SYNACTHEN DEPOT AMPOULES 1MG/ML

Active substance: TETRACOSACTIDE ACETATE

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PATIENT INFORMATION LEAFLET
Synacthen® Depot Ampoules 1mg/ml
tetracosactide acetate
Read all of this leaflet carefully before you are given this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet please tell your doctor.
The information in this leaflet has been divided into the following sections:
1. What Synacthen Depot is and what it is used for
2. Check before you receive Synacthen Depot
3. How Synacthen Depot is given to you
4. Possible side effects
5. How to store Synacthen Depot
6. Further 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 steroids.

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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 and rheumatoid arthritis. 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. Check before you receive Synacthen Depot
You should not be given Synacthen Depot if:
• you are allergic (hypersensitive) to adrenocorticotropic hormone (ACTH),
tetracosactide acetate or any of the ingredients of Synacthen Depot (see
Section 6 Further information), particularly benzyl alcohol
• you suffer from any allergies, including allergies to any medicines
• you suffer from any serious mood or mental health disorders
• you have or have you ever had TB (tuberculosis)
• 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
• you suffer from asthma
• you are pregnant, trying to become pregnant, or breast-feeding.
Synacthen Depot is not for use in children under 3 years of age.
If any of the above applies to you, or if you are not sure, speak to your doctor or
pharmacist before you are given Synacthen Depot.
Take special care with Synacthen Depot
Before you are given Synacthen Depot tell your doctor if:
• you have been vaccinated recently or are planning to have a vaccination
• your immune system is not working properly
• you have any disorder of the intestines, e.g. ulcerative colitis, diverticulitis
• you have recently had surgery on your intestines (bowel)
• you suffer from high blood pressure
• you have suffered from a blood clot in the past
• you suffer from any serious liver or kidney disease
• you suffer from osteoporosis (thinning of the bones)
• you suffer from myasthenia gravis (an illness causing muscle weakness)
• you have an under active thyroid gland which can cause tiredness or weight
gain.

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If any of the above applies to you, or if you are not sure, speak to your doctor
before you are given Synacthen Depot.
Taking other medicines
Tell your doctor or pharmacist 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.
Please tell your doctor or pharmacist 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
You should not receive Synacthen Depot if you are pregnant, trying to become
pregnant or 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.
Important information about some of the ingredients of Synacthen Depot
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 Synacthen Depot is given to you
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.
Treatment with Synacthen Depot
Your doctor will decide on a suitable dose of Synacthen Depot depending on
your condition. 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.

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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.
Synacthen Depot is not suitable for children under three years of age.
Diagnostic Tests with Synacthen Depot
You will be given one, two or three injections followed by a number of blood
tests.
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.
Very rarely, Synacthen Depot can cause an allergic reaction with skin irritation
and swelling, faintness, wheezing or flushing. 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.
You are unlikely to get any of the following rare side effects but if you do, tell your
doctor as soon as possible.
• menstrual (period) problems
• swelling of the face (moon face)

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increased thirst
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







acne, other skin problems or
unusual bruising
muscle cramps or pain, muscle
weakness
pain in back, hips, arms,
shoulders or legs
poor healing of wounds
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.

Other common side effects (that affect less than 1 person in 10) that may occur
include:
• blood clot
• increased chance of infection
• blood in your stools
• abscess
• blood in your urine
• increase in the number of white
blood cells which can cause
• blood in your vomit
bleeding, fever, infection or
• stomach pain or a bloated
inflammation
stomach
• unusual increase in hair growth
• inflammation of the gullet (food
on body or face
pipe)
• diabetes mellitus (increased
• small, round, dark red spots on
sugar levels in your urine)
the skin
• fluid retention
• bruising
• low levels of potassium which
• facial flushing
can cause muscle weakness,
• darkening or lightening of skin
muscle twitching or abnormal
colour
heart beat or low levels of
• increased sweating
calcium which can cause muscle
• bone thinning and fractures of the
cramps, stomach cramps or
bones
spasms. Your doctor may want to
• ruptured tendon, the symptoms of
take a blood test to measure your
which include severe pain,
blood levels of potassium or
inability to use the affected arm
calcium
or leg and rapid bruising at the
• increased appetite
site
• headache
• slowing of the rate of growth in
• protrusion of the eye-balls in their
children
sockets
• weight increase.
• glaucoma/blurred vision
• a feeling of dizziness or
“spinning”

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Very rare side effects include (that affect less than 1 person in 1000):
• long term use in children up to 5 years may cause changes to the heart.
If any of the side effects gets worse, or if you notice any side effects not listed in
this leaflet, please tell your doctor.

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. Further 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 10 ampoules.
Marketing Authorisation Holder and Manufacturer
The product licence holder is: Alliance Pharmaceuticals Ltd, Avonbridge House,
Chippenham, Wiltshire, SN15 2BB, UK.
Synacthen Depot is manufactured by Nycomed Austria GmbH, St-Peter-Strasse
25, A-4020 Linz, Austria:
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 pharmacist.
This leaflet was last revised in:
September 2012

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Alliance, Alliance Pharmaceuticals and associated devices are registered
Trademarks.
© Alliance Pharmaceuticals Limited 2012.
SYNACTHEN is a registered trademark of Novartis Pharmaceuticals Limited and is used
under licence by Alliance Pharmaceuticals Limited.

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The following information is intended for medical or healthcare professionals only:
Synacthen Depot should be shaken before use.
1. Dosage

Indication

Method of administration

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. 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.
Infants and children under Not recommended due to the presence of benzyl
3 years:
alcohol in the formulation.
Children aged 3 to 5 years: Initially 0.25 to 0.5mg intramuscularly daily; the
maintenance dose is 0.25 to 0.5mg every 2 to 8
days.
Children aged 5 to 12
Initially 0.25 to 1mg intramuscularly daily; the
years:
maintenance dose is 0.25 to 1mg every 2 to 8 days.
Elderly:
There is no evidence to suggest that dosage should
be different in the elderly.
Diagnostic use:

Adults:

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In cases of suspected adrenocortical insufficiency,
where the 30-minute diagnostic test with Synacthen
ampoules (see Synacthen 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.
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.
Adrenocortical function can be regarded as normal
if the post-injection rise in plasma cortisol
concentration increases 2-fold in the first hour, and
continues to rise steadily. The values expected

would be 600 to 1,250nmol/l in the first hour
increasing slowly up to 1,000 to 1,800nmol/l by the
fifth hour. Lower concentrations of plasma cortisol
may be attributable to Addison's disease, secondary
adrenocortical insufficiency due to a disorder of
hypothalamo-pituitary function, or overdosage of
corticosteroids.

Children:

Elderly:

A 3-day test with Synacthen Depot may be used to
differentiate between primary and secondary
adrenocortical insufficiency.
No paediatric dosage has been established.
Synacthen Depot is not recommended for children
under 3 years of age due to the presence of benzyl
alcohol in the formulation.
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.

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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.

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