DEXAMETHASONE 3.3 MG/1 ML SOLUTION FOR INJECTION

Active substance: DEXAMETHASONE SODIUM PHOSPHATE

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• An infection affecting the whole
body which is not being treated with
antibiotics (dexamethasone treatment
may still be used if it is considered to be
life saving).

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Dexamethasone 3.3 mg/ml Solution
for Injection
(3.3 mg/1 ml ampoules)
• Dexamethasone is a steroid
medicine, prescribed for many different
conditions, including serious illnesses.
• You need to take it regularly to get
the maximum benefit.
• Don’t stop taking this medicine
without talking to your doctor – you may
need to reduce the dose gradually.
• Dexamethasone can cause side
effects in some people (read section 4
below). Some problems such as mood
changes (feeling depressed or ‘high’),
or stomach problems can happen
straight away. If you feel unwell in any
way, keep taking your tablets, but see
your doctor straight away.
• Some side effects only happen
after weeks or months. These
include weakness of arms and legs, or
developing a rounder face (read section
4 for more information).
• If you take it for more than 3 weeks,
you will get a blue ‘steroid card’:
always keep it with you and show it to
any doctor or nurse treating you.
• Keep away from people who have
chicken pox or shingles, if you have
never had them. They could affect you
severely. If you do come into contact
with chicken pox or shingles, see your
doctor straight away.
Now read the rest of this leaflet. It
includes other important information on the
safe and effective use of this medicine that
might be especially important for you.
This leaflet was last updated on
18/01/13

Dexamethasone –
benefit information
Dexamethasone belongs to a group of
medicines called steroids. Their full name
is corticosteroids.
These corticosteroids occur naturally in
the body, and help to maintain health and
well-being.
Boosting your body with extra
corticosteroid (such as dexamethasone)
is an effective way to treat various
illnesses involving inflammation in the
body. Dexamethasone reduces this
inflammation, which could otherwise go
on making your condition worse. You
must take this medicine regularly to get
maximum benefit from it.
Read all of this leaflet carefully before
you start using this medicine.
• Keep this leaflet. You may need to read
it again.
• If you have any further questions, ask
your doctor or pharmacist.
• 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 or
pharmacist.
In this leaflet:
1. What Dexamethasone Solution for
Injection is and what it is used for
2. Before you use Dexamethasone
Solution for Injection
3. How to use Dexamethasone
Solution for Injection
4. Possible side effects
5. How to store Dexamethasone
Solution for Injection
6. Further information

1. WHAT DEXAMETHASONE SOLUTION
FOR INJECTION IS AND WHAT IT IS
USED FOR
Dexamethasone Solution for Injection
belongs to a group of medicines called
steroids.
It is used in acute conditions in which oral
steroid treatment is not possible, such as:
• Shock (e.g. after an accident, after
surgery or due to blood poisoning).
• Swelling of the brain because of a brain
tumour.
• Diseases of joints and soft tissues, such
as rheumatoid arthritis.
• Allergic reactions.
These conditions often require the
use of other medicines in addition to
corticosteroids.

2. BEFORE YOU USE DEXAMETHASONE
SOLUTION FOR INJECTION
Do not use Dexamethasone Solution
for Injection if you have:
• Shown signs of severe allergy
(hypersensitivity) to dexamethasone
or any of the other ingredients of
Dexamethasone Solution for Injection
(see section 6 below) in the past.

Dexamethasone 3.3 mg/ml
Solution for Injection
The following information is intended for
medical or healthcare professionals only
Dexamethasone Solution for Injection is for
intravenous, intramuscular, intraarticular and
intralesional use.
The intravenous and intramuscular route of
administration of dexamethasone should only
be used where acute illness or life-threatening
situations exist. Oral therapy should be
substituted as soon as possible.

Tell your doctor or pharmacist if either
of the above applies to you before this
medicine is used.

