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DEXAMETHASONE 3.3MG/ML SOLUTION FOR INJECTION

Active substance: DEXAMETHASONE SODIUM PHOSPHATE

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Package leaflet: Information for the user

Dexamethasone 3.3 mg/mL
Solution for Injection
Dexamethasone sodium phosphate

Dexamethasone 3.3 mg/mL Solution for Injection will be referred
to as Dexamethasone Solution for Injection throughout the package

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using
Dexamethasone Solution for Injection
• If you have ever had severe depression or manic depression
(bipolar disorder). This includes having had depression before
while taking steroid medicines like dexamethasone.

leaflet.

• If any of your close family has had these illnesses.

Read all of this leaflet carefully before you start using this

Mental problems while taking dexamethasone
Mental health problems can happen while taking steroids like
dexamethasone (see also section 4)
• These illnesses can be serious.

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, pharmacist or
nurse.

• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.

• 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.

What is in this leaflet
1. What Dexamethasone Solution for Injection is and what it is
used for
2. What you need to know 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. Contents of the pack and other information
1. What Dexamethasone Solution for Injection is and what it
is used for
Dexamethasone Solution for injection contains the active substance
Dexamethasone Sodium Phosphate.
Dexamethasone Solution for Injection belongs to a group of
medicines called Glucocorticoid (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.
It is used in acute conditions in which oral steroid treatment is not
possible, such as:
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. What you need to know before you use Dexamethasone
Solution for Injection
Do not use Dexamethasone Solution for Injection:

• if you are allergic to dexamethasone or any of the other
ingredients of this medicine (listed in section 6).

• if you have 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).
Tell your doctor or pharmacist if either of the above applies to you

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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.

• Shock (e.g. after an accident, after surgery or due to blood

before this medicine is used.

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.
Take special care with Dexamethasone Solution for Injection
and check with your doctor first if you have:
• Liver, kidney or heart problems

Children and adolescents
Special care will be taken if Dexamethasone Solution for Injection
is to be given to babies or children.
Other medicines and Dexamethasone Solution for Injection
Tell your doctor or pharmacist if you are using, have recently used
or might use any 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 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)

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Aminoglutethimide (an anti-cancer medicine)

The following information is

Anticoagulants (medicines used to thin the blood)

intended for healthcare professionals

Insulin and other medicines used to used to treat diabetes

only:

Aspirin and other anti-inflammatory drugs (medicines for
treating pain and inflammation)

Dexamethasone Solution for Injection

• Acetozolamide (a medicine for treatment of the eye disorder

is for intravenous, intramuscular,
intraarticular and intralesional use.

glaucoma)






The intravenous and intramuscular

Diuretics (water tablets)

route of administration of

Carbenoxolone (a medicine for treating stomach ulcers)

dexamethasone should only be used

Digoxin and other medicines which regulate heart beat

where acute illness or life-threatening

Antihypertensives (medicines used to treat high blood pressure)

situations exist. Oral therapy should be

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
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 breastfeeding 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.
Driving and using machines
Do not drive or use machines if you experience any side effect
which may lessen your ability to do so.
Dexamethasone Solution for Injection contains sodium
This medicine contains 0.26 mmol sodium (6 mg) per 20 mg dose
i.e. essentially “sodium-free”.

substituted as soon as possible.

3. How to use Dexamethasone Solution for Injection
This medicine may be given intravenously (injection into a vein),
intramuscularly (injection into a muscle) or directly into a joint
or soft tissue. This medicine may also be diluted with dextrose 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.
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.
If 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.

phosphate) is given by intravenous

Each ml of Solution for
injection contains 4 mg of
Dexamethasone Phosphate (as
4.4 mg of dexamethasone sodium
phosphate) equivalent to 3.3 mg of
Dexamethasone base.
Incompatibilities
Dexamethasone sodium phosphate
is physically incompatible with
daunorubicin, doxorubicin and
vancomycin and should not be
admixed with solutions containing
these drugs. Also incompatible with
doxapram HCl and glycopyrrolate in
syringe.
Instructions for use and handling
When dexamethasone (as sodium
infusion only 0.9 % w/v Saline
Injection or 5 % w/v Dextrose
Injection 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.
The product should only be used when
the solution is clear and particle free.
For single use only. Discard any
unused contents.
In-use storage precautions
The in use storage condition and shelf
life after dilution of Dexamethasone
3.3 mg/mL solution for injection with
0.9% w/v Saline injection and 5% w/v
Dextrose injection at 25ºC is stable for
24 hours.

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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) have happened when
doses are being lowered or stopped.
If you have any further questions on the use of this medicine, ask
your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine 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.
Carers of patients 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.
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)






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You feel you are picking up minor infections too easily
Irregular periods or absence of periods in woman
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

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• 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist 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
at: www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.
5.
How to store Dexamethasone Solution for Injection
Keep this medicine out of the sight and reach of children
Do not use this medicine after the expiry date which is stated on the
vial label and carton after ’EXP’. The expiry date refers to the last
day of that month.
Store below 25°C. Do not freeze. Keep the vials in the outer carton.
Unused portions of opened vials must not be stored for later use.
The in use storage condition and shelf life after dilution of
Dexamethasone 3.3 mg/mL solution for injection with 0.9% w/v
Saline injection and 5% w/v Dextrose injection at 25ºC is stable for
24 hours.
Do not use this medicine unless it is a clear, particle free solution.
Do not throw away medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer
use. These measures will help protect the environment.
6. Contents of the pack and other information
What Dexamethasone Solution for Injection contains
- The active substance is dexamethasone sodium phosphate. Each
ml of Solution for injection contains 4 mg of Dexamethasone
Phosphate (as 4.4 mg of dexamethasone sodium phosphate)
equivalent to 3.3 mg of Dexamethasone base.

- The other ingredients are sodium citrate, creatinine and Water
for Injections.
What Dexamethasone Solution for Injection looks like and
contents of the pack
It is a clear colorless solution free from visible particulate matter,
filled into a tubular amber colour glass vial with rubber stopper and
aluminium seal.
It is available in packs containing 5 vials. Each vial contains 2 ml of
solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder
Strides Arcolab International Ltd.
Unit 4, Metro Centre, Tolpits Lane,
Watford, Hertfordshire,
WD 18 9SS United Kingdom
Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000
Malta
This leaflet was last revised in 11/2013.

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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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