SYNACTHEN DEPOT AMPOULES 1MG/ML

Active substance: TETRACOSACTIDE ACETATE

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Product Title:

Synacthen Depot PIL

Date:

26-02-14

Product Size:

140 x 420mm

Label Number:

12-217 RFI

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Black

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Helvetica condensed

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PATIENT INFORMATION LEAFLET

Synacthen® Depot Ampoules 1mg/ml
tetracosactide acetate

The information in this leaflet has been divided
into the following sections:
1. What Synacthen Depot is and what it is used
for
2. What you need to know before you are given
Synacthen Depot
3. How to use Synacthen Depot
4. Possible side effects
5. How to store Synacthen Depot
6. 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
steroids.
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:
• you 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
• you suffer from any allergies, including allergies to
any medicines
• you suffer from any serious mood or mental
health disorders
• you have or have 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
• it is for the treatment of primary adrenocortical
insufficiency or adrenocongenital syndrome
(where your adrenal glands are not working).
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:
• 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
• you are pregnant, think you might be pregnant or
are breast-feeding
• you 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 your 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.
Adults
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.

¡

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.
• If 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.
• If you get any side effects talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet.

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
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.

Premature babies and
neonates (less than one
month):

Must not be used due to the presence of benzyl alcohol in the formulation.

Children aged 3 to 5
years:

Initially 0.25 to 0.5mg administered intramuscularly daily; the maintenance dose is 0.25 to
0.5mg every 2 to 8 days.

Children aged 5 to 12
years:

Initially 0.25 to 1mg administered intramuscularly daily; the 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:

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:

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:

Continued overleaf

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
• swelling of the face (moon face)
• 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)
• itching
• 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
• 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
• diabetes mellitus (increased sugar levels in your
blood and urine)
• fluid retention
• sodium retention
• low levels of potassium which can 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
• thinning of skin
• 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
• hormonal imbalance
• 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
• long term use in children up to 5 years may cause
changes to the heart
• may affect the results of skin prick test reactions.
If you get any side effects, talk to your 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 10 ampoules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Alliance Pharmaceuticals Limited, Avonbridge House,
Chippenham, Wiltshire, SN15 2BB, UK.
Manufacturer:
Novartis Pharmaceuticals UK Ltd., Wimblehurst
Road, Horsham, West Sussex, RH12 5AB, UK.
Or Novartis Pharmaceuticals UK Ltd., Frimley
Business Park, Frimley, Camberley, Surrey, GU16
7SR, UK.
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 2014
Alliance, Alliance Pharmaceuticals and associated
devices are registered Trademarks.
© Alliance Pharmaceuticals Limited 2014.
SYNACTHEN is a registered trademark of Novartis AG
and is used under licence by Alliance Pharmaceuticals
Limited.

The following information is intended for healthcare professionals only:
Continued from previous page
Indication

Method of administration

Adults:

¡

Children
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.

Table Hourly cortisol levels:
Time

nmol/L

1st
2nd
3rd
4th
5th

600 - 1250 nmol/L
750 – 1500 nmol/L
800 – 1550 nmol/L
950 – 1650 nmol/L
1000 – 1800 nmol/L

hour
hour
hour
hour
hour

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.
Premature babies and neonates
(less than one month):

Must not be used due to the presence of benzyl alcohol in the formulation.

Children:

No paediatric dosage has been established.

Elderly:

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.

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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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