Check with your doctor first:
• If you have ever had severe
depression or manic depression
(bipolar disorder). This includes having
had depression before while taking
steroid medicines like dexamethasone.
• If any of your close family has had
these illnesses.
If either of these applies to you, talk to a
doctor before taking dexamethasone.

Take special care with Dexamethasone
Solution for Injection and check with
your doctor first if you have:















Liver, kidney or heart problems
High blood pressure
Epilepsy
A history of migraines
Osteoporosis (thinning of the bones)
Had tuberculosis in the past
An under-active thyroid
Had amoebiasis in the past (infection
specific to tropical countries which
causes diarrhoea)
A herpes infection of the eye
Diabetes (or a family history of
diabetes)
An eye disease called glaucoma (or a
family history of glaucoma)
Stomach ulcers
Experienced muscle weakness caused
by previous steroid treatment.

Special care will be taken if
Dexamethasone Solution for Injection
is to be given to babies or children.
Dexamethasone should not be used
routinely in preterm neonates with
respiratory problems.

Taking/using other medicines
You should not be vaccinated with a live
vaccine while having steroid therapy. Tell
your doctor or pharmacist if you are
planning to have a vaccination.
Special care is needed if you are
taking/using other medicines as some
could interact with dexamethasone, for
example:
• Barbiturates (medicines for treating
sleep disorders and epilepsy)
• Ephedrine (a medicine that is used as
a nasal decongestant or for respiratory
conditions)
• Rifampicin and rifabutin (antibiotics that
are used for treating tuberculosis)
• Primidone, phenytoin, carbamazepine
(medicines to treat epilepsy)
• Aminoglutethimide (an anti-cancer
medicine)
• Anticoagulants (medicines used to thin
the blood)
• Insulin and other medicines used to
treat diabetes
• Aspirin and other anti-inflammatory
drugs (medicines for treating pain and
inflammation)
• Acetozolamide (a medicine for
treatment of the eye disorder glaucoma)
• Diuretics (water tablets)
• Carbenoxolone (a medicine for treating
stomach ulcers)
• Digoxin and other medicines which
regulate heart beat
• Antihypertensives (medicines used to
treat high blood pressure)
Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines, including medicines
obtained without a prescription.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant,
trying to become pregnant or
breast-feeding.
If you receive dexamethasone often
or over a long period of time during
pregnancy there may be a risk that the
baby’s growth slows down. The baby
may need careful observation for a
short time after being born.
If you are being given dexamethasone
for a long time during breast-feeding then
the baby’s growth may slow down and it
may have other side effects (see Section
4). Your doctor will discuss this with you
and decide whether you should receive
dexamethasone.
Ask your doctor or pharmacist for advice
before taking any medicine.

Driving and using machines
Do not drive or use machines if you
experience any side effect which may
lessen your ability to do so.

Important information about one of
the ingredients of Dexamethasone
Solution for Injection
This medicine contains 0.26 mmol sodium
(6 mg) per 20 mg dose i.e. essentially
“sodium-free”.

3. HOW TO USE DEXAMETHASONE
SOLUTION FOR INJECTION
This medicine may be given intravenously
(injection into a vein), intramuscularly

Each 1 ml of the solution for injection
contains 3.3 mg dexamethasone (as
sodium phosphate) which is equivalent to
4 mg dexamethasone phosphate or 4.3 mg
dexamethasone sodium phosphate.

Incompatibilities
Dexamethasone (as sodium phosphate) is
physically incompatible with daunorubicin,
doxorubicin and vancomycin and should not
be admixed with solutions containing these
Q75037
W 07-0000
Code 000

Component Specification

Requester

Item number:

Q75037

Request number:

AS2773

Country:

United Kingdom

OI template:
Amalia version:
Mulgrave version:

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Ampoule

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(injection into a muscle) or directly into a
joint or soft tissue. This medicine may also
be diluted with glucose or sodium chloride
solution and given as a slow injection via a
drip into a vein (infusion).

