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Dexamethasone 3.3 mg/ml solution for injection of infusion
Dexamethasone 6.6 mg/2ml solution for injection of infusion
(Called ‘Dexamethasone’ in this leaflet)
Important information about this medicine
• 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: Possible side
effects). 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
medicine, 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, in the UK, you will be given 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.
• 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 your pharmacist
• 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 is and what it is used for
2. Before you have Dexamethasone
3. How you have Dexamethasone
4. Possible side effects
5. How to store Dexamethasone
6. Further information

1. What Dexamethasone is and what it is used for
The name of your medicine is Dexamethasone 3.3 mg/ml Solution for Injection or Infusion
(called ‘Dexamethasone’ in this leaflet). It belongs to a group of medicines called
corticosteroids. Corticosteroids are hormones that are found naturally in your body that help
to keep you healthy and well. Boosting your body with extra corticosteroid, such as
Dexamethasone, is an effective way to treat various illnesses involving inflammation in the
body. Dexamethasone lowers inflammation, which could otherwise go on making your
condition worse. You must take this medicine regularly to get maximum benefit from it.
Dexamethasone can be used to:
• Reduce inflammation
• Treat a number of different diseases of the immune system
2. Before you have Dexamethasone
Do not take Dexamethasone and tell your doctor if:
• You are allergic (hypersensitive) to dexamethasone or any other ingredients in this medicine
(listed in Section 6). The signs of an allergic reaction include a rash, itching or shortness of
• You have an infection that affects the whole body
• You have an infection of a joint
• You have unstable joints. This is a condition where joints, such as the knee, can suddenly
give way.
→ Do not have this medicine if any of the above apply to you, talk to your doctor or
pharmacist before having Dexamethasone.
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
• If any of your close family has had these illnesses
→ If either of these applies to you, talk to a doctor before taking this medicine.
Mental problems while having Dexamethasone
Mental health problems can happen while having 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
In a few cases, mental problems have happened when doses are being lowered or stopped.
Take special care with Dexamethasone
→ Before you have Dexamethasone, tell your doctor if:
• You have a cancer of the blood because you may be at risk of a very rare, potentially lifethreatening condition resulting from a sudden breakdown of tumour cells.
• You have kidney or liver problems
• You have high blood pressure or heart disease
• You have diabetes or there is a family history of diabetes
• You have thinning of the bones (osteoporosis), particularly if you are a female who has
been through the menopause
• You have had muscle weakness with this or other steroids in the past
• You have raised eye pressure (glaucoma) or there is a family history of glaucoma
• You have a stomach (peptic) ulcer
• You have mental problems or you have had a mental illness which was made worse by this
type of medicine such as ‘steroid psychosis’
• You have epilepsy
• You have migraines
• You have an infection with parasites
• You have tuberculosis (TB)
• You have stunted growth
• You have ‘Cushing’s syndrome’
• You have had a head injury
• You have had a stroke
→ If you are not sure if any of the above apply to you, talk to your doctor or pharmacist
before having Dexamethasone.
More important information about having this kind of medicine
If you develop an infection while you are having this medicine, you should talk to your
doctor. Please tell any doctor, dentist or person who may be giving you treatment that you are
currently taking steroids or have taken them in the past.
If you are living in the UK, you should always carry a blue ‘steroid card’ which gives clear
guidance on the special care to be taken when you are taking this medicine. Show this to any
doctor, dentist or person who may be giving you treatment. Even after your treatment has
finished you must tell anyone who is giving you treatment that you have taken steroids in the

Do not use Dexamethasone for the treatment of Acute Respiratory Distress Syndrome
(ARDS; a serious lung disease) if you have been diagnosed with this condition for over 2
Dexamethasone and viral infections
While you are having this kind of medicine, you should not come into contact with anyone
who has chicken pox, shingles or measles if you have not had these illnesses. This is because
you may need specialist treatment if you get these diseases. If you think you may have had
exposure to any of these diseases, you should talk to your doctor straight away. You should
also tell your doctor if you have ever had infectious diseases such as measles or chicken pox
and if you have had any vaccinations for these conditions in the past.
→ Please tell a doctor or anyone giving you treatment, such as at a hospital, if:
• You have an accident
• You are ill
• You need any surgery. This includes any surgery you may have at your dentist’s
• You need to have a vaccination
If any of the above apply to you, you should tell your doctor or the person treating you even
if you have stopped having this medicine.
If a child is having this medicine, it is important that the doctor monitors their growth and
development regularly. Dexamethasone should not be routinely given to premature babies
with respiratory problems.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines. This includes medicines you buy without a prescription, including herbal
medicines. Other medicines can affect the way Dexamethasone works or Dexamethasone can
affect the way they work. In particular:
• Medicines to treat heart and blood problems, such as warfarin, high blood pressure
medicine, and water tablets (diuretics)
• Antibiotics such as rifampicin and rifabutin
• Medicines to treat epilepsy, such as phenytoin, carbamazepine, phenobarbitone and
• Medicines that control pain or lower inflammation, such as aspirin or phenylbutazone
• Medicines used to treat diabetes
• Medicines used to lower potassium levels
• Medicines used to treat myasthenia
• Anti-cancer treatments, such as aminoglutethimide
• Ephedrine used to relieve symptoms of a blocked nose
• Acetazolamide used for glaucoma
• Carbenoxolone sometimes used for ulcers

