Skip to Content



View full screen / Print PDF » Download PDF ⇩

Synacthen® Depot Ampoules 1mg/ml
Tetracosactide acetate
Read all of this leaflet carefully before you are given this medicine because it
contains important information for you
Keep this leaflet. You may need to read it again.
•  you have any further questions, ask your doctor or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It
may harm them, even if their signs of illness are the same as yours.
•  you get any side effects talk to your doctor or nurse. This includes any
possible side effects not listed in this leaflet.
The information in this leaflet has been divided into the following sections:
What Synacthen Depot is and what it is used for
What you need to know before you are given Synacthen Depot
How to use Synacthen Depot
Possible side effects
How to store Synacthen Depot
Contents of pack and other information



1. What Synacthen Depot is and what it is used for
Synacthen Depot belongs to a group of medicines called pituitary hormones.
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 Depot is similar to the hormone that the pituitary gland normally produces (called ACTH) to make the adrenal glands
produce certain steroids. When Synacthen Depot is injected it works on the adrenal glands by ‘telling’ them to produce more
Synacthen Depot is used in place of medicines like prednisolone or cortisone (types of steroids) to treat a number of different
conditions, including ulcerative colitis, Crohn’s disease, rheumatoid arthritis and osteoarthrosis. It is usually only given for a
short time.
Synacthen Depot is also used as a test to find out if the pituitary and adrenal glands are working normally.
2. What you need to know before you are given Synacthen Depot
You should not be given Synacthen Depot if:
•  are allergic (hypersensitive) to adrenocorticotropic hormone (ACTH), tetracosactide acetate or any of the ingredients of
Synacthen Depot (see Section 6 Contents of pack and other information), particularly benzyl alcohol
•  suffer from any allergies, including allergies to any medicines
•  suffer from any serious mood or mental health disorders
•  have or have ever had TB (tuberculosis)
•  have currently got any infections
•  suffer from any known hormone problems, e.g. Cushing’s syndrome or Addison’s disease (over or under active adrenal glands)
•  have an ulcer in your stomach or small intestine
•  suffer from any serious heart disease
•  suffer from asthma
•  is for the treatment of primary adrenocortical insufficiency or adrenocongenital syndrome (where your adrenal glands are not
Synacthen Depot must not be used for premature babies and neonates less than one month. This is due to the presence of benzyl
alcohol, an ingredient that may cause toxic reactions and allergic reactions.
Take special care with Synacthen Depot
Before you are given Synacthen Depot, tell your doctor or nurse if:
•  have been vaccinated recently or are planning to have a vaccination
your immune system is not working properly
•  have any disorder of the intestines, e.g. ulcerative colitis, diverticulitis
•  have recently had surgery on your intestines (bowel)
•  suffer from high blood pressure
•  have suffered from a blood clot in the past
•  suffer from any serious liver or kidney disease
•  suffer from osteoporosis (thinning of the bones)
•  suffer from myasthenia gravis (an illness causing muscle weakness)
•  have an under active thyroid gland which can cause tiredness or weight gain
•  are pregnant, think you might be pregnant or are breast-feeding
•  have ocular herpes simplex (viral infection of the eye).
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 Depot.
If you suffer an injury or have surgery during Synacthen Depot treatment or within one year after the end of the treatment, the
Synacthen Depot dose may have to be increased or the Synacthen Depot treatment restarted.
Taking other medicines
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 Depot:
medicines to control high blood pressure
medicines to control diabetes
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.
Taking with food and drink
Since Synacthen Depot can cause salt and water retention, your doctor may advise a low-salt diet during treatment.
Pregnancy and breast-feeding
If you are pregnant, or think you may be pregnant tell your doctor. Your doctor will discuss with you the potential risk of using
Synacthen Depot during pregnancy.
If you are breast-feeding, tell you doctor. Synacthen Depot 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 Depot, do not drive or operate machinery until these
effects have worn off.
Synacthen Depot contains benzyl alcohol.
Benzyl alcohol can cause toxic reactions and allergic reactions in children less than 3 years old.
Synacthen Depot is essentially ‘sodium-free’ - it contains less than 1 mmol sodium (23 mg) per 1mg.
3. How to use Synacthen Depot
Your treatment with Synacthen Depot 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 Depot. Your doctor will decide on a suitable dose of Synacthen
Depot depending on your condition.

The following information is intended for healthcare professionals only:
Synacthen Depot should be shaken before use.
Synacthen Depot must be injected intramuscularly (i.m.) by a doctor or a nurse.
Synacthen Depot must not be injected intravenously.
1. Dosage
Therapeutic use:

Premature babies and neonates
(less than one month):
Children aged 3 to 5 years:
Children aged 5 to 12 years:
Diagnostic use:

Method of administration
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.
Must not be used due to the presence of benzyl alcohol in the formulation.
Initially 0.25 to 0.5mg administered intramuscularly daily; the maintenance dose is 0.25 to 0.5mg
every 2 to 8 days.
Initially 0.25 to 1mg administered 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 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 including elderly patients will usually start treatment with 1mg once or twice daily for about three days. As your condition
improves, this dose will then be reduced over a period of several weeks, to 0.5mg every two to three days or 1mg once a week
Children aged 3 -12 years will be given a lower dose based on their age and weight. They will start with an injection every day. This
will then be reduced to once every 2 to 8 days.
Your doctor may monitor growth or organise heart scans in children who are given this medicine for a long period of time.
How should Synacthen Depot be given?
The ampoules should be shaken before use. The liquid in the ampoule will be drawn up into a syringe and injected into a muscle
by your doctor or nurse (never into a vein).
For how long should Synacthen Depot be given?
For therapeutic use: Synacthen will not cure your condition but it may relieve some of the symptoms. The injections can be
continued for as long as they are beneficial.
For diagnostic tests use: You will be given a single injection of Synacthen Depot. You will have six blood samples taken, one
before the injection and the others 30 minutes, 1, 2, 3, 4 and 5 hours after the injection. These blood samples will show whether
your adrenal glands are functioning as well as they should.
What to do if you think you have received more Synacthen Depot 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 Depot
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
Do not worry. Like all medicines, Synacthen Depot 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 unwell). This tends to be more severe in people, who suffer from allergies (especially asthma). For this reason, you
should be monitored carefully for 30 minutes after each injection. If you get a reaction like this when you are not under medical
supervision, contact your doctor or nearest hospital accident and emergency department immediately. Once you have had an
allergic reaction like this, you should never be treated with Synacthen Depot or similar medicines again.
bleeding of the adrenal gland (small glands above the kidneys) which may result in sudden pain in the stomach and back,
weakness, fainting, loss of appetite and feeling or actually being sick
• blood clot
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 Depot include the following:
menstrual (period) problems
 levels of calcium which can cause muscle cramps,
swelling of the face (moon face)
stomach cramps or spasms. Your doctor may want to take
• increased thirst
a blood test to measure your blood levels of potassium or
mood changes or fits
decreased or blurred vision
• increased appetite
high blood pressure
• headache
heart problems which can cause shortness of breath or
protrusion of the eye-balls in their sockets
ankle swelling
• glaucoma/blurred vision
inflammation of the blood vessels (sometimes with a rash, • 
thinning of skin
arthritis or kidney failure)
long term use in children up to 5 years may cause
• itching
changes to the heart
inflammation of the pancreas which causes severe
may affect the results of skin prick test reactions.
stomach and back pain
•  feeling of dizziness or “spinning”
acne, other skin problems or unusual bruising
stomach pain or a bloated stomach
muscle cramps or pain, muscle weakness
inflammation of the gullet (food pipe)
pain in back, hips, arms, shoulders or legs
small, round, dark red spots on the skin
poor healing of wounds
• bruising
increased chance of infection
• facial flushing
• abscess
darkening or lightening of skin colour
increase in the number of white blood cells which can
• increased sweating
cause bleeding, fever, infection or inflammation
bone thinning and fractures of the bones
unusual increase in hair growth on body or face
• hormonal imbalance
•  iabetes mellitus (increased sugar levels in your blood and • 
ruptured tendon, the symptoms of which include severe
pain, inability to use the affected arm or leg and rapid
bruising at the site
• fluid retention
slowing of the rate of growth in children
• sodium retention
• weight increase
•  levels of potassium which can cause muscle
weakness, muscle twitching or abnormal heart beat or
If you get any side effects, talk to you doctor or nurse. This includes any possible side effects not listed in this leaflet.
5. How to store Synacthen Depot
Synacthen Depot will be stored in the hospital pharmacy.
Keep out of the reach and sight of children.
Do not use Synacthen Depot after the expiry date which is stated on the ampoule. The expiry date refers to the last day of that
month after Exp/Lot.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist on how to dispose of medicines no
longer required. These measures will help protect the environment.
6. Contents of pack and other information
What is in Synacthen Depot?
The active substance of Synacthen Depot is tetracosactide acetate 1 mg per ampoule.
The other ingredients are zinc chloride anhydrous pure, disodium phosphate dodecahydrate, benzyl alcohol (50 mg/5 ml), sodium
chloride, sodium hydroxide and water for injections.
What Synacthen Depot looks like and contents of the pack
Synacthen Depot is a sterile, milky white suspension in a 1 mL (millilitre) clear glass ampoule. Synacthen Depot comes in packs of
1 ampoule and 10 ampoules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Questcor Operations Limited, 70 Sir John Rogerson’s Quay, Dublin 2, Ireland.
Questcor Operations Limited
Sandyford Business Centre, Unit 7
Dublin 18, Ireland
The information in this leaflet applies only to Synacthen Depot. If you have any questions or you are not sure about anything, ask
your doctor or a nurse.
This leaflet was last revised in: February 2015
© Questcor
SYNACTHEN is a registered trademark of Novartis AG and is used under licence by Questcor.


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:
Table Hourly cortisol levels:
1st hour
2nd hour
3rd hour
4th hour
5th hour

600 – 1250 nmol/L
750 – 1500 nmol/L
800 – 1550 nmol/L
950 – 1650 nmol/L
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.
Premature babies and neonates
(less than one month):

All the plasma samples should be stored in a refrigerator until plasma cortisol level estimation.
Must not be used due to the presence of benzyl alcohol in the formulation.
No paediatric dosage has been established.
There is no evidence to suggest that dosage should be different in the elderly.

2. Storage
Synacthen Depot should be stored in a refrigerator (2-8°C), in the original package.
3. Disposal
Any unused product or waste material should be disposed of in accordance with local requirements.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.