Dose
The dose of medicine given to you will
depend on your age and medical condition
and will be carefully adjusted by your
doctor.
You are unlikely to need Dexamethasone
Solution for Injection for more than a week
or two, unless you receive it for treatment
of arthritic joints when treatment may carry
on for longer. If dexamethasone treatment
needs to continue you may be given
tablets, rather than an injection.
This medicine suppresses your
body’s natural ability to make its own
corticosteroids. As a result, during
prolonged treatment, any new illness,
trauma or surgical procedure will require
a temporary increase in dosage; if
corticosteroids have been recently
stopped they may need to be started
again.

Mental problems while taking
dexamethasone
Mental health problems can happen while
taking steroids like dexamethasone (see
also section 4 Possible Side Effects)
• These illnesses can be serious.
• Usually they start within a few days or
weeks of starting the medicine.
• They are more likely to happen at high
doses.
• Most of these problems go away if
the dose is lowered or the medicine
is stopped. However, if problems do
happen they might need treatment.
Talk to a doctor if you (or someone taking
this medicine), show any signs of mental
problems. This is particularly important if
you are depressed, or might be thinking
about suicide. In a few cases, mental
problems have happened when doses are
being lowered or stopped.

If you are given too much or too little
Dexamethasone Solution for Injection
This medicine will be given to you by a
doctor or nurse. It is unlikely that you will
be given too much or too little, however,
tell your doctor or nurse if you have any
concerns.

When you stop using Dexamethasone
Solution for Injection
Do not stop taking this medicine suddenly
as this might be dangerous. Your doctor
will tell you how the treatment will be
gradually reduced. When treatment is
stopped, a “withdrawal syndrome” can
happen, which includes fever, muscle
pain, joint pain, inflammation of the lining
of the nose, eye discomfort (conjunctivitis),
painful itchy skin lumps and loss of weight.
In children raised pressure in the skull may
occur: if they complain of a headache,
have a fit or are sick then tell a doctor
immediately.
In a few cases, mental problems (see
section 4 Possible Side Effects) have
happened when doses are being lowered
or stopped.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

If any of the following happen, tell
your doctor as soon as possible:
























Fits
Epilepsy or schizophrenia made worse
Breathlessness
Severe thirst or passing urine more
than usual (may indicate raised blood
sugar levels)
Water retention (swelling) and high
blood pressure
Muscle weakness
You feel that you or your surroundings
are spinning
Eye disorders including cataracts and
glaucoma, infections of the eye may
become worse
Swelling and weight gain of the face
and body, excess body hair
Osteoporosis (thinning of the bones) –
the doctor may ask you to have a bone
scan to check for this
Slow growth in children or teenagers
(the doctor will check for this)
You feel you are picking up minor
infections too easily
Irregular periods or absence of periods
in women
Indigestion, stomach ulcers and pain in
stomach and back
Skin disorders such as slow healing
of wounds, increased bruising, broken
veins or stretch marks on the skin,
increased sweating, rashes, or changes
in skin pigmentation, raised itchy
coloured lumps on the skin, itchy red
rash with flaky white patches (thrush),
acne
Headache
Pain, redness or swelling at the
injection site (if the injection is into a
joint)
Increased appetite

Many of the above side effects only occur
after high dose treatment or if treatment
continues for a long period of time.
If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.

5. HOW TO STORE DEXAMETHASONE
SOLUTION FOR INJECTION
Keep out of the reach and sight of children

Expiry
This medicine must not be used after the
expiry date which is stated on the ampoule
and carton after ‘EXP’. Where only a
month and year is stated, the expiry date
refers to the last day of that month.

Storage
The ampoules should be kept in the outer
carton, in order to protect from light, and
stored at or below 25°C. Do not freeze.
Unused portions of opened ampoules
must not be stored for later use.
Prepared infusions should be used
immediately, however, if this is not
possible they can be stored for up to
24 hours in a refrigerator.