Pregnancy and breast-feeding
Talk to your doctor before having this medicine if you are pregnant, planning to become
pregnant or are breast-feeding.
Driving and using machines
Dexamethasone is not likely to affect you being able to drive or use any tools or machines.
Important information about some of the ingredients
This medicine contains less than 1 mmol sodium per ampoule (less than 23 mg per ampoule),
i.e. it is essentially sodium free.
3. How you have Dexamethasone
Dexamethasone is normally given by a doctor. It will be given as an injection into a muscle
or under your skin. It can also be given as an injection into a vein. The dose depends on your
illness and how bad it is. The dose in adults is normally from 0.5 to 24mg daily, and in
children 0.2 to 0.4mg/kg daily. Your doctor will decide the dose.
If you have more Dexamethasone than you should
→ If you think you have been given too much Dexamethasone, tell your doctor straight
away. The following effects may happen:
• Swelling of the throat
• Skin reaction
• Difficulty breathing
If you stop having Dexamethasone
It can be dangerous to stop having this medicine suddenly. If you need to stop this treatment,
follow your doctor’s advice. He or she may tell you to lower the amount of medicine you are
having gradually until you stop having it altogether. If you stop having this medicine too
quickly, your condition may get worse.
You may also feel a ‘withdrawal symptom’. These may include headache, problems with
your vision (including pain or swelling in the eye), feeling or being sick, fever, pain in your
muscles and joints, swelling in the inside of your nose, weight loss, itchy skin and
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Dexamethasone can cause side effects although not everybody gets them.
Dexamethasone can also cause side effects when you stop using it.
• See Section 3, 'If you stop having Dexamethasone'

Serious side 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. These include:
• 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 that 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.
If you have an allergic reaction to Dexamethasone see a doctor straight away
An allergic reaction may include:
• Any kind of skin rash or itching of the skin
• Difficulty in breathing or collapse.
If you get any of the following side effects see your doctor as soon as possible:
• Stomach and gut problems: stomach ulcers which may perforate or bleed, indigestion,
having more of an appetite than usual, diarrhoea, feeling or being sick
• Inflamed pancreas: this may cause severe pain in the back or tummy
• Problems with salts in your blood such as too much sodium or low potassium or calcium.
You may have water retention
• Heart and blood problems: high blood pressure, blood clots
• Bone problems: thinning of the bones (osteoporosis) with an increased risk of fractures,
bone disease, damaged tendons, damage to the joint where the injection was given
• Recurring infections that get worse each time such as chicken pox. Also, thrush
• Skin problems: wounds that heal more slowly, bruising, acne, sweating more than usual.
Burning, redness and swelling where the injection was given. This does not last long
• Eye problems: increased pressure in the eye including glaucoma, eye disorders such as
cataracts, eye infections
• Hormone problems: irregular or missing periods, stunted growth in children and teenagers,
swelling of the face (called a ‘Cushingoid’ or ‘moon’ face), it may affect your diabetes and

you may notice you start needing higher doses of the medicine you take for diabetes, your
body may not be able to respond normally to severe stress such as accidents, surgery or
illness, growth of extra body hair (particularly in women), increased appetite or weight gain
• Nervous system problems: fits or epilepsy may become worse, severe unusual headache
with visual problems, being unable to sleep, feeling depressed, extreme mood swings,
schizophrenia has become worse, headache or problems with your vision (including eye pain
or swelling)
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, Website:
5. How to store Dexamethasone
• Keep this medicine out of sight and reach of children
• Do not store above 25°C
• Do not refrigerate or freeze
• Store in the original package in order to protect from light.
• Do not use after the expiry date which is stated on the pack and on the ampoule after
“Exp.”. The expiry date refers to the last day of that month.
• Do not use this medicine if you notice damages to the glass ampoule.
• Do not throw away any medicine via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help to protect the
6. Further information
What Dexamethasone contains
• The active ingredient is dexamethasone sodium phosphate. Each ml contains 3.3 mg
dexamethasone as the sodium phosphate . Each 2 ml contains 6.6 mg dexamethasone as the
sodium phosphate.
• The other ingredients are creatinine, ascorbic acid (E300), water for injection, sodium
hydroxide (E524), sodium citrate (E331).
What Dexamethasone looks like and contents of the pack
Dexamethasone is a clear, colourless to slightly yellowish liquid. It comes in 1 ml ampoules
in packs of 5 or 10, and in 2ml ampoules in packs of 5.
The Marketing authorisation holder is:
Edmond Pharma S.R.L, Via dei Giovi 131, 20037 Paderno Dugnano (MI), Italy
The Manufacturer is:

Biologici Italia Laboratories S.R.L, Via F. Serpero 2, 20060 Masate (MI), Italy
This leaflet was last revised in 12/2014

The following information is intended for medical or healthcare professionals only
Dexamethasone Solution for Injection may be administered intravenously, subcutaneously,
intramuscularly, by local injection or as a rectal drip.
Dexamethasone is a clear, colourless to slightly yellowish liquid. The change of appearance
of the solution from clear to yellowish is not a sign of deterioration of the product.
Dexamethasone (as sodium phosphate) is physically incompatible with daunorubicin,
doxorubicin and vancomycin and should not be admixed with solutions containing these
drugs. It is also incompatible with doxapram hydrochloride and glycopyrrolate in a syringe.
Instructions for use and handling
Dexamethasone can be diluted with the following infusion fluids:
sodium chloride 0.9%
anhydrous glucose 5%
invert sugar 10%
sorbitol 5%
ringer's solution
dextran 40 10%w/v
Using these infusion fluids, Dexamethasone Injection can also be injected into the infusion
line without causing precipitation of the ingredients. Direct injection into the infusion line is
also possible with mannitol 10%.
For single use only.
Discard any unused contents. 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.
In-use storage precautions
Chemical and physical in-use stability has been demonstrated for 24 h at room temperature
and in daylight conditions when diluted with the above infusion fluids.
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 normally not be longer than 24 hours at 2-8°C, unless dilution has
taken place in controlled and validated aseptic conditions.

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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.