the excipients listed in section 6.1 List of excipients.
Synacthen is contra-indicated in patients with allergic disorders (e.g. asthma) (see Section 4.4 Special warnings and precautions for use), acute psychosis, infectious diseases, peptic ulcer, refractory heart failure, Cushing's syndrome, treatment of primary adrenocortical insufficiency and adrenocongenital syndrome.
4.4. Special warnings and precautions for use
Before using Synacthen, the doctor should make every effort to find out whether the patient is suffering from, or has a history of, allergic disorders (see Section 4.3 “Contra-indications”). In particular, he should enquire whether the patient has previously experienced adverse reactions to ACTH, Synacthen or other drugs.
Synacthen should only be administered under the supervision of appropriate senior hospital medical staff (e.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.
The increased production of adrenal steroids may result in corticosteroid type effects:
• Psychological disturbances may be triggered (e.g. euphoria, insomnia, mood swings, personality changes and severe depression, or even frank psychotic manifestations). Existing emotional instability or psychotic tendencies may be aggravated
• Latent infections (e.g. amoebiasis, tuberculosis) may become activated
• Ocular effects may be produced (e.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.
The solution for injection contains less than 1 mmol sodium (23 mg) per ampoule, i.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. Hence in these circumstances, alternative parameters (e.g., salivary cortisol, free cortisol index, plasma free cortisol) can be used to assess the integrity of HPA axis.
4.5. Interaction with other medicinal products and other forms of interaction
Severe jaundice has been observed for concurrent use of Synacthen and valproate in paediatric population. Their concurrent use should be avoided.
Concurrent use of Synacthen and other anticonvulsants (e.g. phenytoin, clonazepam, nitrazepam, phenobarbital, primidone) may increase the risk of liver damage thus, Synacthen should be used with caution at minimum possible doses and for minimum duration for concurrent treatment.
Endogenous and synthetic oestrogens can cause an increase in total cortisol levels and therefore, it is considered appropriate to use alternative methods (e.g., salivary cortisol, free cortisol index, plasma free cortisol) for interpretation of the results of the HPA axis examination (see Section 4.4 Special warnings and precautions for use).
Since Synacthen increases the adrenocortical production of glucocorticoids and mineralocorticoids, drug interactions of the type seen with these corticosteroids may occur (see Section 4.4 Special warnings and precautions for use). Patients already receiving medication for diabetes mellitus or for moderate to severe hypertension must have their dosage adjusted if treatment with Synacthen is started.
4.6. Fertility, pregnancy and lactation
Pregnancy
There is limited amount of data in the use of tetracosactide in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see Section 5.3 Preclinical safety data). Synacthen should be used during pregnancy only if the expected benefit outweighs the potential risk to the foetus.
Breast-feeding
It is not known whether tetracosactide enters breast milk or not. Because many drugs are excreted in human milk, caution should be exercised when Synacthen is administered to a breastfeeding woman.
Fertility
Animal studies are insufficient with respect to reproductive toxicity (see Section 5.3 Preclinical safety data).
4.7. Effects on ability to drive and use machines
Patients should be warned of the potential hazards of driving or operating machinery if they experience side effects such as dizziness.
4.8. Undesirable effects
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. Infection susceptibility increased
Blood and the lymphatic system disorders
Leukocytosis
Endocrine disorders
Cushing's syndrome, secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, e.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
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 sub capsular cataracts, exophthalmoses
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 and ecchymosis, erythema, hyperhidrosis, acne and skin hyper pigmentation
Musculoskeletal and connective tissue disorders
Aseptic necrosis of femoral and humeral heads, spinal compression fracture, muscle atrophy, myopathy, osteoporosis, muscular weakness, pathological fracture of long bones, tendon rupture
General disorders and administration site conditions
Hypersensitivity reactions 2), growth retardation, weight increased, impaired healing
Investigations
Negative nitrogen balance due to protein catabolism, suppression of skin test reactions
1) Also see section 4.4 Special warnings and precautions for use
2) Also see 4.4. 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. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme by connecting to the following website: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Overdosage is unlikely to be a problem when the product is used as a single dose for diagnostic purposes.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- SYNACTHEN 0,25 mg/1ml prescriptionTETRACOSACTIDUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- CosacthenTetracosactidum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Synacthen Ampoules 250 micrograms. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.