Visible signs of deterioration
Only clear, particle free solutions should
be used.

Disposal
4. POSSIBLE SIDE EFFECTS
Like all medicines, Dexamethasone
Solution for Injection can cause side
effects, although not everybody gets them.

If any the following happen, tell your
doctor straight away:
• Severe allergic reaction – you may
experience a sudden itchy rash (hives),
swelling of the hands, feet, ankles, face,
lips, mouth or throat (which may cause
difficulty in swallowing or breathing),
and you may feel you are going to faint.
• Severe infection and/or fever which
makes you feel very ill.
These are very serious side effects. You
may need urgent medical attention. All of
these very serious side effects are rare.

Serious effects: tell a doctor straight
away
Steroids including dexamethasone can
cause serious mental health problems.
These are common in both adults and
children. They can affect about 5 in
every 100 people taking medicines like
dexamethasone.
• Feeling depressed, including thinking
about suicide.
• Feeling high (mania) or moods that go
up and down.
• Feeling anxious, having problems
sleeping, difficulty in thinking or being
confused and losing your memory.
• Feeling, seeing or hearing things
which do not exist. Having strange and
frightening thoughts, changing how you
act or having feelings of being alone.
If you notice any of these problems talk to
a doctor straight away.

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.

6. FURTHER INFORMATION
What Dexamethasone Solution for
Injection contains
The active substance is dexamethasone.
Each millilitre (ml) of solution contains
3.3 milligrams (mg) of dexamethasone (as
sodium phosphate) which is equivalent to
4 mg dexamethasone phosphate or 4.3
mg dexamethasone sodium phosphate.
The other ingredients are sodium citrate,
creatinine, sodium hydroxide, hydrochloric
acid and Water for Injections.

What Dexamethasone Solution for
Injection looks like and contents of the
pack
This medicine is presented in glass
containers called ampoules. Each millilitre
(ml) of solution contains 3.3 milligrams
(mg) of dexamethasone (as sodium
phosphate) which is equivalent to 4 mg
dexamethasone phosphate or 4.3 mg
dexamethasone sodium phosphate. It is
available in packs containing 5 ampoules.

Marketing Authorisation Holder and
Manufacturer
The marketing authorisation holder and
company responsible for batch release
in the European Union is Hospira UK
Limited, Queensway, Royal Leamington
Spa, Warwickshire, CV31 3RW.
This leaflet was last revised in
January 2013.

Carers of patients taking/using
dexamethasone should talk to the
doctor straight away if the patient shows
any signs of mental problems. This is
particularly important if the patient appears
to be depressed, or mentions thoughts of
suicide.

drugs. It is also incompatible with doxapram
hydrochloride and glycopyrrolate in a syringe.

For single use only. Discard any unused
contents.

Instructions for use and handling

In-use storage precautions

When dexamethasone (as sodium phosphate)
is given by intravenous infusion only Sodium
Chloride Injection BP or Glucose Injection
BP should be used as diluents. The exact
concentration of dexamethasone (as sodium
phosphate) per infusion container should be
determined by the desired dose, patient fluid
intake and drip rate required.

From a microbiological point of view, the
product should be used immediately after
dilution. If not used immediately, in-use
storage times and conditions prior to use are
the responsibility of the user and would not
normally be longer than 24 hours at 2-8°C,
unless dilution has taken place in controlled
and validated aseptic conditions.
Q75037
W 07-0000
Code 000

The product should only be used when the
solution is clear and particle free.

Component Specification

Requester

Item number:

Q75037

Request number:

AS2773

Country:

United Kingdom

OI template:
Amalia version:
Mulgrave version:

WBI002
8
n/a

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

500 x 144 mm
Ampoule

Previous Item Number: Q72176 / W07-6228
Latest QP Release Date:

n/a
n/a
Yes
No

Signed:
Date:

Pharma code:
Pharma code length:
Supplier Code:

Decimal (Binary)
## mm
#

Colours
Black:

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.

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